J&J vaccine use to resume next week, CDC committee recommends
Use of the Janssen (also known as Johnson & Johnson) COVID-19 vaccine should resume next week after a “pause” begun on April 13. At the end of a six-hour meeting today, the Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention (CDC) voted, 10-4-1, to recommend resumption of the use of the Janssen vaccine with no specific restriction by age or sex. By Tuesday, the CDC director is expected to decide whether to accept the recommendation, ordinarily a formality, and if so it will be published by the agency as formal guidance for public health systems throughout the nation.
The pause was in response to six cases of an unusual blood clotting condition accompanied by a drop in blood platelet count, all in women ages 18 to 49, an incidence below one-in-a-million out of nearly seven million doses. (See “Don’t panic! J&J vaccine pause and rare blood clots: One-in-a-million risk”, by Michael Bilow, Apr 14, 2021.) During the pause the total of identified cases increased to 15, of which three were fatal.
Asked for comment by Motif, the RI Department of Health (RIDOH) responded this evening, “RIDOH is aware that the Advisory Committee on Immunization Practices (ACIP) has made a recommendation about continued use of the Johnson & Johnson (Janssen) vaccine. We will review all of the information and data and will make a decision next week. RIDOH is storing roughly 5,000 doses of Johnson & Johnson vaccine, as we were instructed to do. We would not expect to get another shipment of Johnson & Johnson vaccine for another two to three weeks. We do not expect this to have any impact on Rhode Island’s COVID-19 vaccination efforts because the state’s weekly allocation of Pfizer and Moderna vaccines has been increasing.”
The ACIP quickly dispensed with other options on the table, including stopping use of the Janssen vaccine entirely. The ACIP concluded that restricting the vaccine to men would be unwise, both in terms of practical constraints on how to do that at points of dispensing (PODs) and because the tiny number of cases made it impossible to quantify the risk to men as opposed to women.
Eventually the ACIP reached a consensus that individuals should be given the choice whether to accept the Janssen vaccine, subject to informed consent about its known risk, in consultation with their healthcare provider, and therefore decided against restricting use to age 50 and older. In the end, members of the committee differed only as to whether their recommendation should explicitly mention that women younger than 50 may want to consider choosing an alternative vaccine, but there were concerns this would be misinterpreted and no such proviso was appended.
The ACIP made clear that there was an understanding patients who receive the Janssen vaccine in the future would be given explicit warning using language approved by the US Food and Drug Administration (FDA) listing the symptoms of the rare blood clot reaction, detailing what to watch for and what do.
Because the Janssen vaccine is the only one authorized by the FDA for use in the US that needs a single dose and can be stored in ordinary refrigerators rather than deep freezers, it is valuable for providers dispensing small numbers of doses, especially in rural areas, and for reaching populations for whom it would be difficult to arrange a second dose, such as the home-bound, the homeless, migrants, transients and the incarcerated. As a result, the CDC internally concluded that the loss of use of the Janssen vaccine could result in more deaths due to the virus than cases of the rare blood clotting reaction, as well as tens of times more intensive care unit (ICU) unit admissions and hundreds of times more hospitalizations.
The ACIP meeting included a half-hour of public comments, limited to three minutes each, chosen by lottery from applicants in advance. A significant number of the commenters appeared to be anti-vaccine conspiracy theorists, and the members of the ACPI made no response beyond the moderator thanking them for their comments.
In “pausing” use of the Janssen vaccine, one of only three COVID-19 vaccines currently authorized for use in the US, RI is following national guidance from the federal Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), the RI Department of Health (DoH) said in an early morning statement on Tuesday, April 13. The Janssen vaccine is also known as the Johnson and Johnson vaccine after the parent company.
The national pause results from cases of an unusual combination of blood clots and decreased platelet counts seen in six women, age 18 to 48, with onset 6 to 13 days after vaccine injection, three senior federal government doctors explained in a telephone conference call with press later Tuesday morning. One of the women died, apparently because she was given the standard treatment for blood clots, an anticoagulant or blood thinner, which in this unusual situation is likely to make the patient worse, they said, and one major reason for the pause is to get information out to the healthcare community how to treat this unusual condition if encountered; that is, blood thinners such as heparin or even aspirin, should not be given.
In a Tuesday afternoon press briefing, Nicole Alexander-Scott, director of RI DoH, said that 31,500 doses of Janssen had been administered in the state prior to the pause, which RI COVID-19 czar Tom McCarthy said represented about 5% of the total. Alexander-Scott emphasized that the adverse reaction is extremely rare and that it had been detected quickly. “It’s important to be able to relay to Rhode Islanders that the robust monitoring system that we have talked about from the beginning is demonstrating its full effect here in our ability to do this with access to data among millions of individuals who have been vaccinated. Because, again, this is a result of six cases out of 6.85 million doses nationally that have been administered.”
Alexander-Scott distinguished the mild flu-like symptoms that often occur in the first few days after vaccination from the more severe symptoms of the rare blood clotting problem that can occur at least six days and up to three weeks after vaccination, with a median onset of nine days. “It’s a combination of the clotting, the low platelets, and the symptoms that patients would watch for: of severe headache, abdominal pain, leg pain or shortness of breath,” she said. “It’s also important to note that the symptoms that I’ve mentioned as a part of this presentation are very different from the mild flu-like symptoms that people experience within a few days after receiving vaccine… Usually the the mild flu-like symptoms that can occur are within that very short window, those few days right after vaccination.
“We would not want to have everyone who’s had Johnson and Johnson just rushing to their provider to be evaluated because of how rare this seems to be. However, we do want to ensure that both patients and providers are informed and equipped with the information of what to monitor for,” said Alexander-Scott, cautioning against public alarm especially among those recently receiving the Janssen vaccine.
Anyone already given the Janssen vaccine, Alexander-Scott said, should not panic. “If you were vaccinated with the Johnson and Johnson vaccine more than a month ago, that’s before March 13, your risk is extremely low for having any sort of complications or challenges… The time frame of six days to 13 days after vaccination makes it such that if you are significantly past that, more than a month ago, of getting vaccinated, your risk is extremely low. If you have been vaccinated with Johnson and Johnson vaccine in the last three weeks, your risk is also very low, given that overall data point, one for every million vaccinated.”
Both Alexander-Scott and McCarthy agreed that the pause would have little practical effect in RI. In response to a question from Motif whether even the temporary loss of the only authorized single-dose vaccine would make it harder to vaccinate people for whom getting them to the second dose might be challenging, especially those in lower socio-economic strata, in hard-hit communities, prisoners, home-bound individuals and the homeless, “We anticipate and certainly look forward to this pause being brief so that it has minimal impact on how valuable Johnson and Johnson is for being able to provide some of the protections in, across the board, the individuals that have had very allergic reactions to vaccines in the past and just want one [dose] or those who are home-bound or hospitalized, or otherwise. We are anticipating that, in the long term, we’ll be able to continue with the appropriate safety mechanisms in place, but, if that were to not be the case, we would be prepared to adjust as we needed to and as we were planning to prior to Johnson and Johnson being available, working with our partners and determining ways that would allow us to ensure that would help ensure that people are able to return to get their second dose,” Alexander-Scott said. “Whether it’s Johnson and Johnson, Moderna or Pfizer, we will make it work.”
McCarthy said, “As we’ve shared over the last few weeks, the amount of Johnson and Johnson vaccine coming into Rhode Island has decreased significantly. Two weeks ago we received 16,000 doses, last week that number decreased to about 6,000, and this week we’re only receiving 2,000 doses of Johnson and Johnson. Now those 2,000 doses are in addition to 1,400 of the Johnson and Johnson vaccine that we’ve carried over from last week for a total of 3,400 doses that are currently in the state.” Most of the patients scheduled for the Janssen vaccine would be switched to one of the others at the same time and place, McCarthy said, with the exception of about 300 appointments at three local pharmacies or clinics without the cold storage and other facilities needed for the other vaccines, naming the Rhode Island Free Clinic, Green Line Pharmacy, and White Cross Pharmacy; those patients were being contacted individually. He said he had no concern about waste of vaccine as a result of the pause: “No, none at all. The team has done a fantastic job. Our waste is well below even one-tenth of a percent at this point.”
