New Treatment Available: Monoclonal antibody treatments for all eligible RI patients
A new treatment for COVID-19 patients is available in RI to anyone who tests positive and is age 65 or older, or has an underlying health condition: a one-shot infusion of monoclonal antibodies. It is most effective when administered as soon as possible after testing positive, and it is hoped that it can reduce severity of sickness and prevent hospitalization.
Monoclonal antibodies are one of the then-experimental treatments given to Donald Trump when he contracted the virus and was hospitalized several months ago, as we reported (“Trump has COVID-19 and it’s not ‘karma’ at all”, by Michael Bilow, Oct 2, 2020): “The AP also reported he received an ‘experimental antibody cocktail’ which The New York Times reported contains Regeneron, an experimental bio-engineered drug made by Eli Lilly, which is in a class of ‘monoclonal antibodies’ that can be designed against a wide range of specific targets, including viruses, cancers and autoimmune diseases.”
At the Department of Health (DoH) press briefing on Friday, January 8, Director Nicole Alexander-Scott said, “Rhode Island now has a doctor-recommended treatment for COVID-19 that is extremely effective at preventing people from developing severe disease and from being hospitalized because of COVID-19. The key, though, is starting early: The earlier you start treatment after testing positive, the better and more effective this can be. After completing a simple infusion, intravenously, of this treatment, many people with COVID-19 start feeling better as early as the next day. The treatment does not require hospitalization, and it’s intended to help prevent people from actually having to be hospitalized.”
Dr. Alexander-Scott has repeatedly emphasized her strategic priority of reducing hospitalizations to protect health care services from being overwhelmed, and this is a major reason the state is pushing the new monoclonal antibody treatment as a matter of policy in addition to its significant benefit to individual patients. Treatment for infection is the third major prong of the state’s pandemic response, along with testing and vaccination.
The goal is to give this monoclonal antibody infusion to as many eligible patients as possible by making the eligibility criteria automatic. Dr. Alexander-Scott said, “If you test positive for COVID-19 and are 65 years of age and older, or you have an underlying health condition, immediately call a health care provider and ask about treatments for COVID-19 you should start with your health care provider.” Patients who do not have a health care provider can access TeleCARE at Brown Emergency Medicine – brownemtelecare.org – to get this treatment, she said, and general information about treatments is available from the DoH website – covid.ri.gov/treatment – directly. “So remember, as we’re expanding testing and you’re getting tested, if you test positive and you qualify, access the treatment that’s available. It makes a difference.”
Dr. Alexander-Scott strongly encouraged the use of the new treatment. “It’s available right away now for everyone who is positive and who qualifies. It has to be ordered by a provider, so your provider has the information. We’ve worked closely with our providers to make sure they know where the resources are, where the infusion sites are, how to get their patient connected, and then we also have the Brown Emergency Medicine TeleCARE option that was described so that you could call and speak to a provider online: That provider can order it for you, get you connected immediately with an infusion site.”
Eventually, the plan is to have infusion sites co-located with larger testing sites, so that eligible patients can get the new treatment immediately after testing positive by a rapid test. “We’re working to build out as many different infusion sites as possible, particularly at places where there is a lot of testing already occurring, so that you can just go to the next room if you’re at one of our testing sites that’s able to accommodate this and get access to the treatment. We want to get at every element,” Dr. Alexander-Scott said. “Thank you to some of our local clinical sites also that are partnering with us to make sure that this treatment can be available in all of the different environments that would work well.”
On the Dotted Line: RI likely unaffected by delay in federal pandemic relief
President Donald Trump signed the combined $900 billion pandemic relief bill and $1.4 trillion omnibus funding bill around 8pm on Sunday, December 27, after almost a week of issuing implied threats that he might not do so. The delay already allowed critical unemployment insurance (UI) provisions to lapse the prior day, although the bill provides that the programs would be restored retroactively should such a gap occur, so that recipients will receive the same amount of payments. The two main UI programs at issue extend the time of eligibility beyond that provided by state programs and make gig workers and freelancers eligible when they otherwise would not be.
While some states warned that delay in approving the bill might interrupt the weekly flow of payments to beneficiaries, RI expects to accommodate the extension of benefits with no trouble within a few days margin of safety. In response to our inquiry, Department of Labor and Training press liaison Margaux Fontaine on Wednesday, December 23, told Motif, “Since payments will still go out next week [for the prior week] regardless, we have some time. Extending the date of the programs is a relatively quick fix, so as long as it’s signed by mid to late next week, we wouldn’t expect most claimants to see an interruption.”
UPDATE: Fontaine clarified on Tuesday, December 29, “Under the law, and per US [Department of Labor], the first payable week for the extra $300 is week ending 1/2/21. Payments for that week go out [the] next week.”
The combined bill on pandemic relief and omnibus funding was agreed after seven months of on-again-off-again negotiations by Congress late on the night of Sunday, December 20, as we reported. In addition to extension of UI eligibility periods and supplementing UI payments by $300 weekly above state benefit amounts through March 14, the bill provides for $600 stimulus payments to nearly every American earning less than $75,000 annually, initiates a new round of aid to small business, extends the federal eviction moratorium until January 31, expands the Supplemental Nutritional Assistance Program (SNAP, commonly still called “food stamps”), and provides funds to state and local governments for support of schools and health care, including the cost of administering the new COVID-19 vaccines. As we reported earlier, the bill includes the “Save Our Stages” provisions advocated by IATSE (the theatrical worker trade labor union) and the National Independent Venue Association, authorizing $15 billion in dedicated funding for live venues, independent movie theaters, and cultural institutions.
Trump’s approval of the bill ends nearly a week of chaos caused by his surprise four-minute video statement released late on the night of Tuesday, December 22, that we reported at the time – facebook.com/motifri/posts/3585321644880532 – contained numerous inaccuracies and falsehoods, criticizing the inclusion of items unrelated to pandemic relief. “Trump conflates two separate bills, one $900 billion for COVID-19 relief and the other $1.4 trillion ‘omnibus’ funding bill that keeps most aspects of the federal government running, which is why everything from foreign aid to fisheries is included,” we explained.
