AstraZeneca’s Covid vaccine is drawing negative headlines again after several incidences of blood clots have been reported, including the death of a 49-year-old nurse from multiple thrombosis 10 days after receiving the shot. On Mar. 10, eight countries had suspended injections from a batch labeled ABV5300 or halted the use of this vaccine pending clarification.
Austria’s national medicines regulator BASG suspended the use of the batch containing 1 million doses that had been delivered to 17 EU countries, while Denmark, Norway, Estonia, Iceland, Lithuania, Luxembourg, and Latvia temporarily stopped administering the AstraZeneca shot partly or altogether as a precaution.
In the aftermath, inoculation with the vaccine developed in the UK by Oxford University continued unrestricted in Sweden, Spain, and the Netherlands, while Italy’s regulator curbed the use of another batch, following two reported deaths.
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) is examining the batch that raised alarm in Austria. The agency said, however, that said there is no immediate evidence the vaccine was to blame for the incidences, adding that a quality defect was considered unlikely, and thrombosis is not listed as a potential side effect.
Altogether, the EMA said, there had been 22 reports of “such conditions” among the 3 million people to receive the AstraZeneca shot in the European Economic Area as of Mar. 9. It said further information would be released as the investigation progresses; however, the data so far “indicate that the number of thromboembolic events in vaccinated people is no higher than that seen in the general population.”
Up to now, no deaths have been directly attributed to injection with the AstraZeneca Covid-19 vaccine or any of the other vaccines developed for the same purpose.
Commenting on the incident, AstraZeneca said the safety of its vaccine “has been extensively studied in Phase 3 clinical trials, and peer-reviewed data confirms the vaccine has been generally well-tolerated.”
The UK drugmaker’s vaccine has been beset by problems since a dosage mix-up during clinical trials was followed by a controversy over whether the vaccine was safe for people over 65 years old. This was ignited further by the company’s inability to deliver the promised number of Q1 doses to the EU on time. The latter constraint triggered the European Commission’s controversial move to restrict exports outside the bloc.
A week ago, France, Germany, and Belgium began offering the British-made vaccine for the first time to people over 65. Spain was poised to follow but has now said to have given itself more time, pending further guidance from the EMA. France and Germany reportedly do not intend to reverse their reversal.
With Europe lagging behind the UK and more recently the US in getting shots in arms, the situation may have little chance of improving any time soon. Some reports suggest it could worsen further, as plans by Sanofi and Novartis to help make the BioNTech-Pfizer vaccine and a pledge by Bayer and Novartis to produce CureVac’s candidate are unlikely to bear fruit before the third quarter.
Following the supply shortfall in January, AstraZeneca CEO Pascal Soriot committed the drugmaker to make 40 million doses available to the EU in the first quarter, but the British newspaper Financial Time said the Commission now believes the company could miss even this heavily reduced target.