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FDA Eyeing Second COVID-19 Booster Shot Approval

Article

The FDA’s authorization would depend on ongoing studies establishing that a fourth dose would shore up people’s molecular defenses that waned after their first booster shot.

The Food and Drug Administration (FDA) is considering authorizing a second booster shot of COVID-19 vaccines this fall, while the Centers for Disease Control and Prevention (CDC) already recommends four doses for immunocompromised individuals.

The FDA’s authorization would depend on ongoing studies establishing that a fourth dose would shore up people’s molecular defenses that waned after their first booster shot, sources told The Wall Street Journal.

While it is still in the early planning stages, the FDA has begun reviewing data so it can make a decision on a second booster of the Pfizer/BioNTech and Moderna vaccines, according to the WSJ.

Among the issues that need to be resolved are whether the second booster should be authorized for all adults or particular age groups, and whether it should target the Omicron variant or be formulated differently, WSJ said.

"Whether the fourth booster could ultimately be the start of an annual COVID-19 vaccination is also under consideration,” according to the publication.

Early last month, the CDC’s Advisory Committee on Immunization Practices recommended that immunocompromised patients get a fourth dose of either the Pfizer/BioNTech or Moderna vaccine at least three months after the last dose of a three-dose series of shots.

The CDC is calling the third shot for people who are immunocompromised a third primary shot, not a booster. It doesn’t recommend the Johnson & Johnson shot for those who are immunocompromised.

Despite the CDC recommendation, a number of news outlets have reported that some pharmacies have turned away immunocompromised patients seeking a fourth shot.

The CDC’s Advisory Committee on Immunization Practices has also recommended that healthcare providers can, on a case-by-case basis, administer additional doses of the Pfizer-BioNTech or Moderna vaccines outside of the FDA and CDC dosing intervals “based on clinical judgement when the benefits of vaccination are deemed to outweigh the potential and unknown risks.”

Around 65% of the U.S. population is fully vaccinated, meaning they have gotten two doses of the vaccine from either Moderna or Pfizer/BioNTech, or one dose of Johnson & Johnson’s vaccine, according to the CDC, per WSJ. About 43% of fully vaccinated people have gotten a booster shot.

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