3 years ago
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By MATTHEW PERRONE
WASHINGTON (AP) — Johnson & Johnson asked the Food and Drug Administration connected Tuesday to let other shots of its COVID-19 vaccine arsenic the U.S. authorities moves toward expanding its booster run to millions much vaccinated Americans.
J&J said it filed a petition with the FDA to authorize boosters for radical 18 and older who antecedently received the company’s one-shot vaccine. While the institution said it submitted information connected respective antithetic booster intervals, ranging from 2 to six months, it did not formally urge 1 to regulators.
Last month, the FDA authorized booster shots of Pfizer’s vaccine for older Americans and different groups with heightened vulnerability to COVID-19. It’s portion of a sweeping effort by the Biden medication to enactment up extortion amid the delta variant and imaginable waning vaccine immunity.
Government advisers backed the other Pfizer shots, but they besides disquieted astir creating disorder for tens of millions of different Americans who received the Moderna and J&J shots. U.S. officials don’t urge mixing and matching antithetic vaccine brands.
The FDA is convening its extracurricular sheet of advisers adjacent week to reappraisal booster information from some J&J and Moderna. It’s the archetypal measurement successful a reappraisal process that besides includes sign-off from the enactment of some the FDA and the Centers for Disease Control and Prevention. If some agencies springiness the go-ahead, Americans could statesman getting J&J and Moderna boosters aboriginal this month.
J&J antecedently released information suggesting its vaccine remains highly effectual against COVID-19 astatine slightest 5 months aft vaccination, demonstrating 81% effectiveness against hospitalizations successful the U.S.
But institution probe shows a booster dose astatine either 2 oregon six months revved up immunity adjacent further. Data released past period showed giving a booster astatine 2 months provided 94% extortion against moderate-to-severe COVID-19 infection. The institution has not yet released objective information connected a six-month booster shot.
FDA’s advisers volition reappraisal studies from the institution and different researchers adjacent Friday and ballot connected whether to urge boosters.
The timing of the J&J filing was antithetic fixed that the FDA had already scheduled its gathering connected the company’s data. Companies usually taxable their requests good successful beforehand of gathering announcements. A J&J enforcement said the institution has been moving with FDA connected the review.
“Both J&J and FDA person a consciousness of urgency due to the fact that it’s COVID and we privation bully information retired determination converted into enactment arsenic soon arsenic possible,” said Dr. Mathai Mammen, caput of probe for J&J’s Janssen unit.
The vaccine from the New Brunswick, New Jersey, institution was considered an important instrumentality successful warring the pandemic due to the fact that it requires lone 1 shot. But its rollout was wounded by a bid of troubles, including manufacturing problems astatine a Baltimore mill that forced J&J to import millions of doses from overseas.
Additionally, regulators person added warnings of respective uncommon broadside effects to the shot, including a humor clot upset and a neurological absorption called Guillain-Barré syndrome. In some cases, regulators decided the benefits of the changeable inactive outweighed those uncommon risks.
Rival drugmakers Pfizer and Moderna person provided the immense bulk of U.S. COVID-19 vaccines. More than 170 cardinal Americans person been afloat vaccinated with the companies’ two-dose shots portion little than 15 cardinal Americans got the J&J shot.
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The Associated Press Health and Science Department receives enactment from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely liable for each content.
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