Johnson & Johnson’s one-dose COVID-19 vaccine has moved closer to U.S. approval this week, but with limited trial data for participants aged 75 years and older.
The Food and Drug Administration on Wednesday released an efficacy and safety report on the vaccine with promising findings overall, and its independent advisory group is expected to vote Friday on whether to recommend the drug for emergency use authorization.
The agency’s trial data analysis found the drug to be safe and 66% effective overall at 28 days or more post-vaccination. In addition, among adults aged 60 years or older with medical comorbidities who received the vaccine, there were no COVID-19-related deaths and no COVID-19 cases that required medical intervention in that time period. But there were not enough participants aged 75 and older to assess efficacy in the oldest subgroup, the agency noted.
There were also not enough data to assess efficacy in certain racial subgroups or among participants who had a prior SARS-CoV-2 infection, the FDA noted.
Comparison by country shows drug can tackle variants
The shots also appeared to be highly effective against severe and/or critical COVID-19 across the United States, South Africa and Brazil, in which different strains of the virus dominate. But lower efficacy was observed for preventing moderate to severe/critical disease in South Africa when compared with the United States. And not enough data existed to draw comparisons with people exposed to the B117 variant originally found in England.
If approved, J&J’s vaccine candidate would be the third authorized for use in the United States along with Pfizer-BioNTech and Moderna’s shots, and would be the only one-dose option in the group. The other two vaccines were approved within a day after FDA advisors’ endorsement.
Exclusion of older adults in vaccine clinical trials has been an ongoing problem throughout the pandemic, researchers have found.
In related news:
J&J, Pfizer, Moderna say they’re ramping up U.S. COVID-19 vaccine shipments Executives with the three drugmakers say they’re ramping up vaccine shipments, reported Kaiser Health news. Pfizer plans to increase weekly shipments to more than 13 million doses, while Moderna is aiming for 40 million doses monthly. J&J meanwhile, is readying shipment of four million doses, according to Reuters.
AstraZeneca expects U.S. vaccine authorization in April AstraZeneca said its vaccine may receive U.S. emergency use authorization in early April, according to Reuters. The company plans to ship 30 million doses of the shot immediately upon approval, an executive told congressional lawmakers on Tuesday.