European Medicines Agency says immune response 'plausible' cause
The European Medicines Agency revealed Wednesday that 79 blood clots and 19 deaths were reported in the UK after receiving the AstraZeneca-Oxford vaccine.
“By the 31st of March over 20 million doses having been given, we have had 79 cases reported. Of the 79 cases, 19 people have sadly died,” June Raine, Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA), told a briefing.
A British government committee advising on coronavirus vaccinations said Wednesday most people under 30 should be offered an alternative to the AstraZeneca jab if possible, due to concerns over blood clots.
“Adults who are aged 18 to 29 years old who do not have an underlying health condition… should be offered an alternative Covid-19 vaccine in preference to the AstraZeneca vaccine, where such an alternative vaccine is available,” Wei Shen Lim of the Joint Committee on Vaccination and Immunisation, said at a press conference.
The watchdog’s findings come after several countries halted the use of the vaccine following dozens of cases of people with clots in blood vessels draining from the brain after receiving jabs, some of them fatal.
Immune response is a ‘plausible’ explanation for the AstraZeneca-Oxford vaccine clots, the European Medicines Agency said on Wednesday.
The EMA said that blood clots should be listed as a “very rare” side effect of the AstraZeneca coronavirus vaccine but that the jab’s benefits continue to outweigh the risks.
“EMA’s safety committee has concluded today that unusual blood clots with low blood platelets should be listed as very rare side effects” of the shot, the Amsterdam-based EU drug regulator said in a statement.
No specific risk factors including age have been identified for blood clots with the AstraZeneca coronavirus vaccine, which could stem from an immune response, the EU’s drug regulator said Wednesday.
Despite the fact that many of the cases have been reported in women under 55, prompting a number of countries to restrict the vaccine’s use to older people, the regulator said it had not been able to pinpoint those at risk.
“Specific risk factors such as age, gender or medical history have not been able to be confirmed, as the rare events are seen in all ages,” EMA chief Emer Cooke told a news conference.
A British trial of the AstraZeneca coronavirus vaccine on children has been paused, Oxford University said Tuesday, as global regulators rushed to assess its possible link to rare blood clots in adults.
The university, which helped develop the embattled vaccine, said in a statement that there were “no safety concerns” in the trial, but acknowledged fears over a potential link to clots by saying that it was awaiting additional data from Britain‘s Medicines and Healthcare products Regulatory Agency (MHRA) before restarting the study.
“Parents and children should continue to attend all scheduled visits and can contact the trial sites if they have any questions,” it added.