WASHINGTON, Feb 24, (AP): Johnson & Johnson’s single-dose vaccine offers strong protection against severe COVID-19, according to an analysis by US regulators Wednesday that sets the stage for a final decision on a new and easier-to-use. shot to help tame the pandemic.
The Food and Drug Administration’s scientists confirmed that the overall the vaccine is about 66% effective at preventing moderate to severe COVID-19, and about 85% effective against the most serious illness. The agency also said J & J’s shot – one that could help speed vaccinations by requiring just one dose instead of two – is safe to use.
That’s just one step in the FDA’s evaluation of a third vaccine option for the US. On Friday, the agency’s independent advisers will debate if the evidence is strong enough to recommend the long-anticipated shot. Armed with that advice, FDA is expected to make a final decision within days.
The vaccination drive has been slower than hoped, hampered by logistical issues and weather delays even as the country mourns more than 500,000 virus-related deaths. So far, about 44.5 million Americans have received at least one dose of vaccine made by Pfizer or Moderna, and nearly 20 million of them have received the second dose required for full protection.
J&J tested its single-dose option in 44,000 adults in the US, Latin America and South Africa. Different mutated versions of the virus are circulating in different countries, and the FDA analysis cautioned that it’s not clear how well the vaccine works against each variant. But J&J previously announced 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. Still, South Africa recently began giving the J&J vaccine to front-line health workers on a test basis after deciding that a vaccine from rival AstraZeneca hadn’t shown strong enough study results. Across all countries, Wednesday’s analysis showed protection began to emerge about 14 days after vaccination.
But by 28 days after vaccination, there were no hospitalizations or deaths in the vaccinated group compared with 16 hospitalizations and 7 deaths in study recipients who received a dummy shot. The FDA said effectiveness and safety were consistent across racial groups, including Black and Latino participants.
While the overall effectiveness data may suggest the J&J candidate isn’t quite as strong as the two-dose Pfizer and Moderna options, all of the world’s COVID- 19 vaccines have been tested differently, making comparisons nearly impossible. It wouldn’t be surprising if one dose turns 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. Like other COVID-19 vaccines, the main side effects of the J&J shot are pain at the injection site and flu-like fever, fatigue and headache. No study participant experienced the severe allergic reaction, called anaphylaxis, that is a rare risk of some other COVID-19 shots, although one experienced a less serious reaction.
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