The European Union drug regulator said that “unusual blood clots” should be included as a “very rare” side effect of the AstraZeneca AZN vaccine, -1.14% AZN, -1.17% COVID-19, but insisted that the The benefits of the injection outweigh the risks. The UK regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), also said the cases were “extremely rare”, emphasizing that the benefits outweigh the risks for the “vast majority” of people, and recommended not there are age restrictions for the vaccine.
However, MHRA Executive Director Dr. June Raine said that for youth it was more “finely balanced.” As a result, the UK government‘s Joint Committee on Vaccination and Immunization said that people under the age of 30 would be offered an alternative vaccine, such as that made by German biotech BioNTech BNTX, -3.63% with US pharmaceuticals. Pfizer PFE, -0.25% or the Modern American biotech MRNA shot, -0.82%. The MHRA said the evidence for a link between the AstraZeneca vaccine and unusual blood clots is “stronger, but more work is still needed,” while the European Medicines Agency (EMA) said it had found a “possible link. “. By March 31, 20.2 million doses of the AstraZeneca vaccine had been administered in the UK, meaning the overall risk of these blood clots is approximately four people in a million who receive the vaccine, the MHRA said. Read: US Government to Study Allergic Reactions to COVID-19 Vaccines The EMA laid out its own conclusions on Wednesday after an in-depth investigation into the possible link between reported cases of rare blood clots and the vaccine of the British and Swedish pharmaceutical company. The in-depth review analyzed 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic vein thrombosis, 18 of which were fatal. The cases came mainly from the spontaneous reporting systems of the European Economic Area and the United Kingdom, where around 25 million people had received the vaccine, the EMA said. He added that most cases have occurred in women under the age of 60 within two weeks of vaccination. The EMA safety committee urged people who have received the vaccine to seek medical help if they develop symptoms of blood clots and low platelet levels. Symptoms include shortness of breath, chest pain, leg swelling, abdominal pain, persistent headaches, and small spots of blood under the skin. The UK MHRA listed the same symptoms and echoed the EMA’s advice. The EMA said a plausible explanation for the combination of blood clots and low platelets is an immune response, leading to a condition similar to that sometimes seen in heparin-treated patients (heparin-induced thrombocytopenia or HIT). Read: Oxford suspends AstraZeneca COVID vaccine trial in children and adolescents due to a blood clotting problem On Tuesday, Oxford University said it had stopped a small UK trial testing the vaccine in children and adolescents, while the MHRA investigated a possible link to rare diseases. blood clots in adults. AstraZeneca said on March 14 that its own review of the safety data of more than 17 million vaccinated people in the UK and the EU had shown no evidence of an increased risk of blood clots. AstraZeneca shares were trading 1% lower in London afternoon trading and are now down 2.9% year-to-date. Most EU countries restarted the use of the AstraZeneca vaccine at the end of last month, after the EMA concluded that the injection is “safe and effective” and “is not associated with an increase in the overall risk of clots. of blood”. However, some countries, including France and Germany, have limited the use of the vaccine to people under the age of 60.