Johnson & Johnson COVID-19 vaccine backed by advisory panel, U.S. authorization to follow

[rooster59]

Johnson & Johnson COVID-19 vaccine backed by advisory panel, U.S. authorization to follow

By Manas Mishra and Michael Erman

 

A vial of Johnson & Johnson's Janssen coronavirus disease (COVID-19) vaccine candidate is seen in an undated photograph. Johnson & Johnson/Handout via REUTERS.

 

(Reuters) - A panel of expert advisers to the U.S. Food and Drug Administration on Friday voted to recommend authorization of Johnson & Johnson's one-dose COVID-19 vaccine for emergency use, bringing it an important step closer to a U.S. rollout.

 

The FDA is likely to authorize the vaccine for emergency use within a day or so, making it the third available in the United States, and the only one that requires a single shot.

 

The panel consisting of doctors, infectious disease experts and medical researchers voted unanimously that the benefits of the vaccine outweigh its risks in people age 18 and over.

 

“We believe our COVID-19 vaccine candidate has the potential to help change the trajectory of the pandemic and stand ready to make it available to protect the public as soon as possible,” Dr. Paul Stoffels, J&J's chief scientific officer said in a statement.

 

The company said it is prepared to supply its vaccine immediately if it receives emergency use authorization (EUA), as expected. J&J has said it will be able to ship three million to four million doses of its vaccine next week.

 

The company expects to have enough supply to vaccinate 20 million people by the end of March.

 

Senior White House adviser Andy Slavitt tweeted that the FDA would meet to finalize the EUA on Saturday. "A third safe and effective vaccine is very welcome news," he said.

 

More than 50 million vaccine shots have been administered nationwide, a milestone highlighted by President Joe Biden on Thursday.

 

But the emergence of highly contagious new virus variants has only enhanced the urgency to get hundreds of millions more people inoculated against a virus that has claimed the lives of more than a half a million people in the United States.

 

Panel member Jay Portnoy, professor of pediatrics at the University of Missouri-Kansas City School of Medicine, said the race was on to stop the pandemic before new virus variants cause further disease.

 

"The fewer people who are infected with the virus, the less opportunity it has to emerge as a more virulent strain. So we're in a hurry to get this vaccine out," he said.

 

The head of the U.S. Centers for Disease Control and Prevention on Friday expressed concern that a recent decline in U.S. COVID-19 cases may be stalling.

 

In a 44,000-person trial, the J&J vaccine overall was 66% effective at preventing moderate-to-severe cases of COVID-19 compared with a placebo.

 

Two-dose vaccines made by Pfizer Inc with BioNTech SE and Moderna Inc were about 95% effective in their pivotal trials.

Experts cautioned against drawing too much of a distinction between the vaccines because the trials had somewhat different goals, and importantly, the Pfizer/BioNtech and Moderna studies were conducted before the more transmissible virus variants had emerged in South Africa, Brazil and the UK.

 

J&J's trial was underway when the new variants were circulating and even prevalent in some countries where it was tested.

 

Still, its vaccine was 100% effective at preventing hospitalizations 28 days after vaccination and there were no COVID-19 deaths among those who received the shot.

 

During the meeting, a J&J vaccine executive said the company was developing a second-generation vaccine that would target the concerning South African variant and will be ready to start Phase I trials by this summer.

 

The J&J vaccine can be stored in normal refrigerator temperatures, making distribution easier than for the Pfizer/BioNTech and Moderna shots that use messenger RNA technology and are shipped frozen.

 

J&J's vaccine uses a common cold virus known as adenovirus type 26 to introduce coronavirus proteins into cells in the body and trigger an immune response.

 

(Reporting by Manas Mishra in Bengaluru, Michael Erman in New York and Julie Steenhuysen in Chicago; Editing by Caroline Humer and Bill Berkrot)

 

-- © Copyright Reuters 2021-02-27

 

- Whatever you're going through, the Samaritans are here for you

- Follow Thaivisa on LINE for breaking COVID-19 updates

[Rimmer]

An off topic unattributed post has been removed 

[Tug]

Excellent another arrow in our collective quiver follow safe protocols stay safe and let’s kick this scourges (rear end)

[mtls2005]

FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine

 

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.

 

“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” said Acting FDA Commissioner Janet Woodcock, M.D. “The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”

 

https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine