FDA Authorizes Johnson & Johnson Vaccine, Arming U.S. With Third Weapon Against COVID-19

The FDA granted an Emergency Use Authorization (EUA) for a third COVID-19 vaccine Saturday, clearing Johnson & Johnson’s (J&J) single shot following unanimous support from its vaccines advisory panel.

The agency’s decision came just one day after its vaccines advisory committee voted 22-0 in support of authorizing the one-dose COVID-19 vaccine, which data show has a 72 percent efficacy in the U.S. against moderate-to-severe infection. Notably, the vaccine appears to provide protection against viral variants that have shown up in the U.S. The committee concluded that its benefits outweighed its risks for people age 18 and up.

Only 4 million doses are immediately available for distribution, but J&J has prepared for large-scale manufacturing of the shot and expects to supply 20 million doses by the end of March and an additional 80 million doses by the end of June.

The single-dose vaccine offers significant advantages in terms of logistics, as it can be shipped at standard refrigerator temperatures and stored at such temperatures for three months. Additionally, it can be frozen for up to two years and does not need to be diluted. And it will expedite the government’s vaccination efforts because the other two vaccines that have been authorized (Moderna and Pfizer/BioNTech) require two doses.

However, the vaccine advisory panel members did express concern about the vaccine’s apparently lower effectiveness (42 percent) at preventing moderate-to-severe COVID-19 in adults over age 60 with comorbidities, a population vulnerable to the virus.

According to J&J’s vaccine presentation, its phase 3 study, which enrolled more than 44,000 participants and was done during the peak of the pandemic, found that the vaccine strongly protected against severe COVID-19 and fully prevented hospitalization and death, including for viral variants.

J&J found in its late-stage trial that the shot demonstrated 85 percent efficacy internationally against severe COVID-19 at least four weeks after inoculation, including in the U.S. and South Africa, where a concerning strain has emerged and spread, according to Johan Van Hoof, head of infectious diseases and vaccines at J&J subsidiary Janssen, who presented the findings during the panel meeting. Onset of protection was observed as early as one week after vaccine administration.

Against moderate-to-severe disease, it was shown to be 66 percent effective across all countries, with onset appearing as early as day 14 and increasing through day 56. In the U.S., the vaccine demonstrated 72 percent efficacy against moderate-to-severe disease, Van Hoof said.

Van Hoof noted that J&J, which is monitoring its phase 3 trial participants for up to two years, plans to soon begin enrollment in a trial evaluating the vaccine’s safety and effectiveness in children under 17. It will also begin a study of the vaccine in late March or early April of pregnant women, he said. The company is also developing a vaccine tailored for coronavirus variants that should start being assessed in phase 1 trials before the summer.

J&J’s vaccine is still being evaluated as a two-dose regimen in a phase 3 trial that could show two shots are more effective than one. That trial is likely to report results in May. Marion Gruber, the director of FDA’s Office of Vaccines Research and Review, said if a two-dose regimen turns out to be more effective, an EUA for a single-shot regimen could be amended to allow for use of the double shot.

The European Medicines Agency is reportedly planning to recommend authorizing the single-dose J&J vaccine on March 11, a recommendation the European Commission would likely adopt. The COVID-19 vaccine would become Europe’s fourth should it receive conditional marketing authorization, following shots from Pfizer, Moderna and AstraZeneca. — James Miessler