Janet Woodcock, acting FDA commissioner, said on the morning call that she expected the pause to be brief. “The time frame will depend obviously, on what we learn in the next few days. However, we expect it to be a matter of days for this pause.”
Although only six individual cases have been reported in the US out of nearly 7 million doses administered of the Janssen vaccine, fewer than one per million, US regulators are recommending the national pause because the unusual adverse reaction essentially never occurs naturally and appears to be similar to an adverse reaction to the AstraZeneca-Oxford (AZ-O) vaccine observed in 222 cases out of 34 million dose administrations as of April 4, a rate of about one per 100,000 recipients; the AZ-O vaccine is not yet authorized for use in the US, but as of March 22 European regulators had conducted reviews of 86 of the cases, of which 18 were fatal.
“The combination here, that’s the real thing that is so notable here,” said Peter Marks, the director of the FDA Center for Biologics Evaluation and Research, on the call. “Those two things [blood clots and low platelet counts] can occur. It’s their occurrence together that makes a pattern, and that pattern is very, very similar to what was seen in Europe with another vaccine. So I think we have to take the time to make sure we understand this complication, and we address it properly.” He emphasized that it was critical to avoid the use of blood thinners in treating the unusual adverse reaction: “Together, the CDC and the FDA are reviewing data involving six reports of a rare type of blood clot called cerebral venous sinus thrombosis, or CVST, in combination with low levels of platelets in the blood, called thrombocytopenia… Treatment of this specific type of blood clot is different from typical treatments for other types of blood clots, which usually involve an anticoagulant called heparin. With cerebral venous sinus thrombosis, heparin may be dangerous and alternative treatments need to be given, preferably under the guidance of physicians experienced in the treatment of blood clots.”
In fact, before the emergence of what is coming to be called “vaccine-induced immune thrombotic thrombocytopenia” or “VITT,” almost all previously observed cases of the same unusual combination of blood clotting and low platelet count was caused by heparin, a rare autoimmune syndrome known as “heparin-induced thrombocytopenia” or “HIT.”
Alexander-Scott was even more emphatic about the need for the pause to allow reaching out to patient-facing health care providers: “One of the elements that is different about the thrombosis that has been identified in these six cases is, clinically, we would usually treat thrombosis with the medication referred to as heparin. Being able to pause with just the six that we have to get the message out to all providers that this presentation is leading to not using heparin as a treatment option. Being able to get that message to providers has been a critical element of this and warranted the pause so that we could make that clear, because that is a definitive shift from how we would usually treat such a condition identified.”
None of the worldwide cases occurred in anyone age 50 or older, and many countries have resumed use of the AZ-O vaccine with an age floor between 50 and 60 depending upon the country, based upon an assessment of risks versus benefits, taking into consideration that older people are more vulnerable to hospitalization and death from COVID-19 as well as apparently less susceptible to the particular adverse reaction.
The CDC will convene its Advisory Committee on Immunization Practices (ACIP), an independent panel of outside experts, on Wednesday, April 14, said Anne Schuchat, principal deputy director of the CDC, on the morning call, and they could choose to recommend age or other restrictions for the Janssen vaccine as other countries have done for the AZ-O vaccine. The meeting will be broadcast live on the web – ustream.tv/channel/VWBXKBR8af4 – 1:30-4:30pm ET. [UPDATE: After running long by an hour, at 5:30pm the ACIP reached a consensus that there was insufficient data to vote on any recommendation, and so decided to allow the pause to continue until they could schedule another meeting to be held in 7 to 10 days, hoping that clearer quantitative evidence of risks would develop.]
“We are committed to an expeditious review of the available information and to an aggressive outreach to clinicians so that they know how to diagnose, treat and report. One of the things that the ACIP deliberation will do is review the data on the cases and the context of risks, benefits and possible subsets of the population that may be in a different category. So I think our intent is, in the days ahead, to provide an update regularly and that the pause provides us time for deliberation and assuring appropriate diagnosis and treatment,” she said.
The Janssen and AZ-O vaccines use similar delivery vectors to produce immune response in the body, although using different carrier adenoviruses. The Pfizer-BioNTech and Moderna vaccines, the only remaining COVID-19 vaccines currently authorized for use in the US, both use a messenger RNA (mRNA) delivery vector and not an adenovirus. Marks said that the adverse reaction was strongly likely to be induced by vaccine rather than coincidence, given its near-zero occurrence naturally. “It’s plainly obvious to us already that what we’re seeing with the Janssen vaccines looks very similar to what was being seen with the AstraZeneca vaccines. The AstraZeneca is a chimpanzee adenoviral-vectored vaccine. The Janssen is a human adenoviral-vectored vaccine. So I think we can’t make some broad statement yet. But obviously, they are from the same general class of viral vectors.”
There are hypotheses about the cause of the unusual adverse reaction but little is known with confidence. Marks said, “We don’t have a definitive cause, but the probable cause that we believe may be involved here that we can speculate is a similar mechanism that may be going on with the other adenoviral-vectored vaccine [AZ-O] is that this is an immune response that occurs very, very rarely after some people receive the vaccine, and that immune response leads to activation of the platelets and these extremely rare blood clots.” Woodcock agreed, “The person being vaccinated makes an immune response potentially that actually involves their own platelets or other parts of the coagulation system, and can cause this problem. And that’s the sort of leading theory or hypothesis about what’s going on here.”
“Just to remind clinicians and the public that 121 million people have been vaccinated with at least one dose of one of the three vaccines, and the vast majority of the doses were of the other two products, the Pfizer and Moderna products. With our intensive safety monitoring, we have not detected this type of syndrome with the low platelets among the other vaccines” authorized in the US, Schuchat said.
Despite all of the US cases so far occurring in women of child-bearing age, Marks said, the vaccine-induced adverse reaction is unlikely to be associated with that, because the type of blood clots sometimes seen as side effects from oral contraceptives are substantially different in both loci and absence of correlation with low platelet count. “It’s not clear that there’s any association with the oral contraceptive pill, birth control, in the individuals who had these blood clots,” Marks said, pointing out that generalizing from only six cases was impossible. “Additionally, I think it’s too early to make any speculation on how many cases will come out.”
Schuchat agreed with Marks, “We’re working right now from a small number, from the six events that have been reported here in the US, and so while we’re seeing them in women under 50, I think we are going to need to take some time and have our Advisory Committee on Immunization Practices take additional time to review. My understanding is that there weren’t predisposing conditions for these events in at least some of those individuals.” Asked to clarify, she said, “What I tried to say is there were not [predisposing conditions] in all of them. So not to say that there may have been in some, but I think my main point is that review of six is difficult to make generalizations from. We’re going to have our expert committee take a careful look, and we’re, of course, trying to assure that providers will report suspect episodes so that they can be further investigated, because the numbers are quite small, small enough that it’s hard to generalize, but large enough that we wanted to take the action with the pause.”
In response to a question from Motif whether the Janssen pause could increase vaccine hesitancy, even if fears were irrational and unfounded given the one-in-a-million risk, and what effect that might have in RI on his previously stated goal of reaching 70% of everybody eligible to be vaccinated by May 15 and 70% of the entire population by June 5, especially because in order to reach 70% of the entire population of the state we have to reach about 84-85% vaccine take-up in those eligible to be vaccinated, McCarthy said, “Absolutely, and that’s something that’s top of mind for me. It’s ambitious but it’s absolutely achievable, and why I am confident in it is that among those groups of Rhode Islanders that are currently eligible, we have seen uptake rates around that mid-80th percentile. So I think it’s absolutely doable and achievable, but the important thing is we all have a part to play, whether it be getting vaccinated, having conversations with your loved ones, your neighbors, folks in the community, to make sure that people are educated, they have the facts, I find that there’s a tremendous amount. It’s something we’ve seen throughout the pandemic, just based on how dynamic it is and how quickly things change. There is a lot of information out there, making sure we get the right information, the facts to build that confidence, is going to be important. Again, before even this consideration, we knew that it was going to have to take a deliberate intentional community effort to achieve those goals. I don’t think that has changed. I do think though this gives us an opportunity to focus some of our conversations even more about some of the specific safety and impacts of the different vaccines.”
