FDA analysis of J&J COVID vaccine booster sets the stage for public hearing

By |2021-10-13T16:23:23-04:00October 13th, 2021|Uncategorized|

Enlarge this image Janet Gerber, a health department worker in Louisville, Ky., processes boxes containing vials of the Johnson & Johnson COVID vaccine in March. Jon Cherry/Getty Images Jon Cherry/Getty Images A Food and Drug Administration analysis of Johnson & Johnson's application for authorization of its COVID vaccine booster tees up deliberations at a public meeting of agency advisers Friday. The document was posted Wednesday. The questions that will be put before the committee will include whether the data supports the safety and effectiveness of a booster dose of the company's COVID vaccine after at least two months have elapsed since initial immunization with the one-shot vaccine and whether the data shows that there is a stronger response at a six-month interval as well. J&J has asked for an authorization of a booster for people 18 and older six months after initial immunization, with an option to vaccinate after two months depending on local conditions and the needs of specific groups of people.