FDA clears updated COVID boosters suitable for Omicron subvariants

The Biden administration’s planned fall COVID-19 recall campaign has lifted a key regulatory hurdle, after the Food and Drug Administration announcement On Wednesday, he authorized updated shots suitable for Omicron variant of the virus for Americans from the age of 12.

People could get the new booster as little as 2 months after their last injection of a COVID-19 vaccine. Moderna’s new vaccines are licensed for Americans as young as 18. Pfizer and BioNTech can be administered for up to 12 years.

The original formulation boosters are no longer authorized for use among Americans who are eligible to receive the new boosters.

“As we head into the fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection. against the variants currently in circulation,” said FDA commissioner Dr. Robert Califf in a statement. Release.

This decision means that shipments of new doses from Pfizer-BioNTech and Moderna can now begin. Many state and local health departments already placed pre-orders last month for the first waves of deliveries.

A Pfizer spokesperson said the company could ship up to 15 million doses of the new vaccine by the end of next week, pending “final quality checks”.

However, as with previous COVID-19 vaccine deployments, vaccinators will have to wait for the Centers for Disease Control and Prevention’s own recommendation before administering their first vaccines from the new vials. This green light is expected by the end of this week, following a two-day meeting of external vaccine advisors this Thursday and Friday.

Pfizer plans to submit an application to the FDA “in early October” to give the new booster to children up to 5 years old, the company said in a statement, and is also working on a submission to boost children as young as 6 months old. .

The new formulations mark the first significant change to COVID-19 vaccines since they were rolled out earlier in the pandemic.

The vials of each company’s so-called “bivalent” projectiles mix one component of their original “prototype” projectiles with another designed to target the Omicron BA.4 and BA.5 sub-variants — the strains which are now rampant throughout the country.

“As we head into the fall and winter season, with the potential for greater spread of SARS-CoV-2 in schools and at work, it is important to stay up to date with vaccines as first line of defense against COVID-19 disease,” Pfizer CEO Albert Bourla said in a statement.

Pfizer COVID-19 Vaccine Booster Vials
Vials of Pfizer-BioNTech’s new COVID-19 vaccine booster shots, formulated to target Omicron BA.4 and BA.5 subvariants.


Why are booster shots changed?

The decision changing the design of COVID-19 vaccines to target these strains stems from meetings of FDA’s outside vaccine advisors June and April earlier this year to weigh the issue, ahead of the months-long ramp-up needed for manufacturers to redirect their vaccine factories.

At the time, a majority of committee members favored an approach that was not far removed from that offered by Pfizer and BioNTech to speed up the authorization of new vaccines that could boost their effectiveness before another feared deadly winter wave of the virus.

The FDA finally said it would not require lengthy clinical trials of the injections targeting BA.4 and BA.5 in humans before authorizing the new booster supply of Modern as good as Pfizer and BioNTech.

Instead, authorization would be based largely on trial data collected during safety and immune response tests triggered by the new vaccines in animals, as well as data from other formulations previously tested by the vaccine manufacturers.

“In the middle of a pandemic, if you’re waiting for all this data to come in, you’ve missed the boat. And so you need to be pre-emptive,” said FDA Commissioner Dr. Robert Califf. “Public Health on Call” podcast Tuesday.

Califf compared the authorization to the regulator’s approach to updating the annual flu vaccine, citing “the totality of the evidence” supporting their decision.

Dr Céline Gounder on the Omicron booster shot and monkeypox concerns


In a separate interview this week, CDC director Dr. Rochelle Walensky hinted that she was also leaning towards signing the new snaps.

She pointed to her agency estimateswhich show that the BA.4 and BA.5 subvariants and their descendants currently constitute virtually all new infections across the country.

“The strategy now is to tailor the vaccine to give us the greatest span of response, ideally one that would have less decline over time,” Walensky told the “Healthcare Conversations” radio program.

However, even with clearance in hand, the two vaccine makers say they still plan to complete human clinical trials of these new vaccines.

Federal health officials say they requested the trials to track the vaccine’s ability to curb future variants of the virus later this year, which could look very different from the BA.4 and BA.5 strains currently circulating.

Deployment of bivalent booster injections

The push for new fall boosters will not be without obstacles for state and local health departments, which now also juggle annual flu shots and the rollout of the monkeypox vaccine.

Twenty million doses have been made available to vaccinators for pre-order, from states to pharmacies, according to a Department of Health and Human Services spokesperson. All 50 states and the District of Columbia called for shots.

Planning documents released by the CDC last month urged state and local health departments to prepare to distribute the first shipments to providers who can first vaccinate “those most at risk of severe COVID-19 illness,” like in nursing homes.

In a first for COVID-19 vaccines, part of the Biden administration’s new vaccine supply bought from Pfizer and BioNTech are expected to come in single-dose vials. FDA approved last monththese vials could significantly reduce wasted doses and make it easier for providers to offer injections.

However, the first tranche of bivalent vaccines from Pfizer is expected to be much heavier: boxes of 10 vials containing 6 doses each, shipped in minimum order of 300 doses. Moderna’s vaccine will be available in minimum orders of 100 doses.

The new recall campaign could also make it harder for unvaccinated Americans to find shots from the main series, which will still require the original formula. The United States currently receives an average of fewer than 40,000 first doses per day, according to to CDC figures.

Results from human clinical trials will be needed before first round of vaccines can be switched, FDA says said earlier this year.

“Many COVID-19 vaccine providers are expected to offer bivalent booster doses, but not all providers should continue to offer primary series COVID-19 vaccines,” the CDC said in its statement. planning guide.

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