Khmer During COVID-19: A conversation with Andy Chao of the Cambodian Society of Rhode Island
One week before COVID-19 caused Rhode Island to enter a state of emergency, the Cambodian Society of Rhode Island announced its plans for the Khmer New Year. Along the Pawtuxet River in Cranston, Buddhist monks from the state’s temples would bless attendees during a morning ceremony as local Cambodian families gathered to remember and honor their ancestors. At night, a Khmer dance troupe would perform as the featured act in an annual celebration intended to preserve a cultural heritage. With nearly 6,000 Rhode Islanders identifying as Cambodian in the 2010 U.S. Census and nearly 4,000 residents living in a household in which Khmer is spoken, their experiences differ across generations. The cancellation of the April event ushered in a year focused instead on community health and safety.
Between 1975 and 1979, an estimated 1.2 million to 2.8 million of Cambodia’s nearly 8 million people were murdered or starved to death under the Khmer Rouge. In the preceding period, from 1969 to 1973, the U.S. Air Force conducted covert bombing campaigns — Operation Menu and Operation Freedom Deal — which led to the deaths of an estimated tens of thousands of civilians. By 1980, half a million Cambodians were estimated to be living in limbo in refugee camps in Thailand. In a statement delivered to a U.S. Congressional subcommittee, a program director with the International Rescue Committee advocated for urgent assistance with their resettlement: “They are the survivors brought back from the edge of death… It would be too cruel and ironic a fate if they were to be abandoned and forgotten.”
In Rhode Island, thousands of Cambodian refugees found a new home, but little immediate refuge. Reports from the 1980s noted doctors declining appointments on account of language limitations and frequent victimization by landlords, employers and neighbors. Local community organizations started up to provide support and advocate for the new arrivals. Four decades later, Rhode Island today has the largest per capita Cambodian population in the country. At the start of another Khmer New Year, Motif’s Sean Carlson interviewed Andy Chao, president of the Cambodian Society of Rhode Island, about the organization’s evolution and community-based health outreach during the COVID-19 crisis.
Sean Carlson (Motif): From your beginnings as a resource for new refugees, how has the Cambodian Society of Rhode Island (CSRI) adapted to the needs of the community you serve?
Andy Chao: We were founded in 1982 to bring Cambodian refugees and their families together and to help them transition into life in America. As they began to stand on their own, we shifted more into cultural arts to help preserve and educate others about our Cambodian heritage. One thing that hasn’t changed over the years is our advocacy for members of the Khmer community. This past year, during the COVID-19 pandemic, we shifted our energy and efforts toward becoming a health resource as well. We now plan to further expand our mission to include more social work geared toward Cambodians locally.
SC: For those who came as refugees to Rhode Island, what effects have you seen from their traumas?
AC: The families who fled and came to the United States often missed out on their education and had undiagnosed PTSD after surviving genocide and war. In many cases, they were never taught how to effectively communicate with one another, and this only led to fractures and disagreements continuing for generations within our community. Families often don’t know how to handle conflict or find resolution, or how to use their communication skills to deepen how they understand one another. We see this worsened by the language barrier that exists today between Khmer elders and youth. We hope to be able to provide social workers who are bilingual in Khmer and English and can assist with therapeutic and meditative care. Our elders need closure. Many still live with the pain they experienced 45 years ago.
SC: This week marks the Khmer New Year. You usually celebrate the holiday with an event held at Rhodes on the Pawtuxet in Cranston. How have you had to adapt on account of the pandemic?
AC: Because of COVID-19, we haven’t been able to hold any community events or social gatherings. We cancelled our annual Khmer New Year celebration, annual community potluck, and annual community camping trip. These events usually bring in donations, so we’ve also faced financial struggles for the year. We’re fortunate to have an all-volunteer board so we’re able to function even with low funds, but the past year has been tough on everyone in our community so we haven’t expected too many donations. Thanks to the Rhode Island State Council on the Arts, we were able to acquire emergency funding to keep us afloat and upgrade our old technology to be able to host virtual meetings and events.
SC: But you’ve also taken steps to provide public health information and support within the community.
AC: We held multiple COVID-19 testing events at the heart of the West End of Providence. Collaborating with the West Elmwood Housing Development Corporation (WEHDC), we handed out almost 1,000 bags of adult masks, children masks and hand sanitizer within the Khmer community. One of our initiatives was to bring PPE to every Cambodian-owned business, and we counted nearly 60 — though we know we missed a lot. We translated the Rhode Island Department of Health’s flyers into Khmer, and we distributed hundreds of copies. We worked with Wat Thormikaram, the temple across the street from our office, to register Cambodian residents for vaccination appointments. And last winter we held a flu clinic as well.
SC: The COVID-19 testing events you’ve managed have been open to the public, not only to Khmer speakers or the Cambodian community. How did this initiative come together?
AC: One of our board advisors, Phanida Phivilay, acted as a liaison with the Department of Health. She connected us with the National Guard team who’s organizing COVID-19 testing, we chose a date and we set up our first testing event to welcome Khmer-speaking and other members of our local community. Every time we held another testing event, we improved based on what we learned from the previous one. Overall, we’ve tested around 400 people for COVID-19. Many Cambodian elders came into our office with no idea how to answer the questions required for testing. Without our translation and interpretation, it would have been difficult for them to be tested anywhere due to the language barrier. Being a center for the community, we were able to help folks who were scared to feel more comfortable.
SC: The Department of Health has published some COVID-19 materials in more than a dozen languages, including Khmer, but its testing and vaccination portals are available only in English, Spanish and Portuguese. What’s your process for sharing information in Khmer? How do you get the word out?
AC: We use the English versions hosted on the RIDOH website and hire translators to write up Khmer editions. We post these at local businesses and temples. We also include them with the bags of PPE we distribute. Word of mouth is especially important because that’s how news travels within our close-knit community. For many of our elders, because they left school early in Cambodia, they may not be able to read well even though they speak Khmer — and would rather learn from talking with others or listening to podcasts. It’s important that our flyers don’t only include words, but that our visuals speak for themselves.
SC: Are you also leading on any community initiatives around vaccination efforts?
AC: While we haven’t been able to provide vaccinations yet, we offer general support and answer any questions our community may have about the vaccination in general or about registering for updates or making appointments. We’re discussing with the Rhode Island Department of Health and the National Guard whether we can offer vaccinations, either at our temple on Hanover Street in Providence or in the West End Community Center’s gym since our office is so small. But we’re waiting on vaccine availability.
SC: What unique needs or sensitivities should be taken into consideration when discussing vaccination?
AC: We still see a stigma attached to Western medicine and practices. Some of this relates to drug abuse within our community as a way to cope with the PTSD and intergenerational PTSD of war. For refugees, medicines were not readily available when growing up in Cambodia. If they were available, they were expensive. As a result, many of the elders in our community weren’t educated about different types of medicine, and that lack of education can equal a lack of trust. We see that now with the COVID-19 vaccination. But the best way to address these hesitations is not just to force people to take it, but to help them understand what it is and how it works. We can’t look down on those who are uncomfortable with the vaccine and treat them like they are ignorant. This will only make members of the community less likely to ask the questions on their minds and eventually to warm up to the idea of getting vaccinated.
SC: We’ve discussed community outreach overall, but are there any personal stories you can share, too?
