AstraZeneca vaccine benefits ‘outweigh risk’ says EMA – but UK will offer alternative to under-30s

The European Medicines Agency (EMA) has said that the benefits of the Oxford-AstraZeneca vaccine in preventing Covid-19 outweigh the risk of “very rare” and unusual blood clots.

While the EMA did find a possible link between the vaccine and the blood clots, it said they are very rare events.

Executive director of the EMA, Emer Cooke, said that the AstraZeneca vaccine was “highly effective” at preventing serious illness and hospitalisation and was “saving many lives” in the fight against Covid-19.

“Vaccination is extremely important in helping us in the fight against Covid-19 and we need to use the vaccines we have to protect us from the devastating effects of the disease”.

In total, there were 18 fatalities across Europe from these blood clots in people after they received the vaccine. Over 25 million people that have received the vaccine thus far, the EMA said.

“So far, most of the cases reported have occurred in women under 60 years of age within two weeks of vaccination. Based on the currently available evidence, specific risk factors have not been confirmed,” a statement from the EMA said.

A review by the EMA’s safety committee concluded on Wednesday that “unusual blood clots with low blood platelets should be listed as very rare side effects” of the Oxford/AstraZeneca vaccine.

The Committee carried out an in-depth review of 86 clots reported in the EU drug safety database as of March 22, 2021 - 18 of which were fatal.

“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,” the EMA has said, while requesting new studies to provide further information.

The EMA is advising anyone who gets the AstraZeneca vaccine and has any of the following symptoms, to seek medical assistance immediately:

• Shortness of breath
• Chest pain
• Swelling in your leg
• Persistent abdominal (belly) pain
• Neurological symptoms, including severe and persistent headaches or blurred vision
• Tiny blood spots under the skin beyond the site of injection

The UK medicines watchdog also echoed the findings that the benefits of the Oxford/AstraZeneca vaccine continue to outweigh any risks for most people.

In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) said there were still huge benefits of the vaccine in preventing Covid-19 and serious disease.

However, due to a very small number of blood clots in younger people, those under the age of 30 will be offered Pfizer or Moderna instead.

More to follow..

Online Editors