Final Decision Soon: FDA says J&J 1-dose shot prevents COVID

WASHINGTON (AP) — Johnson & Johnson’s single-dose vaccine offers strong protection against severe COVID-19, consistent with an analysis by U.S. regulators Wednesday that sets the stage for a final judgment on a replacement and easier-to-use shot to assist tame the pandemic.

The Food and Drug Administration’s scientists confirmed that overall the vaccine is about 66% effective at preventing moderate to severe COVID-19, and about 85% effective against the foremost serious illness. The agency also said J&J’s shot — one that would help speed vaccinations by requiring only one dose rather than two — is safe to use.

That’s only one step within the FDA’s evaluation of a 3rd vaccine option for the U.S. On Friday, the agency’s independent advisers will debate if the evidence is robust enough to recommend the long-anticipated shot. Armed thereupon advice, FDA is predicted to form a final judgment within days.

The vaccination drive has been slower than hoped, hampered by logistical issues and weather delays whilst the country mourns quite 500,000 virus-related deaths. So far, about 44.5 million Americans have received a minimum of 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 within the U.S., Latin America and South Africa . Different mutated versions of the virus are circulating in several countries, and therefore 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 within the U.S. -- 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 doctors 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 have been no hospitalizations or deaths within the vaccinated group compared with 16 hospitalizations and seven 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 report from

While the general effectiveness data may suggest the J&J candidate isn’t quite as strong because the two-dose Pfizer and Moderna options, all of the world’s COVID-19 vaccines are tested differently, making comparisons nearly impossible. It wouldn’t be surprising if one dose seems to be a touch weaker than two doses and policymakers will decide if that’s a suitable trade-off to urge more people vaccinated faster.

Like other COVID-19 vaccines, the most 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 allergy , called anaphylaxis, that's a rare risk of another COVID-19 shots, although one experienced a less serious reaction.

The FDA said there have been no serious side effects linked to the vaccine thus far , although it recommended further monitoring for blood clots. within the study, those were reported in about 15 vaccine recipients and 10 placebo recipients, not enough of a difference to inform if the vaccine played any role.

J&J was on target to become the world’s first one-dose option until earlier this month, Mexico announced it might use a one-dose version from China’s CanSino. That vaccine is formed with similar technology as J&J’s but initially was developed as a two-dose option until beginning a one-dose test within the fall.

The Pfizer and Moderna vaccines now getting used within the U.S. and various other countries must be kept frozen, while the J&J shot can last three months within the refrigerator, making it easier to handle. AstraZeneca’s vaccine, widely utilized in Europe, Britain and Israel, is formed similarly and also requires refrigeration but takes two doses.

Full Coverage: Coronavirus vaccine

If the FDA clears the J&J shot for U.S. use, it won’t boost vaccine supplies significantly directly . Only a couple of million doses are expected to be ready for shipping within the first week. But J&J told Congress in the week that it expected to supply 20 million doses by the top of March and 100 million by summer.

European regulators and therefore the World Health Organization are also considering J&J’s vaccine. Worldwide, the corporate aims to be producing around a billion doses by the top of the year.

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