New Jersey-based company Johnson & Johnson immediately resumed the rollout of its COVID-19 vaccines, also known as Vaccine Janssen, following the official statement released by the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) stating that “the overall benefits of COVID-19 Vaccine Janssen in preventing COVID-19 outweigh the risks of side effects.” Shipments to the European Union, Norway, and Iceland restarted instantly after the EMA statement was released.
The agency also stated that blood clots should be listed on the label as a very rare side effect of the Johnson&Johnson vaccine. The company said a new package label is now available and now includes a warning on the rare side effects following the EMA statement. It also includes instructions on how to recognize and treat it.
On April 14, 2021, U.S. federal health agencies recommended that the vaccine producer pause from rolling out its COVID-19 vaccine for a couple of days after six women below 50 years of age experienced a rare blood clot after getting the shot. The company instantly made a commitment to pause rolling out its vaccines in Europe. Soon thereafter, South Africa also suspended the use of Vaccine Janssen.
In the United States alone, more than eight million citizens have been given the Johnson & Johnson shot. The Netherlands resumed administering the vaccine to its citizens last April 21.
“The safety and well-being of the people who use our products is our number one priority. 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,” says Dr. Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson.
“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. We are committed to equitable access and to bringing an affordable COVID-19 vaccine to the public on a not-for-profit basis for emergency pandemic use,” Dr. Stoffels adds.
Earlier this April, EMA released the same recommendation for the COVID-19 vaccine produced by Oxford-AstraZeneca. It came out after 86 individuals from the 25 million Europeans who received the vaccines developed unusual blood clots. As a response, the United Kingdom ceased administering shots to its citizens under 30 years old using the AstraZeneca vaccine.
“One plausible explanation for the combination of blood clots and low blood platelets is an immune response, leading to a condition similar to one seen sometimes in patients treated with heparin called heparin-induced thrombocytopenia, HIT,” the EMA explains.
The EMA further warns people that it is best to be aware of the symptoms of a potential blood clot after getting a shot of the vaccine. Common symptoms include shortness of breath, chest pain, leg swelling, persistent abdominal pain, neurological symptoms such as persistent headaches and blurred vision, and tiny blood spots under the skin beyond the site of the injection.
Individuals who experience any or a combination of these symptoms within three weeks after getting a COVID-19 vaccine are advised to immediately seek appropriate medical attention.