Sun Sentinel Palm Beach Edition
J&J seeking booster authorization
Company appears to agree that single shot not enough
WASHINGTON — Johnson & Johnson asked the Food and Drug Administration on Tuesday to allow extra shots of its COVID-19 vaccine as the U.S. government moves toward expanding its booster campaign to millions more vaccinated Americans.
J&J said it filed a request with the FDA to authorize boosters for people 18 and older who previously received the company’s one-shot vaccine. While the company said it submitted data on several different booster intervals, ranging from two to six months, it did not formally recommend one to regulators.
Last month, the FDA authorized booster shots of Pfizer’s vaccine for older Americans and other groups with heightened vulnerability to COVID-19. It’s part of a sweeping effort by the Biden administration to shore up protection amid the delta variant and potential waning vaccine immunity.
Government advisers backed the extra Pfizer shots, but they also worried about creating confusion for tens of millions of other Americans who received the Moderna and J&J shots. U.S. officials don’t recommend mixing and matching different vaccine brands.
The FDA is convening its outside panel of advisers next week to review booster data from both J&J and Moderna. It’s the first step in a review process that also includes sign-off from the leadership of both the FDA and the Centers for Disease Control and Prevention. If both agencies give the go-ahead, Americans could begin getting J&J and Moderna boosters later this month.
Although the federal government has emphasized for months that all three vaccines are highly effective, a recent study by the CDC found that Johnson & Johnson’s single-dose vaccine was only 71% effective against hospitalization from COVID-19, compared with 88% for Pfizer-BioNTech’s vaccine and 93% for Moderna’s.
“Real-world data suggest that the two-dose Moderna and Pfizer-BioNTech mRNA vaccine regimens provide more protection” than the single dose of Johnson & Johnson, the researchers said. Other research found that J&J recipients were more likely to have breakthrough infections or symptomatic COVID-19 than recipients of the other two vaccines.
J&J cites some studies with better results: A study of nearly 2 million, funded by the company, estimated the vaccine was 81% effective against hospitalization. Other research suggests that protection from Johnson & Johnson’s vaccine doesn’t wane over time like protection from Pfizer-BioNTech’s vaccine.
J&J now appears to agree with officials that a single shot of its vaccine is not enough.
Last month, the company announced that a second dose, given two months after the first, increased the vaccine’s effectiveness against symptomatic COVID-19 by about 22 percentage points, to 94%. The firm also said two shots were 100% effective against severe disease, although that estimate was less conclusive.
“The data shows that there is a dramatic increase in efficacy when the boost is given at two months. And we believe that it’s potentially even better when given later,” said Dr. Dan Barouch, a virus expert at Beth Israel Deaconess Medical Center in Boston who helped develop the vaccine.
“I’m not a public health authority, but I would say it’s scientifically reasonable for people who are desiring a higher level of efficacy to obtain a booster shot” between 2-6 months after the first shot of the vaccine, he said.
FDA’s advisers will review studies from the company and other researchers Oct. 15 and vote on whether to recommend boosters.
The timing of the J&J filing was unusual given that the FDA had already scheduled its meeting on the company’s data. Companies normally submit their requests well in advance of meeting announcements.
A J&J executive said the company has been working with the FDA on the review.
“Both J&J and FDA have a sense of urgency because it’s COVID and we want good data out there converted into action as soon as possible,” said Dr. Mathai Mammen, head of research for J&J’s Janssen unit. “We look forward to our discussions with the FDA and other health authorities to support their decisions regarding boosters.”
The vaccine from the New Brunswick, New Jersey, company was considered key in fighting the pandemic because it requires only one shot. But its rollout was hurt by a series of troubles, including manufacturing problems at a Baltimore factory that forced J&J to import millions of doses from overseas.
Additionally, regulators have added warnings of several rare side effects to the shot, including a blood clot disorder and a neurological reaction called Guillain-Barre syndrome. In both cases, regulators decided the benefits of the shot still outweighed those uncommon risks.
Rival drugmakers Pfizer and Moderna have provided the majority of U.S. COVID19 vaccines. More than 170 million Americans have been fully vaccinated with the companies’ two-dose shots while less than 15 million Americans got the J&J shot.