FDA pledges to expedite authorization of J&J shot
WASHINGTON — The Food and Drug Administration said Friday evening that it will “rapidly work” to authorize Johnson & Johnson’s single-shot COVID-19 vaccine, shortly after an expert committee unanimously recommended it.
In a statement, the FDA said it has notified the company and federal officials involved in vaccine distribution so that they can prepare to ship the vaccine shortly. The FDA may issue an emergency use authorization as soon as Saturday, with the first few million doses of a shot that is relatively simple to store, handle and administer distributed next week.
On Friday, the agency’s vaccine
advisory committee strongly endorsed the Johnson & Johnson vaccine, which will be the third COVID-19 vaccine in the U.S. and the first to require just a single dose.
The third vaccine will arrive just as the U.S. this week marked the grim milestone of 500,000 COVID-19 deaths at a crucial moment in the pandemic. After weeks of declining new cases, the downward trend has stalled — a change that makes many experts uneasy that officials are relaxing restrictions and people are letting their guard down.
The J&J vaccine was 85% effective at protecting against severe cases of illness, and there were no deaths or hospitalizations a month after participants received the vaccine. The vaccine was less effective at preventing moderate to severe cases of illness, and some experts have feared there could be an erroneous perception among the public that they should wait for other vaccines, which could prolong the pandemic and leave people unprotected.
“It’s a relatively easy call; it clearly gets way over the bar, and it’s nice to have a single-dose vaccine,” said Eric Rubin, an infectiousdisease specialist at the Harvard T.H. Chan School of Public Health and a member of the advisory committee. “It’s a bit challenging about how to use it clinically right now, but the demand is so large, it clearly has a place.”
Adding another vaccine will help bolster the nation’s limited supply of the two authorized shots from PfizerBioNTech and Moderna. It should help accelerate the vaccination campaign, although the initial impact of the J&J vaccine is expected to be modest as the company ramps up manufacturing over the next month, with the first 20 million doses expected to be delivered by the end of March.
“There are limited options to control the virus,” said Dr. Gregory Poland, director of the Vaccine Research Group at the Mayo Clinic, who
spoke to the FDA advisers as part of the J&J presentation and is a paid expert consultant to the company. “We need vaccines that are effective and well-tolerated and — importantly — ones that are simple to deploy.”
Dr. Poland argued that a one-dose vaccine could speed up and simplify the effort to reach individual and herd immunity, making mass immunization campaigns that could end the pandemic more logistically feasible.
J&J applied to the FDA for emergency use authorization in early February, submitting clinical trial data involving 44,000 participants in eight countries. The data showed the vaccine was 72% effective in preventing cases of moderate to severe COVID19 in the U.S., where variants of concern have only recently begun to be detected.
In South Africa, where a variant capable of evading some parts of immunity became dominant late last year, the J&J shot was 64% effective against moderate to severe illness. Across countries, it was completely effective in preventing hospitalization and deaths a month after study participants received the shot.
During the presentation to FDA advisers, J&J officials underscored the strong protection the vaccine provided against severe bouts of illness, the outcome that is of greatest concern. That protection was
just as robust even in regions of the world where concerning variants have arisen.
J&J, like other companies, is working to create a second generation of the vaccine tailored to the variants as a precaution. An updated version of the vaccine would be ready to be tested in people in a small study before summer in case it is needed, said Johan Van Hoof, global therapeutic area head of vaccines for Janssen, the J&J division that developed the vaccine.
The emergence of the variants has raised a debate among experts about when and whether vaccines might need to be updated — and whether they protect not only against illness but infection.
“In the long run, we have to stop infection in order that we don’t give the coronavirus the opportunities to mutate and adapt,” said A. Oveta Fuller, an associate professor of microbiology and immunology at the University of Michigan Medical School.
The U.S. backed the development of the vaccine and has ordered 100 million doses through $1.5 billion in contracts. Federal health officials have said 3 million to 4 million doses could be shipped within a week of authorization, with 20 million doses total expected in March. The remaining 80 million are scheduled to be delivered by the end of June.