Trump’s video statement also picked up untrue right-wing media talking points. We wrote, “Some of the claims Trump asserts in this video are false, especially that undocumented immigrants are eligible for stimulus payments, when in fact only persons legally present in the US, either as citizens or permanent residents (Green Card holders), are eligible for the stimulus payments. What is different in this latest bill is that mixed-status households, such as a US citizen married to an undocumented immigrant with a US citizen child, were completely not eligible for the stimulus round months ago, but would be eligible for the stimulus round now, provided that only those in the household with legal status, such as the US citizen spouse and child, are eligible for the payments.”
The main objection Trump raised in the video, that the $600 stimulus payments were too low and should be raised to $2,000, was seen as especially bizarre because Treasury Secretary Steven Mnuchin, representing the White House in negotiations with Congress, had repeatedly fought Democrats trying to increase the amount, and the $600 number was a compromise between $2,000 wanted by the Democratically-controlled House and zero wanted by the Republican-controlled Senate. In a rare session on Thursday, December 24 – Christmas Eve – House Speaker Nancy Pelosi called for a vote on increasing the payments to $2,000, but the short notice required unanimous consent under the rules and Minority Leader Kevin McCarthy objected on behalf of the Republican caucus.
Democrats have said they will hold the vote on increasing the stimulus payments to $2,000 on Monday, December 28, when Congress will reconvene after the holiday break in order to consider overriding Trump’s veto of the National Defense Authorization Act (NDAA), the annual appropriation of funds for the Department of Defense. Trump objected that the NDAA would allow changing the names of military bases currently bearing the names of Confederate soldiers, as well as Congress refusing his demand to repeal Section 230 of the Communications Decency Act of 1996 that provides “safe harbor” immunity for online forums, such as Facebook and Twitter, so they are not subject to paying damages from libel and slander claims arising from unmoderated posts by their users. Trump also claimed the NDAA was not tough enough on China.
RI Sen. Jack Reed, who served with the 82nd Airborne Division as an alumnus of West Point where he later served as a professor, and who is now the ranking minority member on the Senate Armed Services Committee, said “President Trump clearly hasn’t read the [NDAA] bill, nor does he understand what’s in it. There are several bipartisan provisions in here that get tougher on China than the Trump Administration has ever been.”
Even if the increase to $2,000 passes the House, it is widely considered dead-on-arrival in the Senate, unlikely even to be called up for a vote.
Don’t Panic: Explaining coronavirus mutations
In the last few days, there has been a near-panic reaction to the discovery of a mutation of the SARS-CoV-2 virus that causes COVID-19. The mutated lineage – in virology, a “lineage” suggests a variant somewhat closer to its immediate ancestors than a “strain” – is now named “Variant of Concern 202012/01,” having been referenced as “Variant Under Investigation 202012/01” and “B.1.1.7” earlier. (The VOC nomenclature is simply “year 2020, month 12, variant 01.)
Worries about the new variant focus on four main issues:
Does it spread more easily?
Does it cause more severe sickness or greater likelihood of death?
Does it have resistance to vaccines just approved for use?
Does it have the ability to escape detection by widely deployed PCR tests?
Mutations occur fairly often in the course of virus replication, essentially just inevitable errors making copies of copies of copies, but the vast majority have no meaningful effect. By random chance, very rarely a mutation gives an evolutionary reproductive advantage to the virus, which is how SARS-CoV-2 arose in the first place, probably many years ago in an animal reservoir, such as bats, until a spillover occurred to humans. Like every virus, this virus continues to mutate, and some random variations could boost the mutated lineage in epidemic risk. Thousands of such mutations have been observed and recorded in SARS-CoV-2; by one estimate about 12,000 distinct variants so far, but most do not seem to do anything different.
As the Global Initiative on Sharing Avian Influenza Data (GISAID) explained in a statement, “Mutations are naturally expected for viruses and are most often simply neutral regional markers useful for contact tracing. The changes seen have rarely affected viral fitness and almost never affected clinical outcome… Changes in the spike protein have relevance for potential effects on both host receptor as well as antibody binding with possible consequences for infectivity, transmission potential and antibody and vaccine escape. Actual effects need to be measured and verified experimentally.”
According to an advisory from the World Health Organization (WHO), by December 13 there were 1,108 known infections with this new variant in the UK. Ordinary COVID-19 testing is not intended to distinguish between variants, but in the UK between 5% and 10% of samples are routinely sent for genomic analysis that can distinguish between variants, and 4% of samples in southeastern England are sent for genomic analysis. The new variant accounts for over half of COVID-19 infections in southeastern England, after having been first seen in September in Kent, and is disproportionately more likely to be seen in young rather than old patients.
It is not clear why the variant is significantly more prevalent in the affected area, but one possible explanation is that the mutation makes the virus more transmissible from person to person, and if so this would be a major concern. The WHO warns, “Preliminary reports by the United Kingdom are that this variant is more transmissible than previous circulating viruses, with an estimated increase of between 40% and 70% in transmissibility (adding 0.4 to the basic reproduction number R0, bringing it to a range of 1.5 to 1.7).” On the other hand, according to a news article in Science, generally considered the most prestigious scientific journal in the US, “Scientists, meanwhile, are hard at work trying to figure out whether B.1.1.7 is really more adept at human-to-human transmission – not everyone is convinced yet – and if so, why.”
Sometimes increased prevalence is a result of a biological property of the virus, but this is not always so. It is widely known that the lineages of infections in the US toward the West Coast tend to be genetically closer to those found in Asia while the lineages of infections in the US toward the East Coast tend to be genetically closer to those found in Europe, but that almost certainly reflects patterns in airline travel rather than any intrinsic property of the mutations in the lineages. Likewise, the higher prevalence of the new variant in the UK could reflect human behavior, such as young people being more likely than old people to transmit infections in bars or restaurants, rather than any biological underpinning.