AC: One older Cambodian man and his family were referred to us by another organization who had difficulty communicating with him in Khmer. After being hospitalized with COVID-19, he had been discharged but didn’t understand what the next steps were with his care or how to get his vehicle back from hospital parking. We were able to speak with the hospital about his situation and ensure he faced no extra charges as a result of the confusion. Every two weeks, we checked up on him and his family and dropped off boxes of fresh groceries. Another time, a single mother with a toddler reached out to ask for help with getting masks for her child. Adult masks are easy to find, but you rarely see children’s masks.
SC: Given the difficulty of the past year, have any particular Cambodian-owned businesses stood out?
AC: While so many businesses have been shutting down during COVID-19, we want to highlight two new Khmer businesses: Pailin Cuisine (705 Cranston St., Providence) and We Stand Social Club (174 Taunton Ave., East Providence), which is a tattoo parlor and tea cafe. Both opened up despite the challenges and have been especially active in the community. We Stand even sponsored the West Elmwood Intruders youth football team and held a turkey and toy drive to help during the holidays.
SC: And how have you been processing recent incidents of anti-Asian vitriol and violence nationally?
AC: The recent spike in attacks toward Asians feels like history repeating itself. When Southeast Asian families came to the United States in the 1970s, we experienced a lot of racism, hate, and attacks — so much to the point where we even formed gangs to protect ourselves. It’s still not talked about a lot, and it’s a part of American history that many outside of our community seem to either forget or ignore. Anti-Asian hate is finally gaining mainstream attention, but our only hope is that we can see lasting action and support. When we were refugees, they had nothing to hate on us for, so focused on our physical appearance. Now, we’re scapegoated because of COVID-19. China is blamed for a pandemic that would have affected millions regardless of its origins, and somehow all Asians are facing repercussions.
SC: Thank you for sharing with Motif. Is there anything else you’d like other Rhode Islanders to know?
AC: We’re one of a few Southeast Asian non-profits that have long advocated for Cambodian and other communities: the Alliance of Rhode Island Southeast Asians for Education (ARISE), the Providence Youth Student Movement (PrYSM), and the Center for Southeast Asians (CSEA), which started out as the Socio-Economic Development Center for Southeast Asians (SEDC). Together with these organizations, we pushed for social justice and spoke up to represent voices that were going unheard. For decades, we’ve spread awareness and made steps toward reforming the systems that keep us marginalized.
What’s Cooking?: Vaccination goals in RI are a recipe for failure
At the weekly COVID-19 press conference on Thursday, April 8, Gov. Daniel McKee and RI Department of Health (DoH) Director Nicole Alexander-Scott made clear that economic reopening plans were conditioned upon a goal of vaccinating 70% of everyone in the state to approach herd immunity. While a laudable aspirational goal, it is in my opinion unrealistic and unlikely. The RI vaccination effort is doing well by any measure, consistently in the top 10 among the states, but it may soon hit a wall.
“The two key dates that we’re watching right now are May 15 and June 5,” Alexander-Scott said. “By May 15, we expect that 70% of Rhode Islanders 16 and older will have had at least one dose of vaccine and have had two weeks pass since that point so that they can experience the partial vaccination coverage that’s important. Getting 70% of our population to that mark of being two weeks after their first dose is a milestone for us. And that’s that May 15 target, being able to reach that allows us to have the confidence as we continue to make the changes and expansion in reopening our economy.”
“And by June 5, we expect that 70% of all Rhode Islanders who could get a dose – out of all Rhode Islanders: children, adults, and all – that, it will be two weeks after all of those individuals have had at least one dose,” Alexander-Scott continued. “Let’s work with everyone around you to get us to that May 15 point so that anyone who is eligible, 16 and older, is able to have at least one vaccine administered to them and receive the protection from that two weeks from there. That’s our May 15 date. And by June 5, it’s out of all Rhode Islanders, it’s 70% of all Rhode Islanders that we’re aiming for. With those dates in mind, and everyone centered on getting as many people around you that you know to get vaccinated, that’s the confidence we can have to move forward in reopening our economy incrementally, safely and effectively.”
At present, no vaccine is authorized for administration to anyone younger than age 16, and only one (Pfizer) of the three vaccines authorized by the US Food and Drug Administration (FDA) for emergency use in the US can be administered to anyone younger than age 18. There are currently no applications in the FDA pipeline for expansion of age criteria, although Pfizer is known to have compiled trial data for age 12 to 15 and is expected to file for authorization within the next few weeks. The most optimistic scenario is for an emergency use authorization for age 12 and older before school reopening in September, but authorization for younger children is unlikely before 2022. Practical as well as ethical considerations limit the speed at which clinical trials can be conducted and reviewed.
As of the most recent US Census data from 2019, there are 179,661 people younger than age 16 in RI out of a total population of 1,059,361, leaving 879,700 age 16 or older eligible to be vaccinated. To vaccinate 70% of the entire population of 1,059,361, it would be necessary to vaccinate 741,553 people, which is 84.3% of those age 16 and older eligible to be vaccinated.
Vaccine administration has for months been limited by supply far short of demand, but everyone knows that will reverse soon. I asked RI COVID-19 planning czar Tom McCarthy on March 30 when he expected that to happen, and he predicted the last week of June or the first week of July. Nationally, however, leading non-profit think tank Surgo Ventures predicts vaccine demand will plateau by the end of April, forcing a shift in strategy by public health agencies to convince people to want to be vaccinated rather than struggle to deliver enough physical doses.
Surgo previously warned in February that vaccine hesitancy would present a significant obstacle with only 40% eager to be vaccinated, 17% unwilling to be vaccinated under any circumstances, and 43% “persuadable.” Surgo divided this last group into three sub-groups labeled the “Watchful” 20% of people waiting to see what others they knew did, the “Cost-Anxious” 14% who worried about access issues such as appointment scheduling, transportation, or lost time at work, and the “System Distrusters” 9% consisting of those, often people of color, concerned they would not be treated fairly by the healthcare system. Hesitancy can and likely will decline over time, but how much and how soon are hard to forecast. Of the 17% not persuadable, 84% falsely believe that COVID-19 is exploited by government to control people, 65% falsely believe COVID-19 was caused by a ring of people who secretly manipulate world events, and 36% falsely believe microchips are implanted with the COVID-19 vaccine.
What disturbed me most about the April 8 press conference was that everyone except Alexander-Scott, including McCarthy, McKee, and Commerce Secretary Stefan Pryor, talked about the goal of 70% by June 5 as if they not only expect it to happen, but are depending upon it to justify a substantial reopening of the economy, allowing large gatherings for proms, commencements, weddings, concerts and festivals. By contrast, Alexander-Scott, a highly competent and respected medical professional and scientist, chose her words carefully, making no promises amidst all of the happy talk from her state government colleagues. She opened her remarks by conceding the data were not good: RI has seen increasing cases for weeks, with hospitalizations increasing as a lagging indicator following cases, and community spread in municipalities not previously hard hit, naming Bristol, Middletown and West Warwick, attributing the increasing incidence in part to the inference that more transmissible mutated variants of the virus were infecting younger people under age 40 who have not yet been vaccinated – precisely the vulnerable demographic most likely to attend those large events. Reading between the lines, Alexander-Scott may be laying down markers for where the numbers need to be with vaccination in order to allow reopening, preparing to test those markers against actual results. The problem with this approach is it will be hard to backpedal from promised reopening, with everything from weddings to parades and major music festivals already given the go-ahead signal.
To emphasize, the June 5 goal of vaccinating 70% of the total population of the state, which mathematically implies vaccinating 84.3% of those eligible to be vaccinated, will be effectively impossible: there simply will not be enough people willing to be vaccinated. Remember, we’re now only at 37.7%, a long way from 70%. If meeting that goal is prerequisite for reopening the economy, it is a recipe for failure.
Their Bad: Thousands notified in error of end of RI Unemployment Insurance eligibility
Motif previously reported (“Unemployment insurance runs out for hundreds in RI”, by Michael Bilow, Mar 1, 2021) that 213 beneficiaries had exhausted their available Pandemic Unemployment Assistance (PUA), but further information emerged on Wednesday, March 3, from the RI Department of Labor and Training (DLT), which administers the program, that many more were notified in error, setting off near panic for thousands.
