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Health officials have authorized a second COVID-19 vaccine booster dose for immunocompromised adolescents and adults as well as everyone 50 years and older. Certain adults of any age vaccinated with the Johnson & Johnson vaccine also are eligible.
The Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) both signed off on the boosters Tuesday to address waning protection against serious illness in these groups.
“The FDA believes this option will help save lives and prevent severe outcomes among our highest risk patients, which has been a top priority since the vaccines were first introduced,” Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, said in a call with reporters Tuesday.
A second booster of Pfizer-BioNTech or Moderna vaccine could be given at least four months after a first booster of any authorized COVID-19 vaccine.
These second boosters have been authorized for people ages 12 and older who have undergone solid organ transplantation or who are living with conditions considered to have equivalent levels of immunocompromise. Pfizer-BioNTech vaccine can be used for those ages 12 and older, and Moderna vaccine is authorized for those 18 years and older. This would be a fifth dose for people who are immunocompromised as they previously were eligible for a three-dose primary series and a booster.
“Immunocompromised individuals who don’t tend to make the most robust immune responses to begin with, they tend to have more rapid waning of those immune responses,” Dr. Marks said.
A second booster of Pfizer-BioNTech or Moderna vaccine also has been authorized for all adults 50 years and older.
“This is especially important for those 65 and older and those 50 and older with underlying medical conditions that increase their risk for severe disease from COVID-19 as they are the most likely to benefit from receiving an additional booster dose at this time,” CDC Director Rochelle P. Walensky, M.D., M.P.H., said in a statement.
In addition, the CDC authorized second boosters with an mRNA vaccine for adults of any age who received Johnson & Johnson for their primary vaccine and first booster.
The FDA said its authorization was based on safety data from Israel where 700,000 adults received a fourth dose of the Pfizer-BioNTech vaccine at least four months after a third dose. There also was an independent study in which the Moderna vaccine was administered as a second booster to 120 adults. Neither data set showed new safety concerns.
Immunogenicity was assessed in an ongoing study of 274 adult health care workers in Israel who received a second booster of the Pfizer-BioNTech or Moderna vaccine. Neutralizing antibody levels against SARS-CoV-2 virus, including delta and omicron variants, two weeks after a second booster increased compared to levels five months after a first booster.
Dr. Marks said the FDA’s decision to authorize second boosters was done without its advisory committee because it was straightforward. The Vaccines and Related Biological Products Advisory Committee will meet April 6 to discuss boosters more broadly, including for additional ages and variant-specific boosters. He did not rule out the possibility that groups recommended for a booster now could be recommended for another in the fall.
Vaccines for young children
Moderna is expected to apply for emergency use authorization for its vaccine in children under 6 years in the coming weeks, and Pfizer is likely to do so this spring for children under 5 years.
Dr. Marks said the FDA understands both the urgency in authorizing a vaccine for young children and the need for careful evaluation that will include the advisory committee.
“We want to make sure when we go into the youngest children, we provide the excellent data that will be needed on safety and effectiveness that will help people have the confidence to vaccinate their children,” he said.