Category: Breaking News

A new “variant of concern” (VOC) for the virus that causes COVID-19 has today been assigned Greek letter “Omicron” by the World Health Organization (WHO) at an emergency meeting of the organization’s Technical Advisory Group on SARS-CoV-2 Virus Evolution (TAG-VE).

In the particular case of the new Omicron variant, designated B.1.1.529 in the PANGOLIN nomenclature, its prevalence where found so far in South Africa and Botswana strongly suggests that it is more highly transmissible than the Delta variant B.1.617.2 it supplanted. “This variant has a large number of mutations, some of which are concerning. Preliminary evidence suggests an increased risk of reinfection with this variant [in patients recovered from infection from another variant], as compared to other VOCs. The number of cases of this variant appears to be increasing in almost all provinces in South Africa,” the WHO said in a statement.

According to WHO, the first known case of the Omicron variant was found in a specimen collected on Nov 9. According to the PANGOLIN sheet, it was first sequenced for detection on Nov 11.

WHO TAG-VE said that while standard tests are able to detect the Omicron variant, one of its characteristic mutations, called “S gene dropout,” causes one of the components of ordinary polymerase chain reaction (PCR) analysis to fail, and “this test can therefore be used as marker for this variant, pending sequencing confirmation. Using this approach, this variant has been detected at faster rates than previous surges in infection, suggesting that this variant may have a growth advantage.”

Whether the Omicron VOC exhibits harmful behavior beyond increased transmissibility, such as increased virulence or increased resistance to vaccines and treatments, is not yet known and is unlikely to be known for several weeks, but at this time there is no evidence for it. Vaccines work by training the immune system using proteins present on the outer surface of the virus, so in theory the more mutations a variant exhibits the greater the risk that the immune system trained by either a vaccine or a prior infection will be unable to recognize the variant as effectively.

Promoted from status as a “variant under monitoring” (VUM), the VOC designation of Omicron is the most severe classification, used for variants with significant genetic mutations that demonstrate, at a level of global public health effect, evidence of increased transmissibility, increased virulence, or increased ability to escape tests, vaccines, or treatments. The status of “variant of interest” (“VOI”) is between the two, with evidence of significant mutations and consequence but not yet affecting global public health. WHO assigns Greek letter designations to VOIs and VOCs to aid in public recognition: there are currently four active VOCs (Alpha, Beta, Gamma, Delta) and two VOIs (Lambda, Mu) prior to the new Omicron designation. Variants demoted from VOC or VOI to VUM retain their Greek letters (Eta, Iota, Kappa, Theta).

Shortly after the WHO announcement, President Joe Biden issued a statement that the US would ban travel from a number of African countries: “As a precautionary measure until we have more information, I am ordering additional air travel restrictions from South Africa and seven other countries. These new restrictions will take effect on November 29. As we move forward, we will continue to be guided by what the science and my medical team advises.” Biden further said the best way for Americans to protect themselves is to get a booster shot if they have already been vaccinated and to get vaccinated if not already.

Biden noted the global spread of the pandemic: “Finally, for the world community: the news about this new variant should make clearer than ever why this pandemic will not end until we have global vaccinations. The United States has already donated more vaccines to other countries than every other country combined. It is time for other countries to match America’s speed and generosity.”

Maureen O’Gorman was so eager to schedule a COVID-19 vaccination for her 10 year-old daughter Charlotte that she began refreshing her web browser repeatedly 15 minutes before appointments opened yesterday at 2:00pm. They were able to obtain a 7:30am slot this morning at the state-run Sockanosset facility when it opened, making Charlotte one of the first in RI to receive a dose of the Pfizer pediatric vaccine.

In addition to vaccination appointments at state-run facilities and independent pharmacies at vaccinateri.org there will be children-only clinics at schools with a continuously updated list at covid.ri.gov/5to11vaccine. Every school clinic is open to all children aged 5-11 regardless of which school they attend or where they live. Chain pharmacies (including CVS, Walgreens, Walmart, and Stop and Shop) offer scheduling through their own web sites. Family and pediatric medical offices are in many cases offering vaccinations with further information available by contacting the office directly. (See “RI Children Ages 5-11 Likely Start COVID-19 Vaccinations Nov 8”, by Michael Bilow, Oct 27.)

UPDATE: On November 5, the RI Department of Health (DoH) cautioned that it is important to register for vaccination in advance: “Vaccination sites plan the amount of vaccine to have on hand using registration information. People who arrive at vaccination clinics without appointments may not receive a vaccine if there is not enough supply at the clinic. Registering in advance is the best way to guarantee that a dose will be on site for your child.”

