Johnson & Johnson could seek emergency use authorization for its single-dose COVID-19 vaccine within a couple of weeks, White House advisor Dr. Anthony Fauci said.
The New Brunswick-based company’s vaccine has been in a Phase 3 clinical trial, known as “Ensemble.”
“I would think that no more than two weeks from now the data will be analyzed in the similar fashion, the way we analyzed it with the Moderna and the Pfizer candidate,” Fauci said Friday on “The Rachel Maddow Show” on MSNBC. “That is an independent data and safety monitoring board (that) will look at the data, determine if it’s ready … They can go to the FDA and ask to see if they can get an emergency use authorization.
“You know, I don’t want to get ahead of them, but I have to tell you, I would be surprised if it was any more than two weeks from now that the data will be analyzed and decisions would be made.”
The pharmaceutical giant then hopes to supply the U.S. 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 one-dose vaccine could be a game-changer. The vaccines by Pfizer/BioNTech and Moderna require two doses. Johnson & Johnson’s vaccine candidate, on the other hand, is a single-dose shot that doesn’t require special freezers. Pfizer’s inoculation requires ultra-cold storage.
Vaccine demand continues to far outweigh supply in New Jersey and elsewhere. Officials eagerly await the approval of the Johnson & Johnson candidate, especially after Kenilworth-based Merck recently gave up on two potential coronavirus vaccines, according to The Associated Press. Hopes were dashed after poor results arose in early-stage studies. The company is shifting to two potential treatments for COVID-19.
Johnson & Johnson will need emergency use authorization from the Food and Drug Administration before its vaccine can be distributed.
“That’s really good news … because that would be — if it does get emergency use authorization — yet again another candidate that does have some differences,” Fauci said. “And that’s good because it gives a wider range of flexibility.”
New Jersey has administered 565,401 coronavirus vaccine doses, according to the state’s dashboard. More than 492,000 were first-dose shots and 72,700 were boosters. The state has received nearly 1 million doses from the federal government, according to a running tally by the Centers for Disease Control and Prevention.
Although the second wave of the COVID-19 pandemic seems to have plateaued, New Jersey has reported 598,660 confirmed cases since its first positive test March 4. The state has suffered nearly 21,000 deaths, including 1,869 in January, as the nation approaches another grim milestone: 500,000 deaths.
Developed by Johnson & Johnson’s Belgian division, Janssen Pharmaceutica, the potential vaccine differs from the Pfizer and Moderna shots, which use mRNA technology.
Johnson & Johnson uses an adenovirus — “a type of virus that causes the common cold — that has been made unable to replicate,” said Dr. Mathai Mammen, global head for Janssen Research & Development at Johnson & Johnson, in a statement on the company’s website.
“The adenovirus carries a gene from the coronavirus into human cells, which then produce the coronavirus spike protein, but not the coronavirus itself. This spike protein is what primes the immune system to fight off a subsequent infection by the virus.”
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Spencer Kent may be reached at skent@njadvancemedia.com.
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