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Johnson & Johnson could apply for emergency use authorization for its single-dose COVID-19 vaccine in a matter of weeks, White House adviser Dr Anthony Fauci said.
The vaccine from the New Brunswick-based company has undergone a Phase 3 clinical trial, called “Ensemble”.
“I think no more than two weeks from now the data will be analyzed the same way, the way we analyzed it with Moderna and the Pfizer candidate,” Fauci said on Friday on “The Rachel Maddow Show” on MSNBC. “It’s an independent data and safety oversight committee (that) will review the data, determine if it’s ready… They can go to the FDA and ask to see if they can get approval for use. emergency.
“You know, I don’t want to get ahead of them, but I have to tell you that I would be surprised if in more than two weeks the data is analyzed and decisions made.”
The pharmaceutical giant then hopes to deliver 100 million doses to the United States by April, Johnson & Johnson board member Dr. Mark McClellan told CNBC.
The company did not respond to a request for comment.
The single-dose vaccine could be a game-changer. The vaccines from Pfizer / BioNTech and Moderna require two doses. Johnson & Johnson’s vaccine candidate, on the other hand, is a single-dose vaccine that does not require special freezers. Inoculation of Pfizer requires ultra-cold storage.
Demand for vaccines continues to far outstrip supply in New Jersey and elsewhere. Officials are eagerly awaiting the approval of candidate Johnson & Johnson, especially after Kenilworth-based Merck recently dropped two potential coronavirus vaccines, according to the Associated Press. Hopes were dashed after poor results surfaced in preliminary studies. The company is switching to two potential treatments for COVID-19.
Johnson & Johnson will need emergency use authorization from the Food and Drug Administration before their vaccine can be distributed.
“This is really good news … because that would be – if he gets emergency use authorization – again another candidate that has some differences,” Fauci said. “And that’s good because it gives a wider range of flexibility.”
New Jersey administered 565,401 doses of the coronavirus vaccine, according to the state’s Scoreboard. Over 492,000 were first dose injections and 72,700 were boosters. The state has received nearly a million doses from the federal government, according to an ongoing tally from the Centers for Disease Control and Prevention.
Although the second wave of the COVID-19 pandemic appears to have reached a plateau, New Jersey has reported 598,660 confirmed cases since its first positive test on March 4. The state has suffered nearly 21,000 deaths, including 1,869 in January, as the country nears another grim milestone. : 500,000 dead.
Developed by Johnson & Johnson’s Belgian division, Janssen Pharmaceutica, the potential vaccine differs from injections by Pfizer and Moderna, which use mRNA technology.
Johnson & Johnson uses an adenovirus – “a type of virus that causes the common cold – which has been rendered incapable of replicating itself,” said Dr Mathai Mammen, global head of Janssen Research & Development at Johnson & Johnson, in a statement on the company’s website.
“The adenovirus carries a coronavirus gene into human cells, which then produce the coronavirus spike protein, but not the coronavirus itself. This spike protein is what prepares the immune system to fight off further infection with the virus. “
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Spencer Kent can be reached at [email protected].
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