The new variant is characterized primarily by three distinct mutations, labeled “N501Y,” “P681H,” and “69-70del.” The detection of the new variant in the UK is a coincidence because a common commercial PCR test, known as TaqPath, consists of a three-part panel of subtests, one of which looks for the component of the virus that goes missing in the 69-70del mutation; as a result, a positive indication on the other two subtests and a negative indication on that subtest allowed the UK to go back over their existing test data and estimate the prevalence of the new variant.
While the 69-70del mutation can cause anomalous results in some PCR tests, it is the other two mutations that are of real concern, modifying the receptor-binding domain (RBD) that controls how the virus infects hosts cells. This could give the variant an advantage invading host cells, increasing ease of transmission from person to person, as the WHO fears. One indication of this possibility is that the N501Y mutation has been seen elsewhere in the world, with a few dozen cases known in Australia and Africa. In fact, it was the University of KwaZulu-Natal in South Africa that first identified the N501Y mutation in a separate lineage and made the UK aware of its potential importance. The independent evolution of this same mutation in different parts of the world strongly suggests that the mutation gives the virus some reproductive advantage and is therefore favored by natural selection. Whether this is true and if so to what extent is unknown pending further study.
So far, there is no evidence that the new variant causes more severe sickness or increased likelihood of death, even if it does have an advantage in being able to infect the host and therefore spread more easily. There is no known biological reason to expect a change in the RBD of the virus to result in worse sickness.
It’s too early to know whether the new variant is more resistant to immunity, whether acquired through recovered infection or vaccine, but theoretical models strongly suggest that the mechanisms of action by immune antibodies will be just as effective and are not affected by the particular mutations that characterize the new variant. Eventually, although SARS-CoV-2 mutates relatively slowly, it may be necessary to formulate a slightly modified vaccine periodically, similar to seasonal influenza vaccines that must be given annually.
Is the new variant in the US, or even in RI? Experts believe it almost certainly is, but there has been no testing for it until extremely recently, so it is impossible to know for certain. We asked that question, and Joseph Wendelken, spokesman for the RI Department of Health, told Motif, “Rhode Island participates in a CDC initiative to sequence SARS-CoV-2 from throughout the USA by regularly submitting positive specimens collected from Rhode Island residents. We are not aware of any such specimens being confirmed as the UK mutant strain. The State Health Laboratories (SHL) is also currently working with Rhode Island scientists on sequencing SARS-CoV-2 positive specimens at time points throughout the pandemic and in a sampling of isolates collected in March through August none were the UK mutant strain. These efforts are continuing.” However, as Wendelken made clear, at this point data more recent than August is not yet available, a month before the new variant was first detected in the UK. Motif asked the CDC directly, but so far they have not replied.
Wendelken was confident, however, that PCR testing accuracy in RI should not be affected if encountering the new variant. “Rhode Island clinical laboratories utilize a diversity of molecular amplification detection methods and many have multiple tests online – the SHL alone currently has five different ‘PCR’ tests. Each test uses different virus gene targets for detection and many use a multi-target approach. For this reason, if virus mutations in one area affect detection of a certain gene, the built-in redundancy would detect the other virus gene targets, thus lessening the potential for a ‘false negative’ result for the UK mutant strain.”
No Holiday for Death at the ACI
A second inmate has died from COVID-19 at the Adult Correctional Institution (ACI), according to a statement from the RI Department of Corrections (DoC) on the afternoon of Friday, December 25. Motif previously reported the first inmate death on Saturday, December 19, and the first staff death on Monday, December 14.
“The inmate requested ‘Comfort Measures Only’ and that no extraordinary measures be taken to keep him alive. He was 79 years old,” the DoC said. “The inmate had other serious complicating health conditions that contributed to his death. He was being treated at Rhode Island Hospital for complications of COVID-19. The inmate was housed in the Medium Security facility of the ACI, where he was serving a life sentence for murder, and a concurrent expired sentence for manslaughter. The inmate’s family has been notified.” As is customary for DoC, the name of the deceased was withheld, citing “medical privacy laws.”
Although DoC usually releases an update every Friday via their official Facebook page of the number of cases and deaths as of the prior day, it appears to be delayed this week due to the holiday. The most recent weekly report published by DoC as of December 17 listed 1,098 total COVID-19 cases, of which 808 are among incarcerated persons and 290 among staff.
Code Black RI, “a coalition of medical professionals, healthcare workers and trainees taking a stand against racism and racist systems,” held a protest rally in front of the governor’s residence on Wednesday, December 23, resulting in at least five arrests, that was broadcast via Facebook Live by UpriseRI. The group published a statement that evening on UpriseRI, saying “Mass incarceration is a threat to health equity and a public health crisis. As of December 17, greater than 90% of the inmates in Maximum Security tested positive for COVID. Cases are rising at the surrounding facilities. None of these outcomes are due to happenstance. Since March, the Decarcerate NOW Coalition and many others have called for the state to halt arrests; release as many incarcerated people as possible on parole and into community confinement – centering elderly and medically vulnerable people; and provide adequate PPE and universal testing to incarcerated people. These measures were not taken, or taken in half-measure.”
DoC Director Patricia A. Coyne-Fague said in today’s announcement of the second inmate death, “Any loss of life is very painful for friends and families, especially around the holidays, and we are keeping all who have lost relatives and loved ones in our thoughts during this difficult time. We are doing everything we can to keep people as safe as possible – no one wants to see more people die as a result of this virus that has claimed already too many lives in our state, and the rest of the world.”
Double Shot: Moderna COVID-19 vaccine second to be approved in RI
The Moderna vaccine against COVID-19 was unanimously approved for use in RI this morning at an emergency meeting of the RI Department of Health (DoH) Vaccine Sub-Committee, following the issuance by the US Food and Drug Administration (FDA) of an Emergency Use Authorization (EUA) on Friday, December 18. Doses are expected to begin arriving in RI later today, a planned total of 19,000 over the next week, according to Alysia Mihalakos of DoH.
