AP

Johnson & Johnson asks US regulators to OK its one-shot COVID-19 vaccine

Feb 4, 2021, 6:46 PM
Johnson & Johnson COVID-19 Vaccine...
This Dec. 2, 2020 photo provided by Johnson & Johnson shows vials of the Janssen COVID-19 vaccine in the United States. On Thursday, Feb. 4, 2021, Johnson & Johnson has asked U.S. regulators to clear the world’s first single-dose COVID-19 vaccine, an easier-to-use option that could boost scarce supplies. (Johnson & Johnson via AP)
(Johnson & Johnson via AP)

Johnson & Johnson asked U.S. regulators Thursday to clear the world’s first single-dose COVID-19 vaccine, an easier-to-use option that could boost scarce supplies.

J&J’s vaccine was safe and offered strong protection against moderate to severe COVID-19, according to preliminary results from a massive international study.

It didn’t appear quite as strong as two-dose competitors made by Pfizer and Moderna — a finding that may be more perception than reality, given differences in how each was tested.

But the Food and Drug Administration is asking its independent advisers to publicly debate all the data behind the single-dose shot — just like its competitors were put under the microscope — before it decides whether to greenlight a third vaccine option in the U.S. The panel will meet on Feb. 26.

Dr. Peter Marks, FDA’s vaccine chief, has cautioned against making comparisons before the evidence is all in.

“With so much need to get this pandemic under control, I think we can’t ignore any tool in the tool chest,” he told the American Medical Association last week. “We will have to do our best to try to make sure that we find the populations that benefit the most from each of these vaccines and deploy them in a very thoughtful manner.”

WHAT THE NUMBERS SHOW

Overall, the single-dose vaccine was 66% effective at preventing moderate to severe COVID-19, according to early findings from a study of 44,000 people in the U.S., Latin America and South Africa.

But it was 85% protective against the most serious symptoms — and starting 28 days after their shot, researchers found no one who got the vaccine needed hospitalization or died.

WEAKER BUT STILL FIGHTS MUTATING VIRUS

The one-dose option 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, where a more contagious mutant virus is spreading.

Scientists have been looking for real-world evidence about how vaccines work as the world races to stay ahead of the rapidly mutating virus, and welcomed the news that the J&J option — while weaker — did still offer protection.

OTHER OPTIONS

In large U.S. studies, two doses of the Pfizer and Moderna vaccines proved 95% protective against any symptomatic COVID-19.

But those studies were finished before the record virus surges of recent months and the appearance of the worrisome mutants, meaning such testing might not turn out the same if repeated today.

J&J also is studying a two-dose version of its vaccine, but results won’t be available for several more months.

THE SUPPLY

J&J said it would have some vaccine ready to ship if the FDA allows emergency use of the shot, but it didn’t reveal how much. The pharmaceutical giant said it expects to supply 100 million doses to the U.S. by the end of June.

It expects to file a similar application with European regulators soon.

___

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.

Today’s Top Stories

AP

DOHA, QATAR - NOVEMBER 25: A giant flag of IR Iran on the pitch prior to the FIFA World Cup Qatar 2...
ALI ABDUL-HASSAN and ABBY SEWELL Associated Press

US-Iran match reflects a regional rivalry for many Arab fans

The U.S. team’s must-win World Cup match against Iran will be closely watched across the Middle East, where the two nations have been engaged in a cold war for over four decades and where many blame one or both for the region’s woes.
4 days ago
Irene Cara in 'Fame' (Photo courtesy of Mgm/Kobal, Shutterstock)...
MARK KENNEDY, AP Entertainment Writer

‘Fame’ and ‘Flashdance’ singer-actor Irene Cara dies at 63

singer-actress Irene Cara, who starred and sang the title cut from the 1980 hit movie “Fame” and then belted out the era-defining hit “Flashdance ... What a Feeling” from 1983's “Flashdance,” has died. She was 63.
6 days ago
The U.S. Coast Guard ship Bernard C. Webber, leaves the coast guard base, Monday, July 19, 2021, in...
Associated Press

‘Miracle’: Missing cruise ship passenger found OK in water

The U.S. Coast Guard says a passenger who went overboard from a cruise ship in the Gulf of Mexico was rescued on Thanksgiving after likely being in the water for hours.
7 days ago
FILE - A Montana man was sentenced to three years in prison for his role in the Capitol riot. (AP P...
The Associated Press

Montana man gets 3 years in prison for role in Capitol riot

A Montana man will spend three years in federal prison for his role in the Jan. 6, 2021, riot at the U.S Capitol.
8 days ago
Debbie, left, and Chet Barnett place flowers at a memorial outside of the Chesapeake, Va., Walmart ...
The Associated Press

Walmart shooter left ‘death note,’ bought gun day of killing

According to authorities in Virginia, the Walmart shooter bought his gun just hours prior to killing six employees.
8 days ago
Dry lakebed...
Kira Hoffelmeyer

Lawsuit looms over tiny fish in drought-stricken West

RENO, Nev. (AP) — Conservationists have notified U.S. wildlife officials that they will sue over delayed decisions related to protections for two rare fish species that are threatened by groundwater pumping in the drought-stricken West. The Center for Biological Diversity sent a formal notice of intent to sue the Fish and Wildlife Service last week […]
10 days ago

Sponsored Articles

Spicy Homemade Loaded Taters Tots...
Macey's

5 game day snacks for the whole family (with recipes!)

Try these game day snacks to make watching football at home with your family feel like a special occasion. 
Happy joyful smiling casual satisfied woman learning and communicates in sign language online using...
Sorenson

The best tools for Deaf and hard-of-hearing workplace success

Here are some of the best resources to make your workplace work better for Deaf and hard-of-hearing employees.
Team supporters celebrating at a tailgate party...
Macey's

8 Delicious Tailgate Foods That Require Zero Prep Work

In a hurry? These 8 tailgate foods take zero prep work, so you can fuel up and get back to what matters most: getting hyped for your favorite
christmas decorations candles in glass jars with fir on a old wooden table...
Western Nut Company

12 Mason Jar Gift Ideas for the 12 Days of Christmas [with recipes!]

There are so many clever mason jar gift ideas to give something thoughtful to your neighbors or friends. Read our 12 ideas to make your own!
wide shot of Bear Lake with a person on a stand up paddle board...

Pack your bags! Extended stays at Bear Lake await you

Work from here! Read our tips to prepare for your extended stay, whether at Bear Lake or somewhere else nearby.
young boy with hearing aid...
Sorenson

Accommodations for students who are deaf and hard of hearing

These different types of accommodations for students who are deaf and hard of hearing can help them succeed in school.
Johnson & Johnson asks US regulators to OK its one-shot COVID-19 vaccine