J&J seeks US authorisation for its COVID booster shot | Coronavirus pandemic Information
A panel of FDA well being specialists will meet subsequent week to think about booster pictures 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 increase its booster campaign to tens of millions of vaccinated Individuals.
J&J stated on Tuesday that it requested the US Meals and Drug Administration (FDA) authorise boosters for folks aged 18 and older who beforehand obtained the corporate’s one-shot vaccine.
The drugmaker additionally stated its submission contains knowledge from a late-stage examine that discovered a booster given 56 days after the first dose supplied 94 p.c safety towards symptomatic COVID-19 within the US and 100% safety towards extreme illness, a minimum of 14 days after the booster shot.
Whereas scientists are divided over the need for booster pictures when so many individuals within the US and different nations stay unvaccinated, the administration of President Joe Biden announced a push for boosters in August to shore up safety towards the extremely transmissible Delta variant.
“Each J&J and FDA have a way of urgency as a result of it’s COVID and we would like good knowledge on the market transformed into motion as quickly as potential,” stated 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 folks aged 65 and older, folks at excessive danger of extreme illness, and others who’re usually uncovered to the virus.
Pfizer had additionally requested the FDA to increase its vaccine approval to incorporate boosters for anybody aged 16 and older, however the regulator determined to restrict their use saying proof confirmed they had been useful to older folks and people at excessive danger.
J&J Knowledge launched knowledge final month exhibiting that giving a booster shot at two months supplied 94 p.c safety towards reasonable to extreme COVID-19 an infection [File: Emily Elconin/Reuters]Vaccine-maker Moderna additionally submitted an software searching 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 stated it plans to submit the information to different regulators, the World Health Organization and Nationwide Immunization Technical Advisory Teams to tell decision-making on native vaccine administration methods, as wanted.
Pfizer and Moderna have supplied the overwhelming majority of COVID-19 vaccines within the US, with greater than 170 million Individuals totally vaccinated with the businesses’ two-dose pictures.
About 15 million Individuals aged 18 and older have obtained J&J’s one-dose vaccine, in line with the newest knowledge from the US Facilities for Illness Management and Prevention (CDC).