Charlotte herself has been eager to be vaccinated. When she received her flu shot a few weeks ago, she joked that she was “practicing” for her COVID-19 shot. “Everyone there, they were really comforting. ‘It’s not going to hurt. We’ve got your vaccine.’ Everyone was very nice. It was fun,” Charlotte said about her experience, but “I don’t feel any different.” The Band-Aid hurt more than the shot, she said.

Maureen said that the facility was well set up; she was surprised there were not more children in queue, but guessed that the early morning time might not be popular although hers was one of three or four family groups in that time slot. It worked out well for them, she said, because they could go on their way before school and work.

“They had a separate shot area. They had three stations set up to handle kids in a separate area with a separate waiting space. There were coloring pages during your wait period. They gave all the kids a fidget spinner. They asked which arm they wanted,” Maureen said. “There are three kids named ‘Charlotte’ getting their shot at Sockanosset today,” so the facility was careful to distinguish by surname and date of birth, she said.

Maureen works as an educational supervisor and as an adjunct college professor. “I decided to get Charlotte vaccinated because, with the holidays coming up, she’ll be mixing with people of all ages and I want to make sure that everybody involved is as safe as possible, for her health and the health of those around her. I also consider it very high priority because I work in a congregate care setting… that’s had several outbreaks, so she’s at high risk of exposure through me,” she said. “I want to keep her as safe as possible. At the beginning of this, she actually stayed with relatives, but now that’s not practical because of the spotty nature of the thing and she has to go to school in person.”

Nationally, non-profit organization focusing on health issues KFF reported parents of children aged 5-11 attitudes toward COVID-19 vaccination: 34% eager, 32% wait and see, 7% only if required, and 24% definitely not. KFF separately explained, “This means there initially will likely be high demand for vaccines, when scale up and distribution issues noted above may pose challenges. After this initial surge, however, the primary challenge is likely to shift to addressing concerns or questions that contribute to reluctance to vaccinating younger children.”

The RI Department of Health (DoH) recommends COVID-19 vaccination for everyone eligible. DoH said in a statement yesterday, “Children of all ages can become ill with COVID-19. Most children do not become as sick as adults. However, some children become severely ill with COVID-19. Children with underlying conditions, such as obesity, diabetes, and asthma, may be at higher risk of serious illness with COVID-19. Since the start of the pandemic, 194 children 14 and younger have been hospitalized in Rhode Island with COVID-19. Additionally, children can spread COVID-19 to the other people in their lives (who may be more vulnerable).”

A personal experience started Maureen thinking that an encounter with COVID-19 infection could “come back to haunt” Charlotte long into the future: before she was old enough to attend school herself, Maureen caught chicken pox from her older brother, a typical childhood case that was almost forgotten until decades later, in 2020, when she had an outbreak of shingles as an adult.

“I know that in most kids COVID-19 is not a big deal, and you could probably count on one hand the number of children my daughter’s age who have died of COVID-19, but nowadays post-polio syndrome is a thing and people who had chicken pox get shingles [later in life]. We don’t know what the COVID virus that lies in your body is going to look like in 30 or 40 years. So I’m kind of thinking long-term on this. I don’t consider her high-risk at this moment in time; of course she could get COVID and she is low risk for immediate danger now, however I don’t know what carrying COVID in her body for 30 or 40 years, what that would look like. So my middle-aged daughter will be thanking me someday.”

Maureen emphasized, “Charlotte will never get shingles because she got the chicken pox vaccine. Charlotte will never get post-polio because she will never get polio thanks to a vaccine. I do not know what post-COVID will look like in 2058, but Charlotte will never need to worry about it.” In other words, from a cost-benefit perspective the risks of not vaccinating are substantial and unknowable, while the risks of vaccinating are quantifiable and understood.

“I don’t have any anxiety about the vaccine. My understanding is the only serious side effect is the myocarditis [heart inflammation] that’s only been an issue with males, and insofar as I’m aware there are no cases of that not resolved successfully,” she said. “It’s easy for me to be brave and say I have no concerns about the vaccine, but I have a daughter so, right then and there, we’re talking about a myocarditis risk that goes from a very slim chance to effectively zero chance,” she said.

Disclosure: Maureen O’Gorman is an occasional contributor to Motif. She wrote about the first day of drive-through COVID-19 testing in RI (“Drive-Thru for COVID-19 Test: These efficient test sites will help RI reach the goal of testing 1,000 Rhode Islanders a day”, Apr 1, 2020).

September 17, 2021 — In an all-day meeting that became somewhat disorganized at the end, the Vaccines and Related Biologic Products Advisory Committee (VRBPAC) of the US Food and Drug Administration (FDA) recommended, by unanimous 18-0 vote, authorization for third booster doses of the Pfizer COVID-19 vaccine, officially now called Comirnaty, but restricted to those either age 65 and older or at “high risk of severe COVID-19.” By informal poll, the committee also recommended including in the latter category health care workers and others at increased likelihood of exposure by virtue of occupation. Exactly who is at “high risk” will be left to the Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention (CDC) who are expected to meet next week. Basic eligibility for booster doses kicks in six months after primary vaccination has been completed.

