FDA Lays Out Plan for Vaccine Shots of COVID-19, Suggesting One Shot Per Year Needed

FDA Recommendations for Covid Shot (Photo: Waldo Swiegers)

The Food and Drug Administration (FDA) has outlined a plan for the future administration of Covid-19 vaccines.

In a briefing document released on Monday, the FDA indicated that due to the ongoing evolution of the virus, Covid-19 vaccines will likely require annual updates.

According to the plan, the FDA would choose the specific Covid strain for the vaccine each spring, enabling updated vaccines to be available by September for the fall vaccination campaign.

Most individuals would receive a single shot to maintain protection against the virus going forward, the document stated.

This single dose would apply to those who have been exposed to the virus’s spike protein at least twice, whether through vaccination or previous infection.

However, older adults and individuals with compromised immune systems might require two doses, as per the proposed vaccination schedule.

Young children who have previously received only one shot would also be administered two doses.

Ahead of an upcoming meeting of the FDA’s independent vaccine experts scheduled for Thursday, the FDA released this road map.

Covid Vaccination (Photo: Getty Images)

During this meeting, the expert panel will vote on whether to update all Covid vaccines in the United States to include protection against both the omicron BA.5 subvariant and the original Covid strain discovered in Wuhan, China, in late 2019.

Presently, only the booster doses from Moderna and Pfizer target the omicron variant. If the proposal is adopted, the primary vaccine series would also encompass the omicron strain.

The proposed approach to updating Covid vaccines mirrors the annual selection process for flu shots conducted by the FDA.

The agency emphasized its ability to update and distribute Covid vaccines without requiring new clinical data, similar to the process for annual adjustments to flu vaccines.

Additionally, the Centers for Disease Control and Prevention (CDC) is expected to provide further details on Thursday regarding its investigation into a potential, albeit “very unlikely,” risk of stroke in seniors who received Pfizer’s omicron booster.

Initial safety data concerns were received by the CDC from its Vaccine Safety Datalink late last year. While subsequent reviews of four other major databases did not identify an increased risk of stroke, the CDC’s investigation remains ongoing.

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