AstraZeneca Vaccine Judged Safe by European Medicines Agency

The European Medicines Agency (EMA) has issued a press release, with a press conference and Q&A summarised in English here, to announce the findings of its review into the safety of the Oxford University-AstraZeneca (AZ) vaccine. The agency concluded that the benefits of the AZ vaccine outweigh the risks, even in light of recent cases of sinus vein thrombosis (clotting) in seven recent vaccine recipients in Germany.

In regard to the seven cases, of which three died, the EMA concludes that they cannot rule out the possible link with the AZ vaccine. They note that while the disease is very serious, it is also very rare; roughly 11 million people have been given the AZ vaccine in the UK, along with approximately 7 million in the EU. There have been 18 cases of adverse blood clotting reported following the AZ vaccine, as part of normal vaccine surveillance and reporting.

The agency advised that anyone experiencing “persistent bleeding, multiple small bruises, reddish or purplish spots, or blood blisters under the skin” after receiving the AZ vaccine should “promptly” seek medical assistance.

Although the investigation was triggered by the slight up-tick in the rate of occurrence of this rare disease, the agency, as expected, also sought to shore up vaccine sentiment. “When you vaccinate millions of people,” the spokesperson commented, “it’s inevitable that rare or serious illnesses will occur in the time immediately following vaccination.”

Their investigation also found no general increase in incidence of serious blood clotting following administration of the AZ vaccine. They note that given that Covid-19 itself can cause medically serious clotting, the vaccine reduces the overall incidence of this problem.

The EMA also noted the very high numbers of Covid-19 cases and deaths in recent weeks, reiterating the urgency of recommencing AZ vaccine roll-out without delay. Individual European countries will now be free to decide, based on the review, whether to recommence vaccination with the AZ vaccine.

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