NEW BRUNSWICK, NJ–Widely viewed as potentially game-changing, a single-dose COVID-19 vaccine produced by Johnson & Johnson (J&J) is on track to receive federal approval within weeks.
On February 4, the Hub City-based pharmaceutical company said it had submitted an application to the Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate.
Janssen Biotech, Inc., is a J&J subsidiary with offices in Titusville, NJ.
Many scientists expect the new vaccine will offer strong protection against COVID-19 and clear advantages over the two others authorized in the United States.
The advantages include streamlined logistics for the official health sites administering the shots: J&Js inoculation would be the first that doesn’t require double doses, while the vaccine remains stable in a refrigerator, unlike the others that must be frozen.
While we don’t know how durable a single-dose vaccine is, in another plus, people won’t have to sit, waiting 15 minutes after receiving J&J’s shot. When it becomes available, the likelihood of more pop-up or mobile vaccination sites increases.
According to a January 27 Center for Disease Control (CDC) presentation, the J&J vaccine is on the “adenovirus vector” platform, while the other two vaccines approved are both categorized as “nucleic acid (mRNA).”
The vaccine uses a common virus edited with genetic material from the coronavirus, prompting the immune system to become familiar with fighting the infection.
Governor Phil Murphy, who has in recent months cited positive discussions with Alex Gorsky, J&J’s chief executive, said on February 5 that, if the drug giant received their EUA, “They’ve said … they could start shipping in early March.”
That’s only “four weeks from now,” noted Murphy.
On the same day that J&J said it had requested its EUA, FDA said it had scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on February 26 to review J&J’s request.
FDA indicated that it would soon issue a Federal Register notice detailing the meeting, and cite guidelines for a docket in which public comments will be submitted; it said it would review all comments.
“FDA intends to livestream the VRBPAC meeting on the agency’s YouTube, Facebook and Twitter channels,” it said, adding that it also would make its own webcast available.
And, whether to give the vaccine candidate the official go-ahead, FDA also cited talks by the advisory committee members to review submitted data in support of safety, and the need for the public’s clear understanding of scientific data and information.
“The FDA remains committed to keeping the public informed about our evaluation of the data for COVID-19 vaccines, so that the American public and medical community have trust and confidence in FDA-authorized vaccines,” said Acting FDA Commissioner, Dr. Janet Woodcock.
The FDA says it will make background materials available to the public, including the meeting agenda, as the date of the meeting nears.
“While the FDA cannot predict how long its ongoing evaluation of the data and manufacturing information will take following the VRBPAC meeting to make a decision on the EUA request, the agency will review the request as expeditiously as possible, taking into consideration the discussion by the advisory committee, while still doing so in a thorough and science-based manner,” Woodcock said.
“In terms of timing for convening the VRBPAC meeting following the submission of the EUA request,” continued Woodcock, “this amount of time will allow the FDA to thoroughly evaluate the data and information submitted in the EUA request before the meeting and to be prepared for a robust public discussion with the advisory committee members.”
The EUA submission “is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose vaccine met all primary and key secondary endpoints,” J&J said on February 4.
While J&J expects to ship product immediately following authorization, it did not specify how many Regimens.
“Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping,” said Dr. Paul Stoffels, J&J’s chief scientific officer.
Amid J&J’s “ongoing reviews with other health authorities around the world,” J&J is working hard to make the vaccine available as quickly as possible, added Stoffels.
J&J also initiated rolling submissions with several health agencies outside the United States and will submit a Conditional Marketing Authorization Application with the European Medicines Agency in the coming weeks.
J&J’s “global team of experts has worked tirelessly alongside BARDA and scientific partners to pursue a SARS-CoV-2 vaccine,” Stoffels said in August when the company signed a $1 billion “Operation Warp Speed” (OWS) contract with the federal government, agreeing to have 12 million doses ready by the end of this month, according to a “Milestone Payment Schedule” documented in the contract.
The schedule promises a total of 100 million doses to be produced by the end of June, so the company is behind on its OWS manufacturing guarantee.
“We greatly appreciate the United States government’s confidence in our R&D platform … and the scalability of our vaccine technology,” added Stoffels. “We are scaling up production in the United States and worldwide.”
But J&J is not likely to be able to deliver as many doses this spring as promised, due to unforeseen manufacturing delays, according to a New York Times report in mid-January.
J&J said on February 4 that it expects to supply 100 million doses to the nation “in the first half of 2021.” In late January, the company said it expects to meet this year’s production objectives.
Stoffels would reportedly not provide the Times with details on how many doses could be produced, while the company has reportedly declined to confirm the delay.
But the Government Accountability Office said in a January 28 report that J&J would have about 2 million doses ready by the time of FDA’s authorization.
“Federal officials have been told that the company has fallen as much as two months behind the original production schedule and won’t catch up until the end of April, when it was supposed to have delivered more than 60 million doses,” wrote the Times, citing two people familiar with the situation.
Moreover, Carlo de Notaristefani, the head manufacturing adviser for OWS, cited a delay, saying that J&J possibly could “catch up with initial production goals by March,” according to the Times.
Still, de Notaristefani told the Times he agreed there was a production problem.
“Manufacturing of pharmaceuticals is not a black box where you turn the key and start counting,” de Notaristefani said.