Please ensure Javascript is enabled for purposes of website accessibility
Johnson & Johnson Asks US Regulators to OK its One-Shot COVID Vaccine
gvw_ap_news
By Associated Press
Published 4 years ago on
February 4, 2021

Share

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.

FDA Chief Cautions Against Comparisons

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.

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.

RELATED TOPICS:

DON'T MISS

Russia Urges Citizens to Leave Israel as Tensions with Hezbollah Escalate

DON'T MISS

Taxpayers in 24 States Will Be Able to File Their Returns Directly With the IRS in 2025

DON'T MISS

California Collects Millions in Stolen Wages, but Can’t Find Many Workers to Pay Them

DON'T MISS

Sweet Lola on the Mend, Ready for a Forever Home

DON'T MISS

Houthis Vow Retaliation Against US for Yemen Airstrikes

DON'T MISS

Chavez-Quintero Debate: How Would You Rate City-County Cooperation?

DON'T MISS

Biden Talks Election, Economy and Middle East in Surprise News Briefing

DON'T MISS

Big Money Rolling in from Commercial Builders for Local School Bond Measure Campaigns

DON'T MISS

Behind the Scenes at Fresno Chaffee Zoo’s Sea Lion Cove: A Flipper-tastic Adventure

DON'T MISS

Clovis Daytime Burglary: 2 Suspects Arrested, 1 at Large

UP NEXT

Clovis Daytime Burglary: 2 Suspects Arrested, 1 at Large

UP NEXT

Tulare County Teen Arrested for School Shooting Threat

UP NEXT

Chemical Smoke Spewing From a Georgia Factory Is Projected to Spread Toward Atlanta as Winds Shift

UP NEXT

Hurricane Helene’s Death Toll Passes 150 as Crews Search for Survivors

UP NEXT

81-Year-Old South Korean Falls Short in Bid to Become Oldest Miss Universe Contestant

UP NEXT

Traffic Stop Leads to Cocaine Bust on Highway 99

UP NEXT

Will an October Surprise Shake Up the Trump-Harris Race?

UP NEXT

US Is Sending a Few Thousand More Troops to the Middle East to Boost Security

UP NEXT

Satellite Service DirecTV Buys Rival Dish as It Fights the Onslaught of Streaming Services

UP NEXT

Supplies Rushed to Communities Isolated by Helene as Death Toll Hits 121

Sweet Lola on the Mend, Ready for a Forever Home

22 hours ago

Houthis Vow Retaliation Against US for Yemen Airstrikes

1 day ago

Chavez-Quintero Debate: How Would You Rate City-County Cooperation?

1 day ago

Biden Talks Election, Economy and Middle East in Surprise News Briefing

1 day ago

Big Money Rolling in from Commercial Builders for Local School Bond Measure Campaigns

2 days ago

Behind the Scenes at Fresno Chaffee Zoo’s Sea Lion Cove: A Flipper-tastic Adventure

2 days ago

Clovis Daytime Burglary: 2 Suspects Arrested, 1 at Large

2 days ago

Trump Stalled California Wildfire Aid? Ex-Aide Reveals Political Motive

2 days ago

Costa Bill Opens Grants for Heavy Manufacturers to Start Using Hydrogen

2 days ago

Watch: Fresno County Supervisor District 3 Debate

2 days ago

Russia Urges Citizens to Leave Israel as Tensions with Hezbollah Escalate

Russia has advised its citizens to leave Israel amid rising tensions with Hezbollah and Iran, reports Newsweek. Moscow’s ambassador to...

19 hours ago

19 hours ago

Russia Urges Citizens to Leave Israel as Tensions with Hezbollah Escalate

22 hours ago

Taxpayers in 24 States Will Be Able to File Their Returns Directly With the IRS in 2025

22 hours ago

California Collects Millions in Stolen Wages, but Can’t Find Many Workers to Pay Them

22 hours ago

Sweet Lola on the Mend, Ready for a Forever Home

1 day ago

Houthis Vow Retaliation Against US for Yemen Airstrikes

Challenger Luis Chavez and incumbent supervisor Sal Quintero debate in Fresno, Thursday, Oct. 3, 2024.
1 day ago

Chavez-Quintero Debate: How Would You Rate City-County Cooperation?

1 day ago

Biden Talks Election, Economy and Middle East in Surprise News Briefing

2 days ago

Big Money Rolling in from Commercial Builders for Local School Bond Measure Campaigns

MENU

CONNECT WITH US

Search

Send this to a friend