Johnson & Johnson booster authorization


FILE – On this April 8, 2021, file picture, registered nurse fills a syringe with the Johnson & Johnson COVID-19 vaccine at a pop up vaccination website within the Staten Island borough of New York. (AP Picture/Mary Altaffer, File)

(NEXSTAR) — Johnson & Johnson plans to ask federal regulators early this week for authorization of its COVID-19 booster shot, The New York Times reported Monday. The news is in response to officers conversant in the corporate’s plans.

Final month, regulators approved a booster shot for some recipients of the Pfizer-BioNTech’s vaccine and are contemplating authorization this month for recipients of the Moderna vaccine.

Federal officers are involved that the greater than 15 million U.S. recipients of the J&J vaccine are at too nice a threat of extreme COVID-19, the Instances reported.

The Meals and Drug Administration on Friday scheduled an Oct. 15 assembly of its advisory committee to debate whether or not to grant emergency use authorization of a J&J booster shot.

The U.S. Facilities for Illness Management and Prevention says you’re fully vaccinated two weeks after receiving a second dose of the Pfizer or Moderna vaccine, or one J&J dose.

Although the vaccines provide sturdy safety in opposition to severe sickness, U.S. well being officers now suggest boosters for some individuals at increased threat for extreme sickness from COVID-19 primarily based on proof that safety in opposition to milder illness can wane, particularly amongst older adults.

The CDC says individuals 65 and older, long-term care residents and others ages 50 to 64 with well being issues similar to diabetes or coronary heart illness ought to get boosters in the event that they acquired Pfizer photographs not less than six months in the past.

The company stopped wanting recommending boosters for individuals 18 to 49 with well being issues however says they will additionally get the shot after contemplating their particular person threat. The identical is true for anybody 18 to 64 whose job may put them at increased threat for an infection, similar to well being care staff, lecturers, first responders, agriculture staff and public transit staff.

Final month, Johnson and Johnson announced {that a} second dose of its vaccine boosts efficacy by about 22% proportion factors, to 94%, when given two months after the primary.

“Our single-shot vaccine generates sturdy immune responses and long-lasting immune reminiscence. And, when a booster of the Johnson & Johnson COVID-19 vaccine is given, the power of safety in opposition to COVID-19 additional will increase,” Mathai Mammen, M.D., Ph.D., International Head, Janssen Analysis & Growth, Johnson & Johnson, mentioned in a press release on the time.

The Related Press contributed to this report. | Johnson & Johnson booster authorization


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