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U.S. regulators say transplant recipients and others with severely weakened immune systems can get an extra dose of the Pfizer or Moderna COVID-19 vaccines to better protect them as the delta variant continues to surge. The late-night announcement Thursday by the Food and Drug Administration applies to several million Americans who are especially vulnerable because of organ transplants, certain cancers or other disorders. Several other countries, including France and Israel, have similar recommendations. (Neergaard and Perrone, 8/13)

The Food and Drug Administration is authorizing an additional dose of a COVID-19 vaccine for certain people with weakened immune systems caused either by disease, medical treatments or organ transplants. The move comes after studies have shown these people may not have sufficient immunity to head off the more serious complications of COVID-19 after the standard vaccine regimen. Late Thursday night, the FDA amended the emergency use authorizations for both the Pfizer-BioNTech and Moderna COVID-19 vaccines to allow for an additional dose for certain immunocompromised people, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. The CDC estimates the population to be less than three percent of adults. (Stone and Greenhalgh, 8/13)

"Making the booster shots available to us is imperative," said Michele Nadeem-Baker, a patient with chronic lymphocytic leukemia, a type of blood cancer. "The immunocompromised community has felt forgotten This gives us hope that we have not been." A study in people with solid organ transplants, for instance, showed only about 15% had an immune response to the first dose and roughly half mounted one to a second dose. Later research found a quarter of those with no response to the first two doses responded to a third. Even those who had an antibody response had a lower one than those with normal immune systems. (Weintraub, 8/12)

The action by the Food and Drug Administration means that additional shots could be available as soon as this weekend for patients who have received organ transplants or have certain types of cancer or other illnesses. The move was applauded by medical experts worried about people unable to generate robust anti-virus responses even after being fully vaccinated. Details about how the shots will be administered — and who exactly will be eligible for them — are expected to be hashed out Friday during a meeting of Centers for Disease Control and Prevention advisers. (McGinley and Sun, 8/12)

KHN: Pfizer CEO To Public: Just Trust Us On The Covid Booster 

Pfizer CEO Albert Bourla was confident in June about the ability of his company’s vaccine to protect against the highly contagious delta variant, as it marched across the globe and filled U.S. hospitals with patients. “I feel quite comfortable that we cover it,” Bourla said. Just weeks later, Pfizer said it would seek authorization for a booster shot, after early trial results showed a third dose potentially increased protection. At the end of July, Pfizer and BioNTech announced findings that four to six months after a second dose, their vaccine’s efficacy dropped to about 84%. Bourla was quick to promote a third dose after the discouraging news, saying he was “very, very confident” that a booster would increase immunity levels in the vaccinated. (Tribble, 8/13)

Israel approved the use of the Pfizer-BioNTech booster vaccine for those over the age of 50 from Friday, as the country grapples with its fourth wave of Covid-19. Israel’s Covid-19 national experts advisory team had recommended that the age of eligibility be lowered to 50 from 60, and it was accepted by the Ministry of Health, according to a government statement. Healthcare workers, prisoners, prison wardens and some high-risk patients under the age of 50 will also be offered the third shot. (Avis, 8/13)