facebook linkedin twitter

FDA Says J&J 1-Dose Shot Prevents COVID; Final Decision Soon

February 24, 2021by Lauran Neergaard and Matthew Perrone, Associated Press
FILE - This Dec. 2, 2020 photo provided by Johnson & Johnson shows vials of the Janssen COVID-19 vaccine in the United States. Johnson & Johnson’s single-dose vaccine protects against COVID-19, according to an analysis by U.S. regulators Wednesday, Feb. 24, 2021, 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 overall, it's about 66% effective and also said J&J's shot, one that could help speed vaccinations by requiring just one dose instead of two, is safe to use. (Johnson & Johnson via AP)

WASHINGTON (AP) — Johnson & Johnson’s single-dose vaccine protects against COVID-19, according to an analysis by U.S. 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 overall the vaccine is about 66% effective at preventing moderate to severe COVID-19. 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 U.S. 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 have received the second dose required for full protection.  

J&J tested its single-dose option in 44,000 people in the U.S., 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 U.S. — 72% effective against moderate to severe COVID-19, compared with 66% in Latin America and 57% in South Africa. 

Still, in every country it was highly effective against the most serious symptoms, and early study results showed no hospitalizations or deaths starting 28 days after vaccination. 

While the overall effectiveness numbers may suggest the J&J candidate isn’t quite as strong as two-dose competitors, all of the world’s COVID-19 vaccines have been tested differently, making comparisons nearly impossible. While it wouldn’t be surprising if one dose turns out to be a little weaker than two doses, policymakers will decide if that’s an acceptable trade-off to get more people vaccinated faster. 

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

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

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

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

___ 

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

Health

FDA Panel Takes Up Tough Questions on J&J COVID-19 Boosters

WASHINGTON (AP) — U.S. health advisers on Friday tackled who should get boosters of Johnson & Johnson's single-shot COVID-19 vaccine... Read More

WASHINGTON (AP) — U.S. health advisers on Friday tackled who should get boosters of Johnson & Johnson's single-shot COVID-19 vaccine and when — and whether using a competing brand for the second dose might provide better protection. The push for boosters kicked off last month after... Read More

FDA Panel Endorses Lower-Dose Moderna COVID Shot for Booster

U.S. health advisers said Thursday that some Americans who received Moderna's COVID-19 vaccine should get a half-dose booster to bolster... Read More

U.S. health advisers said Thursday that some Americans who received Moderna's COVID-19 vaccine should get a half-dose booster to bolster protection against the virus. The panel of advisers to the Food and Drug Administration voted unanimously to recommend a booster shot for seniors, adults with other... Read More

Nursing Schools See Applications Rise, Despite COVID Burnout

STORRS, Conn. (AP) — Nurses around the U.S. are getting burned out by the COVID-19 crisis and quitting, yet applications... Read More

STORRS, Conn. (AP) — Nurses around the U.S. are getting burned out by the COVID-19 crisis and quitting, yet applications to nursing schools are rising, driven by what educators say are young people who see the global emergency as an opportunity and a challenge. Among them... Read More

FDA Spells Out Lower Sodium Goals for Food Industry

NEW YORK (AP) — Food companies are coming under renewed pressure to use less salt after U.S. regulators spelled out... Read More

NEW YORK (AP) — Food companies are coming under renewed pressure to use less salt after U.S. regulators spelled out long-awaited guidelines aimed at reducing sodium levels in dozens of foods including condiments, cereals, french fries and potato chips. The voluntary goals finalized Wednesday for 163... Read More

October 13, 2021
by Alexa Hornbeck
Gene Editing Treatment Used in Human Subjects With Rare Genetic Blindness

WASHINGTON — New data presented by researchers from Editas Medicine, a leading genome editing company, reveals that gene editing treatments... Read More

WASHINGTON — New data presented by researchers from Editas Medicine, a leading genome editing company, reveals that gene editing treatments are not only safe in humans, but may hold promise of treating a rare retinal disease that leads to blindness. “We believe these findings validate the... Read More

October 13, 2021
by Alexa Hornbeck
How Telehealth is Helping Address Veteran Food Insecurity

WASHINGTON -- The COVID-19 pandemic has impacted veterans' access to food, leading to greater food insecurity, and according to officials... Read More

WASHINGTON -- The COVID-19 pandemic has impacted veterans' access to food, leading to greater food insecurity, and according to officials from the United States Department of Veterans Affairs, telehealth is now helping to combat the issue.  “The COVID-19 pandemic certainly has been impactful for many Americans,... Read More

News From The Well
scroll top