Denmark and Norway have suspended the use of the Oxford-AstraZeneca vaccine in yet another blow to Europe’s stumbling vaccine rollout.
The Danish and Norwegian moves Thursday came after Austria suspended the use of a specific batch of the AstraZeneca vaccine because a patient was diagnosed with multiple thrombosis (blood clots) and died 10 days after being vaccinated with the product. Another patient suffered a pulmonary embolism but is recovering.
In a statement published Wednesday, after Austria suspended the use of the vaccine, the European Medicines Agency (EMA) said, “There is currently no indication that vaccination has caused these conditions, which are not listed as side effects with this vaccine.”
The EMA said: “The information available so far indicates that the number of thromboembolic events in vaccinated people is no higher than that seen in the general population,” adding that, as of March 9, 22 thromboembolic cases had been reported among the three million people who had received the AstraZeneca vaccine.
In Italy, national and Sicilian media have reported the deaths of two Sicilian men a few days after receiving the AstraZeneca vaccine. According to a report from Reuters, Italian health authorities ordered the withdrawal of a batch of AstraZeneca vaccine after the deaths, but it was a precautionary measure and no direct link had been established. Local media reported that a 43-year-old navy officer died of a heart attack the day after his shot and a 50-year-old policeman died some 12 days after being diagnosed with deep vein thrombosis after his jab.
The EMA has launched an investigation into the product to determine if the deaths and illnesses were vaccine-related. The quality of the batch used in Austria will be inspected for possible defects.
The same batch of one million doses, known as ABV5300, was used in 16 other countries in the European Union, including Spain, Sweden and the Netherlands.
According to the EMA, that particular batch was not used in Italy. But the Italian drug regulator halted the use of a separate batch, ABV2856, after the two Sicilian deaths.
Austria intends to suspend its use for 14 days while the investigation takes place. By Thursday, seven European countries, including Iceland, Estonia and Luxembourg, had halted the use of the ABV5300 batch. The Spanish Health Ministry said it would continue to administer doses from the batch because it was unaware of any related cases of blood clots.
The AstraZeneca product is one of three available in the EU; the others are made by Pfizer-BioNTech and Moderna.
The AstraZeneca vaccine has also been approved for use in Canada, however no shipments have arrived yet. The country is receiving the same drug made using a different manufacturing process in India, where it is called Covishield.
On Thursday, the EMA approved the one-dose Johnson & Johnson vaccine, though supply constraints will ensure that its EU rollout will be slow.
In an interview, Pierre Morgon of MRGN Advisors, a Swiss-based biotech and vaccine consultancy, said: “This is a reminder that the safety database of a novel medication isn’t comprehensive until there’s a very large number of people having used the medication, representing all, or almost all, medical situations and conditions.”
Typically, vaccines and other medications are developed through clinical trials with inclusion and exclusion criteria. Any adverse effects among people with medical conditions excluded from the trials would not be known until after a product was approved and made available to the public.
AstraZeneca said patient safety was its “highest priority” and that the vaccine “has been extensively studied in Phase 3 clinical trials and peer-reviewed data confirms the vaccine has been generally well tolerated.”
The suspensions of the use of the product, which has been ordered in far greater quantities by governments around the world than any other vaccine, will inevitably slow the European vaccination campaign. According to the Bloomberg Vaccine Tracker, the EU has administered doses to less than 10 per cent of the population. Vaccination rates in the U.K. and the U.S. are three times higher.
In London trading, AstraZeneca shares lost 2.7 per cent.
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