Johnson & Johnson's one-shot COVID-19 vaccine highly effective: FDA
Johnson & Johnson's single-dose vaccine offers strong protection against severe COVID-19, according to an analysis released by US regulators that sets the stage for a final decision on a new and easier-to-use shot. The long-anticipated shot could offer the nation a third vaccine option and help speed vaccinations by requiring just one dose instead of two. J&J's shot is safe, the agency said.
How effective is the one-dose shot?
Food and Drug Administration scientists on Wednesday confirmed that the vaccine is about 66% effective at preventing moderate to severe COVID-19, and about 85% effective against severe illness. The analysis is just the first step as on Friday, the agency's independent advisers will debate if the evidence is strong enough to recommend the shot. Then, the FDA will make the final decision within days.
How well does the vaccine work against mutated variants?
J&J tested its vaccine on 44,000 adults in the US, Latin America, and South Africa. The FDA analysis cautioned that it's not clear how well the vaccine works against mutated variants circulating in different countries. J&J previously announced that the vaccine worked better in the US- 72% effective against moderate to severe COVID-19, compared with 66% in Latin America and 57% in South Africa.
South Africa began giving J&J vaccine to frontline health workers
South Africa recently began giving the J&J vaccine to frontline health workers on a test basis after deciding that a vaccine from rival AstraZeneca had not shown strong enough study results against the variant spreading there. AstraZeneca's vaccine requires two doses as compared to J&J.
Manufacturers are working on adjustments in case vaccines need update
"I was reassured that despite different variants, the J&J shot still protected against serious illness," said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief. In case the vaccines eventually need to be updated, manufacturers are working on adjustments to their recipes. Moderna announced that it is ready to begin testing experimental doses that better match the mutated virus in South Africa.
Protection emerged about 14 days after vaccination
J&J vaccine's analysis everywhere showed protection began to emerge about 14 days after vaccination. But by 28 days, there were no hospitalizations or deaths in the vaccinated group compared with 16 hospitalizations and seven deaths in study recipients who received a dummy shot.
Effectiveness and safety consistent across racial groups: FDA
The FDA said effectiveness and safety were consistent across racial groups, including Black and Latino participants. All of the world's COVID-19 vaccines have been tested differently, making comparisons nearly impossible. It would not be surprising if one dose turned out to be a little weaker than two doses, and policymakers will decide if that's an acceptable trade-off to get more people vaccinated faster.
Study underway to see if second dose works better
J&J has another large study underway to see if the second dose of its vaccine works better, raising the prospect that countries could eventually add a booster if one turned out to be warranted.
What are the side effects of the J&J shot
Like other vaccines, the side effects of the J&J shot are pain at the injection site, flu-like fever, fatigue, and headache. No participant experienced anaphylaxis, a severe allergic reaction, which is a rare risk of some other COVID-19 shots, although one experienced a less serious reaction. There were no serious side effects linked to the vaccine, although FDA recommended further monitoring for blood clots.
Vaccination drive in US has been slower than expected
COVID-19 death toll in the US topped 500,000 this week, and the vaccination drive has been slower, hampered by logistical and weather delays. About 44.5 million Americans have received at least one dose of vaccine made by Pfizer or Moderna, and nearly 20 million have received the second dose. Tests showed the Pfizer and Moderna vaccines were 95% effective at protection against symptomatic COVID-19.