Did you receive J&J COVID vaccine? Here’s the latest on potential booster shots
Johnson & Johnson has submitted booster shot data for its single-dose COVID-19 vaccine to the U.S. Food and Drug Administration, according to an Oct. 5 announcement. The company is asking the FDA to support use of the booster shot in people ages 18 and older.
It’s unclear how long it will take the FDA to review the data and vote on the amendment to the existing emergency use authorization for the J&J COVID-19 vaccine, but the move finally includes the nearly 15 million people in the U.S. who have received the jab in the booster shot conversation.
Dr. Mathai Mammen, global head of Janssen Research & Development with Johnson & Johnson, told CNN the company is leaving the decision of who can get their booster and when up to federal health officials.
“The process is not that we asked for a very specific interval — we’re providing them data and we’re going to be presenting to the committee,” Mammen told the outlet. “They’ll take all that into consideration when they ultimately decide on an appropriate interval.”
As of Sept. 23, some adults who have received the Pfizer coronavirus vaccine are eligible for a Pfizer booster shot. The FDA is currently reviewing booster shot data for the Moderna COVID-19 vaccine. An advisory committee is scheduled to discuss booster data for Moderna and J&J on Oct. 14 and Oct. 15, respectively.
“We look forward to our discussions with the FDA and other health authorities to support their decisions regarding boosters,” Mammen said in a news release. “At the same time, we continue to recognize that a single-shot COVID-19 vaccine that provides strong and long-lasting protection remains a crucial component to vaccinating the global population.”
The news comes several weeks after J&J revealed a booster dose of its vaccine two months after receipt of the first shot offers 94% protection against moderate to severe COVID-19 in the U.S. The booster also offers 100% protection against severe/critical COVID-19 at least two weeks after receiving the booster dose, according to results from an ongoing clinical trial.
Put another way, antibody levels rose four to six times higher following a booster shot given two months after the first dose of the J&J COVID-19 vaccine. And when given six months after the first dose, the booster led to a 12-fold increase in antibody levels after about a month.
Real-world evidence outside clinical trials also showed that just one dose of the J&J vaccine was 79% effective against coronavirus infection and 81% effective against COVID-19-related hospitalization. This protection did not wane over the study’s duration, even when the highly contagious delta variant dominated the U.S., the company said.
Real-world data included more than 390,000 people who received the J&J vaccine and more than 1.52 million unvaccinated people.
But a recent Centers for Disease Control and Prevention study among more than 3,600 coronavirus patients found that a single-dose of the J&J vaccine was 71% effective against COVID-19 hospitalization, which is much lower than what the company found in its own real-world evaluation. It’s important to note the CDC’s sample size was also much lower than J&J’s.
This drop in effectiveness worried doctors who participated in the CDC’s advisory panel meeting on Pfizer boosters last month.
“To me, the biggest policy question out there is the Johnson & Johnson [booster],” Dr. Helen Keipp Talbot at Vanderbilt University, who’s a member of the CDC’s Advisory Committee on Immunization Practices, told the panel, according to NPR. “I worry we’re getting distracted by the question of boosters of Pfizer when we have bigger and more important things to do in the pandemic.”
More than 14.8 million people have received the single-dose J&J COVID-19 vaccine as of Oct. 4, a CDC tracker shows.
The vaccine was granted an emergency use authorization in the U.S. on Feb. 27.
This story was originally published October 5, 2021 at 11:22 AM with the headline "Did you receive J&J COVID vaccine? Here’s the latest on potential booster shots."
