FDA decision on booster shots for immunocompromised expected soon

Coronavirus

PROVIDENCE, R.I. (WPRI) — The nation’s top infectious disease doctor says he believes booster shots for the COVID-19 vaccine should be given “reasonably soon” to people with weakened immune systems.

“We need to look at them in a different light,” Dr. Anthony Fauci said on CNN’s ‘Fareed Zakaria GPS’ on Sunday. “We would certainly be boosting those people before we boost the general population that’s been vaccinated, and we should be doing that reasonably soon.”

The comments from the lead medical adviser to the White House on the pandemic are a change in messaging from about a month ago.

In July, the U.S. Food and Drug Administration, along with the U.S. Centers for Disease Control and Prevention (CDC), released a joint statement saying fully vaccinated Americans “do not need a booster shot” at this time.

The statement from the nation’s top health agencies was issued hours after Pfizer announced it would ask for authorization of a third dose of its vaccine.

The vaccine maker said another shot within 12 months could dramatically boost immunity and maybe help ward off the highly contagious delta variant.

Noting Pfizer’s new efficacy data, Israel became the the first nation to roll out booster shots widely on Sunday, saying it had given more than 420,000 third shots to people 60 and older. The country started giving individuals with weakened immune systems a third shot in July.

Last week, Moderna also announced it believes people who received two doses of its vaccine will need a booster shot before winter to protect against virus variants.

Dr. Fauci made comments about potential booster shots as so-called breakthrough COVID-19 infections have been occurring, spurring new mask guidance from the CDC in recent weeks.

Health officials have noted the vaccine may not be as effective in people with compromised immune systems, including those with organ transplants or undergoing chemotherapy.

Speaking on CBS’s Face the Nation on Sunday, former FDA commissioner Dr. Scott Gottlieb says he expects a decision on immunocompromised patients may come from the agency within a week, while a decision on patients older than 65 may come by September.

“I think, unfortunately, it’s going to come a little bit too late for this delta wave, because by the time you actually make that decision, then CDC issues a recommendation, then you start operationalizing a booster campaign,” he noted. “You’re talking about maybe late October at the earliest if the decision comes in September that you can start really getting a sizable number of people boosted.”

“It takes time to get that stood up and get people into the doctor’s office to get those injections,” Gottlieb added. “And it’s going to take a couple of weeks for the immunity that the booster is offered to mature.”

In early March, the R.I. Department of Health expanded vaccine eligibility to an estimate of more than 160,000 Rhode Islanders ages 60 and older and those with certain health conditions that may result in a weakened immune system, including:

  • Cancer
  • People who get chemotherapy or radiation
  • People who have had a transplant or are waiting for a transplant
  • HIV/AIDS
  • Sickle cell disease
  • People who have a disease that weakens the immune system
  • People who take medicine that weakens the immune system
  • Pregnancy

As of Friday, the Health Department reported there were 198,743 eligible Rhode Islanders with unknown vaccine status, while just over 80% of the state’s eligible population has received at least one dose.

Gottlieb said in addition to considering boosters for people who are immunocompromised and with pre-existing health conditions, he thinks federal health officials need to explore boosters for vulnerable people in congregate settings like nursing homes and long-term care facilities.

When asked if other groups should get booster shots, Dr. Fauci said the CDC is ready to give such recommendations once they see clear evidence to do so from the data.

“As soon as they see that level of durability of protection goes down, then you will see the recommendation to vaccinate those individuals,” Fauci said Sunday.

Copyright 2021 Nexstar Media Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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