The count of 213 was correct, DLT spokesman Margaux Fontaine confirmed to Motif, but many more apparently received a notice after completing their weekly re-certification on the DLT website that read, “Your certification has been successfully recorded.. However, you have exhausted your benefits balance. If you are still in need of assistance, you will need to file a new claim to have your eligibility determined.”
Adding to the panic, the DLT telephone help line, the only way for claimants to obtain information about their unemployment insurance status, has been overwhelmed to the point of inaccessibility, hanging up on callers and telling them to call back later.
Late on Tuesday, March 2, DLT sent an e-mail message explicitly countermanding their benefits exhaustion notice on the web (emphasis added): “This [e-mail] notice is to inform you that you have collected 46 weeks out of the 50 weeks available through Pandemic Unemployment Assistance (PUA). This means that you currently have four (4) weeks of benefits left. Note: If you received a message on UI Online that said you exhausted your benefits, you can disregard it. For the next four weeks, you may continue certifying as usual on UI Online or over the phone beginning Sunday, March 7, 2021. You will receive this week’s payment by Wednesday. The U.S. Congress is currently considering a bill that would extend PUA benefits. If that bill passes, DLT will work to implement the additional weeks as quickly as possible. There is no need to contact the UI Call Center.”
“People should only disregard the [web] message if they specifically received that e-mail, which confirms that they are at 46 weeks,” Fontaine told Motif in response to an inquiry. “We sent the email out to all 2,740 people who were at 46 weeks as a precaution.”
Asked to explain what happened, Fontaine told Motif, “Claimants are notified a week ahead of any benefits exhausting when they certify. We will also keep claimants informed of what happens with the bill in Congress (depending on when/if the bill passes, this may [be] an email or a message on our website and social media). Rhode Island has consistently been one of the fastest states at implementing federal programming changes so we anticipate being able to add additional weeks quickly, should they pass. We are currently working on creating an online system that will give claimants a lot more insight into their claims. This is set to launch later this spring.”
PUA is a new program created to cope with the COVID-19 pandemic by the federal CARES Act that became law on March 27, 2020, extending unemployment insurance to those not previously eligible, primarily formerly self-employed, contract and gig workers. It is distinct from the regular unemployment insurance program, which was also separately extended by Pandemic Emergency Unemployment Compensation (PEUC) that provided an additional 13 weeks for those who have otherwise exhausted unemployment benefits. Both are distinct from Federal Pandemic Unemployment Compensation (FPUC) that boosted weekly benefits by $600 until July 2020.
Unemployment insurance runs out for hundreds in RI
As the latest pandemic relief bill crawls through Congress with a provision that would extend the program, Pandemic Unemployment Assistance (PUA) benefits have ended for many individual recipients. According to spokeswoman Margaux Fontaine of the RI Department of Labor and Training (DLT) that administers unemployment insurance, “To date, 213 people have completely exhausted all 50 weeks of PUA.” This has been widely reported to have occurred without warning as recipients received notice only as they submitted their required weekly re-certifications of eligibility that their benefit payments this week (attributable to the prior week) would be their last.
Acting Director Matt Weldon of DLT told Motif, “Pandemic Unemployment Assistance (PUA) is a federal program that currently provides each claimant with up to 50 weeks of benefits. As we approach the one-year mark of the COVID shutdowns, unfortunately this means some PUA claimants are beginning to exhaust their benefits. We hope Congress will act soon to extend this essential program. If additional weeks become available to claimants, the Department will notify them as soon as possible.” The RI DLT Twitter feed echoed Weldon’s comments.
Weldon also cited a previously issued statement that warned of the problem in general terms after the most recent pandemic relief bill was signed into law on Dec 27, 2020 (emphasis added): “Pandemic Unemployment Assistance (PUA) claimants were previously eligible for up to 39 weeks of benefits. Now, they will be eligible for up to 50 weeks of benefits. The program will be extended through 4/10/21. Please note that you may exhaust your individual benefits before that date, depending on how many weeks you have left. No new applications will be accepted after 3/13/21.”
PUA is a new program created to cope with the COVID-19 pandemic by the federal CARES Act that became law on March 27, 2020, extending unemployment insurance to those not previously eligible, primarily formerly self-employed, contract, and gig workers. It is distinct from the regular unemployment insurance program, which was also separately extended by Pandemic Emergency Unemployment Compensation (PEUC) that provided an additional thirteen weeks for those who have otherwise exhausted unemployment benefits. Both are distinct from Federal Pandemic Unemployment Compensation (FPUC) that boosted weekly benefits by $600 until July 2020.
In response to a question from Motif, “Can someone who has exhausted PUA switch to PUEC?” Fontaine replied, “Unfortunately, they cannot. Per federal guidelines, PEUC is only available to regular UI claimants, not PUA claimants.” Fontaine said that the pending bill could address the problem: “At present, Congress is considering a bill that would extend PUA from 50 weeks to 74 weeks. If that passes and is signed into law, we will work as quickly as possible to implement those additional weeks.”
Many were publicly critical of how RI handled the situation. Well-known local musician Bob Giusti (@lambgiuse) replied to RI DLT on Twitter, saying “Same thing happened to me – no warning – I would have planned differently in spending leading up (not that there’s any extra) I didn’t even apply until April last year so it definitely wasn’t 50 weeks.” Twitter user Jaydeez (@Jimdeez78) replied to Giusti, “NO heads up nothing… What a joke.. Like we don’t have enough anxiety… MA has a sweet app shows you the balance of your acct.”
RI COVID-19 vaccinations open for age 75-plus now, age 65-74 next week
COVID-19 vaccination reservations can now be made for everyone age 75 or older who lives, works, or goes to school in Rhode Island, the RI Department of Health (DoH) announced this morning. Actual vaccination appointments begin tomorrow, Thursday, February 18, at the two state-run points of dispensing (PODs), Dunkin Donuts Center POD, 1 La Salle Square, Providence, and Sockanosset POD, 100 Sockanosset Cross Road, Cranston.
Reservations for those age 65-74 will open Monday, February 22. In a press briefing this afternoon, RI DoH Director Nicole Alexander-Scott confirmed in response to a question from Motif that actual vaccinations for this age group would begin the following day, Tuesday, February 23.
Each eligible age group can schedule a vaccination appointment on the web – VaccinateRI.org – and, although the web is preferred, voice telephone is available for others – 844-930-1779 (weekdays 7:30am–7:00pm, weekends 8:00am–4:30pm) – unable to use the web. It is possible to make an appointment for oneself or for another eligible person using either system.
Alexander-Scott said that the website is a work in progress for which significant improvements are planned. “Another thing that I wanted to share is that the customer experience is going to be a little different today than it will be in the near future. Today, when you go into the system, you have to submit all your information. And then once you do that, you can see if any slots are available. We recognize that is not ideal, especially for someone who is going to be repeatedly looking in the system for an appointment. We are working to adjust that process so that it’s a little more user-friendly, wanting to get started first, and then we’ll continue to make the improvements as we go.”
“As of 12:30pm today [Wednesday, February 17], we have made 1,331 appointments, 86 of those over the phone and the rest of them online… at the two state-run sites we have activated,” Alexander-Scott said. “On the topic of the speed of vaccinating, another piece of good news is that we got a little bump in our allocation of vaccine. We had been at the mark of 16,000 doses a week, for the last few weeks. We found out yesterday that our weekly allocation from the feds is going to be increasing to 22,500 first doses. Part of this is an actual increase in Pfizer vaccine and part of it is that Pfizer made a change that allows six doses to be drawn from vials that we were previously getting five doses from. Again, very good news.”
The telephone system also is planned for improvement, Alexander-Scott said. “Right now when you call, the system is automated: You will be prompted to enter your phone number and then you will get a call back. Our goal is to get it set up so that when you call you get a live person right away; we expect to have this in place soon. Like everything with this pandemic, we’re looking forward and making improvements every step of the way as we go.”
