The FDA vaccine advisory board recommends booster shots of both the J&J and Moderna vaccines
The Food and Drug Administration (FDA)’s Vaccines and Related Biological Products Advisory Committee has voted unanimously to recommend a second shot of Johnson & Johnson (J&J)’s COVID vaccine for the more than 15 million adults who have already received a dose.
While the FDA usually follows the advice of its advisory committee, a final decision cannot be made until the vaccine advisory group of the Centers for Disease Control and Prevention (CDC) has recommended the second jab, although this is expected within days.
“Today’s recommendation is based on the totality of evidence, with clinical and real-world data showing that while a single shot offers strong and long-lasting protection against COVID-19, a booster given after the single-dose primary vaccination increases protection, in particular against symptomatic COVID-19,” said Paul Stoffels, chief scientific officer at J&J.
However, widespread concerns have been voiced about the real-world protection offered by the single-dose J&J vaccine, which has been shown to be comparatively less effective than the two-dose messenger RNA vaccines made by Pfizer-BioNTech and Moderna.
Paul Offit from the Children's Hospital of Philadelphia said: “This, frankly, was always a two-dose vaccine. I think it’s better as a two-dose vaccine, it’d be hard to recommend this as a single-dose vaccine at this point, given this two-month data.”
J&J’s data showed that a second shot of its vaccine boosts protection to 94% against symptomatic moderate-to-severe infection when administered two months after the first dose, similar efficacy to the mRNA vaccines.
Read more: http://www.pmlive.com/pharma_news/the_fda_vaccine_advisory_board_recommends_booster_shots_of_both_the_j_and_j_and_moderna_vaccines_1381612
While the FDA usually follows the advice of its advisory committee, a final decision cannot be made until the vaccine advisory group of the Centers for Disease Control and Prevention (CDC) has recommended the second jab, although this is expected within days.
“Today’s recommendation is based on the totality of evidence, with clinical and real-world data showing that while a single shot offers strong and long-lasting protection against COVID-19, a booster given after the single-dose primary vaccination increases protection, in particular against symptomatic COVID-19,” said Paul Stoffels, chief scientific officer at J&J.
However, widespread concerns have been voiced about the real-world protection offered by the single-dose J&J vaccine, which has been shown to be comparatively less effective than the two-dose messenger RNA vaccines made by Pfizer-BioNTech and Moderna.
Paul Offit from the Children's Hospital of Philadelphia said: “This, frankly, was always a two-dose vaccine. I think it’s better as a two-dose vaccine, it’d be hard to recommend this as a single-dose vaccine at this point, given this two-month data.”
J&J’s data showed that a second shot of its vaccine boosts protection to 94% against symptomatic moderate-to-severe infection when administered two months after the first dose, similar efficacy to the mRNA vaccines.
Read more: http://www.pmlive.com/pharma_news/the_fda_vaccine_advisory_board_recommends_booster_shots_of_both_the_j_and_j_and_moderna_vaccines_1381612