British-Swedish company AstraZeneca on Sunday said that a safety review of people inoculated with its coronavirus vaccine has shown no evidence of increased risk of blood clots, even as two more European countries halted vaccinations.
The Cambridge-based company said it has reviewed data from 17 million people vaccinated in the United Kingdom and European Union after reports of blood clotting problems among people who recently received shots in Norway.
“A careful review of all available safety data of more than 17 million people vaccinated in the European Union and UK with Covid-19 vaccine AstraZeneca has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia, in any defined age group, gender, batch or in any particular country,” the company said in a statement.
As of March 8, AstraZeneca said there had been 15 cases of deep vein thrombosis and 22 of pulmonary embolism reported among those who took the jab. “This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed Covid-19 vaccines,” it added.
The Netherlands and Ireland on Sunday became the latest countries to suspend the use of the AstraZeneca vaccine as concerns mount about its possible side effects. Other countries who have suspended vaccinations with the AstraZeneca jab include Denmark, Norway, Bulgaria, Iceland, Thailand. Last week, Austria stopped using a batch of its shots to investigate a death from coagulation disorders.
Ireland’s Health Minister Stephen Donnelly tweeted: “The decision to temporarily suspend use of the AstraZeneca Covid-19 vaccine was based on new information from Norway that emerged late last night. This is a precautionary step. The National Immunisation Advisory Committee meets again this morning and we’ll provide an update after that.”
The Dutch government said the suspension will continue until at least 29 March, adding that it was a precaution, BBC reported. “We can’t allow any doubts about the vaccine,” Dutch Health Minister Hugo de Jonge said. “We have to make sure everything is right, so it is wise to pause for now.”
Peter English, a retired British government consultant in communicable disease control, told Reuters, that it is “most regrettable” that countries have suspended use of the vaccine on precautionary grounds. “It risks doing real harm to the goal of vaccinating enough people to slow the spread of the virus, and to end the pandemic,” English said.
AstraZeneca, which developed the vaccine with Oxford University, in its statement said there has been no evidence of increased bleeding in over 60,000 participants enrolled for the clinical trials.
“The nature of the pandemic has led to increased attention in individual cases and we are going beyond the standard practices for safety monitoring of licensed medicines in reporting vaccine events, to ensure public safety,” the company said. “The safety of the public will always come first.”
Leading public health agencies, including the World Health Organization and the European Medicines Agency, have pointed out that millions of people have been vaccinated across the world without experiencing blood clotting problems. They have said the vaccine’s benefits continue to outweigh its risks.