“Appointments are currently open through February 27. Additional appointments may be added through the week as slots open. Appointments are expected to fill up quickly,” DoH said in a statement. In the next few weeks, RI expects to bring additional state-run sites into operation in the northern and southern regions, with a goal of doubling the daily capacity at state-run sites from 1,400 to 2,800.
The Dunkin Donuts Center POD is using the Pfizer vaccine and the Sockanosset POD is using the Moderna vaccine, both of which require two doses separated by 3 to 4 weeks: this is not important for first doses, but each recipient must get a second dose of the same type as their first dose. On the website, Alexander-Scott said, users are “signing up for the first dose as the starting point, and then as they are getting that first dose, we have as many steps in place as possible to help ensure that they enroll for the second dose right then and there, so that they’re able to come back.”
In addition to the two state-run PODs, vaccination is available from select retail pharmacies, and those 75 and older can schedule appointments at a retail pharmacy location: either CVS.com, using the CVS Pharmacy phone app, or calling 800-746-7287; or Walgreens.com/ScheduleVaccine or calling any local Walgreens. Municipalities are managing the scheduling process for additional local and regional clinics; contact each city or town directly.
Alexander-Scott said that the goal is to move eligibility in lock-step across all vaccination methods, opening up to each cohort at the same time. “We want to ensure that when we move to the next eligibility group, it is done consistently the same across all three channels from the pharmacies, as well as the local-regional approach, as well as the state run approach,” she said.
For those age 65 or older, Alexander-Scott recommends using the larger-capacity state-run PODs in order to reserve smaller-capacity local and regional for those age 75 or older who may have difficulty traveling or using the web. “I do want to encourage that for going to 65-plus, we really push people toward the larger volume sites with the state-run approach that is activated. Now, when that opens on Monday [for age 65 or older], it’s really ideal to go there because it is designed to move through hundreds of individuals with vaccinating. We want our local-regional approach – our municipalities have been doing a fantastic job – really catering to those 75 years of age and older, supporting them in accessing vaccine and being able to register as they need to, making sure that they can stay local and where they need to go. I just left the call with the municipal leaders where we’re continuing to say to keep that going, make sure that they are filling all of their 75-plus slots because they’ve done a great job getting vaccine out to them, and we really want to encourage those 65 and older to go to the state run sites. We’re activating it for high volume, we want to do it as quickly and as streamlined as possible,” Alexander-Scott said. DoH spokesman Joseph Wendelken said that the daily capacity at the Sockanosset POD is 900 doses and at the Dunkin Donuts Center POD is 500 doses.
It is not necessary to schedule more than one appointment because everyone scheduled is guaranteed to be vaccinated in their assigned time slot, so making multiple reservations disadvantages others eligible for access to the extremely limited supply of vaccine.
After those age 65 and older, vaccination will be available to everyone between 16 and 64 with an underlying health condition (kidney disease, heart disease, diabetes, lung disease, immuno-compromised) that puts them at high risk of complications from COVID-19 and then by age strata for otherwise healthy people. Everyone not immediately eligible to schedule a vaccination (that is, everyone 16 to 64) can sign up to be notified when they are eligible at portal.ri.gov – where many people already have an account if they previously signed up for COVID-19 testing.
Under the RI COVID-19 vaccination plan, persons age 75 or older are covered in the 5th and final sub-phase of Phase 1, and persons age 65-74 are covered in the 1st sub-phase of Phase 2. Moving into each sub-phase does not require completing any prior sub-phase; for example, persons age 65-74 will become eligible while some age 75 and older will not yet have been vaccinated.
In response to a question from Motif, Alexander-Scott said that for those younger than age 65, “Going to the next level should be sometime in March. We can certainly move that up as we continue to accelerate our ability to push vaccine out and have additional supply to be able to do that… So for right now we’re in that same mid-March time, but certainly with each day we’ll continue to assess as we’re pushing it out, we’ll hope to speed it up. So no updates yet, but we’ll certainly be making that known as we have it.”
Responding to criticism about the slow pace of vaccination compared to other states – as of yesterday, according to data from the US Centers for Disease Control and Prevention (CDC), RI is tied for 48th place in doses administered per 100,000 population – DoH in a statement said, “Phase 1 of Rhode Island’s vaccination campaign has been focused on preserving the healthcare system and reaching groups most likely to be hospitalized – nursing home and other congregate residents, people in high-density communities, and older Rhode Islanders. While targeting these high-risk groups took more time than opening appointments to the general population from the outset, it also had the intended effect of preventing more severe cases of COVID-19, more significantly decreasing hospitalizations, and speeding up the reopening of our economy. Over the past month, Rhode Island saw a 46% decrease in hospitalizations, compared to 32% nationally and 22% in our neighboring states. And the decrease is even more significant among those in targeted groups. Because of this positive impact from Phase 1, Rhode Island can now move into Phase 2 and begin vaccinating every Rhode Islander by age group. This will allow for a significantly faster pace of vaccination.”
Alexander-Scott said at today’s press briefing, “We know that treatment with monoclonal antibodies is having a big impact. We know that our leadership with testing is an important component as well. But there is also clarity on the fact that our strategy is meeting the main objectives of the first portion of our vaccination campaign in Rhode Island. The first was to protect people in our nursing homes and other congregate settings, and the second was to make sure we have a health care workforce. Nursing homes are where we have seen the vast majority of our unfortunate deaths. And we need a healthcare workforce so that emergency care is there when you need it.”
Warwick Goes It Alone for Vaccine Reservations
Much to the apparent surprise of RI Department of Health (RI DoH) Director Dr Nicole Alexander-Scott, who was caught unaware on live television at her press conference at 1pm on Friday, January 28 – “RI Health Director Defends Vaccine Rollout”, Jan 28, by Michael Bilow – the City of Warwick opened a web page at 2pm to accept reservations for residents age 75 or older to be vaccinated against COVID-19. As Alexander-Scott was repeatedly saying that no action was required at this time to sign up, Warwick did exactly what she said would not happen.
According to Elizabeth Tufts, press secretary to Mayor Frank J. Picozzi, “Every municipality in the state was contacted by the Department of Health, literally yesterday [Thursday, January 27] saying, ‘Listen, we have some extra vaccines, we can start this rollout for 75-plus a little bit earlier, but we, depending on the size of your city or town, we’re going to give you a limited amount.’ So we got 390 doses, we were told literally yesterday, we had to come up with a plan how to get the word out. Unfortunately, with 75-plus… they’re not tech savvy. So we did what we could on social media with the news outlets. Also the mayor sent out a robo-call to let people know… We had to create a link and a registration form.”
The available 390 slots filled up within a half-hour of the web page opening, but Tufts said the state had told the city to expect thousands more doses later in February, allowing the entire population age 75 and older to be vaccinated. There are an estimated 8,000 people in the city in this age range, she said, but many have already been vaccinated, including residents of nursing homes and assisted living facilities.
The city is aware that a web page may not be well suited to the elderly population. Tufts said, “If they don’t have access to a computer, we’re asking family to help out or they can contact Senior Services [401-468-4073], there’ll be people on hand to help punch in their information to get them an appointment. I know, again, at 75 a lot of people don’t have access to a computer, but there’s no other way to do this because we can’t go door to door, we can’t have them start lining up outside of City Hall with COVID.”
Signing up on the web form is “just simply your name, your date of birth, your address and your phone number,” Tufts said. “They’re grabbing a spot. Tomorrow [Friday, January 29], we compile all this information. We have 10 to 12 volunteers calling them back” to provide specific appointment times. The Swift Community Center in East Greenwich is a regional vaccine point of dispensing (PoD), Tufts said, serving seven municipalities allocated vaccine for this round based upon population, with Warwick and Cranston receiving 390 doses each and East Greenwich receiving 80. “Once we [Warwick] get our time slots, we’re going to call them back and give them the day because we’re having a February 1st, 2nd, 3rd and then we’re going to say, ‘Okay, can you do Monday at 2pm?’ If they can’t, then they lose their spot because… they can’t pick and choose at this point because we don’t know what’s going to happen.” This specific clinic will be at this PoD because it was already set up to vaccinate first responders, Tufts said, but future clinics for Warwick residents will be in Warwick. “We just have to do it quickly because it’s the Moderna vaccine. We have to use it by a specific date, and we have it so that place was ready to go.”
