The European Medicines Agency determined that the benefits of Johnson & Johnson’s COVID-19 vaccine outweigh the risks. The vaccine is still paused in the United States.
Johnson & Johnson will resume the rollout of its COVID-19 vaccine in Europe following a temporary halt due to reports of rare blood clots in a few individuals who received the vaccine, the company announced on Tuesday.1
On Tuesday, the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) determined that the vaccine has possible links to the rare blood clot incidents, but the benefits of the vaccine outweigh the potential risks. The EMA also recommended the addition of a warning about the risk of rare blood clots with low blood platelet count to the vaccine’s product label.1,2
Johnson & Johnson will restart shipments to the European Union, Norway, and Iceland, with an updated package label for the vaccine to include a warning on the risk of a rare adverse effect and instructions for health care providers on how to recognize and treat it.1
“The safety and well-being of the people who use our products is our number one priority,” said Paul Stoffels, MD, vice chairman of the executive committee and chief scientific officer at Johnson & Johnson.1 “We appreciate the rigorous review of the PRAC and share the goal of raising awareness of the signs and symptoms of this very rare event to ensure the correct diagnosis and appropriate treatment.”
According to the EMA, the cases reviewed were very similar to those that occurred with the COVID-19 vaccine developed by AstraZeneca.2
“One plausible explanation for the combination of blood clots and low blood platelet counts is an immune response, leading to a condition similar to one seen sometimes in patients treated with heparin called heparin induced thrombocytopenia, HIT,” the agency said in a news release.2
Rollout of the Johnson & Johnson vaccine was temporarily halted in the United States last week, following reports of the rare, potentially lethal blood clots combined with a low blood platelet count in 6 woman who had received the vaccine. To date, nearly 8 million individuals in the United States have received the Janssen vaccine. The CDC and FDA are reviewing reports of these adverse events.
The CDC’s Advisory Committee on Immunization Practices (ACIP) met last Wednesday to review the data and declined to change the current pause on distribution of the J&J vaccine in the United States. The committee cited the need for more robust evidence prior to voting on a recommendation. The ACIP will reconvene on Friday, April 23, for further discussion.