April 21, 2021
Johnson & Johnson announced it would resume shipping its COVID-19 vaccine to Europe after the European Union's health agency said a warning about a possible connection to blood clots should be attached to the vaccine.
The vaccine's benefits "outweigh the risks of side effects," the European Medicines Agency said in a statement.
Johnson & Johnson said it will ship again to the EU nations, Norway, and Iceland with the warning and provide guidance for health care professionals on possible treatments.
"We strongly believe in the positive benefits of our single-shot, easily transportable COVID-19 vaccine to help protect the health of people everywhere and reach communities in need globally," Paul Stoffels, M.D., chief scientific officer at Johnson & Johnson, said in a statement.
The company stopped shipping in Europe last week after U.S. regulators decided to suspend use of the J&J vaccine while an investigation was conducted into reports that a small number of people who got the vaccine developed blood clots.
While U.S. regulators have not lifted the pause on the J&J vaccine yet, the EMA's drug regulating arm, the Pharmacovigilance Risk Assessment Committee (PRAC), said Monday the vaccine could go back into use with the warning.
"Health care professionals and people who will receive the vaccine should be aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within 3 weeks of vaccination," the EMA said in a statement.
"COVID-19 is associated with a risk of hospitalisation and death. The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of (the vaccine) in preventing COVID-19 outweigh the risks of side effects."
The CDC and FDA recommended a temporary pause last week after six women reported a rare blood-clotting disorder. The women, who are between ages 18-48, experienced symptoms 6 to 13 days after receiving a Johnson & Johnson shot. A seventh case involving a woman was later reported, as was a case involving a man who developed a blood clot during the Johnson & Johnson clinical trials.
Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, has said federal health officials will likely make a decision by Friday about whether to end the pause on the use of the Johnson & Johnson COVID-19 vaccine.
The EMA said more than 7 million people had received the J&J vaccine as of April 13.
Health experts had welcomed the use of the J&J vaccine. Unlike the Pfizer/BioNTech and Moderna vaccines, it only requires one dose and can be easily shipped without super-cold temperatures.