FDA Approves Boosters for Immunocompromised, Pfizer and Moderna Set to Reap Billions From Sales of Third Shot

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The U.S. Food and Drug Administration authorized a third COVID shot for immunocompromised patients. The Pfizer and Moderna vaccines have not been fully approved, and neither company has completed late-stage clinical trials proving a third dose will work.

The U.S. Food and Drug Administration (FDA) Thursday authorized a third doseof Pfizer-BioNTech and Moderna COVID vaccines for people with compromised immune systems.

Neither vaccine has yet received full FDA approval, and neither has completedlate-stage clinical trials proving a third dose will boost immunity or work against COVID variants.

The amended Emergency Use Authorization allows people who have had an organ transplant, or those with a similar level of weakened immune system, to get an extra COVID vaccine dose.

The FDA did not approve a Johnson & Johnson booster, citing insufficient data.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices today voted unanimously to recommend the CDC follow the FDA’s guidance by also approving the third shots for immunocompromised patients.

Thursday’s decision by the FDA “allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19,” Dr. Janet Woodcock, FDA acting commissioner, tweeted Thursday.

“Others who are fully vaccinated are adequately protected & do not need an additional dose of COVID-19 vaccine at this time,” Woodcock said in the tweet. The vulnerable group of patients eligible for the third shot make up less than 3% of U.S. adults, according to Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC).

Israel started administering booster vaccines on July 12, to people 60 or older, and other countries plan to follow. On Aug. 13, Israel expanded the booster vaccination campaign to include people 50 years and older — a revision from the previous age eligibility requirement of 60 years and up.

Yet, Israeli Health Ministry data published Aug. 12 showed 14 Israelis had been infected with COVID a week after receiving a booster shot. Eleven people infected were 60 or older, and two were hospitalized — while the other three received a third dose because they are immunocompromised.

If confirmed in larger samples, the Internal Health Ministry said figures could cast doubt on the effectiveness of the booster shot, which Israel started administering before major health agencies around the world approved it.

The FDA’s authorization came as Biden administration officials and pharmaceutical companies appear increasingly convinced boosters for the broader population will be necessary.

Scientists are divided over the broad use of COVID vaccine boosters among those without underlying problems, as benefits of the boosters remain undetermined.

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