Johnson & Johnson to Seek FDA Authorization for Booster Shot

click to enlarge A woman shows her green passport, issued to fully vaccinated Israelis, before entering a show at the opera house in Tel Aviv, Israel, March 19, 2021. Israel on Sunday, Oct. 3, introduced new rules for determining coronavirus vaccination status, making a booster shot a requirement for full inoculation and vaccination passports. - DAN BALILTY/THE NEW YORK TIMES
Dan Balilty/The New York Times
A woman shows her green passport, issued to fully vaccinated Israelis, before entering a show at the opera house in Tel Aviv, Israel, March 19, 2021. Israel on Sunday, Oct. 3, introduced new rules for determining coronavirus vaccination status, making a booster shot a requirement for full inoculation and vaccination passports.

By Sharon LaFraniere
The New York Times

WASHINGTON — Johnson & Johnson is planning to ask federal regulators early this week to authorize a booster shot of its coronavirus vaccine, according to officials familiar with the company’s plans. The firm is the last of the three federally authorized vaccine providers to call for extra injections, amid mounting evidence that at least the elderly and other high-risk groups need more protection.

Federal officials have become increasingly worried that the more than 15 million Americans who received the Johnson & Johnson vaccine face too much risk of severe COVID-19. The Food and Drug Administration on Friday scheduled a meeting on Oct. 15 of its expert advisory committee to discuss whether to grant emergency use authorization of a booster shot of Johnson & Johnson’s vaccine.


That is part of a broader effort by the government to shore up the protection provided by all three vaccines. Regulators last month authorized a booster shot for many recipients of Pfizer-BioNTech’s vaccine and are contemplating doing the same this month for recipients of Moderna’s.

The fact that the advisory committee meeting on Johnson & Johnson was scheduled even before the company filed an application to the FDA reflects a particular sense of urgency in the Biden administration to provide more protection to recipients of that vaccine.

Although the federal government has emphasized for months that all three vaccines are highly effective, a recent study by the Centers for Disease Control and Prevention 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 Johnson & Johnson recipients were more likely to have breakthrough infections or symptomatic COVID-19 than recipients of the other two vaccines.


Johnson & Johnson cites some studies with better results: A study of nearly 2 million people, funded by the company, estimated that the vaccine was 81% effective against hospitalization. Other research suggests that protection from Johnson & Johnson’s vaccine does not wane over time like protection from Pfizer-BioNTech’s vaccine.

This article originally appeared in The New York Times.

Video

SpookWalk @ Browne's Addition

Fri., Oct. 29, 6:45-8:30 p.m., Sat., Oct. 30, 6:45-8:30 p.m. and Sun., Oct. 31, 6:45-8:30 p.m.
  • or