close
close

FDA approves latest COVID booster adapted for Omicron subvariant

The Biden administration’s planned fall COVID-19 booster campaign cleared a major regulatory hurdle after the Food and Drug Administration announced Wednesday it had approved an updated shot Fits Omicron variants of viruses for Americans as young as 12 years old.

People are new booster Just two months after the last injection of the COVID-19 vaccine. Moderna’s new shots are licensed for Americans up to her 18th birthday. Pfizer and Biontech shots can be given until she is 12 years old.

Boosters from the original formulation are no longer allowed for use in Americans who are eligible to obtain new Booster Shots.

“As we head into the fall and start spending more time indoors, all eligible individuals should consider receiving a booster dose with the bivalent COVID-19 vaccine to provide better protection against the currently circulating variant. I highly recommend it to anyone,” said Dr. Robert Califf. FDA Commissioner on Release.

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

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

However, as with previous COVID-19 vaccine rollouts, vaccinees will have to wait for the Centers for Disease Control and Prevention’s own recommendations before administering the first shot from a new vial. , is expected by the end of this week, following a two-day meeting of the agency’s external vaccine advisors this Thursday and Friday.

Pfizer plans to submit a request to the FDA “in early October” to give children up to 5 years of age the new booster, and the company said in a release that it would also file an application to boost children as young as 6 months old. Said he was working on it..

The new formulation marks the first significant change to the COVID-19 vaccine since it was deployed early in the pandemic.

Vials of so-called “bivalent” shots from each company consist of the components of the original “prototype” shots, Omicron subspecies BA.4 and BA.5 — A strain that is currently spreading all over the country.

“With SARS-CoV-2 likely to spread in schools and workplaces throughout the fall and winter, it is important to keep vaccines up to date as the first line of defense against COVID-19 disease. Bourra said in a statement.

Pfizer COVID-19 Vaccine Booster Vial
A vial of Pfizer-BioNTech’s new COVID-19 vaccine booster shot formulated to target Omicron variants BA.4 and BA.5.

Pfizer


Why are the booster shots changed?

The decision to fine-tune the design of the COVID-19 vaccine to target these strains came after the FDA’s decision in June and April of this year, ahead of the months-long launch required for manufacturers. It all started with a meeting of external vaccine advisors. to redirect their vaccine factory.

At the time, the majority of committee members favored an approach not far from that proposed by Pfizer and BioNTech, with new shots that could boost its effectiveness before another dreaded winter wave of the virus. has accelerated the approval of

The FDA has finally said it does not need long-term clinical trials of shots for BA.4 and BA.5 in humans before approving the supply of new boosters from Moderna, Pfizer and BioNTech. rice field.

Instead, approval will rely heavily on trial data gleaned from testing the safety and immune responses elicited by the new shot in animals, as well as data from other formulations previously tested by vaccine manufacturers.

“In the middle of a pandemic, waiting for all that data to arrive is missing the boat, so we have to get ahead of the curve,” said FDA Commissioner Dr. said on “Public Health On Call.” Podcast on Tuesday.

Caliph compared the licensing to regulators’ approach to renewing annual flu vaccines and cited “a body of evidence” to support their decision.


Dr Celine Gownder on Omicron Booster Shots and Monkeypox Concerns

04:52

In another interview this week, CDC director Dr. Rochelle Wallenski hinted that she’s also leaning toward approving new shots.

She pointed to her agency’s estimates that BA.4 and BA.5 variants and their descendants now constitute virtually all new infections nationwide.

“The current strategy is to adjust the vaccine to provide maximum coverage, ideally with less fading over time,” Wallenski told radio program Conversations on Health Care. It is to make

But even with approval, two vaccine makers say they are still planning to complete human clinical trials of these new shots.

Federal health officials say they commissioned these trials later this year to track the vaccine’s ability to suppress future virus variants.

Deployment of bivalent booster shots

The fall new booster push is not without hurdles for state and local health departments juggling the rollout of annual flu shots and monkeypox vaccines.

A Department of Health and Human Services spokeswoman said 20 million doses have been made available for vaccinated people to pre-order from states to pharmacies. All 50 states and the District of Columbia require injections.

A planning document released last month by the CDC instructed state and local health officials to distribute early shipments to providers, such as nursing homes, who could vaccinate “people most at risk of severe COVID-19 illness” first. I urge you to prepare to do so.

As the first example of a COVID-19 vaccine, some of the supply of new shots purchased by the Biden administration from Pfizer and BioNTech is expected to come in single-dose vials. FDA approved last monththese vials could dramatically reduce wasted dosage and make it easier for providers to deliver shots.

However, the first tranche of bivalent injectables from Pfizer is expected to be much more cumbersome. Cartons of 10 vials each containing 6 doses are shipped with a minimum order of 300 doses. Moderna vaccines are offered in minimum orders of 100 doses.

The new booster campaign could also make it harder for unvaccinated Americans to find their first series shots. Currently, in the United States, he averages less than 40,000 first doses per day, according to CDC figures.

Earlier this year, the FDA said it would need results from human clinical trials before switching the first series of shots.

In its planning guide, the CDC said, “While many COVID-19 vaccination providers are expected to offer bivalent booster doses, not all providers are expected to continue to offer the primary series COVID-19 vaccine. It’s not,’ he said.

.

Leave a Comment