FDA grants emergency use of COVID-19 booster shot for immunocompromised
As COVID-19 surges behind the highly transmissible delta variant, the U.S. Food and Drug Administration (FDA) has granted emergency use authorization to give immunocompromised Americans the opportunity to enhance their protection with a booster shot.
Booster shots of mRNA vaccines by Moderna and Pfizer-BioNTech will serve as a third dose option for "certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise," the FDA announced Thursday.
The FDA says people who with immune deficiency are "especially vulnerable to infections," putting them at higher risk to COVID-19, adding that a third dose of the Moderna or Pfizer-BioNTech vaccine "may increase protection."
The decision to grant booster shots to a vulnerable population comes as a preprint study (meaning it hasn't been peer reviewed) of Mayo Clinic Health Systems patients found that both mRNA vaccines continue to provide strong protection against severe illness and death from COVID-19, though possibly reduced infection protection.
The study found that, in July, the delta variant reduced infection prevention to 76% in Moderna recipients who were vaccinated in January and 42% in Pfizer-BioNTech recipients. But as Mayo Clinic stated to Bring Me The News, the studies are preliminary.
Booster shots for the general population are still being considered.
"As we’ve previously stated, other individuals who are fully vaccinated are adequately protected and do not need an additional dose of COVID-19 vaccine at this time. The FDA is actively engaged in a science-based, rigorous process with our federal partners to consider whether an additional dose may be needed in the future," FDA Commissioner Janet Woodcock, M.D., said in a release.
The Moderna vaccine is approved for emergency use for everyone over the age of 18, while the Pfizer-BioNTech vaccine is approved for people age 12 and older.
