CDC panel gives green light to new COVID-19 boosters ahead of fall recall campaign

An independent panel of advisors from the Centers for Disease Control and Prevention voted to roll out the newly updated COVID-19 booster shots, clearing the way for CDC Director Rochelle Walensky to give final approval on the reminders on Thursday evening or Friday and for the injections to be administered soon after.

The new recalls have been updated to target two different COVID strains in one shot – the current subvariants of omicronBA.4 and BA.5, which account for 99% of new cases in the United States, and the original strain of COVID-19.

This is the first time that current COVID-19 vaccines have received a major upgrade. Going forward, experts expect vaccines to be updated periodically to match current strains, as the flu shot is slightly different each year.

Public health officials have ordered vaccine companies to create a bivalent vaccine — a vaccine that targets two different strains — in hopes the compilation will provide broader protection against COVID this fall and winter, as infections could increase with flu season, colder weather and more time indoors.

“It matches what’s been circulating right now. And the hope here is that by increasing the amount of antibodies that we have against this particular variant, we’ll restore the kind of protection that we had when we saw these vaccines launched for the first time in late 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 conference in press Wednesday morning.

“We don’t know for sure yet if we’ll reach that same level – but that’s the goal here. And that’s what we believe the evidence we’ve seen helps to indicate,” Marks said.

Marks also stressed that it’s not just about boosting antibodies to boost immediate protection, but working towards yearly injections rather than boosters every few months.

He said he hoped deploying bivalent boosters now would mitigate an incoming winter surge and “hopefully give us the protection we need through October, November and December to prevent another way of shutting down things like vacation plans”.

The FDA issued its emergency use authorization for the updated booster shots Wednesday morning. On Thursday, the CDC’s panel of advisers publicly reviewed the data before taking a vote around 4:30 p.m.

The booster doses were shipped as soon as the FDA issued its clearances, but Walensky’s recommendation, expected Thursday or Friday, is the final step before the shots can go to the arms. The appointments could seriously increase after the holiday weekend.

The US government purchased approximately 171 million shots, between contracts with Pfizer and Modern.

Pfizer’s updated vaccine is licensed for people 12 and older, while Moderna’s vaccine is for people 18 and older. The use of the two bivalent vaccines is authorized two months after people have received either their series of primary vaccines or their last booster shot.

The Moderna bottle will have a dark blue cap and a label with a gray border, while the Pfizer bottle will have a gray cap and a label with a gray border.

Marks was hesitant to give an exact timetable on when shooting would be allowed for under-12s, but said he expected more data in a few months.

“I can’t promise an exact timing, but we expect to start seeing … this decline in the younger age brackets within the next one to two months,” Marks said.

“And so, as we receive submissions from companies, we will act with due diligence, because we are aware that there are, particularly in the slightly older age brackets of children, some kids who are due for reminders,” he said.

Currently, anyone over the age of five is eligible for a booster shot five months after their primary vaccine series. People over 50 or immunocompromised can receive a second booster dose four months after their first booster.

If the CDC director signs off, people under 50 who received their first booster could now get a second. But anyone who didn’t get a booster at all could also get the dual booster as their first booster – which officials have asked for.

“Unfortunately, only about half of eligible Americans have received their first booster dose,” FDA commissioner Dr. Bob Califf told reporters at the same press conference.

“CDC data indicates that those who are up to date on their vaccines have a 13 times lower risk of dying from COVID compared to those who are not vaccinated, and a three times lower dose of death than those who do not. have had only 1 recall compared to 2. So this is a remarkable opportunity to improve our life expectancy and reduce the number of deaths 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 shots to test their long-term safety and effectiveness. However, federal health officials emphasize that these new vaccines will still be as safe as the original vaccines because the underlying vaccine platform, mRNA, is the same and has been the subject of many varied clinical trials. .

Part of this review was an evaluation of a clinical study of another updated booster shot that vaccine makers had done during a previous wave of omicron. The clinical trial of this booster injection, which targeted the BA.1 variant and the original strain of COVID, was deemed sufficiently relevant for bivalent vaccines targeting the BA.4/BA.5 variant and the original strain of omicron .

Officials also said the decision not to use time-consuming clinical trials for every new vaccine is a strategic move, with the goal of keeping vaccines up to date with rapidly evolving variants — a process that will likely mimic how the flu vaccine is changed every year.

“If we wait for all the evidence to come in, the wave will have already passed us and the damage will be done,” Califf said.

“It’s fair for people to raise questions. But it’s really the best consensus we have among the experts that this is the best way forward,” he added.

Marks has also repeatedly defended the data used by the FDA to obtain this clearance – clinical trial data on a bivalent vaccine targeting a different omicron subvariant and the original COVID-19 strain, which makes it very similar to this booster shot that targets the BA.4 and 5 subvariant with the original COVID-19 strain – plus actual data on millions of people who received the vaccines and mRNA boosters in the 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 strain changes where we’re not doing clinical studies for them in the United States,” said Marks said.

“We know from how the vaccine works and the data we have that we can predict how well our vaccine will work,” Marks said.

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