UK watchdog: No decision made yet on regulatory action over AstraZeneca shot
Yesterday [April 5], two senior sources from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) told Channel 4 that, while the data is still unclear, there are growing arguments to not administer COVID-19 Vaccine AstraZeneca, now called Vaxzevria, to those younger than 30.
In an emailed statement to BioPharma-Reporter today, the UK watchdog said no conclusions have been drawn as yet in that respect, and the agency continues to review reported adverse effects.
Dr June Raine, MHRA CEO, said: “People should continue to get their vaccine when invited to do so. Our thorough and detailed review is ongoing into reports of very rare and specific types of blood clots with low platelets following the COVID-19 Vaccine AstraZeneca. No decision has yet been made on any regulatory action.”
The MHRA said its experts are investigating reports of a very rare and specific type of blood clot in the brain, known as cerebral venous sinus thrombosis (CVST) occurring together with low levels of platelets (thrombocytopenia) following vaccination. It is also considering other very rare blood clotting cases (thromboembolic events) alongside low platelet levels.
The UK regulatory body has reported 30 cases of rare blood clots out of the 18.1m shots of the vaccine given in the UK, up to and including March 24. The data, which was released last week, showed 22 cases of CVST. These were accompanied by low levels of platelets. The MHRA also found other clotting problems alongside low platelet levels in eight people. Seven of those 30 individuals have died, the agency confirmed.
EU countries halting vaccinations with Vaxzevria for younger people
The Netherlands on Friday last [April 2] became the latest in a line of European countries to pause vaccinations with the jab for people under the age of 60 due to blood clotting fears. The decision followed five new cases in the Netherlands affecting women between 25 and 65 years of age, one of whom died.
The European Medicine Agency (EMA) is expected to give an updated recommendation on the issue tomorrow, April 7.
Last Wednesday, the EMA’s safety committee (PRAC) said that the review, to date, has not identified any specific risk factors, such as age, gender, or a previous medical history of clotting disorders, for these very rare events. “A causal link with the vaccine is not proven but is possible and further analysis is continuing.”
Again the EMA stressed that it believes the benefits of the AstraZeneca vaccine in preventing COVID-19, with its associated risk of hospitalization and death, outweigh the risks of side effects.
