Author: David Phineas
The F.D.A has approved COVID booster shots targeting the omicron BA.5 sub-variant.
The United States is getting ready for a new wave of infections. This is the first time the F.D.A. authorizes a new vaccination formula since the initial injection in December 2020.
Pharmacies will begin prescribing the new boosters after Labor Day Weekend.
Over 171m doses of Pfizer and Moderna’s revised shots have been distributed in the U.S. Pfizer’s new booster dose is approved in patients 12 years and older.
Nonetheless, Moderna’s new shots are approved for use in adults 18 years and older.
The qualifying groups can get their current booster with the old vaccinations. They can also get their primary set two months after finishing it. The original vaccines will no longer be administered as booster doses in the U.S. for anyone 12 years and older.
Why are the booster shots being modified?
The F.D.A.’s external vaccine consultants met in June and April of this year to discuss the issue and make a decision. This was before the requisite months-long ramp-up for makers to reroute their vaccine factories. Those meetings resulted in the decision to modify the COVID-19 vaccines’ design to target these strains.
The majority of the committee’s members at the time were in support of a strategy that was quite similar to the one Pfizer and BioNTech. This was to speed up the approval of new vaccines that could increase their efficacy against another wave of the virus.
To round it up, the F.D.A. said it would approve the new booster supply from Moderna, Pfizer, to BioNTech without requiring extensive clinical trials of the doses targeting BA.4 and BA.5 in humans.
The approval would primarily be based on trial data examining the safety and immune response induced by the new doses in animals. Moreover, data from existing formulations previously tested by the vaccine manufacturers were included.
Califf compared the approval to how the regulator updates the seasonal flu vaccination, stating “the totality of the evidence” to support their choice.
In a different interview, Dr. Rochelle Walensky hinted that she was inclined to approve the new vaccinations. According to estimates, the BA.4 and BA.5 subvariants and their offspring currently account for most new infections in the nation.
Federal health officials claim they requested these trials to monitor the vaccine’s capacity to prevent potential viral variants later this year. This could differ significantly from the current BA.4 and BA.5 strains.
Rolling out bivalent booster shots
State and municipal health officials managing the deployment of a monkeypox vaccine and annual flu injections may have challenges in pushing for the new fall booster shots.
20 million doses were made available for pre-order by states and pharmacies for vaccine recipients. The requests were from all 50 states and the District of Columbia.
The C.D.C. issued planning documents urging state and local health authorities to prepare to distribute the early shipments.
This will focus on physicians who can vaccinate those at the highest risk of severe COVID-19 disease, such as those in nursing homes.
A portion of the fresh doses ordered from Pfizer and BioNTech are anticipated to come in single-dose vials.
The containers the F.D.A. approved last month, could significantly reduce dose waste. Moreover, it will make it simpler for healthcare professionals to administer the shots.
The initial batch of Pfizer’s bivalent injections will come in cartons of 10 vials with six doses each and supplied in minimum orders of 300.
It is anticipated to be much more cumbersome. The minimum order quantity for the Moderna vaccination is 100 doses.
The new booster campaign may also make it more difficult for Americans who haven’t received their primary series vaccinations to get those shots.
According to C.D.C., not all providers will continue carrying primary series COVID-19 vaccines. However, many COVID-19 vaccination providers will offer bivalent booster doses.