The two vaccines are very similar and both are based on mRNA technology, but there are some important differences. The Pfizer vaccine is approved for patients age 16 and older, while the Moderna vaccine is approved for patients age 18 and older. Both require two doses for full immunity, but the Pfizer vaccine recommends 21 days between doses and the Moderna vaccine recommends 28 days between doses. (Although it is recommended that the second dose be given as soon as allowed, neither vaccine has a maximum interval between doses, so giving the second dose late is better than not giving it all.) While the Moderna vaccine requires cold storage and transportation, it is less demanding than the Pfizer vaccine that requires extremely cold temperatures below -80°C. The vaccines cannot be combined or interchanged, such as by giving a first dose of one and a second dose of the other. Neither vaccine should be given to anyone with a known allergy to any of its ingredients.
In response to a question from Motif, sub-committee member Pablo Rodriguez confirmed that patients who are pregnant or lactating should follow the same procedures for both vaccines, which is to consult with their PCP for an independent evaluation of risk factors.
In response to questions from Motif, Mihalakos said that despite the unexpected shortfall in doses of Pfizer vaccine, the Moderna supply is as expected. “We are on track to receive our 19,000 this week, so there have been no changes overall in the planning estimates that you may have heard about previously. The vaccine will be distributed to all hospitals because we have not received nearly enough vaccine yet to cover all of the employees of all hospitals.” All of the first week supply of Pfizer vaccine, which was received last week, was allocated to hospitals to vaccinate their front-line staff, but the vast majority of the second week supply of Pfizer vaccine, nearly half of which is delayed, was allocated for federally contracted pharmacy partners, CVS and Walgreens, to vaccinate nursing home residents and staff, especially because the contractors are equipped to provide the extremely cold storage and handling needed. The plan was therefore to use the Moderna vaccine when possible primarily for hospital staff beginning this coming week. “We’re vaccinating the vaccinators, so our two mass-vaccinator partners received an initial supply of vaccine last week they will continue this week. We will be working with community health centers to ensure that their staff can start to be vaccinated. Again, we are moving on some plans for rolling vaccine because everybody can’t be vaccinated at once. There will be some additional vaccine that goes to the ACI to follow up on the initial doses they got this week,” Mihalakos said. “The Pfizer vaccine that we are allocated in this [coming] week, the majority of that will go to the pharmacy partnership for the beginning of the nursing home vaccinations. So you’ve heard us speak previously about that we needed to have 50% of the vaccine for staff and residents up-front.”
Much of the work of the sub-committee is highly dependent upon data and guidance supplied by the US Centers for Disease Control and Prevention (CDC), particularly its Advisory Committee on Immunization Practices (ACIP), which published clinical recommendations for the Moderna vaccine only yesterday in a special edition of the Morbidity and Mortality Weekly Report (MMWR), the principal journal of the CDC. RI sub-committee meeting facilitator Mckenzie Morgan, noting how well things were going, joked, “It’s really nice once in the past month to not get surprises this weekend, which was, I don’t know about you guys, but a welcome relief for me. And I’m sure the rest of the RI DoH team got a huge sigh of relief. When I read the MMWR, I was like, ‘Okay, nothing crazy. All right. Awesome.’”
The next regular meeting of the Vaccine Sub-Committee is scheduled for Friday, January 8, skipping the holiday week when the usual meeting day, Friday, would fall on New Year’s Day, but members were warned that emergency meetings may be called if needed.
Death Sentence: First COVID-19 inmate death at RI ACI
The first inmate death due to COVID-19 at the RI Adult Correctional Institution (ACI) was confirmed today to Motif by the Department of Corrections (DoC), having occurred on Saturday, December 19. The deceased was a 66-year-old male “who had other complicating co-morbidities that likely contributed to his death [and] was at Rhode Island Hospital being treated for complications of COVID-19.”
The most recent weekly report published by DoC lists 1,098 total COVID-19 cases, of which 808 are among incarcerated persons and 290 among staff.
The DoC statement declined to fully identify the deceased: “Due to medical privacy laws the name of the individual is not being released.” All the DoC said in the statement by way of identification was that, prior to hospitalization, “The inmate was housed in the Maximum Security facility of the ACI since 1988, where he was serving life without parole for the sexual assault and resulting death of a 73-year-old double amputee woman.” That description, however, leaves little practical doubt that the deceased is Jeffrey Washington, whose situation was summarized in a July 2005 ruling by Judge Judith Colenback Savage of the Superior Court challenging “conviction after trial by jury in May 1989 for felony murder for his rape and the resulting death of Alice Carcieri, a 73-year-old double amputee, and his sentence, imposed by the Court upon the jury’s finding of aggravated battery, of life without the possibility of parole.”
The activist group Direct Action for Rights and Equality (DARE) late Saturday published a statement on their Facebook feed: “We just learned that a person incarcerated in the maximum security facility has passed away from COVID. There are really no words. This person’s life was taken by the state. This is a murder. His blood is on their hands: [RI Gov. Gina] Raimondo, [DoC Director Patricia A.] Coyne-Fague, [RI Department of Health Director Nicole] Alexander-Scott. We don’t know if he is one of our own loved ones and we are praying for his family. Until there is justice for our people, there will be no peace.”
In an earlier statement on December 9, DARE alleged that basic health measures against the virus were being ignored within the ACI: “From the beginning of the pandemic, over and over again, community members, public health experts, and organizers called on the Governor, [the Department of Health], [DoC], and the [attorney general] to take the recommended precautions. And yet we are currently watching as hundreds of our incarcerated community members – disproportionately Black, brown, and low-income people – have become infected and disease is rapidly spreading inside a place already notorious for abusive conditions and substandard healthcare.… There is no possible excuse for what has happened to our loved ones. They have been held in inhumanely restrictive conditions for nine months, with severely limited access to showers, phone calls, and time outside, without access to educational programming or video visitation with loved ones. We were told over and over again by [DoC] that these measures were necessary for their safety. Yet we continued to get reports long into the fall that the most basic recommended measures – such as providing prisoners with more than one mask and supplies to clean them – were not followed. We are now learning from family members that COs [correctional officers] are returning to work a week after testing positive. That COs do not consistently wear their masks in common spaces and around prisoners. That prisoners testing positive or still showing symptoms are grouped together and put back into units and cells with those who are healthy, and simply told to stay six feet apart.”
