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The Food and Drug Administration has laid out a road map for what Covid-19 vaccination may appear to be moving forward.
In a briefing document published Monday, the FDA said the vaccines will probably need an annual update because the virus continues to evolve. The agency would choose the Covid strain for the vaccine within the spring so the updated shots could roll out every September in time for a fall vaccination campaign.
Most individuals would receive one shot to revive their protection against the virus moving forward, in keeping with the briefing document. This is able to apply to individuals who have been exposed to the virus’s spike protein a minimum of twice, either through vaccination or infection.
But older adults and other people with compromised immune systems might have two doses, in keeping with the proposed vaccination schedule. Young children who’ve received just one shot previously would also get two doses.
The FDA released the road map ahead of a gathering of the agency’s independent vaccine experts scheduled for Thursday. The expert panel will vote on whether to make all Covid vaccines within the U.S. bivalent shots, meaning they protect against each the omicron BA.5 subvariant in addition to the unique strain of Covid discovered in Wuhan, China, in late 2019.
Currently, only Moderna’s and Pfizer’s booster doses goal the omicron variant. If adopted, the first series would also contain the omicron strain.
The proposed system for updating Covid vaccines resembles how the FDA selects flu shots every yr. The agency said it could update and rollout the Covid vaccines without clinical data, which can be the case with the annual process to alter the flu shot.
The Centers for Disease Control and Prevention on Thursday can be expected to supply more details about an investigation into what it has described as a “not possible” risk of stroke in seniors who received Pfizer’s omicron booster.
The CDC received preliminary safety concern data from its Vaccine Safety Datalink late last yr. A subsequent review for 4 other major databases didn’t discover an increased risk for stroke, however the CDC investigation is ongoing.
