After EMA decision: Austria continues vaccination with AstraZeneca

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AstraZeneca’s Corona vaccine is safe, according to the European Medicines Agency (EMA), so Austria also plans to continue its vaccination program unchanged. But a warning about rare blood clots (thromboses) in cerebral veins will be included among the possible side effects, the authority said Thursday in Amsterdam. The benefits would outweigh the drawbacks, EMA Director Emer Cooke said, adding that the drug is “safe and effective” against Covid-19.

Austria’s National Vaccination Panel concurred. “Following the assessment of the EMA, it is recommended to continue the vaccination program unchanged,” it said in a written statement this evening. It said there was no evidence of a problem associated with individual batches of the vaccine or with specific manufacturing sites.

Further investigations needed
The EMA said further investigations will be needed into a number of incidents of blood clots following vaccination with the drug. There are some case reports of extremely rare cases of thrombosis of the cerebral veins, said Sabine Straus of the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) in Amsterdam. The data situation is not yet sufficient to say for sure whether an association with AstraZeneca can be excluded, she said. The committee therefore recommends creating greater awareness of risks and including them in the vaccine package insert.

Consequently, this is also being implemented in Austria. In women younger than 55 years, there is an indication of a very small risk (less than 1:100,000) of a rare form of coagulation disorder with blood clots after vaccination against Covid-19, and this should be pointed out in the pre-vaccination information, the national panel said.

Kurz: decision was expected
Chancellor Sebastian Kurz (ÖV) welcomed the EMA’s decision. “The decision was expected. The EMA has once again confirmed that all vaccines that have been approved by the EMA should be used, and in this respect it also confirms the path that the Austrian experts have already taken anyway.” He hoped that this would bring some reassurance and that the uncertainty among the population could decrease again, Kurz said in Berlin on Thursday. “The different reactions in different member states have of course led to uncertainty among the population,” a decision by the competent European body would therefore be good, the chancellor stressed.

Health Minister Rudolf Anschober (Greens) stressed in a statement that it was right to have demanded a detailed investigation and recommendation from the EMA instead of a hasty political decision. “It is important that the EMA has made a clear decision today: the continuation of vaccinations with AstraZeneca’s vaccine and corresponding adjustments to the vaccine’s technical information are the basic message. For me, a joint European approach is particularly important,” he said.

Several countries, including the EU states of Germany and France, had temporarily suspended vaccinations with the vaccine from the British-Swedish manufacturer after isolated cases of thrombosis and pulmonary embolism were reported. In Germany, there are now 13 reported cases of blood clots in cerebral veins in temporal connection with vaccinations, the Ministry of Health in Berlin announced.

In Austria, too, the death of a nurse (49), who died close to the time of vaccination in Lower Austria, has been investigated for about two weeks; a causal relationship has not yet been established. The National Immunization Panel (NIG) advised against a vaccination stop. The World Health Organization also spoke out with recommendations for continued use. On Friday, the WHO plans to comment again on AstraZeneca.

Britain’s Medicines and Healthcare products Agency (MHRA) said Thursday that so far there is nothing to suggest the vaccine causes blood clots. But it was investigating a very rare and specific type of such incident in the brain: “A further detailed review of five U.K. reports of a very rare and specific type of blood clot in the cerebral veins that occurred along with decreased platelets is ongoing.”