FDA advisory panel recommends Moderna, Johnson & Johnson vaccine booster shots
Although the panel gives guidance, the FDA does not have to follow its nonbinding recommendations.
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The U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) now recommends that all COVID-19 vaccines available in the U.S. be authorized for booster shots in certain populations.
Following the emergency use authorization (EUA) of a booster shot of Pfizer and BioNTech's vaccine given six months after the last regular dose in individuals 65 years and older and for adults of any age at high risk of severe COVID-19, the VRBPAC convened this week to review data for Moderna and Johnson & Johnson's candidates.
On Thursday, the committee unanimously voted to recommend a EUA for a booster dose of the Moderna COVID-19 vaccine. The VRBPAC indicated that the Moderna vaccine should also be given six months after the last regular dose in people 65 years and older and for adults at high risk of severe COVID-19.
Then on Friday, the advisory panel again unanimously voted to recommend a EUA for a second shot of Johnson & Johnson's vaccine.
This time, however, the VRBPAC's recommendation differs compared to the other two vaccines in that it says all adults who received one shot of the Johnson & Johnson vaccine should get a booster. It also suggests that this population get a follow-up shot at least two months after the initial vaccination, versus six months later for the Pfizer and Moderna vaccines.
While the VRBPAC offers guidance, its recommendations are nonbinding, and the FDA doesn't have to follow them.
As a next step in the EUA-process, the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) will meet to discuss their recommendation for the use of COVID-19 boosters.
WHY IT MATTERS
The VRBPAC's decisions are based on data submitted by Moderna and Johnson & Johnson that showed both vaccines' booster shots elicited increased antibody responses.
Booster shots are becoming a major component of U.S. COVID-19 mitigation strategy.
Reports now indicate that there are more people getting their third dose than there are people getting their first. As of October 13, a weekly average of 362,000 people a day got booster shots, about 57% more than the 231,000 people per day who started their first doses.
About 9.7 million booster shots have been administered so far in the U.S., representing 5.2% of the population, according to CDC data. In all, 56.8% of the population is fully vaccinated.
THE LARGER TREND
The vote follows a newly-released National Institutes of Health study suggesting that mixing and matching COVID-19 vaccines is safe and effective, although the findings have yet to be peer-reviewed.
The researchers found that people who originally received the Johnson & Johnson vaccines produced stronger antibody levels after they got Moderna or Pfizer booster shots. Additionally, they saw that those who first got vaccinated with the Pfizer or Moderna vaccines and received either company's booster shot produced similarly strong immune responses.
In addition to booster shots, vaccinating the nation's children is becoming a priority for controlling the pandemic. After releasing data showing a lower dose of the Pfizer vaccine is safe and effective among children ages 5 to 11, the company submitted a request for EUA to the FDA last week.
ON THE RECORD
"This positive recommendation is supported by data on the 50 µg booster dose of our COVID-19 vaccine, which shows robust antibody responses against the original virus, but also against the Delta variant," said Stéphane Bancel, CEO of Moderna, in a statement.
"We remain committed to staying ahead of the virus and following the evolving epidemiology of SARS-CoV-2. We look forward to making our booster available to people in the U.S. to help protect themselves against this ongoing public health emergency."
Twitter: @HackettMallory
Email the writer: mhackett@himss.org
