U.S. Food and Drug Administration staff confirmed data showing Johnson & Johnson’s single-injection Covid-19 vaccine is safe and effective, and found it to work almost as well in preventing serious illness caused by the variant first discovered in South Africa.
Scientists at the US regulator found in a report Wednesday that the J&J jab was 82% effective in preventing serious or critical illness at its test site in South Africa, where the 501.V2 variant was prevalent. This compares to 86 percent effectiveness in participants in the United States and 88 percent in Brazil, starting at 28 days after vaccination.
The vaccine was less effective in preventing moderate to severe disease in the South African group, at 64%, compared to 72 and 78% at sites in the United States and Brazil.
The FDA’s vaccine advisory group will meet on Friday to discuss the vaccine, which could receive its first emergency use authorization as early as the weekend. J&J said on Tuesday it would have 4 million shots to ship immediately after approval to the United States, which has recorded more than 500,000 deaths from Covid-19.
The report will offer some relief to public health experts who fear that vaccines may prove less effective against the 501.V2 variant. NOT A WORD and Novavax’s vaccines performed less well in South African trials, while laboratory tests showed reduced efficacy for several other injections.
Anthony Fauci, the White House’s chief medical adviser, said when J&J first released its Phase 3 data was a ‘wake-up call’ about the need to adapt to new variants. This week the FDA urged vaccine manufacturers to start studies of reformulated or booster vaccines to tackle new variants.
As the first single-injection vaccine, J & J’s jab will be an important contribution to the global race to immunize people around the world. The vaccine is easy to transport and store, and it is produced on a not-for-profit basis, making it more likely to be widely adopted in developing countries.
Scientists also suggested in their report that the vaccine could impact the transmissibility of the virus, even through asymptomatic carriers. But they cautioned that there was not yet enough evidence for this finding to be statistically significant.
While one of the main goals of vaccinations is to prevent hospitalization and death, public health experts are closely monitoring whether any of them can also reduce the spread of the disease, which would lead the way the removal of measures such as social distancing and the wearing of masks.
The FDA report showed that the vaccine’s efficacy was generally consistent in people with different demographics and comorbidities. For people over 60 with underlying conditions, efficacy estimates seemed slightly lower but increased over time. However, the scientists said it could simply be an “inaccuracy” associated with a smaller number of cases in this group.
Scientists said the vaccine had a “favorable safety profile,” with no concerns that would prevent emergency clearance. The main side effects of the vaccine were pain at the injection site, headache, and fatigue, like most other injections. There have been a few cases of hives, but not enough to prove a link to the vaccine.