In the DoC statement announcing the inmate death, Director Patricia A. Coyne-Fague said, “It is clear that we must continue our efforts to mitigate the spread of COVID-19. Thanks to the hard work and dedication of our medical and security staff, we have not experienced the heartbreaking losses that other [departments of corrections] across the country have. However, this is a strong reminder as to why we must continue to wear our masks, get vaccinated, and follow our health safety protocols to keep everyone as safe as possible.”
At the regular meeting on Friday, December 18, the RI Department of Health Vaccine Sub-Committe adopted guidance for five subphases of Phase 1 of the RI vaccination priority groups, expected to take a minimum of three months. The second highest priority subphase 1.2 includes corrections staff working in physical and mental health, and also includes incarcerated persons at high-risk because they are immuno-compromised, 65 years of age or older, or other factors. The third highest priority subphase 1.3 includes all other correctional officers and staff. Most incarcerated persons are not on the priority list for vaccination at all.
RI COVID-19 vaccine update: Shortages, priority criteria, pregnancy, equity
A press briefing from the RI Department of Health (RI DoH) COVID-19 vaccine team late in the afternoon on Wednesday, December 16, sounded like a victory lap: Everything was going to plan, the complicated series of deliveries of the Pfizer vaccine – so far the only one granted an Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) – was arriving at hospitals, and nearly 500 high-risk, front-line healthcare workers had received the first of two required injections. Nearly 10,000 doses of the Pfizer vaccine were scheduled to arrive this week and another 10,000 doses were scheduled to arrive next week. If the FDA approves an EUA for the Moderna vaccine later this week as expected, about 19,000 doses would arrive next week.
UPDATE: The FDA approved an EUA for the Moderna vaccine late Friday night, December 18. An emergency meeting of the RI DoH Vaccine Sub-Committee is expected to be scheduled imminently, probably Monday morning.
Tricia Washburn of RI DoH said at the press briefing, “As of the end of day yesterday [Tuesday] in Rhode Island, we had received 4,875 doses of the Pfizer vaccine: of that 2,925 were received by the Lifespan healthcare system among Rhode Island Hospital, Miriam Hospital and Newport. And then the remaining doses were received, 1,950 doses received by the New England healthcare system among Kent Hospital and Woman and Infants hospital. And as of yesterday, the total number of front-line healthcare workers that were vaccinated was 489. We’re thrilled at the progress that we are making.”
The “pause” in RI, now expected to last three weeks, is working, as all leading metrics – percent positive in testing, new hospital admissions, and new cases per capita – have decreased this week compared to last week. As of December 17, the CDC reported that RI, recently in worst place for per capita daily cases, had improved to third place (behind Tennessee and Oklahoma).
The next day, Thursday, December 17, a late afternoon statement was issued by Gov. Gina Raimondo that, shortly after the Wednesday press briefing, the state had been informed by the federal government “the state’s allocation of the Pfizer vaccine for Week 2, beginning 12/21, was reduced from 10,725 to 6,825 doses. We have heard accounts of similar reductions in other states, and no clear explanation has been provided by Operation Warp Speed.”
As we previously reported, almost all of the second week supply of Pfizer vaccine in RI was allocated for nursing homes. Mckenzie Morton, the meeting facilitator for the RI DoH Vaccine Sub-Committee, told Motif after their regular weekly session on Friday, December 18, “While there was a change in vaccine supply, this did not impact our prioritization or distribution strategy.” Nursing homes and other long-term care facilities were scheduled to receive 50% of their needed supply next week and the remaining 50% the following week, but because of the decreased supply will instead receive 25% each of the next four weeks. “This additional flexibility has allowed us to stay on course with our plan while not disrupting the plan to vaccinate nursing home staff and residents,” she said. The order in which nursing home residents and staff will be visited by teams from CVS and Walgreens, the contractors chosen by the federal government for the task, will not change, concentrating on where the virus presents most risk due to prevalence. “The prioritization by geography and other factors has been a mainstay of our plan since day one due to RI’s focus on equity as a principle that guides all of our decisions,” she said.
The company issued a statement saying, “Pfizer is not having any production issues with our COVID-19 vaccine, and no shipments containing the vaccine are on hold or delayed. This week, we successfully shipped all 2.9 million doses that we were asked to ship by the US Government to the locations specified by them. We have millions more doses sitting in our warehouse but, as of now, we have not received any shipment instructions for additional doses.”
The unexpected decrease in allocation led to a round of finger-pointing between Pfizer and the federal government, according to numerous news sources, including Bloomberg and The New York Times. According to both, the immediate cause of the confusion was the federal government changing their day of allocation from Friday to Tuesday in response to pleas from states to get information earlier, leading to allocations using earlier and therefore smaller numbers, effectively delaying shipment from warehouses by one week. According to Bloomberg, the federal strategy of holding back supply for second required second doses also plays a role.
Raimondo continued, “We are calling on the Trump administration to honor its commitments and provide the full allocation to Rhode Island. In the meantime, we are continuing to distribute the vaccine as quickly as possible to our frontline healthcare workers, and we are evaluating the impact of these reductions on our vaccination planning.”
The main topic of the RI DoH Vaccine Sub-Committee at their regular meeting on Friday, December 18, was finalizing a recommendation for the criteria for Phase 1 of the vaccination effort. Due to the limited supply of vaccine and resources to administer it, Phase 1 is expected to take a minimum of three months. Under the recommended criteria, an estimated 150,000 people – 15% of the state population – will be eligible within the five subgroups named in order of decreasing priority as Phases 1.1 through 1.5. Within subphases 1.1 and 1.2, the plan distinguishes those who will be vaccinated directly under the state program and those who will be vaccinated by pharmacy contract partners (that is, CVS and Walgreens). Contractors are expected to visit 295 sites, according to Alysia Mihalakos of RI DoH at the Wednesday briefing.
