Johnson & Johnson’s one-time coronavirus vaccine protected against symptomatic and asymptomatic infection and prevented hospitalization and death in all participants 28 days after vaccination, according to new clinical trial results published Wednesday.
The vaccine was, on average, 67 percent effective against moderately to severely critical COVID-19 at least 14 days after administration, and 66 percent effective 28 days after vaccination, according to data published in the New England Journal of Medicine.
The vaccine was approximately 77 percent effective against severe / critical COVID-19 14 days after administration and 85 percent after 28 days.
The results are consistent with the initial figures reported by the company in January – the vaccine provides a level of protection higher than the Food and Drug Administration (FDA) minimum, but lower than the Pfizer and Moderna vaccines.
Additional data gathered since the January announcement found no evidence of a decline in protection over time, after monitoring approximately 3,000 participants for 11 weeks and 1,000 participants for 15 weeks, the company said.
The results come from the company’s massive clinical trial spanning three continents and enrolling a total of 43,783 participants.
Importantly, the vaccine also showed efficacy against fast-spreading variants, including the B.1.351 variant, which was identified in 95 percent of COVID-19 cases in South Africa, and the P2 variant, which was identified in 69 percent of COVID-19 cases in Brazil.
In South Africa, the vaccine was 64 percent effective against moderate to severe / critical illness, and efficacy was 82 percent against severe / critical illness from 28 days after vaccination.
Efficacy was also maintained in participants in Brazil, with 68 percent efficacy against moderate to severe / critical illness and 88 percent against severe / critical illness.
Protection was generally consistent across race and age groups, including adults over 60 years old, and those with and without pre-existing conditions.
“This extensive evidence shows that Johnson & Johnson’s one-time COVID-19 vaccine protects and prevents hospitalization and death, including in countries where viral variants are common,” said Paul Stoffels, Johnson & Johnson’s Chief Scientific Officer.
“Regardless of race and ethnicity, age, geographic location and co-morbidity, these results remain consistent. A single-use vaccine that provides this level of protection is an important tool in the global fight against COVID-19 as we strive to end this deadly pandemic. The safety and well-being of every person who receives a Johnson & Johnson product remains our top priority, and this data confirms our confidence in the protective benefits of our COVID-19 vaccine, ”said Stoffels.
Use of the vaccine in the US is currently being interrupted due to concerns about an extremely low number of serious blood clots in combination with low platelets in individuals who have received the vaccine.
An advisory panel from Centers for Disease Control and Prevention will meet for a second time on Friday to discuss next steps for the vaccine.
In what could be a preview of the CDC meeting, the European drug regulator on Tuesday recommended adding a warning to the vaccine about its possible link to blood clots, but noted that they are “very rare” and that the benefits still outweigh the risks.