Monday, October 18, 2021

J&J seeks US approval for COVID-19 vaccine booster dose

WASHINGTON – Johnson & Johnson asked the Food and Drug Administration on Tuesday to allow additional shots of its COVID-19 vaccine as the US government moves to expand its booster campaign to millions more vaccinated Americans.

J&J said it filed a request with the FDA to authorize boosters for people age 18 and older who had 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 has not formally recommended one to regulators.

Last month, the FDA authorized booster shots of Pfizer’s vaccine for older Americans and other groups with high vulnerability to COVID-19. It is part of a broader effort by the Biden administration to shore up the protection between the delta version and potential waning vaccine immunity.

Government advisers supported the additional Pfizer shots, but they were also concerned about causing confusion for the millions of other Americans who received Moderna and J&J shots. US officials do not recommend mixing and mixing different vaccine brands.

The FDA is convening its external panel of advisors next week to review booster data for both J&J and Moderna. It is the first step in the review process that also includes sign-offs from both the FDA and the Centers for Disease Control and Prevention. If both agencies go ahead, Americans may start getting J&J and Modern boosters later this month.

J&J previously released data suggested its vaccine remains highly effective against COVID-19 for at least five months after vaccination, demonstrating an 81% effectiveness against hospitalization in the US.

But the company’s research shows that immunity increases even more with a booster dose in two or six months. Data released last month showed that giving a booster over two months provides 94% protection against moderate to severe COVID-19 infection. The company has yet to release clinical data on the six-month booster shot.

Read Also:  Health Tips: In addition to reducing fat, these 5 great benefits also give you plank exercises.

FDA advisors will review studies by the company and other researchers next Friday and vote on whether to recommend the booster.

The timing of the J&J filing was unusual because the FDA had already scheduled its meeting on the company’s data. Companies typically submit their requests prior to completing announcements. A J&J executive said the company is working with the FDA on the review.

“There is a sense of urgency in both J&J and the FDA because this is COVID and we want good data to be converted into action as quickly as possible,” said Dr. Mathai Maimon, head of research at J&J’s Janssen unit.

Nation World News Desk
Nation World News is the fastest emerging news website covering all the latest news, world’s top stories, science news entertainment sports cricket’s latest discoveries, new technology gadgets, politics news, and more.
Latest news
Related news
- Advertisement -