In Phase 1.1, hospital staff, EMS, home-health and hospice workers will be vaccinated directly, while nursing home staff and residents will be vaccinated by contractors. In Phase 1.2, vaccinators, community healthcare staff, COVID-19 specimen collectors, urgent care clinic staff, pharmacists, corrections medical and mental health workers, and high-risk incarcerated persons (over age 65, immuno-compromised, or other high-risk factors) will be vaccinated directly, while other long-term care facility staff and residents (assisted living, group homes, elderly housing with residential services) will be vaccinated by contractors.
Phase 1.3 covers firefighters; law enforcement; targeted high-density communities; COVID-19 testing lab staff; public health and emergency preparedness workers; school nurse teachers; harm reduction staff; patient-facing clinical students; community and family caregivers, and corrections officers and staff. Phase 1.4 covers dentists; outpatient providers; dialysis center staff; staff handling donations of blood, organs, or tissue; morticians, death care, and funeral home workers. Phase 1.5 covers individuals being treated through specialty health care providers for multiple co-morbid conditions.
Pregnancy and Breastfeeding
Considerable attention has been accorded to the advice that women who are or may be pregnant, or who are breastfeeding, should consult with their PCP in deciding whether to be vaccinated, but what advice should be given to PCPs how to counsel patients?
At the Wednesday press briefing, Pablo Rodriguez made attendees aware of a formal practice advisory just released from the American College of Obstetricians and Gynecologists – acog.org/clinical/clinical-guidance/practice-advisory/articles/2020/12/vaccinating-pregnant-and-lactating-patients-against-covid-19 – which states, “Important considerations include: the level of activity of the virus in the community; the potential efficacy of the vaccine; the risk and potential severity of maternal disease, including the effects of disease on the fetus and newborn; the safety of the vaccine for the pregnant patient and the fetus.” The statement continues, “Vaccines currently available under EUA have not been tested in pregnant women. Therefore, there are no safety data specific to use in pregnancy… Pregnancy testing should not be a requirement prior to receiving Pfizer-BioNTech vaccine. Pregnant patients who decline vaccination should be supported in their decision.”
An article published December 17 in The Lancet, generally regarded as the most prestigious medical journal in the UK, noted that the lack of data about drug safety in pregnancy is a result of 75% – 80% of studies excluding pregnant women by protocol, even in relatively low-risk innocuous situations: “Of 35 studies that evaluated high-dose vitamin treatment for COVID-19, 27 (77%) excluded pregnant women.”
At the Wednesday press briefing, Philip Chan of RI DoH and Brown Medical School answered a question from Motif about how to advise pregnant patients in considerable detail, giving practical advice. “First off, I do want to say that the studies are in progress. So as we every single week, every month here, is that we are going to have more and more accumulating data certainly about the vaccine and pregnancy. Certainly as people start to get vaccinated, we’re going to have a whole lot of information in the near future.”
Chan continued, “What I do when I talk to my patients about things like this, I have to look at the person, I have to understand who the patient is in front of me. I have to understand what their risk is of COVID-19. So I have some colleagues that are pregnant, who are testing and treating COVID-19 in the hospital. So to me, that’s a really high-risk situation, and I would be more likely to encourage someone in that situation to get the vaccine. If there’s an average Rhode Islander who is at home or working from home, pregnant, who’s not coming into known contact with COVID-19 on a daily basis, I may be more likely to tell them to hold off on the time being until we receive more data. So that’s why it’s a little bit more of this nuanced individual discussion: You want to take into account, obviously, a person’s values, obviously hear what their concerns are. But as a physician, you also want to take into account their exposures in order to best best guide them. So that’s how I think about it, and that’s why we’re sort of encouraging people to have an individual level discussion with their primary care provider.”
In response to a follow-up question from Motif whether there was any evidence that pregnant and breastfeeding women should not be vaccinated, Chan said there was not. “If we – the scientific community, public health physician community – if we had any reasons to suspect this vaccine was a danger to individuals that were pregnant or breastfeeding, then absolutely we would not recommend it. But your point is, there’s no evidence and there’s no biological indications or thought process that it would be damaging, which is why, in general, the CDC [and] we feel comfortable at least offering it to pregnant women, especially because of some of the potential complications that can arise from COVID-19 and pregnancy.”
Equity of Access
In response to a question from Motif about equity of access at the Wednesday briefing, especially to contractor-provided vaccinations, reaching both nursing home residents and staff who may have significant disabilities, including cognitive disabilities, as well as limitations of English language and transportation, Mihalakos said, “We have asked [contractors] for the their language capability, and hope that, as they’re going through their recruitment process, that they are recruiting staff who are reflective of the communities that they’re going to be serving.”
Mihalakos said, “One-hundred percent of staff in those facilities will be offered the vaccine, and one of the challenges and one of the factors that we’re considering is that if – there is no finalized plan for this, I want to be really clear on this – but one of the things that we’re exploring is that if we offered more opportunities so that we can safely rotate staff so that they’re not all getting vaccinated at once… we want to ensure that the folks who who don’t have easy access to transportation are vaccinated on site and those who do have transportation are able to drive to a vaccination site. We want to make sure that people for whatever reasons are not blocked from the opportunity to be vaccinated. So as we learn more about what the opportunities are, we will work with the leadership of the nursing homes, and after that the assisted livings, the group homes, and the residential care facilities to ensure that they all know and understand that as well, so that when they’re making decisions about the staff. We don’t have the same concerns about the residents: all of the residents can get vaccinated at the same time, because we don’t have that same concern about protecting the protectors. But we want to ensure that all staff have absolute, unfettered access to getting vaccinated.”
In response to another question from Motif about outreach to home healthcare workers who would not be covered as nursing home staff, Mihalakos said, “We’ve begun the conversation with the administrators of the home health agencies to let them know what our expectations are for the first round of available vaccination, which is via regional pod model. So at the same time the municipalities will be activating those points of dispensing, we will be offering that opportunity up to all home health and hospice workers to ensure that they have access as well. It is imperfect because it is a regional model.”
