By Gina DiPietro, Novant Health Healthy Headlines
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Millions of Americans are one step closer to being eligible for a COVID vaccine booster.
A Food and Drug Administration (FDA) advisory panel voted in favor of emergency use authorization (EUA) to administer a booster dose of Moderna’s COVID vaccine to those who qualify. EUA provides access to medical products that may be effective in preventing or treating a disease – only if it’s determined the potential benefits outweigh any potential risks.
The advisory panel also endorsed a booster of Johnson & Johnson’s vaccine, citing growing concern that Americans who got the single-dose shot aren’t as protected as those who received other brands.
The FDA will still need to sign off on the recommendations. When the time comes for those eligible to receive booster shots, Novant Health will inform patients how and where to make an appointment.
Moderna
The committee endorsed Moderna’s booster for people 65 and older, as well as younger adults at high risk due to medical conditions or jobs that put them more at risk – the same groups who became eligible for a Pfizer-BioNTech booster in September.
Dr. David Priest
Moderna has said that a third dose was needed because the potency of its vaccine wanes over time, with antibody levels decreasing about six to eight months after the second dose.
The company also cited “real world evidence of reduced effectiveness against the delta variant.” It is common for antibodies to decrease with time, said Dr. David Priest, Novant Health chief safety, quality and epidemiology officer.
“What a third dose does is increase the amount of neutralizing antibodies, making it less likely that someone would have a serious COVID illness that results in hospitalization – or worse,” Priest said.
If FDA-approved, those eligible for a Moderna booster would receive a half-dose, administered at least six months after the second vaccine.
“Additional research has shown that a half-dose gives an excellent antibody response, so it appears a full dose is not necessary as a third booster for Moderna,” said Dr. Charles Bregier, Novant Health medical director of corporate health.
Johnson & Johnson (Janssen)
Pfizer
In line with FDA guidance, people who qualify can now receive a booster dose of Pfizer’s COVID vaccine. It’s recommended to wait at least six months after the second dose.
Pfizer’s vaccine, FDA-approved for people 16 and older, already carries EUA for adolescents ages 12 to 15. And later this month, Pfizer’s vaccine will be considered for EUA in kids ages 5 to 11.
Following its clinical trial of more than 2,200 children, the company released data showing its COVID vaccine is safe and effective in this younger age group. The 5- to 11-year-olds received 10 micrograms – one-third of the dose for adults and adolescents, who receive 30 micrograms.
Pfizer is still studying its COVID vaccine in children under 5 years old. A tenth of the adult dose – 3 micrograms – appears “sufficient” so far, experts said.
Moderna and J&J are also studying their vaccines in children but have not yet released the findings.
Novant Health
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