Health officials in the United States have lifted the 11-day pause on Johnson & Johnson vaccinations following a recommendation by a Centers for Disease Control and Prevention advisory panel.
On Friday, the advisers said the benefits of the single-dose COVID-19 shot outweigh the rare risk of blood clots.
A CDC advisory panel voted Friday to recommend lifting the pause on the Johnson & Johnson COVID-19 vaccine.
The Advisory Committee on Immunization Practices (ACIP) voted Friday afternoon after hearing more about the rare instances of dangerous blood clots. The information was provided by CDC scientists and from Johnson & Johnson scientists on what research they had done, and potential additions to warning information.
On April 13, the CDC and FDA recommended a pause in the use of the Johnson & Johnson vaccine after receiving reports that six women had suffered an extremely rare but severe clotting disorder within weeks of taking the vaccine.
Prior to the pause, nearly 7 million people had safely received a dose of the vaccine.
The ACIP met a day after the pause but decided to take no action on the pause in the hopes of gathering more information.
During Friday's meeting, a representative from the CDC told the ACIP members there are now 15 cases of the dangerous blood clots they are aware of. All of the cases are in women, tragically, three women have died.
Those who suffered the clotting disorder were women between the ages of 18 and 48 who suffered from thrombocytopenia, or low levels of blood platelets.
The cases are still extremely rare, with 15 cases of blood clots confirmed out of nearly 8 million doses of the Johnson and Johnson vaccine.
The ACIP debated lifting the pause with no other action, add an additional warning on the Johnson & Johnson vaccine, or limiting the vaccine to a specific age group.
In the end, the group said the chance of reactions was very rare, however dangerous. They stressed there needs to be an awareness campaign among doctors and those giving the vaccine to make sure people, and especially women, understand the risks and what their vaccination options are.
They voted to recommend lifting the pause, and to again allow the Johnson & Johnson COVID-19 vaccine to be given to all Americans age 18 and older under the FDA's emergency use authorization.
While some are concerned that the pause will lead to a decrease in confidence in the J&J vaccine, other health officials like Dr. Anthony Fauci say the pause is a reason to have confidence in the FDA and other regulatory bodies.
At a White House COVID-19 response team briefing on Friday, CDC Director Dr. Rochelle Walensky said she believes there is "plenty of people" who are interested in the Johnson & Johnson vaccine, noting that because it is the only single-shot vaccine on the market, it could be an "attractive option" for those who may not have access to a two-shot vaccine.
Earlier this week, the European Union’s top medical agency said the benefits of the Johnson & Johnson vaccine outweigh the risks but said that a warning about clotting issue should be added to packaging.