J&J Seeks US Clearance for COVID-19 Vaccine Booster Doses

October 5, 2021by Matthew Perrone, AP Health Writer
J&J Seeks US Clearance for COVID-19 Vaccine Booster Doses
This Saturday, March 6, 2021, file photo shows vials of Johnson & Johnson's COVID-19 vaccine at a pharmacy in Denver. (AP Photo/David Zalubowski)

WASHINGTON (AP) — 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.

J&J previously released data suggesting its vaccine remains highly effective against COVID-19 at least five months after vaccination, demonstrating 81% effectiveness against hospitalizations in the U.S.

But company research shows a booster dose at either two or six months revved up immunity even further. Data released last month showed giving a booster at two months provided 94% protection against moderate-to-severe COVID-19 infection. The company has not yet released clinical data on a six-month booster shot.

FDA’s advisers will review studies from the company and other researchers next Friday 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 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.

The vaccine from the New Brunswick, New Jersey, company was considered an important tool 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-Barré syndrome. In both cases, regulators decided the benefits of the shot still outweighed those uncommon risks.

Rival drugmakers Pfizer and Moderna have provided the vast majority of U.S. COVID-19 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.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

A+
a-
  • COVID-19 vaccine
  • Johnson & Johnson
  • In The News

    Health

    Voting

    Health

    Biden Announcing New Rule to Protect Consumers Who Purchase Short-Term Health Insurance Plans

    President Joe Biden on Thursday announced new steps to protect consumers who buy short-term health insurance plans that critics say amount to junk. A... Read More

    President Joe Biden on Thursday announced new steps to protect consumers who buy short-term health insurance plans that critics say amount to junk. A new rule finalized by the Democratic president's administration will limit these plans to just three months. And the plans can only be renewed for a maximum... Read More

    March 27, 2024
    by Dan McCue
    One-Time Treatment Could Revitalize Immune Systems in the Elderly

    PALO ALTO, Calif. — A new study suggests that a one-time treatment that modulates the composition of a type of... Read More

    PALO ALTO, Calif. — A new study suggests that a one-time treatment that modulates the composition of a type of immune cell could potentially revitalize the immune systems of the elderly, helping their bodies better react to viral and bacterial threats. The research was carried out... Read More

    March 27, 2024
    by Dan McCue
    Insurers to Expand Access to ‘Navigation Services’ for Cancer Patients

    WASHINGTON — Seven of the nation’s largest health insurance companies are expanding access to so-called “navigation services” to help patients... Read More

    WASHINGTON — Seven of the nation’s largest health insurance companies are expanding access to so-called “navigation services” to help patients and their families navigate the myriad challenges that might arise during treatment for cancer and other serious illnesses. The insurers involved are Aetna; Blue Cross Blue... Read More

    Five Takeaways From the Abortion Pill Case Before US Supreme Court

    WASHINGTON (AP) — U.S. Supreme Court justices on Tuesday did not appear ready to limit access to the abortion pill mifepristone,... Read More

    WASHINGTON (AP) — U.S. Supreme Court justices on Tuesday did not appear ready to limit access to the abortion pill mifepristone, in a case that could have far-reaching implications for millions of American women and for scores of drugs regulated by the Food and Drug Administration. It's... Read More

    Biden and Harris Argue Democrats Will Preserve Health Care and Republicans Would Take It Away

    RALEIGH, N.C. (AP) — President Joe Biden and Vice President Kamala Harris on Tuesday promoted their health care agenda in... Read More

    RALEIGH, N.C. (AP) — President Joe Biden and Vice President Kamala Harris on Tuesday promoted their health care agenda in the battleground state of North Carolina, arguing that Democrats like themselves would preserve access to care while Republicans would reverse gains made over the past decade... Read More

    March 26, 2024
    by Tom Ramstack
    Supreme Court Skeptical of Ban on Abortion Pill Mifepristone

    WASHINGTON — A hearing Tuesday before the Supreme Court indicated a majority of the justices want to maintain women’s access... Read More

    WASHINGTON — A hearing Tuesday before the Supreme Court indicated a majority of the justices want to maintain women’s access to the abortion pill mifepristone despite objections from anti-abortion activists. The doctors and organizations who sued argued the Food and Drug Administration was wrong in granting... Read More

    News From The Well
    scroll top