WATCH: EMA declares AstraZeneca vaccine ‘safe and effective’

A preliminary review by the European Medicines Agency has concluded that the Oxford/AstraZeneca COVID vaccine is “safe and effective”.

Thursday afternoon’s highly-anticipated report came after several European nations temporarily suspended their rollout of the vaccine after isolated reports of blood-clotting in some of the vaccine’s recipients.

The EMA says it will continue to study possible links between blood clots and the vaccine, but revealed it did not find evidence of a causal relationship between the small number of cases of unusual blood disorders, finding the vaccine to be “not associated” with a higher risk of blood clots.

The EMA’s safety committee, PRAC, provided the following information for patients:

• COVID-19 Vaccine AstraZeneca is not associated with an increased overall risk of blood clotting disorders.
• There  have been very rare cases of unusual blood clots accompanied by low levels of blood platelets (components that help blood to clot) after vaccination. The reported cases were almost all in women under 55.
• Because COVID-19 can be so serious and is so widespread, the benefits of the vaccine in preventing it outweigh the risks of side effects.
• However, if the patient develops any of the following after receiving the COVID-19 Vaccine AstraZeneca: breathlessness, pain in the chest or stomach, swelling or coldness in an arm or leg, severe or worsening headache or blurred vision after vaccination, persistent bleeding, multiple small bruises, reddish or purplish spots, or blood blisters under the skin, they should seek prompt medical assistance.

However, these are “rare cases”, and of the 20 million people in the UK and EEA that had received the vaccine as of 16th March, the EMA said it has reviewed only seven cases of disseminated intravascular coagulation and 18 of CVST.

“A causal link with the vaccine [and blood clotting] is not proven, but is possible and deserves further analysis”, it says.

Further conclusions expected

The World Health Organization (WHO) is set to release the results of its own review into the vaccine’s safety on Friday, but has already called on countries to continue to use the vaccine.

AstraZeneca has issued a statement on the issue, reiterating the vaccine’s safety and indicating that occurrences of blood clots in its recipients did not reflect an abnormal level not usually found in the general population.

Several prominent EU countries, including Germany, France, Italy, and Spain had suspended their use of the COVID vaccine produced by AstraZeneca as a “precautionary measure”, in light of isolated reports of blood clots in recipients of the vaccine, though it is not immediately clear if they will lift the suspension following the EMA announcement.

Debate has raged over the merits of the rollout suspension, with some accusing the countries of doing so out of political motives.