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Boosters Okayed for Some, Not All

Thu, 09/09/2021 - 03:41
A woman waited in an observation area after getting a Covid-19 shot at an East Hampton CVS; to receive a third dose people are supposed to attest to having a moderate or severe immune disorder.
Jamie Bufalino

Booster shots of Covid-19 vaccines may be on the horizon, but until the federal Food and Drug Administration determines whether additional doses are safe and effective for the general population, only people with moderately or severely impaired immune systems should seek a third dose, according to health care professionals.

Last month, the F.D.A. authorized the use of an additional dose of the Pfizer-BioNTech and Moderna vaccines for organ transplant recipients and others with equally compromised immune systems. "The country has entered yet another wave of the Covid-19 pandemic, and the F.D.A. is especially cognizant that immunocompromised people are particularly at risk for severe disease," said Dr. Janet Woodcock, the agency's acting commissioner. "Other individuals who are fully vaccinated are adequately protected and do not need an additional dose of Covid-19 vaccine at this time."

The agency's Vaccines and Related Biological Products Advisory Committee has been evaluating the safety and efficacy of booster shots, and will meet next Friday to discuss whether to authorize the Pfizer-BionNTech one. A decision on a Moderna booster will likely come later, Dr. Anthony Fauci, the White House chief medical adviser, said on Sunday, and one for the Johnson and Johnson vaccine will take a few more weeks, according to the Centers for Disease Control and Prevention.

The C.D.C. has found that the protection vaccines offer against Covid-19, and the Delta variant in particular, wanes over time, and has recommended that, starting in the fall, people get a booster shot eight months after having received the second dose of the Pfizer-BioNTech or Moderna vaccines. President Joseph R. Biden's administration set Sept. 20 as the start date for the rollout of booster shots to the general public.

"The Biden administration doesn't get to decide that," said Dr. Gail Schonfeld of East End Pediatrics, who has overseen vaccination clinics for East Hampton Town. Approval from the F.D.A. is what matters. "I trust what they have to say," she said.

At Stony Brook Southampton Hospital, those who are now eligible to receive a third dose per C.D.C. guidelines include patients who have received organ transplants, those who have received a stem cell transplant within the past two years, people undergoing active cancer treatment for tumors or cancers of the blood, those with immunodeficiency diseases such as DiGeorge or Wiskott-Aldrich syndromes, those with an advanced or untreated H.I.V. infection, and those taking high-dose corticosteroids or other drugs that may suppress the immune response, according to Barbara Jo Howard, the hospital's spokeswoman. Patients must wait at least 28 days after receiving the second vaccine dose before getting a third, and must fill out a form that attests to their eligibility.

Because the state requires only self-attestation to receive a third dose, people without immune disorders could claim to have one in order to get access to a booster, but Dr. Schonfeld strongly advises against it. "Lying is always a big mistake when it comes to health care," she said.

If booster shots receive approval, the Biden administration has said that, because of a large stockpile of vaccines and an abundance of vaccination sites, they will be as "easy and convenient" to get as an initial dose. Gov. Kathy Hochul announced on Aug. 31 that the state has set aside $65 million to provide quick distribution of the doses.

Individuals who were given first access to the Pfizer-BioNTech and Moderna vaccines during the initial rollout, including health care providers, the elderly, and residents of nursing homes and other long-term care facilities, would be the first to receive a booster, according to the Department of Health and Human Services. The F.D.A. has given the Pfizer vaccine full approval for people 16 and older and authorized its emergency use for people 12 to 15; the Moderna vaccine is authorized for emergency use for people 18 and older.

The C.D.C. recommends receiving the same brand of vaccine as a booster, but allows for mixing doses of either Pfizer or Moderna if one is not available. The research on mixing is scarce, however, noted Dr. Schonfeld. "Clinical trials were conducted using the same vaccines, so I recommend sticking with the same one," she said. 

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