FDA states J&J 1-dose shot prevents COVID; final choice soon

WASHINGTON (AP)– Johnson & Johnson’s single-dose vaccine secures versus COVID-19, according to an analysis by U.S. regulators Wednesday that sets the stage for a last decision on a brand-new and easier-to-use shot to help tame the pandemic.

The Food and Drug Administration’s scientists validated that general the vaccine is about 66?fective at avoiding moderate to severe COVID-19

That’s just one step in the FDA’s examination of a third vaccine choice for the U.S. On Friday, the company’s independent advisers will debate if the proof is strong enough to recommend the long-anticipated shot. Equipped with that suggestions, FDA is expected to make a final decision within days.

The vaccination drive has actually been slower than hoped, hampered by logistical problems and weather delays even as the country grieves more than 500,000 virus-related deaths. Far, about 44.5 million Americans have gotten at least one dose of vaccine made by Pfizer or Moderna, and almost 20 million have received the second dosage needed for full defense.

J&J evaluated its single-dose alternative in 44,000 people in the U.S., Latin America and South Africa.

Still, in every country it was highly efficient versus the most serious symptoms, and early study results revealed no hospitalizations or deaths beginning 28 days after vaccination.

While the overall efficiency numbers might suggest the J&J candidate isn’t rather as strong as two-dose competitors, all of the world’s COVID-19 vaccines have been evaluated differently, making comparisons nearly difficult. While it wouldn’t be unexpected if one dosage ends up being a little weaker than 2 dosages, policymakers will decide if that’s an acceptable compromise to get more people immunized faster.

J&J was on track to become the world’s very first one-dose alternative up until previously this month, Mexico revealed it would use a one-dose version from China’s CanSino. That vaccine is made with similar innovation as J&J’s however initially was established as a two-dose choice up until beginning a one-dose test in the fall.

The rival Pfizer and Moderna vaccines being utilized in the U.S. and numerous other nations must be kept frozen, while the J&J shot can last 3 months in the refrigerator, making it easier to deal with. AstraZeneca’s vaccine, widely used in Europe, Britain and Israel, is made likewise and also requires refrigeration but takes 2 doses.

If the FDA clears the J&J shot for U.S. usage, it will not enhance vaccine supplies substantially right away.

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

___

The Associated Press Health and Science Department gets support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely accountable for all content.