This unplanned vote was taken after the planned vote on authorizing third booster doses for the general public without age or other restrictions was resoundingly defeated, 16-2. The consensus expressed by the members seemed to be that the data provided by Pfizer with their application was of low quality and based on a study with small sample size of 330 test subjects. The cost-benefit balance was clearer, the committee clearly thought, with older people whose immune systems are naturally and normally less robust. Because vaccines work by teaching the immune system to recognize a virus, the effectiveness of a vaccine is ordinarily reduced with age.

The first vote was a blunt rejection of expressed desire for widespread booster dose authorization sought by Pfizer and the Biden administration. While the FDA is not obligated to follow the recommendations of its advisory committees of outside experts, it is extremely rare for them to be overruled.

Most of the questions from the committee were directed to guest experts from the Israeli Ministry of Health and the Weizmann Institute. Israel leads the world in vaccinating its population, approximately three months ahead of the US and the UK, and made the decision to authorize third booster doses beginning in July in phases, first to age 60 and older and eventually within a few weeks down to age 16 and older. The Israeli experts said that the virus reproduction rate, known as R0 (“R-nought”), was about 1.3 when booster doses began to be administered, a bad situation corresponding to a doubling of infections every 10 days, and fell to 0.96 by the end of August, a slight day-to-day decrease in total infections. They said that their model predicted that without booster doses the entire hospital capacity of the nation would have been exhausted by the beginning of September.

The Israeli experts emphasized that the vaccines even without a third booster dose remained very protective, but they observed a reduction in effectiveness from 97% after initially completing full vaccination to 85% six months later. While any vaccine more than 50% is medically valuable, they explained that these numbers implied a breakthrough rate of 3% (=100%-97%) rising to 15% (=100%-85%), a five-fold increase. Officially, the committee was supposed to consider only the data submitted by Pfizer with the application, using the Israeli data only for general guidance.

Because almost all useful data on the virus now must be derived from real-world observational studies rather than randomized controlled trials, it is difficult if not impossible to determine whether increasing occurrences of breakthrough infections are attributable to waning vaccine effectiveness per se or to other factors such as the nearly universal prevalence of the newer delta variant of the virus. Such statistical confounding factors left the committee unsure of how to compare risks and benefits. Ultimately, the committee was concerned that booster doses in young people might cause rare but significant adverse effects, such as myocarditis (inflammation of the heart muscle), and seemed to conclude that the data were insufficient to compare such risks to those resulting from COVID-19 infection.

There was a clear expectation that Pfizer would reapply for authorization of booster doses for the general public without age restriction once they had better data.

The US Food and Drug Administration (FDA) today approved full licensure for the two-dose Pfizer-BioNTech COVID-19 vaccine that was given Emergency Use Authorization (EUA) on December 11, 2020, for recipients age 16 and older. It will now be known under the trade name “Comirnaty” (pronounced koe-mir’-na-tee). The identical vaccine will continue to be available under EUA issued May 10, 2021, for recipients ages 12 to 15 and under subsequent EUA as a third dose for immuno-compromised recipients.

About 92 million people in the US have been administered the Pfizer vaccine under EUA. Full approval is expected to persuade some who have been hesitant to get an “experimental” vaccine. Full approval may also smooth legal obstacles to COVID-19 vaccine mandates by public and private employers and schools, where existing vaccines (such as for measles, mumps, and rubella) are already mandated.

In a statement, the FDA said approval was based upon clinical trial data from both before and after the EUA, including one for effectiveness with 40,000 participants and one for safety with 44,000 participants, in each case half receiving the vaccine and half receiving a placebo. The vaccine was found 91% effective in preventing sickness from COVID-19. About 12,000 vaccine recipients were monitored for adverse events for at least six months.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”

In Rhode Island, free vaccination sites can be found on the state government web site vaccinateri.org for the general public, as well as more than 100 back-to-school clinics in communities listed at back2schoolri.com.

RI Gov. Dan McKee said in a statement, “To anyone who was on the fence, the science is crystal clear. These vaccines are safe, and they are very effective at keeping people healthy. It is time. It is time to protect yourself. It is time to protect your family. It is time to get vaccinated. We have vaccination opportunities available in communities across Rhode Island. If you have not gotten your shot, get vaccinated today.”

“The FDA did an extremely thorough review of this vaccine and reaffirmed that it absolutely was safe,” said RI Director of Health Nicole Alexander-Scott, MD, MPH, in a statement. “It is undeniable that the COVID-19 vaccines save lives. If you are eligible, get vaccinated today to protect you and your family. It’s easier than it has ever been before.”