The Food and Drug Administration said that Johnson & Johnson’s single-dose COVID-19 vaccine candidate has no unexpected safety concerns, in a step that moves the experimental vaccine one step closer to emergency authorization.
Shares of J&J
were up 1.2% in premarket trading on Wednesday after the regulator published its report as planned and in advance of Friday’s Vaccines and Related Biological Products Advisory Committee meeting.
The committee, which is made up of a group of independent medical experts, will discuss and then vote on whether they believe the benefits of the vaccine outweigh the risks. The FDA is not required to follow the committee’s recommendation but often does, and did so in the case of the BioNTech SE
and Moderna Inc.
vaccines, which both received emergency use authorization in December.
There are several differences between those vaccines and J&J’s investigational COVID-19 vaccine candidate. J&J’s product is adenovirus-based and is not mRNA-based like Pfizer’s and Moderna’s vaccines. It does not require special refrigeration, and it also requires only one shot, rather than two doses.
However, it was less efficacious than those vaccines in clinical trials. The Phase 3 clinical trial found that J&J’s vaccine candidate had an efficacy rate of 66.1% in all countries where it was studied, compared with the roughly 95% efficacy rates reported by the other vaccines in their late-stage studies.
The FDA said in the report that the vaccine candidate has a “favorable safety profile with no specific safety concerns identified that would preclude issuance
of an EUA.”
Johnson & Johnson’s stock is up 9.9% over the past 12 months, while the broader S&P 500
has gained 16.3%.