FDA and CDC Authorize Covid-19 Booster Shot for Some Immunocompromised People

Certain transplant recipients, cancer patients and others can soon get a third dose of the Pfizer-BioNTech or Moderna vaccine

Vials of the Pfizer-BioNTech vaccine
Those eligible for boosters include some organ transplant recipients, those with certain cancers, and others with similarly compromised immune systems. Photo by AHMAD GHARABLI/AFP via Getty Images

The United States Food and Drug Administration (FDA) authorized an additional Covid-19 vaccine dose to boost protection for certain immunocompromised people. The decision comes after mounting evidence that vaccinations may not trigger an adequate immune response in some groups of people. A panel of advisors from Centers for Disease Control and Prevention gave final authorization Friday, and vaccine distributors are now permitted to administer booster doses immediately, report Manas Mishra and Michael Erman for Reuters.

Those eligible for boosters include some organ transplant recipients, those with certain cancers, and others with similarly compromised immune systems, report Laurie McGinley and Lena H. Sun for the Washington Post. Both the Pfizer-BioNTech and Moderna vaccines have been given the green light to distribute booster shots. According to the CDC, either mRNA shot may be administered if an individual's original vaccine is not available. Per Reuters, proof of a medical condition will not be required to receive additional dosage.

"The country has entered yet another wave of the Covid-19 pandemic, and the FDA is especially cognizant that immunocompromised people are particularly at risk for severe disease," Acting FDA Commissioner Janet Woodcock wrote in a Tweet late Thursday evening. "After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna vaccines.”

The mRNA-based Pfizer-BioNTech and Moderna vaccines work by showing our immune system what a viral invader looks like before it arrives. That way, our body is already trained to spot, neutralize and destroy the virus if we’re infected. For some people with compromised immune systems, two doses of the Pfizer-BioNTech or Moderna vaccination may not have triggered a robust enough anti-virus response to offer long-term protection, reports Jacqueline Howard for CNN.

“As we’ve been saying for weeks, emerging data show that certain people who are immunocompromised, such as people who have had organ transplant and some cancer patients, may not have had an adequate immune response to just two doses of the Covid vaccine,” said CDC director Rochelle Walensky during yesterday’s White House Press Briefing. “To be clear, this is a very small population. We estimate it to be less than 3 percent of adults.”

Organ donor recipients and other immunocompromised people are especially vulnerable to infections, hospitalization, and death from viruses like SARS-CoV-2. For those without compromised immune systems, there is no evidence yet that a booster dose is needed to provide added protection against the virus.

“Others who are fully vaccinated are adequately protected and do not need an additional dose of Covid-19 vaccine at this time,” said Woodcock in a Tweet.

The rampant spread of the Delta variant and rising breakthrough infections in healthy, fully vaccinated people—though extremely rare—has put pressure on wealthy nations to consider widespread booster shots. Meanwhile, many developing countries are struggling to access the first doses necessary to halt the virus’ spread and mutation, report Manas Mishra and Michael Erman for Reuters. In an effort to close the vaccine gap between high- and low-income countries, the World Health Organization has called for a moratorium on booster shots until at least the end of September.