EMA has stressed that the overall benefits of getting the shot outweigh the risks
The European Union’s (E.U.’s) medical regulator – European Medicines Agency (EMA) has found a link between the Johnson & Johnson’s (J&J’s) Coronavirus (COVID-19) vaccine and rare blood clots.
The study was undertaken after 86 out of 25 million Europeans administered with the jab, developed the unusual blood clots. The EMA also studied the 8 reports of serious and unusual blood clots from the (U.S.), where more than 7 million doses of J&J vaccine have been given. This comes a week after J&J vaccine rollout was paused in the United states (U.S.)
The EMA said that the combination of blood clots and low blood platelets is very rare. EMA has stressed that the overall benefits of getting the shot outweigh the risks. The EMA said that a warning about unusual blood clots with low blood platelets should be added to the product information.
The EMA has highlighted symptoms that people need to be aware of after getting J&J vaccine. The symptoms are shortness of breath, chest pain, leg swelling, persistent abdominal pain, neurological symptoms, such as severe and persistent headaches or blurred vision and tiny blood spots under the skin beyond the site of the injection. If a person develops any of these symptoms within three weeks of getting the jab, they should seek urgent medical attention.
A statement from EMA read, “All cases occurred in people under 60 years of age within three weeks after vaccination, the majority in women. Based on the currently available evidence, specific risk factors have not been confirmed.”
Mentioning the Chair of Pharmacovigilance Risk Assessment Committee (PRAC) – Sabine Straus, EMA tweeted,
Sabine Straus, PRAC Chair: “The #COVID19vaccine Janssen has demonstrated in clinical trials and it is highly effective in preventing infections caused by #COVID19.”
— EU Medicines Agency (@EMA_News) April 20, 2021
Speaking on the PRAC’s findings, the Chief Scientific Officer of J&J – Dr. Paul Stoffels said, “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.”
EMA stated in its report that the reported cases occurred mostly in women under 60 years, within the first 3 weeks following vaccination. It stated that when vaccines are rolled-out to large numbers of people, very rare events can occur that were not identified in the clinical trials.
J&J awaits another report from the U.S. medical regulators. Meanwhile, J&J will now resume the shipments to E.U., Norway and Iceland.
It is to be noted that EMA had authorised Johnson & Johnson’s shot for emergency use in March 2021. The vaccine has been positioned as a major success because, unlike other vaccines, it is given in 1 shot. All other vaccines require 2 shots.
J&J’s vaccine was the second to be paused in Europe over fears that it can cause rare blood clots. Prior to this, AstraZeneca was also paused for several days after reports blood clots came to light. The EMA has also cleared the AstraZeneca vaccine for use. However, there are a few European nations are restricting use of the shot to older age groups.
