Vaccine booster approval expected
Specifically targets immunocompromised
Federal health officials are racing to ensure that millions of Americans with weakened immune systems can get additional shots of coronavirus vaccines to protect them against the highly contagious delta variant.
The extra shots are expected to be authorized within days or weeks, according to federal officials who spoke on the condition of anonymity because the plan has not been announced.
The stepped-up activity reflects increased urgency by the Biden administration to shield some of the nation’s most vulnerable adults as coronavirus cases rise sharply. The pressure has also grown as several other countries have taken steps to get additional shots to people who are immunocompromised or older, and as some Americans pursue such shots on their own.
In the next week or two, the Food and Drug Administration is expected to review data from the Centers for the Disease Control and Prevention supporting the use of additional vaccine doses for
the immunocompromised. If officials are persuaded, they will amend the emergency use authorizations for the vaccines to permit the extra inoculations. Advisers to the CDC and the agency, in turn, will urge people with certain medical conditions to talk to their doctors or pharmacists about getting the shots.
Immunocompromised patients represent about 7 million adults in the United States, including those who have received organ transplants, patients on cancer treatments and those with rheumatologic conditions and HIV, according to the CDC. They are more likely to become seriously ill from COVID-19 and might more frequently spread the virus to others, experts say.
“It is extremely important for us to move to get those individuals their boosters, and we are now working on that,” Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said Thursday at a White House briefing. He said that many immunosuppressed people did not have a vaccine response “that we feel would be adequately protective.”
For Ileana Benitez, of Kensington, Md., the change cannot come soon enough. Ms. Benitez, 41, had a kidney transplant in her 20s. Her husband, Jeremy Young, 43, was the donor.
Even after getting the Johnson & Johnson vaccine in March, the couple avoids grocery stores and restaurants. And with school starting soon, they fear their 8-year-old daughter might bring the coronavirus home. “It would be such a difference,” Ms. Benitez said.
The focus on the immunocompromised comes as officials scramble to develop a more comprehensive strategy for vaccine boosters for others, including older people, as first reported by The Wall Street Journal. But those plans will not be completed until September, when additional data is collected, and would be put into effect only if officials conclude that boosters are needed more broadly because of waning immunity. Those shots would probably not be rolled out until October, they said.
Both the PfizerBioNTech and Moderna vaccines are now authorized for a two-dose regimen and Johnson & Johnson for one shot. The goal is to permit extra doses of all three vaccines, but officials said that decision would depend on the data. They also are unsure what the data will show about mixing and matching — using a Pfizer or Moderna vaccine, for example, to bolster Johnson & Johnson’s shot.
Meanwhile, the Biden administration on Friday unveiled the attestation form that federal employees will need to fill out confirming whether they have been fully vaccinated against the virus, adding legal teeth to the president’s mandate.
Employees will face disciplinary action and potentially criminal prosecution if they lie on the form.
The Associated Press obtained a copy of the form that was distributed Friday to agency leadership and points of contact for COVID safety protocol implementation.
Under Mr. Biden’s policy, those who are not vaccinated or choose not to complete the form will be subject to mandatory maskwearing and social distancing requirements and will be ineligible for official travel in most cases.
Immunocompromised patients represent about 7 million adults in the United States, including those who have received organ transplants, patients on cancer treatments and those with rheumatologic conditions and HIV, according to the CDC.