Johnson & Johnson may seek emergency use authorization for its single-dose vaccine COVID-19 within a few weeks, said White House adviser Dr. Anthony Fauci.
The vaccine from the New Brunswick-based company is in a Phase 3 clinical trial, known as “Ensemble”.
“I think no more than two weeks from now the data will be analyzed in a similar way, the way we analyzed it with Moderna and the Pfizer candidate,” said Fauci on Friday at “The Rachel Maddow Show ”On MSNBC. “This is an independent data monitoring and security council (which) analyzes the data, determines whether they are ready … They can go to the FDA and ask to see if they can obtain an emergency use permit.
“You know, I don’t want to get ahead of them, but I have to say that I would be surprised if it were more than two weeks from now that the data would be analyzed and decisions would be made.”
The pharmaceutical giant then hopes to supply the United States with 100 million doses 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 can change the game. Pfizer / BioNTech and Moderna vaccines require two doses. The Johnson & Johnson vaccine candidate, on the other hand, is a single dose injection that does not require special freezers. Pfizer inoculation requires ultra-cold storage.
Demand for vaccines continues to far exceed supply in New Jersey and elsewhere. Officials are eagerly awaiting approval from the Johnson & Johnson candidate, especially after Merck, based in Kenilworth, recently gave up two potential coronavirus vaccines, according to The Associated Press. Hopes were dashed after poor results in early-stage 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 its vaccine is distributed.
“This is really good news … because it would be – if he obtains authorization for emergency use – yet another candidate who has some differences,” said Fauci. “And that’s a good thing because it offers a wider range of flexibility.”
New Jersey administered 565,401 doses of the coronavirus vaccine, according to the state panel. More than 492,000 were first dose injections and 72,700 were boosters. The state received nearly 1 million doses from the federal government, according to an ongoing count by the Centers for Disease Control and Prevention.
Although the second wave of the COVID-19 pandemic appears to have stalled, New Jersey has reported 598,660 confirmed cases since its first positive test on March 4. The state suffered nearly 21,000 deaths, including 1,869 in January, while the country is approaching another dismal milestone: 500,000 deaths.
Developed by Johnson & Johnson’s Belgian division, Janssen Pharmaceutica, the potential vaccine differs from Pfizer and Moderna vaccines, which use mRNA technology.
Johnson & Johnson uses an adenovirus – “a type of virus that causes the common cold – that has become unable to replicate,” said Dr. Mathai Mammen, global head of Janssen Research & Development at Johnson & Johnson, in a statement about the company’s website.
“Adenovirus carries a coronavirus gene into human cells, which then produce the coronavirus spike protein, but not the coronavirus itself. This peak protein is what prepares the immune system to fight a subsequent infection with the virus. “
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Spencer Kent can be contacted at [email protected].