CORONAVIRUS

J&J Asks US Regulators To OK Its One-Shot COVID-19 Vaccine

Feb 4, 2021, 4:28 PM | Updated: 6:15 pm
FILE (Photo by Spencer Platt/Getty Images)...
FILE (Photo by Spencer Platt/Getty Images)
(Photo by Spencer Platt/Getty Images)

(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 green light a third vaccine option in the U.S. The panel will meet 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.

KSL 5 TV Live

Top Stories

Coronavirus

RSV and flu...
Deidre McPhillips, CNN

Flu season intensifies, holiday gatherings could make it worse

Americans gathered for Thanksgiving last week amid a flu season that's worse than any has been in more than a decade, and experts continue to urge caution as multiple respiratory viruses circulate at high levels nationwide.
3 days ago
Protesters hold up blank papers and chant slogans as they march in protest in Beijing, Sunday, Nov....
Jessie Yeung and CNN's Beijing bureau

Rare protests are spreading across China. Here’s what you need to know

From Shanghai to Beijing, protests have erupted across China in a rare show of dissent against the ruling Communist Party.
3 days ago
Police officers block Shanghai's Urumqi Road on Sunday. (Hector Retamal/AFP/Getty Images)...
CNN's Beijing bureau and Nectar Gan

Protests erupt across China in unprecedented challenge to Xi Jinping’s zero-Covid policy

Protests erupted across China throughout the weekend, including at universities and in Shanghai where hundreds chanted "Step down, Xi Jinping! Step down, Communist Party!"
4 days ago
Salt Lake City Police at the University of Utah Hospital due to a possible bomb threat. (Salt Lake ...
Michael Houck

Police: Unattended bag led to bomb squad response at U of U Hospital

Salt Lake City Police responded to a possible bomb threat at the University of Utah hospital Tuesday afternoon.
16 days ago
Evusheld...
Elizabeth Cohen and Naomi Thomas, CNN

COVID-19 medicine for immunocompromised patients is losing effectiveness

Judy Salins considers herself a smart, empowered patient, but until this week, she had no idea that the medicine she takes to defend herself against Covid-19 isn't protecting her as well as it used to.
20 days ago
Paxlovid, the antiviral pill that reduces the risk of hospitalization and death from Covid-19, also...
Jamie Gumbrecht, CNN

Paxlovid reduces risk of long Covid, Veterans Affairs study finds

Paxlovid, the antiviral pill that reduces the risk of hospitalization and death from Covid-19, also reduces the risk of long Covid, according to a new study by the US Department of Veterans Affairs.
25 days ago

Sponsored Articles

house with for rent sign posted...
Chase Harrington, president and COO of Entrata

Top 5 reasons you may want to consider apartment life over owning a home

There are many benefits of renting that can be overshadowed by the allure of buying a home. Here are five reasons why renting might be right for you.
Festive kitchen in Christmas decorations. Christmas dining room....
Lighting Design

6 Holiday Decor Trends to Try in 2022

We've rounded out the top 6 holiday decor trends for 2022 so you can be ahead of the game before you start shopping. 
Happy diverse college or university students are having fun on their graduation day...
BYU MBA at the Marriott School of Business

How to choose what MBA program is right for you: Take this quiz before you apply!

Wondering what MBA program is right for you? Take this quiz before you apply to see if it will help you meet your goals.
Diverse Group of Energetic Professionals Team Meeting in Modern Office: Brainstorming IT Programmer...
Les Olson

Don’t let a ransomware attack get you down | Protect your workplace today with cyber insurance

Business owners and operators should be on guard to protect their workplace. Cyber insurance can protect you from online attacks.
Hand turning a thermostat knob to increase savings by decreasing energy consumption. Composite imag...
Lighting Design

5 Lighting Tips to Save Energy and Money in Your Home

Advances in lighting technology make it easier to use smart features to cut costs. Read for tips to save energy by using different lighting strategies in your home.
Portrait of smiling practitioner with multi-ethnic senior people...
Summit Vista

How retirement communities help with healthy aging

There are many benefits that retirement communities contribute to healthy aging. Learn more about how it can enhance your life, or the life of your loved ones.
J&J Asks US Regulators To OK Its One-Shot COVID-19 Vaccine