J&J seeks US authorisation for its COVID booster shot

A panel of FDA well being specialists will meet subsequent week to contemplate booster photographs of the J&J and Moderna vaccines.

Drugmaker Johnson & Johnson has requested United States regulators for emergency use authorisation of its COVID-19 booster shot, the corporate introduced, because the US authorities strikes to broaden its booster marketing campaign to thousands and thousands of vaccinated Americans.

J&J mentioned on Tuesday that it requested the US Food and Drug Administration (FDA) authorise boosters for individuals aged 18 and older who beforehand acquired the corporate’s one-shot vaccine.

The drugmaker additionally mentioned its submission consists of information from a late-stage research that discovered a booster given 56 days after the first dose offered 94 p.c safety in opposition to symptomatic COVID-19 within the US and 100 p.c safety in opposition to extreme illness, not less than 14 days after the booster shot.

While scientists are divided over the necessity for booster photographs when so many individuals within the US and different nations stay unvaccinated, the administration of President Joe Biden introduced a push for boosters in August to shore up safety in opposition to the extremely transmissible Delta variant.

On September 27, US President Joe Biden acquired his COVID-19 booster jab as a part of a wider effort to induce extra Americans to comply with go well with [Kevin Lamarque/Reuters]

“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,” mentioned Dr Mathai Mammen, head of analysis for J&J’s Janssen unit.

J&J’s submitting comes after the FDA final week scheduled an October 15 assembly of its skilled advisory committee to debate whether or not to authorise a second shot of the corporate’s single-dose vaccine.

The FDA has already authorised a booster dose of the vaccine developed by Pfizer and companion BioNTech for individuals aged 65 and older, individuals at excessive danger of extreme illness, and others who’re frequently uncovered to the virus.

Pfizer had additionally requested the FDA to broaden its vaccine approval to incorporate boosters for anybody aged 16 and older, however the regulator determined to restrict their use saying proof confirmed they have been useful to older individuals and people at excessive danger.

J&J Data launched information final month displaying that giving a booster shot at two months offered 94 p.c safety in opposition to average to extreme COVID-19 an infection [File: Emily Elconin/Reuters]

Vaccine-maker Moderna additionally submitted an software looking for authorisation for a booster shot of its two-dose vaccine final month, and an FDA panel will maintain a gathering on October 14 to debate that submission.

J&J mentioned it plans to submit the info to different regulators, the World Health Organization and National Immunization Technical Advisory Groups to tell decision-making on native vaccine administration methods, as wanted.

Pfizer and Moderna have offered the overwhelming majority of COVID-19 vaccines within the US, with greater than 170 million Americans totally vaccinated with the businesses’ two-dose photographs.

About 15 million Americans aged 18 and older have acquired J&J’s one-dose vaccine, in keeping with the most recent information from the US Centers for Disease Control and Prevention (CDC).


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