COVID-19: FDA advisers unanimously endorse second dose of Johnson & Johnson vaccine

The external advisers of the Food and Drug Administration (FDA) from USA voted this Friday unanimously in favor of recommending that regulators authorize a second injection of the vaccine COVID-19 from Johnson & Johnson (J&J), to better protect those who received a single dose.

The FDA’s Vaccines and Related Biologics Advisory Committee endorsed injections for all J&J Janssen vaccine recipients over 18 years of age at least two months after their first dose.

The decision will help end a sense of limbo for 15 million Americans who received the single dose but who were concerned whether it would be enough to protect them, especially after the rise of the delta variant.

Committee members, convened by the FDA, agreed with the pharmaceutical company that safety and efficacy tests favored a second dose of this originally single-dose vaccine.

It is possible that the FDA and Centers for Disease Control and Prevention (CDC) further modify the recommendation, which should be followed by an emergency use authorization in a matter of days or weeks.

Several of the independent experts suggested that, although J&J had requested authorization for a booster, a second vaccine from J&J should, in fact, be considered an “additional” dose necessary to achieve full vaccination.

“I think this was frankly always a two dose vaccine. It’s hard to recommend it as a single-dose vaccine, ”said Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia.

The panel was also asked to discuss, but not vote, the issue of the so-called “mix and match” booster, in which a person receives a brand or type of vaccine from a different technology than that used for the initial dose.

FDA scientist Peter Marks said “it is possible” that this issue will be voted on in the future.

A preliminary study conducted this week showed that people who have received the J&J vaccine may benefit from a booster dose of a different, messenger RNA (mRNA) vaccine, such as those from Pfizer or Moderna.

J & J’s single-shot vaccine was never as effective as its double-dose mRNA counterparts, but some evidence suggests that it is less susceptible to decline than Pfizer and Moderna, due to the viral vector technology behind it.

However, the company presented data showing that efficacy against symptomatic COVID-19 increased from 70% to 94% in a trial conducted in the United States after a second dose given two months after the first. These figures are similar to those associated with mRNA vaccines.

Friday’s meeting came after the same panel voted Thursday to authorize a booster dose of Moderna’s vaccine for risk groups.

At that meeting, the panel decided to authorize a booster dose of Moderna for those over 65, people between the ages of 18 and 64 who are at increased risk of developing a severe version of the coronavirus, and those whose job or situation may involve frequent exposure to the virus.

A similar decision was already made for the Pfizer vaccine several weeks earlier, as experts were concerned that a booster might not be suitable for everyone, especially for younger men at risk of developing myocarditis (inflammation of the lungs). heart) as a side effect.

But J & J’s decision applies more broadly, to all people over the age of 18 who have received the first injection of the vaccine at least two months before.