After an 11 day pause of administering Johnson and Johnson’s COVID-19 vaccines in the United States, scientific advisors reached the conclusion that the benefits outweighed a rare risk of blood clot.
The government found 15 vaccine recpients who developed a very unusual kind of blood clot, out of nearly 8 million people given the J&J shot. All were women, almost all under the age of 50. Three died, and seven remain hospitlized.
Federal health officials ultimately decided the J&J’s one-dose vaccine (the only one of its kind approved in the US) is essential to fight the pandemic – and that warnings can help young women decide if they should use that shot or an alternative.
Shots may resume as early as Saturday, based on the Food and Drug Administration updated online vaccine information leaflets. The Centers for Disease Control and Prevention said the J&J vaccine has important advantages for some people who were anxiously awaiting its return.
“This is not a decision the agencies reached lightly,” FDA Acting Commissioner Janet Woodcock told reporters late Friday.
The US decision is similar to the way European regulators are rolling out J&J’s shot. Panelists voted 10-4 to resume vaccinations without outright age restrictions, but made it clear that clear warnings about clots must be present.