It is not clear whether other cities and towns will follow the lead of Warwick in setting up their own vaccine reservation system instead of the state-run system contemplated by Alexander-Scott.
Cranston announced that “Residents interested in pre-registration are to call the Cranston Senior Services Center at 401-780-6000 on Friday, January 29, 2021 from 9:00am to 4:00pm. At this time, due to the limited allotment of doses available during this initial phase, the vaccine will be administered to Cranston residents according to their date of birth with the 390 oldest residents given priority. RIDoH regulations require resident email addresses in order to pre-register. A government issued ID and proof of residency are also required. Following pre-registration, qualifying applicants will be contacted by a city representative on Saturday, January 30, 2021 or Sunday, January 31, 2021 to schedule their first and second vaccination appointments.”
RI Health Director Defends Vaccine Rollout
On Friday, January 28, the regular weekly COVID-19 press conference conducted by Dr. Nicole Alexander-Scott, director of the RI Department of Health (RI DoH), was unusually chaotic.
In prepared remarks that were uncharacteristically defensive for the normally diplomatic Alexander-Scott, she avoided mentioning. but tacitly addressed, recent criticism in the media for what is widely seen as a slow rollout of the vaccination program in RI. In a Twitter exchange on January 25 involving several members of the press and the General Assembly, I said that the low ranking of RI by the US Centers for Disease Control and Prevention (CDC), 45th place among the states in percentage of doses administered out of doses received (then 45.28%), looked to be a data-reporting lag rather than a substantive problem; by January 28, three days later, RI had improved to 35th (52.16%). Alexander-Scott said, “A total of 86,315 doses have been administered in Rhode Island: 64,435 first doses and 21,880 second doses. As I have said in past weeks, we are overall in a good place and have a strong system in place. The CDC continues to publish rankings for states for doses administered, Rhode Island is close to the national average for total doses administered per capita. And we are just outside the top 10 nationally for second doses administered.” As of January 28, the CDC reports that RI has administered 7,565 doses per 100K population, exactly in 25th place among the states, and 1,752/100K second doses, in 9th place.
Alexander-Scott said there is a trade-off between getting doses out rapidly as opposed to getting them out most effectively. “While we all want as many doses as possible administered as quickly as possible, speed is only one of the measures of success we have prioritized. In addition to how many people you vaccinate, who you vaccinate matters… There are specific aims to the first phase of our vaccination campaign: ensuring the stability of the hospital and healthcare systems, and protecting the residents of nursing homes and other congregate living facilities. That means going to each nursing home and each assisted living facility in the state. That also means working through employers to get emergency medical services personnel and public safety workers scheduled for their shots. That also means getting very specific types of outpatient health care providers vaccinated.” Alexander-Scott credited the effectiveness of the system for keeping wasted vaccine doses very low, estimated at 0.2%.
RI DoH medical experts, notably Dr. Philip Chan, who is the consultant medical director for the vaccine program, have expressed disfavor about using large facilities, such as Massachusetts is doing at Gillette Stadium, both because it is difficult to get the people who most need vaccination to such a facility and there is risk of the vaccination process itself becoming a super-spreader event as a large number of people gather. Alexander-Scott said, “When you bring vaccine to people in congregate settings, and when you coordinate vaccination through people’s employers, that takes a little more time than just opening a large clinic at a public site somewhere, but we recognize that because it accomplishes our goal of making sure that we have a hospital and healthcare system for people when they need care. And it accomplishes our goal of protecting people in the congregate settings that have been most devastated by this pandemic. On the issue of timing and how quickly doses are administered, the good news is that we are very close to starting the portion of our vaccination campaign that will focus primarily on age. This approach is much less complicated and means vaccine will get administered more quickly.”
Alexander-Scott was obviously blindsided by the City of Warwick independently opening a web page to reserve vaccination appointments for persons age 75 and older. She outright said three times that no action was necessary at this time to schedule vaccinations, before being made aware of the Warwick situation by press questions. (See “Warwick Goes It Alone for Vaccine Reservations”, Jan 28, by Michael Bilow.) She said that the plan was to use an existing state website set up for those needing COVID-19 services to sign up for vaccination as they became eligible: “Starting this weekend, some limited vaccination will be happening for people who are 75 and older at our five regional clinic sites; that’s roughly 5,000 doses. We have an emergency registry at the Rhode Island Department of Health that people can sign up for to indicate that they need extra help during an emergency. That already existing list is primarily being used to do this initial vaccinating. The people in the registry will be getting contacted directly. We expect that within two weeks additional people who are 75 and older will be able to start registering.”
Near the end of the press conference, Alexander-Scott was directly asked, “Warwick is going to administer the vaccines in East Greenwich. Why is that? And is that then open to East Greenwich residents?” Her response, clearly having no idea about the Warwick situation, was simply, “We’ll get back to you on that detail.” (The answer is that the East Greenwich facility is regional, serving seven municipalities.)
There was good news, Alexander-Scott said, with continuing improvements in incidence measures. “We had 618 new cases to report from yesterday. That’s out of 18,678 tests. That means we had a test percent positivity of 3.3%. Our weekly percent positive number is 4.1%, which is down from 5% last week. This is very encouraging. It’s the exact direction that we need to go.”
Much of Alexander-Scott’s prepared remarks described Phase 2 of COVID-19 vaccinations, expected to begin in a matter of weeks. As we extensively reported in detail last week – “Vaccine Phase 2 First Look”, Jan 22, by Michael Bilow – criteria for priority will be based upon age, high-risk medical conditions, and geography. Most people age 75 or older can expect to be vaccinated beginning in mid-February in Phase 1.5, the final sub-phase of Phase 1. Depending upon vaccine supply, Phase 2 is expected to begin vaccinating people age 65 or older in early March. Alexander-Scott said, “Our entire approach was developed based on the science and the data. Almost two-thirds of all our hospitalizations are among people who are older than 60, and 94% of our fatalities have been among people in this age group older than 60. So that’s where age is our primary consideration.”
The next cohort in late March or early April would include all people age 64 and younger who have one of five high-risk medical conditions as well as healthy people age 60 or older. “People who are 16 to 64 years of age who have kidney disease, heart disease, diabetes, lung disease, or who are immuno-compromised will have accelerated access to vaccine. People who are immuno-compromised include patients receiving chemotherapy for cancer. It includes patients on immuno-suppressant medications due to organ transplants, and includes pregnant women. People who have kidney disease, heart disease, diabetes, lung disease, or who are immuno-compromised will be able to be vaccinated at the same time as people who are 60 to 64 years of age,” Alexander-Scott said.
Taking into account age, high-risk medical conditions and geography together is intended to serve the goal of minimizing hospitalization and death. “The last consideration in our next phase is geography. As I shared, the data here is clear. People in certain communities are at greater risk. It’s not because of genetics. It’s not because of anything particular to those individuals. It is connected to the environments and the conditions in those environments. Unfortunately, we have the example that the hospitalization rate in Central Falls is 67% higher than the statewide average. The hospitalization rate in Providence is 58% higher than the statewide average. Getting people in harder hit communities vaccinated quickly is the right thing to do. It’s the right thing to do ethically, and it’s the right thing to do to manage this pandemic most effectively,” Alexander-Scott said. “While the first phase of our campaign was focused on ensuring the stability of the healthcare system, making sure that we would not be overwhelmed and able to handle it, as well as protecting the residents of nursing homes and other congregate settings, the aims of this next phase are to protect those most at risk for hospitalizations and deaths from COVID-19. This is a critical point.”
