FDA Discusses Vaccinating Children, Extends Shelf Life of Johnson and Johnson Covid-19 Vaccine

Yesterday FDA vaccine advisers debated what kind of information would be needed to consider authorizing the use of Covid-19 vaccines in children younger than 12. Some advisers argued that it’s too soon to rush the use of the vaccine in children because they are at such low risk from the virus and others said it was important to have the authorizations on hand in case there’s a resurgence  of the virus in the Fall and Winter. Members of the committee did not vote or provide specific advice on the topic. The FDA will advise companies on what kinds of trials and data it would like to see to consider extending use of the vaccine in children and it’s up to companies to ask the FDA to extend their authorization or approve new age groups. Currently the Pfizer vaccine is  authorized for people as young as 12 and the Moderna vaccine is authorized for people 18 years of age and older.

In other vaccine news, Johnson and Johnson announced yesterday that the FDA also authorized an extension of the shelf life of it’s Covid-19 vaccine doses that were set to expire.  The move increased the refrigerated storage time from 3 months to 4 and a half months. In a statement Johnson and Johnson said “the decision is based on data from ongoing stability assessment studies, which have demonstrated that the vaccine is stable at 4.5 months when refrigerated at temperatures of 36-46 degrees Fahrenheit.” It is unclear how many doses of the vaccine were set to expire before being used.