Mihalakos continued, “We’ve been talking to the leadership of the trade organization that represents home care about this opportunity. We also queried all of the home health agencies to see who was willing to vaccinate both their own patients when we get to that phase and individuals with co-morbidities who may be covered by home care workers already, but also because we know that there are several large home health agencies in the state that already provide vaccination services to other home health agencies that are near them. So we may be able to leverage that opportunity with a dozen or more large home health agencies that have have raised their hands and said yes, they’re willing to help with this initiative. So we’re going to try to create the broadest coverage we can… We have pledged to then survey after we go through the first round to see what type of coverage we got so that we understand what may have been due to people’s either unwillingness to get vaccinated at the time or not having a level of interest of getting vaccinated at the time that they were offered, or if there were other barriers to them getting vaccinated so that we can create more targeted approaches.”
Hold the Line: Best times to telephone RI Unemployment Insurance
The telephone help line for RI Unemployment Insurance has been so busy since the now-three-week “pause” beginning on November 30 that some callers are told by the automated attendant the queue is full and to call again later before it just hangs up on them. We reached out to the RI Department of Labor and Training (RI DLT), which operates the help line, and they said they are aware of the problem but are unable to quantify its extent.
DLT did, however, provide extremely helpful information that could guide strategy in when to call. Their volume is heavily weighted early in the day, so simply calling later is more likely to get through. As of August, the 401-415-6772 call center hours are Monday–Thursday 8am – 6pm, Friday 9am – 6pm, and Saturday 8am – 11:30am.
Claim-specific inquiries can be directed to the call center, but general information is available on the DLT website: dlt.ri.gov/faq
First prison-associated COVID-19 death in RI
RI experienced its first COVID-19 death associated with the state prison system among either staff or inmates, the Department of Corrections confirmed to Motif.
In a statement dated Monday, December 14, Director Patricia A. Coyne-Fague said, “It is with a heavy heart that I must report the loss of Lt. Russell Freeman, who passed away early this morning from complications of COVID-19.” Freeman was graduated from the training academy in 1991 and promoted to lieutenant in 2014. He is survived by his wife, Lisa Favino-Freeman, who is also a correctional officer, and three children. Arrangements are in process and will be announced when they are completed, the statement said.
Prisons have been a serious locus of COVID-19 cases and deaths, second only to nursing homes as high-risk congregate care facilities. According to the Marshall Project in co-operation with the Associated Press, as of December 11 there have been 1,657 inmate deaths nationally but only six states (Maine, Nevada, New Hampshire, Rhode Island, Vermont, Wyoming) have reported none, out of 249,883 inmate cases (of whom 166,382 have recovered). Staff are associated with COVID-19 risk carrying infection both into and out of correctional facilities. As of December 11, the Marshall Project reports 108 staff deaths, out of 62,171 cases (of whom 40,972 have recovered).
RI has been relatively fortunate, with 605 inmate cases and 232 staff cases, according to the Marshall Project. (UPDATE: The official DoC Facebook page reports 731 inmate cases and 271 staff cases as of last week.) Some states have reported catastrophic rates of infection among their inmate population: 70.2% in South Dakota, 59.6% in Kansas, 49.8% in Iowa, 49.7% in Michigan, 44.5% in Wisconsin, 43.4% in Minnesota, 43.2% in North Dakota, and another 17 states between 40% and 20%. Among inmate deaths, there have been 189 in Florida, 167 in Texas, 116 in Ohio, 94 in Michigan, 93 in California, and 82 in Georgia.
On a national basis, researchers have been extremely critical of how prisons and jails responded to the pandemic threat. In a report released this month by the Prison Policy Initiative, Research Director Wendy Sawyer and sociology professor Gregory Hooks of McMaster University wrote:
Since the beginning of the pandemic, it was abundantly clear that the crowded and unsanitary conditions in American prisons and jails would facilitate the rapid spread of the virus, putting incarcerated people and staff at serious risk once the novel coronavirus entered facilities. Officials across the country ignored the threat for too long, perhaps imagining that confined populations would be too isolated from the outside world to contract the virus. But the boundaries between life “inside” and surrounding communities are actually quite porous, with staff, vendors, volunteers, and visitors constantly flowing in and out of correctional facilities — not to mention the frequent turnover and transfers of incarcerated people themselves.
RI did react early by shutting down visitation and other risks, but it is impossible to completely prevent transmission of the virus in a prison, and until now the state has been the beneficiary of a combination of small size and dumb luck, the latter of which has finally run out – especially for Lt. Freeman and his family.
A Shot in the Arm: COVID-19 vaccine approved for use in RI, starts arriving
Approval was granted this morning at an emergency meeting of the Vaccine Sub-Committee at the RI Department of Health (RI DoH), conducted virtually, to begin administering vaccines against COVID-19. According to Mckenzie Morton who acted as meeting facilitator, the vote was 95% in favor.
The supply of vaccine will be severely limited, and at this point, the state has been given no projections beyond the next two weeks, according to Alysia Mihalakos, the chief of the Center for Emergency Preparedness and Response at RI DoH. “It’s an amazingly exciting day. It was a whirlwind of activity all weekend long preparing for today,” she said. The Monday emergency meeting was the result of a call at 2pm Sunday, she said.
Early in the meeting, the “guiding principles” of the sub-committee were reviewed: “Safety is paramount,” “Minimize morbidity,” “Efficient distribution,” and “Access.”
The RI authorization allows “high-risk” front-line healthcare workers 16 years of age or older to be vaccinated. Each hospital or healthcare provider is responsible for defining and assessing “high-risk” in this context. Several different vaccines from different makers are in the approval pipeline, and so far the US Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to only the Pfizer vaccine this past Friday, December 11, but is expected to authorize the Moderna vaccine within the next few days. Two doses are required for full effectiveness, 21 days apart for the Pfizer vaccine and 28 days apart for the Moderna vaccine. In trials involving 30,000 volunteers each, both vaccines were shown to be 95% effective at preventing COVID-19 disease, an extremely high level of vaccine efficacy.
