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FDA Proposes Annual Covid Vaccine for Most Americans

Kate O’Leary, an EMT for Cataldo Ambulance and Nursing student prepares a Pfizer/BioNTech coronavirus vaccination dose in Boston, Mass., January 29, 2021. (Faith Ninivaggi/Reuters)

The FDA on Monday proposed that vaccination against Covid be recommended on a yearly basis, like the annual flu shot.

Most Americans, including adults and children, could receive one shot a year, eliminating the need for multiple doses and tracking months in between.

As the virus continues to mutate, FDA officials want to rollout an annual strategy in which an updated strain-specific vaccine is developed in the spring for fall rollout. The plan was outlined in a briefing document published Monday.

People who have some immunity from vaccination or previous infection would only need to receive one dose to maintain resilience against the virus. However, elderly or immunocompromised people may require an additional dose for extra protection. Young children who haven’t been exposed to the virus spike protein may also be urged to take two doses.

“This simplification of vaccine composition should reduce complexity, decrease vaccine administration errors due to the complexity of the number of different vial presentations, and potentially increase vaccine compliance by allowing clearer communication,” the FDA said.

The new vaccine plan comes before the FDA’s expert panel will decide Thursday whether Pfizer and Moderna’s bivalent vaccines, which target both the Omicron and the original variants, would be used for all Covid vaccine doses, and not just as boosters, Reuters noted.

Currently, vaccine administration in the U.S. is involved and somewhat convoluted. People in the U.S. today must first receive one dose of the original Covid vaccine, wait at least about three to four weeks, and then receive a second dose. Individuals can then receive a booster shot a few months later.

While over 80 percent of the U.S. population has had at least one vaccine dose, booster uptake has been comparatively low. The FDA’s proposal is an attempt to streamline the process by combining primary and booster vaccinations into a single vaccine composition.

The CDC also may release updates on Thursday about the investigation into the slightly elevated risk of stroke found in individuals aged 65 and older who received Pfizer’s bivalent Omicron booster. The agency’s Vaccine Safety Datalink identified a safety concern, although the other four major databases did not detect the signal. Pfizer and BioNTech later said in a statement that there is “no evidence to conclude that ischemic stroke is associated with the use of the companies’ COVID-19 vaccines,” noting the lack of similar findings on other monitoring systems in the U.S. and across the world.

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