An advisory group of medical experts is recommending that a second dose of Johnson & Johnson’s COVID-19 vaccine be made available to individuals 18 years and older at least two months after their first dose.
During a virtual meeting Friday, Oct. 15, the U.S. Food & Drug Administration’s independent advisory committee voted unanimously (19-0) to recommend emergency use authorization (EUA) for an additional dose, in an effort to expand protection against COVID-19.
In doing so, the committee members agreed the data supported the notion that an additional dose would be safe and effective.
It’ll now be up to the FDA now to decide whether to grant Johnson & Johnson’s application for EUA. While the regulatory agency doesn’t have to follow the committee’s recommendation, it typically has leaned on its guidance in the past, as it relates to COVID-19 vaccines.
Before the vote, members of the Vaccines and Related Biological Products Advisory Committee received a presentation of data from Johnson & Johnson’s clinical trials. Representatives indicated that a second dose increased antibody levels.
During the discussion that followed, a number of members said the Johnson & Johnson vaccine should likely have been a two-dose vaccine from the start and should be moving forward. A few members also voiced concern regarding the limited size of Johnson & Johnson’s study.
There was talk of whether to recommend a longer time period of six months between doses, but the committee settled on the two-month period given the urgency to get recipients further protected against the delta variant.
The FDA first granted an EUA for the single-dose Johnson & Johnson vaccine February 27. Since then, more than 355,200 Michigan residents have gotten the shot.
The two other available COVID-19 vaccines -- developed by Pfizer and Moderna -- were two-dose shots initially, and vaccine providers have begun administering third-dose booster shots to specific at-risk groups including individuals who are immunocompromised.
A recording of Friday’s seven-hour meeting is available on the FDA’s YouTube page, here. To find a vaccine near you, visit Michigan’s COVID-19 vaccine website or go to VaccineFinder.org.
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