Data from more than 40,000 participants in a clinical trial of a single-dose coronavirus vaccine by Johnson & Johnson, which shows the vaccine achieves 85 percent effectiveness 28 days after inoculation, was publicly released by the Food and Drug Administration (FDA) Wednesday ahead of a critical review by an advisory panel on Friday.
The data contained in a 62-page report showed FDA backing for the vaccine, which would join two previously approved vaccines by Pfizer-BioNTech and Moderna, as front line weapons against the coronavirus pandemic.
“Based on the totality of scientific evidence available, the benefits of the Ad26.COV2.S vaccine outweigh its risks for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older,” the report said. "The analysis supported a favourable safety profile with no specific safety concerns identified that would preclude the issuance of an EUA [emergency use authorization]."
The vaccine achieved 76.7 percent effectiveness 14 days after the shot and 85.4 percent after 28 days, the report said.
Unlike its predecessor vaccines, which require two doses and storage at temperatures well below freezing, the Johnson & Johnson version requires a single dose and can be kept in an ordinary refrigerator. For that reason, many healthcare providers consider it a potential game-changer, especially in global vaccination efforts that must reach poor nations without the health infrastructure of advanced nations.
On Friday, the FDA’s independent Vaccines and Related Biological Products Advisory Committee will decide whether to recommend that the vaccine receive authorization for people 18 years old and above, the report said.
In support of their emergency use authorization request, Johnson & Johnson subsidiary Hanssen Biotech submitted safety and efficacy data from a Phase 3 randomized, double-blind trial of a single dose to more than 40,000 participants. Half received the vaccine and the other half a placebo.
“There were no COVID-19-related deaths and no COVID-19 cases requiring medical intervention occurring 28 days or more post-vaccination among participants age 60 years or older with medical comorbidities in the vaccine group,” the release said.
The most common adverse reactions were site pain, headache, fatigue and muscle soreness – symptoms described as mild to moderate.