‘Another huge milestone’: FDA panel endorses one-shot J&J vaccine
An FDA advisory panel voted unanimously Friday to recommend authorizing a single-shot COVID-19 vaccine for emergency use in the United States, potentially changing the landscape of the nation’s response.
The shot, developed by Johnson & Johnson subsidiary Janssen, would become the third COVID-19 vaccine available in the U.S. if the FDA follows the recommendation of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) and issues an emergency use authorization (EUA), which it is widely expected to do.
“Another huge milestone in helping to contain the COVID-19 pandemic,” Krutika Kuppalli, MD, an assistant professor of medicine in the division of infectious diseases at the Medical University of South Carolina and emerging leader in biosecurity fellow at the Johns Hopkins Center for Health Security, told Healio.
An EUA requires that the known and potential benefits of a product outweigh the known and potential risks. In December, the VRBPAC recommended authorizing the vaccines manufactured by Pfizer-BioNTech and Moderna for emergency use, which was followed shortly in both instances by the FDA issuing an EUA.
Both of those vaccines are given in two shots, either 21 or 28 days apart. The Johnson & Johnson vaccine has been heralded as a potentially transformative vaccine for the U.S. and global response not only because it is given in just one shot, but also because it can be kept for months at normal refrigerated temperatures rather than in extremely cold storage.
Members of the VRBPAC voted 22-0 to recommend that the FDA issue an EUA for the Johnson & Johnson vaccine for adults aged 18 years or older. The vote came at the end of a daylong discussion and review of relevant clinical trial data that included presentations by Janssen, outside comments from physicians and public representatives, and questions from the panel. The meeting was held days after the FDA said in a briefing document that it had determined that Johnson & Johnson “provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA.”
Johnson & Johnson previously announced positive data from the phase 3 ENSEMBLE trial showing that the vaccine was around 85% efficacious at preventing severe disease at least 28 days after vaccination, and 66% efficacious overall at preventing moderate to severe or critical disease. Efficacy was reported to be 72% in the U.S. arm of the study, 66% in Latin America, and 57% in South Africa, where 95% of the COVID-19 cases that occurred during the trial were from the B.1.351 variant of SARS-CoV-2.
However, the vaccine was found to be 100% efficacious at preventing hospitalization from COVID-19 at least 28 days after vaccination in all regions, according to the data.
Both Kuppalli and Infectious Disease News Editorial Board Member Jeanne M. Marrazzo, MD, MPH, director of the division of infectious diseases at the University of Alabama at Birmingham School of Medicine, called the vaccine a potential “game-changer.”
“First, this vaccine has very forgiving storage and transport requirements, easing the path of distribution, particularly to areas with less infrastructure. Second, a single dose is a huge advantage — one jab and done!” Marrazzo told Healio.
According to the CDC, more than 91.6 million doses of the Pfizer-BioNTech and Moderna vaccines have been delivered in the U.S. since mid-December — enough to vaccinate more than 45 million people. A Johnson & Johnson executive said this week that the company remained on track to deliver 100 million doses of its vaccine to the U.S. by the end of June, including 20 million doses by the end of March, which would greatly expand the availability of vaccine.
The single-dose schedule and less demanding storage requirements “will make the logistics of vaccine rollout and administration exponentially easier than it has been to this point,” Kuppalli agreed.
“It will make it easier for us to get into communities to reach disenfranchised patient populations and those in difficult to reach communities so we can vaccinate vulnerable individuals at higher rates,” she said. “Finally, it will allow us to have a greater supply of vaccine so we can work to vaccinate people all over the world and hopefully end this pandemic.”
More than 28 million cases of COVID-19 have been reported in the U.S. alone, including nearly 510,000 deaths, according to tracking from Johns Hopkins University. Weeks of good news about declining case counts ended Friday when CDC Director Rochelle P. Walensky, MD, MPH, warned in a White House press briefing that the daily case count had potentially leveled off, with increases reported in each of the past 3 days.
Marrazzo noted that the Johnson & Johnson vaccine’s protection against severe disease could help give hospitals a break.
“Even if the reduction of mild-moderate community-based disease is less impressive — and it will still be 55% to 60%, which is great in itself — that benefit could give our systems, and more importantly our health care workforce, time to recover from the last year,” she said.
Johan Van Hoof, MD, Janssen’s global head of vaccines, said during Friday’s meeting that the company was working on a second-generation vaccine to address emerging SARS-CoV-2 variants that could enter phase 1 testing before the summer. Moderna this week announced that it sent a variant-specific booster vaccine to the NIH for phase 1 testing.