Johnson & Johnson’s Covid-19 vaccine will get emergency use authorization from FDA

FDA advisers to consider EUA recommendation for single-dose Johnson & Johnson Covid-19 vaccine this week

With greater than 28.5 million confirmed Covid-19 instances and over 511,000 reported deaths within the US since the start of the pandemic, and whereas the demand for vaccine nonetheless far exceeds provide, these vaccines cannot come quickly sufficient.
“A third safe and effective vaccine is very welcome news,” Andy Slavitt, the White House’s senior for Covid Response, tweeted on Friday.
The vaccine, made by Janssen, J&J’s vaccine arm, is safe and effective, and it is thought of versatile. It’s a single dose, and it would not require particular storage.

The vaccine is permitted for folks ages 18 and older.

“We need a vaccine that can be quickly mass produced,” Dr. Greg Poland, head of the Mayo Clinic’s Vaccine Research Group, stated Friday. “We’d want to see a reasonable duration of efficacy and protection.

“The Janssen vaccine candidate checks almost all of the bins.”

The vaccine was examined in additional than 44,000 folks within the US, South Africa and Latin America. Globally, it was 66.1% efficient in opposition to average to extreme/crucial Covid-19 at the very least 4 weeks after vaccination, based on an FDA evaluation. In the US, it’s thought of 72% efficient, and supplied 86% safety in opposition to extreme types of the illness.

“One dose will hold you out of the hospital, hold you out of the intensive care unit, and hold you out of the morgue,” Dr. Paul Offit, a vaccine adviser to the FDA, told CNN’s Wolf Blitzer on Friday.

The vaccine comes with few side effects, most of which are mild, including pain at the injection site, headache, fatigue and muscle pain.

Overall, non-fatal serious adverse events were infrequent, according to the FDA’s analysis, and there were no reported cases of anaphylaxis following vaccination in the trial. There have been a small number of severe allergic reactions with the Moderna and Pfizer/BioNTech vaccines. For example, in the first week of the Pfizer vaccine rollout, there were only 29 cases out of 1.9 million doses administered, according to the US Centers for Disease Control and Prevention.
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More analysis is required, however the FDA evaluation additionally hinted that the J&J vaccine might assist stop asymptomatic infections.

A January study from the CDC showed that most coronavirus cases are spread by people without symptoms. If a vaccine prevented asymptomatic infection, it might help reduce opportunities to transmit the disease — not just keep the vaccinated from getting sick.
With a lot optimistic information, an unbiased group of advisers voted unanimously on Friday to advocate the emergency use authorization of the J&J vaccine.
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“I feel it is a comparatively straightforward name. It clearly will get means over the bar, and it is good to have a single-dose vaccine,” Dr. Eric Rubin, a member of the committee who is also the editor in chief of The New England Journal of Medicine and a professor at the Harvard T.H. Chan School of Public Health, said after the vote.

There is some concern that because the public has heard that the shot is only 72% protective in the US, and the Pfizer and Moderna Covid-19 vaccines are about 95% protective, some will think this is a “second class” vaccine, but the experts say those numbers are highly misleading.

“It’s troublesome to make an apples-to-apples comparability between vaccines approved primarily based on information collected earlier than new variants are believed to have been in widespread circulation,” said Sarah Christopher, the policy advocacy director at the National Women’s Health Network. Christopher spoke during the public comment section of the FDA’s advisory meeting on Friday.

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The Pfizer and Moderna Covid-19 vaccines have been examined earlier within the pandemic when there have been fewer recognized variants. FDA analysis discovered that almost all of the instances that occurred through the South African a part of the J&J trial got here from a more moderen and presumably extra contagious variant.

Public well being consultants say folks ought to take no matter shot is first out there to them.

“If I had a J&J vaccine out there right this moment and a Moderna vaccine out there tomorrow, I might be completely happy to take the J&J right this moment. I do not really feel like I would want to attend. They are all terrific vaccines for the issues that we care about,” Dr. Ashish Jha, dean of the Brown University School of Public Health, told a House Ways and Means Health Subcommittee hearing Friday.

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Experts have stated variants might gasoline a surge of instances within the spring within the US, and say that is one cause why it is essential to get as many individuals vaccinated as rapidly as potential.

“We’ll be seeing how a lot of an influence the variants have and the way greatest these vaccines can tackle them, whether or not it is going to be booster doses, or different vaccines,” said Dr. Aditya Gaur, a co-lead investigator on the J&J trial at St. Jude in Memphis. “But I feel one couldn’t have requested for higher from this primary spherical of vaccine improvement from a standpoint of how rapidly it has occurred and the way rapidly it has began to roll out world wide.”

On Sunday, the CDC’s Advisory Committee on Immunization Practices, known as ACIP, will meet to set the guidelines for who should get the vaccine. Their vote is scheduled for 3 p.m. ET.

From there, the much needed vaccine could start rolling out to vaccine centers around the country.

While the initial supply is limited — the company says it only has about 4 million doses of its vaccine ready to ship “instantly” — it should have 20 million ready by the end of March.

The advancement of the Johnson & Johnson coronavirus vaccine is “actually excellent news for the world,” Dr. Francis Collins, director of the National Institutes of Health, told CNN’s Wolf Blitzer on Friday. Even with cases in the US declining recently, the pandemic is far from over. “The greatest option to get performed is with this vaccine being added to the others.”

CNN’s Maggie Fox, Christopher Rios and Lauren Mascarenhas contributed to this report.

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