The decision to not take occupation into account as a criterion for priority in Phase 2 has been frequently criticized, and Alexander-Scott addressed that specifically. “Something else to consider about our approach is that it is very broad. It captures many members of our various critical infrastructure occupations. Take teachers: Many teachers will get vaccinated early on using our framework that I’ve just shared; 58% of cases where teachers and staff are either 55 years of age or older, live in a community harder hit by COVID-19, or have one of the high risk conditions that I discussed. This is important news. Although the data make clear that schools are not higher risk environments, we all recognize how important it is to get teachers and all Rhode Islanders vaccinated as quickly as possible. What we want to do is do it as effectively as possible given the supply that we have.”
What was supposed to be the main news, that early closing restrictions for businesses would end effective Sunday, January 31, was almost lost amid criticism for not doing it immediately. One press questioner asked, “On the rollout with the restaurants, why not now? They will lose a whole weekend’s business.” As Alexander-Scott began to answer, the questioner pressed why the easing of restrictions required several days advance notice: “Restaurants are like, ‘Okay, 10:30.’ They don’t need to have a seminar to figure it out. Right?” As RI Commerce Secretary Stefan Pryor came to the lectern to respond, the questioner continued, “Why not tomorrow, Secretary? Give them another weekend, they’ve waited, this was supposed to be two weeks on a pause and it’s been two months. It’s thousands of dollars that they’re not getting reimbursed for.”
“It’s a fair point, we want to lift restrictions as soon as is feasible. I think it’s terrific that we have reached this point where we can roll back the early closure. It has affected an array of business categories. It’s not just the restaurants, of course, that have been affected. I just want to actually re-articulate the categories of business that are affected: restaurants, recreation and entertainment, historical and cultural sites, personal services, gyms and fitness centers, and sporting facilities,” Pryor said, noting that time was needed to coordinate with DoH and neighboring states. Concern has been expressed previously about the risk that people would cross state lines, possibly carrying the virus, to exploit different closing times. He also emphasized the importance of maintaining public health measures such as wearing face coverings and physical distancing regardless of expanded hours. “One of the things that our team has always emphasized is to communicate effectively and, quite frankly, the dialogue inside our team has been about the fact that people still need to exercise caution, they still need to observe all of the pre-existing rules. The pandemic isn’t over.”
Vaccine Phase 2 First Look
How to define eligibility for priority groups in Phase 2 of the state COVID-19 vaccination program was the subject of the regular weekly meeting of the Vaccine Sub-Committee at the RI Department of Health (DoH) on Friday, January 22. The goal is to have this clearly settled by the time Phase 2 is expected to begin in late March or early April.
The supply of vaccine, currently about 14,000 doses per week, is not expected to increase for the foreseeable future, Alysia Mihalakos of DoH told the sub-committee. Phase 1 began in December with the most high-risk groups, frontline health care providers and nursing home residents and staff in Phase 1.1, moved on to frontline professionals in critical infrastructure such as firefighters and law enforcement in Phase 1.3, and will conclude with all persons 75 years of age or older in Phase 1.5.
The main challenge, according to meeting facilitator Mckenzie Morton, is to specify eligibility criteria that can be “operationalized,” meaning that the state can readily deploy resources in accordance to match and verify eligibility. As a result, the principal criterion proposed is age, which is known to correspond to risk of hospitalization and death, so that Phase 2 would begin with all persons age 65 or older. After that, all adults with medical conditions that put them at high risk would become immediately eligible, and other adults without such medical conditions become sequentially eligible by age strata 60-64, 50-59, 40-49, and finally 16-39.
No vaccine is yet approved by the US Food and Drug Administration (FDA) for persons younger than 16 because clinical trials are still in progress, so there is as yet no data on safety and efficacy. As of last week, a national trial had recruited 800 of a needed 3,000 volunteer test subjects ages 12 to 17.
Although age can be checked with commonly available identity documents, geography is also known to correlate with greater risk of infection, and the proposal is to prioritize in part using the Social Vulnerability Index (SVI) published by the US Centers for Disease Control and Prevention (CDC) that measures “potential negative effects on communities caused by external stresses on human health” with census tract granularity. Exactly how “geography” would be defined for vaccination was not discussed, leaving open such questions as, for example, how a teacher who works in Central Falls and lives in Exeter would be classified.
Although the CDC lists medical conditions known to be associated with increased risk of hospitalization and death from COVID-19, several sub-committee members pointed out problems with the CDC list. Relatively rare conditions, such as amyotrophic lateral sclerosis (ALS), which is commonly called Lou Gehrig’s disease, and Ehlers–Danlos syndrome, probably did not make the list only because of their rarity. It was observed that other conditions on the CDC list may be secondary in risk, such as Down syndrome that is often correlated with heart disease that is also on the CDC list. It was also suggested that substance abuse disorders can result in severe alcohol disease such as cirrhosis, which would put a patient at high risk, but this is not on the CDC list although a history of smoking is on the list. Mental health disorders can result in patients being unable to access reliable physical health care, putting them at higher risk from COVID-19 and also presenting difficulties in making sure they receive a required second dose of vaccine after the first.
Some conditions listed as high-risk by the CDC are so common that they provide little help in prioritizing vaccination, such as high blood pressure, high cholesterol, and obesity that each affect over 30% of the entire population of RI. Nor are such conditions grossly disproportionately reflected in hospital admissions: obesity is present in 25% of hospital admissions for COVID-19 in RI, less than its 30% prevalence. As a result, the proposal focuses on four specific conditions of known prevalence that account for a disproportionate number of hospital admissions in RI at least triple their prevalence: renal disease (22% of admissions, 2%/20,000 prevalence), cardiac disease (30% of admissions, 4%/34,000 prevalence), lung disease (19% of admissions, 7%/59,000 prevalence), and diabetes (30% of admissions, 10%/89,000 prevalence). The proposal also includes those who are immuno-compromised, either because of another medical condition such as HIV positivity or because they are on suppressive drugs as would be the case for organ transplant recipients, accounting for 9% of admissions but of unknown prevalence. (Some patients have more than one condition.)
While there was some concern about people claiming to have high-risk conditions due to anxiety to be vaccinated, DoH Director Nicole Alexander-Scott said that her preference was to follow a “self-attestation” model, essentially putting people on the honor system, especially because the eventual goal is to vaccinate everybody. If there are too many barriers requiring proof of eligibility, the concern is not only would this discourage people in legitimate medical need, but would likely disproportionately discourage the most vulnerable who may not even have a primary care practitioner (PCP).
Consistent with the frequently emphasized goal of equity, several members of the sub-committee raised the concern that COVID-19 has radically disparate effects by race and ethnicity, citing as an example a study that showed infected Black patients in their 50s have a risk of death comparable to those in their 70s among the general population. Rather than take race into account explicitly, the proposal intends the combination of geography and medical conditions to subsume race, as these factors are believed to be significant likely causes of racial disparity in health outcomes.
The proposal avoids distinguishing by occupation in Phase 2, which would be operationally difficult as well as requiring selections among, for example, teachers and grocery store workers, effectively putting different occupations in competition with each other for vaccine. Alexander-Scott said that more than half of teachers would qualify based upon age and medical condition alone, even before taking geography into account, reducing the need to prioritize teachers specifically. Jonathan Brice, a school superintendent representing educational interests, said that he would prioritize teachers who work with students unable practice mask wearing and physical distancing, either because they are very young, in his example kindergarten through second grade, or because they have special needs. It is possible that the federal government may make additional vaccine supply available and earmark it for specific groups such as teachers, Mihalakos said, but at this point there is nothing definite.
One of the main advantages to the proposed structure for Phase 2 is that it would allow communicating to the public approximately when any given adult could expect to be vaccinated, based upon the known supply of doses, one of the most frequently asked questions to DoH, Mihalakos said. If the supply increased, as is expected from additional vaccines being authorized by the FDA and greater production of vaccines already approved, it would be simple to recalculate the improved time estimate.
The final Phase 3 would cover children younger than 16 and all others not previously vaccinated.