Nursing home residents were moved by the federal guidance into the top priority, Mihalakos said, “which shifted our operational planning.” The Pfizer vaccine, shipped in 975-dose batches, will arrive in RI with 9,750 doses this week and 10,725 doses next week, she said, which is consistent with what has been planned for the past two weeks. All of the doses this week and 975 of the doses next week are allocated to healthcare workers. Meeting approximately half the need requested, 9,750 of the doses next week are allocated to nursing homes to be distributed through CVS and Walgreens as partners with the state. RI also expects to receive “19,000-ish” doses of the Moderna vaccine within the next two weeks, she said, assuming it follows a smooth approval process similar to the Pfizer vaccine. Vaccine shipments will be arriving today (Monday) at RI Hospital and Newport Hospital; tomorrow (Tuesday) at Kent County Memorial Hospital, Women and Infants Hospital, and Miriam Hospital; then Thursday at Landmark Medical Center, South County Hospital, and Roger Williams Hospital. Much of the initial allocations reflect logistical constraints because the Pfizer vaccine is shipped in such large batches and has to be stored in special freezers below -80°C. Roger Williams, which has the necessary freezer, will share with Our Lady of Fatima Hospital, which doesn’t. Bradley and Butler hospitals will be covered by their parent organizations this week, but are expected to get direct shipments next week of the Moderna vaccine that has much less stringent storage requirements and is shipped in smaller batches. Westerly Hospital and Eleanor Slater Hospital, because they have fewer staff, will get their vaccines through the redistribution system used for nursing homes.
Considerable discussion at the meeting concerned special situations, such as whether pregnant or breastfeeding women should be vaccinated. Guidance from the Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention (CDC) is that this is a decision for individual patients to make in consultation with their regular physician, taking into account their risk of exposure and risk of bad outcome from pre-exisiting underlying conditions, but several sub-committee members expressed concern with the practical consequences of that advice. Will Giordano-Perez said, “I think it’s important to notify people that they have the opportunity to talk to their PCP, however, we’ve not prepared at all any of our PCPs in this state to really discuss, I think, at length and give recommendations as far as whether or not someone is prepared, or should, or is a candidate for vaccination. I just want to be mindful of that because I know a lot of the PCPs are just going to be like, ‘I have absolutely no idea. Should you get it? I don’t know.’” He continued, “I think that could be a really big burden on PCPs, especially if they’re not properly prepared or haven’t had an opportunity to review the data. I think it will be important whatever we decide here.” Pablo Rodriguez echoed his concern, saying he had been in touch with OB/GYN practitioners and midwives who feel “completely up in the air” as they are waiting for clear CDC guidance. “The statement in the [FDA] Emergency Use Authorization is ‘There is inadequate data on pregnant and breastfeeding women to assess the safety and efficacy of the vaccine,’ so we understand that is going to be a unique challenge for which there is not a strong answer,” Mihalakos said.
Utpala Bandy stressed the importance of providing advice to physicians, noting with regard to known side effects of vaccination, “The main concern is fever, because pregnant women and fever are not a good mix. And fever has been associated with adverse pregnancy outcomes, especially early pregnancy, so the simple answer to that is they should be counseled to be taking Tylenol and that routine testing for pregnancy prior to receipt of the COVID vaccine is not recommended.” She said, “These kinds of non-live vaccines are routinely given to pregnant women, anyway, but not the mRNA, which is a little more innocuous than the [vaccines] we already give them, such as pertussis, such as influenza.” (Both the Pfizer and Moderna vaccines are mRNA-based, containing no virus particles at all.)
Mihalakos reviewed the federal guidelines for vaccination: patients who previously had COVID-19 infections should be vaccinated, although those treated with monoclonal antibodies or convalescent plasma should wait 90 days after treatment; patients who received any other vaccine should wait 14 days; patients with active and symptomatic COVID-19 infection should wait until symptoms subside and at least 10 days after ending isolation. Patients with a history of severe allergic reaction (that is, anaphylaxis) to vaccination should be individually evaluated, and should be monitored for 30 minutes following vaccination; provided that patients with known allergies to specific ingredients in the vaccine (including lipid nanoparticles and polyethylene glycol) should not be vaccinated. Patients with general allergies (food, pets, insects, environmental, latex, oral medication) or a family but not personal history of anaphylaxis can be vaccinated.
Several members, including Giordano-Perez, Joan Kwiatowski, and Chris Abulime, said they wanted to see assurances of equity in vaccine distribution, with outreach to the minority community. Larry Warner expressed a concern about information being made available to visually impaired and non-English speaking patients. “The CDC has pledged to put everything out in 25 languages, so we’re hoping they will do some of the heavy lifting for us,” Mihalakos said, assuring him that this issue would be addressed. Tricia Washburn of DoH cautioned that such issues were beyond the scope of today’s emergency meeting, which is restricted by the state Open Meetings law, but would be discussed at the regular meeting this coming Friday, December 18, along with broader operational matters.
“After a rigorous scientific review, we know that COVID-19 vaccine is safe. We also know that it is one of the most effective vaccines ever developed,” said RI DoH Director Nicole Alexander-Scott, in a statement. “In the coming weeks and months, as vaccine becomes more available, getting vaccinated will be one of the most powerful things you can do to keep yourself and the people you love safe from COVID-19. We are going to work to ensure that every person in every community in Rhode Island has access to the vaccine, especially those communities hardest hit by this virus.”
“We have never had a vaccine that has been – or will be – more closely monitored than the COVID-19 vaccine,” said Philip Chan, consultant medical director for the RI DoH Division of Preparedness, Response, Infectious Disease, and Emergency Medical Services, in the same statement. “Teams of scientists at the national level have been scrutinizing thousands of pages of technical data for weeks, focusing on vaccine effectiveness, safety, and the manufacturing process, and our own local review has happened here in Rhode Island. I absolutely plan on getting vaccinated when it is my turn.”