Enlarge /. A sign on the Johnson & Johnson campus on August 26, 2019 in Irvine, California.
View more stories
According to scientists from the Food and Drug Administration, Johnson & Johnson's single-shot COVID-19 vaccine is effective and has a "favorable safety profile."
The confirmation comes from a review released by the regulator on Wednesday. The FDA has been reviewing data on Johnson & Johnson's vaccine since February 4, when the company filed for emergency approval. The agency's green light is a positive sign ahead of this Friday, February 26, when the FDA will convene an advisory committee to make a recommendation on whether the FDA should grant the EEA. The FDA is not required to follow the committee's recommendation, but it usually does.
If the Johnson & Johnson vaccine is granted an EUA, it will be the third COVID-19 vaccine available in the US. The other two vaccines are two-dose, mRNA-based vaccines, one from Pfizer and its German partner BioNTech and the other from Moderna, who developed its vaccine in collaboration with researchers from the US National Institutes of Health.
Johnson & Johnson's vaccine is less effective than the two mRNA vaccines, both of which were approximately 95 percent effective in preventing symptomatic COVID-19, according to data from a Phase III clinical trial of more than 44,000 participants. Overall, Johnson & Johnson's vaccine was found to be 66 percent effective in preventing moderate to severe COVID-19. However, the effectiveness varied depending on the location of the study. The effectiveness was 72 percent in the USA, 66 percent in Latin America and 57 percent in South Africa. The differences can be partly explained by the prevalence of variants in Latin America and South Africa that have been found to reduce the effectiveness of vaccines.
Overall, however, the Johnson & Johnson vaccine was 85 percent effective against severe COVID-19. Even in South Africa, the vaccine was 82 percent effective against severe and critical COVID-19, according to FDA review.
After the shot, six vaccinated participants and 42 participants who received the placebo were hospitalized. When the researchers checked 28 days after vaccination, no vaccinated participants were hospitalized compared to 16 in the placebo group. There were seven deaths in the study, but all were on placebo.
Although the efficacy numbers are lower than mRNA vaccines, experts point out their high efficacy against serious illness and death – the most critical functions of a vaccine. In addition, the Johnson & Johnson vaccine has clear logistical advantages over the other vaccines. It's just one shot instead of two, and no freezing temperatures are required during shipping.
Regarding side effects, the FDA found that the vaccine has a favorable safety profile with no specific safety concerns. The most common effects are mild to moderate pain at the injection site, headache, fatigue, and myalgia.
The fate of the vaccine now goes to the FDA advisory panel, which is digging deeper into all of the data. If the FDA approves the EEA, Johnson & Johnson's executive director said in a congressional statement this week that the company would provide 4 million doses under the EEA, with a total of 20 million by the end of March and 100 million ready by June .