An independent panel of advisers from the Centers for Disease Control and Prevention voted to roll out the new COVID-19 booster shots, clearing the way for CDC Director Rochelle Walensky to give the final go-ahead of the boosters some Thursday evening. or Friday and for injections to be administered shortly thereafter.
The new booster shots have been updated to target two different strains of COVID at once: the current omicron subvariants, BA.4 and BA.5, which account for 99% of new cases in the US, and the original strain of COVID-19.
This is the first time that current COVID-19 vaccines have had a major update. In the future, experts hope vaccines can be periodically updated to match current strains, just as the flu vaccine is slightly different each year.
Public health officials directed vaccine companies to create a bivalent vaccine, a vaccine that targets two different strains, in hopes that the compilation will provide broader protection against COVID this fall and winter. as infections could increase with the flu season, the cold. time and more time inside.
“It matches what’s currently circulating. And the hope here is that by increasing the amount of antibodies that we have against that particular variant, we’ll restore the kind of protection that we had when we saw these vaccines come out in the latter part . of 2020, early 2021, where we had very good protection against symptomatic disease,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told reporters at a briefing Wednesday morning press
“We don’t know for sure yet if we’re going to get to the same level, but that’s the goal here. And that’s what we think the evidence we’ve seen helps point to,” Marks said.
Marks also emphasized that it’s not just about boosting antibodies to boost immediate protection, but working toward annual shots instead of boosting every few months.
He said he’s hopeful the release of dual-purpose reinforcements now will stem an incoming winter wave and “hopefully they’ll bring us the protection we need through October, November and December to avoid another way that shuts down things like plans on vacation”.
The FDA issued its emergency use authorization for the updated booster shots Wednesday morning. On Thursday, the CDC advisory panel publicly reviewed the data before voting around 4:30 p.m.
The booster doses were sent as soon as the FDA issued its authorizations, but Walensky’s recommendation, expected Thursday or Friday, is the final step before the shots can go into guns. Dating could really pick up after the holiday weekend.
The US government has bought about 171 million shots, including contracts with Pfizer and Moderna.
Pfizer’s updated vaccine is licensed for people 12 years of age and older, while Moderna’s vaccine is for people 18 years of age and older. Both bivalent vaccines are licensed for use two months after people have received their primary vaccine series or the last booster vaccine.
The Moderna vial will have a dark blue cap and a label with a gray border, while the Pfizer vial will have a gray cap and a label with a gray border.
Marks was hesitant to give an exact timeline on when shots will be authorized for those under 12, but said he expected more data in a few months.
“I can’t promise an exact timing, but hopefully we’ll start to see them … come down to the younger age ranges in the next month or two,” Marks said.
“And as we receive the presentations from the companies, we will act with all due diligence, because we are aware that there are, especially in the slightly older age groups of the children, some children who come to receive reinforcements”, he added he said
Currently, everyone over the age of five is eligible for a booster shot five months after their primary vaccine series. People over 50 or immunocompromised may receive a second booster four months after the first booster.
If the CDC director signs off, people under 50 who received their first booster could now get a second. But anyone who hasn’t received a booster shot could also get the bivalent booster as their first booster, officials urged.
“Unfortunately, only about half of eligible Americans have received their first booster dose,” FDA Commissioner Dr. Bob Califf told reporters at the same news conference.
“CDC data indicates that those who are up-to-date on their vaccines have a 13-fold lower risk of dying from COVID compared to those who are unvaccinated, and a three-fold lower death rate than those who only had a boost compared to 2. So this is a remarkable opportunity to improve our life expectancy and reduce the death toll in our population,” Califf said.
Unlike the original vaccines and boosters, these new vaccines will not go through a lengthy clinical trial process where thousands of Americans receive the vaccines to test their long-term safety and effectiveness. However, federal health officials stress that these new vaccines will remain as safe as the original vaccines because the underlying vaccine platform, mRNA, is the same and has gone through many different clinical trials.
Part of that review was an evaluation of a clinical study of a different updated booster injection that vaccine companies had done during a previous omicron wave. The clinical trial of this booster injection, which targeted the BA.1 variant and the original strain of COVID, was considered relevant enough for bivalent vaccines targeting the BA.4/BA.5 variant and the strain omicron original.
Officials also said the decision not to use time-consuming clinical trials for each new vaccine is a strategic move, in an effort to keep vaccines abreast of rapidly evolving variants, a process likely to mimic the flu vaccine altered every year.
“If we had waited for all the evidence to come in, the wave would have passed us by now and the damage would have been done,” Califf said.
“It’s fair for people to raise questions. But really this is the best consensus we have among experts that this is the best way to go,” he added.
Marks also repeatedly defended the data the FDA used to make that authorization: data from clinical trials on a bivalent vaccine that targeted a different omicron subvariant and the original COVID-19 strain, making it very similar to this booster injection that targeted BA.4 and 5, along with the original strain of COVID-19, as well as real-world data from millions of people who have received the vaccines and mRNA boosters worldwide world
“I think we’re pretty confident that what we have is very similar to the situation we’ve had in the past with flu strains where we don’t do clinical studies for them in the United States,” Marks said.
“We know from the way the vaccine works and from the data we have, that we can predict how well our vaccine will work,” Marks said.