F.D.A. Authorizes Third Covid Shot for Immunocompromised
The Food and Drug Administration on Thursday cleared third doses of Pfizer-BioNTech and Moderna coronavirus vaccines for some people with weakened immune systems, giving doctors more leeway to protect those who have not responded sufficiently to an first series of shots.
The authorization, in the form of updates to the existing emergency use authorizations for both vaccines, applies to people who have received solid organ transplants and others whose immune systems are also compromised. , the FDA said.
The agency’s decision came a day before the Centers for Disease Control and Prevention’s independent advisory committee was tasked with reviewing and voting on whether to recommend the decision. The committee is likely to give its approval, and the CDC will follow up with its own approval of additional doses.
“The FDA is particularly aware that people who are immunocompromised are particularly at risk for serious disease,” Dr. Janet Woodcock, acting commissioner of the FDA, said in a statement. “After a careful review of the available data, the FDA determined that this small, vulnerable group could benefit from a third dose of Pfizer-BioNTech or Moderna vaccines.”
The third-dose authorization kicks off what promises to be a busy next step for federal vaccine regulators – and a new phase in the country’s inoculation campaign. By early next month, the agency is expected to grant full approval to Pfizer-BioNTech’s vaccine. This will most likely cause a wave of vaccination warrants from companies and organizations that have waited to demand vaccination until the FDA has fully cleared a vaccine.
At the same time, government scientists and regulators are questioning whether more Americans will need booster doses, a highly controversial decision that many scientists say is yet to be supported by data. Other countries like Israel and Germany have put in place stimulus policies.
“Other fully vaccinated people are properly protected and do not need an extra dose of the Covid-19 vaccine at this time,” Dr Woodcock said in his statement Thursday, adding that the agency was “actively engaged in a scientific project, rigorous process with our federal partners to determine if an additional dose may be needed in the future.
The United States is the latest country to begin offering third doses to people with weaker immune systems. France has offered additional doses of the vaccine to some people with weak immune responses since April, and Germany and Hungary recently followed suit.
About 3% of Americans have a weakened immune system for a variety of reasons, ranging from a history of cancer to the use of certain medications such as steroids.
The FDA’s decision to limit the category of people with weakened immune systems who should receive the additional dose was expected. Many scientists argue that the immunocompromised population is too diverse to uniformly recommend additional injections of the coronavirus vaccine. Some may be protected by the standard vaccine dosage, despite their conditions. Others may be poorly protected by vaccines, but unable to benefit from an additional injection.
Studies suggest that patients such as organ transplant recipients are in between – often showing a weak immune response to the standard vaccination regimen, but getting a third shot. A recent randomized, placebo-controlled study conducted by Canadian researchers found that a third dose of Moderna vaccine improved the immune response in people in this group.
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