Two drug regulators issued a warning about AstraZeneca Plc’s Covid-19 vaccine, which recognizes the association with a rare type of blood clot and has asked the UK to limit the use of the shot in younger adults.
The UK now recommends that those under the age of 30 should receive an alternative vaccine if one is available, the medicine and Health care Products Regulatory Agency said Wednesday.
In the European Union, the The European Medicines Agency has found a ‘strong link’ with blood clots. Although the regulator has not issued any guidelines on age, the group’s health ministers are likely to recommend restricting the use of people over 60, Ansa of Italy reported without naming the source of the information.
The warnings dealt a further blow to the vaccine that Astra developed with the University of Oxford and still clouded global deployment, despite regulators’ insistence that the benefits of the product outweigh the risks, that the appearance of the clot is rare and that the shot should remain an important tool in the pandemic battle.
“We need to use the vaccines we have to protect ourselves from the devastating effects” of Covid-19, which causes thousands of deaths across the EU every day, said Emer Cooke, EMA’s executive director. “When millions of people receive these vaccines, very rare incidents can occur.”
Governments want to speed up vaccination campaigns as Europe battles a third wave of the virus. Italy, France and Germany have recently imposed a new exclusion, and the EU’s exhausting vaccination is far behind those in the UK and US
Concerns about the vaccination center on an unusual type of blood clot in the brain, cerebral venous sinus thrombosis. There were also cases of blood clots in the abdomen and in the veins, which occur along with low platelets. According to the EMA, patients should be treated for symptoms that include chest pain, swelling in the leg, abdominal pain and shortness of breath two weeks after vaccination.
“These coagulation disorders are very rare side effects,” said Sabine Straus, chair of the EMA’s safety committee, during a briefing. June Raine, the chief executive of the British MHRA, also stressed that such events were unusual.
Astra said it was studying the individual cases to understand the “epidemiology and possible mechanisms that could explain these extremely rare events”. It is also working with regulators on their request for new labels on its shots, a statement said.
EU health ministers are meeting to try to reach a common position on vaccination, according to Portugal, the country holding the EU’s rotating presidency. Individual countries can make different recommendations based on their own epidemic situation, the EMA’s Cooke said.
Astra shares traded 1.2% in London on Wednesday. Although the company promised under the pandemic not to take advantage of the vaccine, some analysts have expressed concern that it is a distraction for top management.
The vaccine is plagued by controversy in the EU. Before the health was concerned, the drugmaker became embroiled in a battle with the block after a production issue led to delays in delivery.
The company will now need to conduct additional research on the side effects, including laboratory studies to better understand the impact of the vaccine on coagulation. The universities of Utrecht and Erasmus in the Netherlands will also investigate the risk at the request of the EMA, with the expected data in the next few months.
Parallel Arrow
The EMA safety group has not identified a ‘definitive cause’ or patient profile that is at greatest risk, although younger women are most affected. According to the rates so far observed in Germany, which have been closely monitored, the brain clots probably occur in one vaccinated person per 100,000, according to the agency.
The UK regulator has set the risk at around 4 out of a million, with a ‘slightly higher incidence’ in younger adults.
Peter Arlett, head of analytics at EMA, raised the question of whether the risk is acceptable to otherwise healthy people, and drew a parallel with the contraceptive pill, in which women are willing to take a drug that is expected to cause blood clots in four out of an estimated 10,000 annually.
Jonathan Van-Tam, the British deputy chief medical officer, said the recommendation of the new era would not slow down the country’s vaccination campaign.
“It’s a course correction, but it’s still full for the UK vaccination program,” he said.
– With the help of James Paton, Alex Morales, Chris Reiter, Nikos Chrysoloras, Joao Lima and Chiara Albanese
(Updates with EU Recommendation Report, AstraZeneca Statement)