The U.S. Food and Drug Administration (FDA) authorizes update of COVID boosters that have been adapted to Omicron sub-variants

The enhanced COVID-19 campaign planned by the Biden administration removed a major regulatory hurdle, after the Food and Drug Administration announced on Wednesday that it had allowed the updated shots Adapts to variable Omicron of the virus to Americans younger than 12 years old.

people can get New booster Less than two months after the last shot of the COVID-19 vaccine. New Moderna Snapshots are allowed for Americans up to 18 years of age.

Boosts from the original formula are no longer allowed for Americans eligible for new booster shots.

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

The decision means that shipment of new doses from Pfizer-BioNTech and Moderna can now begin. Several state and local health departments already submitted pre-orders last month for the first waves of deliveries.

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

However, as with previous COVID-19 vaccine rollouts, vaccinators will need to wait for recommendations from the Centers for Disease Control and Prevention before giving the first shots of new vials. That green light is expected by the end of this week, after a two-day meeting of the agency’s external vaccine advisors on Thursday and Friday.

Pfizer intends to file an application with the FDA “in early October” to grant the new booster to children up to age 5, the company said in a statement, and is also working to file an application for a booster for children as young as 6 months old. .

The new formulations represent the first significant change in COVID-19 vaccines since they were introduced earlier in the pandemic.

Vials of so-called “bivalent” shots from each company mix a component of their original “prototype” shots with another component designed to target Omicron BA.4 and BA.5 sub variants – Breeds now prevalent throughout the country.

“As we approach fall and winter, with SARS-CoV-2 potentially spreading further in schools and at work, it is important to keep up with vaccinations as the first line of defense against COVID-19,” Pfizer CEO Albert Borla said in a statement.

Vials of Pfizer's COVID-19 Vaccine Boosters
Vials of Pfizer-BioNTech’s new COVID-19 vaccine booster shots, designed to target Omicron BA.4 and BA.5 sub variants.

Pfizer


Why is booster injection changed?

The decision to modify the design of COVID-19 vaccines to target these strains stemmed from meetings of the FDA’s external vaccine advisors in June and April earlier this year to discuss the problem, before the months-long ramp-up period required for manufacturers to reorient their vaccine plants. .

At the time, the majority of committee members favored an approach not far from the one proposed by Pfizer and BioNTech to speed up the authorization of new shots that might boost their effectiveness before another deadly winter wave that is feared is coming.

The FDA eventually said it would not require extended clinical trials of shots targeting BA.4 and BA.5 in humans before it would authorize the new booster delivery from Moderna as well as Pfizer and BioNTech.

Instead, the license will rely largely on trial data collected from safety testing and the immune response from the new shots in animals, as well as data from other formulas previously tested by vaccine makers.

“In the midst of a pandemic, if you wait for all that data to come in, you’ve missed the boat. And so you have to be protective,” Food and Drug Administration Commissioner Dr. Robert Califf said on Public Health On Demand. Tuesday’s podcast.

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


Dr. Celine Gaunder talks about the Omicron booster vaccine and monkeypox concerns

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In a separate interview this week, the director of the CDC, Dr. Rochelle Walinsky, hinted that she, too, tends to sign the new shots.

She cited her agency’s estimates, which show BA.4 and BA.5 and their descendants make up nearly all of the new infections across the country right now.

“The strategy now is to design a vaccine in order to give us the largest response range, and it is better to have less response over time,” Walinsky told HealthCare Conversations.

However, even with permission in hand, the vaccine makers say they still plan to complete human clinical trials for these new shots.

Federal health officials say they have ordered these trials to track the vaccine’s ability to suppress future virus variants later this year, which may look very different from the BA.4 and BA.5 strains now circulating.

Firing bivalent booster shots

The push for new fall-booster doses will not be without hurdles for state and local health departments, which are also now working to reconcile annual flu shots and roll out the monkeypox vaccine.

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

Planning documents released by the Centers for Disease Control last month urged state and local health departments to prepare to distribute early shipments to providers who can vaccinate “those most at risk of severe COVID-19 disease” first, such as in nursing homes.

For the first time in COVID-19 vaccines, a portion of the supply of new shots the Biden administration has purchased from Pfizer and BioNTech is expected to come in single-dose vials. Approved by the FDA Last monthThese vials can significantly reduce missed doses and make it easier for providers to deliver shots.

However, the initial segment of Pfizer’s divalent shots is expected to be much more challenging: cartons of 10 vials of 6 doses each, shipped in orders of 300 minimum doses. The Moderna vaccine will have a minimum of 100 doses.

The new boost campaign could make it difficult for unvaccinated Americans to find raw, serial shots, which would still require the original formula. The average first dose in the United States is currently less than 40,000 doses per day, according to figures from the Centers for Disease Control and Prevention (CDC).

The Food and Drug Administration said earlier this year that results from human clinical trials would be needed before the initial series of shots could be switched.

“Many providers of coronavirus vaccines are expected to provide bivalent booster doses, but not all providers are expected to continue carrying the initial series of COVID-19 vaccines,” the CDC said in its planning guide.


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