Johnson & Johnson asked the U.S. Food and Drug Administration (FDA) on Tuesday to authorize a booster shot of its COVID-19 vaccine.
The New Brunswick, New Jersey-based company said it filed a request with the FDA to authorize boosters for Americans aged 18 and older.
While J&J 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.
Johnson & Johnson asked FDA on Tuesday authorize a booster shot of its COVID-19 vaccine this week. Pictured: A Johnson & Johnson COVID-19 vial at a Culver City Fire Department vaccination clinic in Culver City, California, August 2021
A meeting had been set to discuss J&J’s boosters on October 15, before the company even filed for approval. Pictured: Chandler Millard (left) of Alexandria, Virginia, receives a Johnson & Johnson vaccine of Nationals Park, September 2021
J&J previously released data suggesting its vaccine remains highly effective against COVID-19 at least five months after vaccination, demonstrating 81 percent 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.
The Phase III two-dose trial of up to 30,000 participants looking at the effectiveness of a second dose given 56 days after the first in adults 18 and older.
Results published last month showed that a booster shot was 94 percent effective against symptomatic COVID-19 in the U.S. and 100 percent effective against critical illness at least 14 days post-vaccination.
This compares to 70 percent protection seen with a single dose.
There was only one case of COVID-19 in the vaccine group and 14 in the placebo group.
J&J said that a booster given two months after the first dose increased antibody levels between four-fold and six-fold.
When given six months after the first dose, antibody levels shot up nine-fold after one week and 12-fold after four weeks.
The vaccine from J&J was considered an important tool in fighting the pandemic because it requires only one shot, but the company has been faced with setbacks leading to just 15 million Americans receiving J&J compared to 229 million who have received Pfizer and 152 million who have received Moderna
These increases were seen regardless of age.
Side effects with two doses were comparable to those seen in studies with the single-dose vaccine.
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.
Government advisers backed the extra Pfizer shots authorized last month, 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.
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.
The vaccine from J&J 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.
Source link : https://www.dailymail.co.uk/health/article-10060733/J-J-seeks-US-clearance-COVID-19-vaccine-booster-doses.html
