Two drug regulators have issued a warning about AstraZeneca Plc’s Covid-19 vaccine, recognizing a link to a rare type of blood clot and causing the UK to limit the use of the vaccine to younger adults.
The United Kingdom now recommends that people under the age of 30 be given an alternative vaccine, if one is available, medicines and Health The product regulatory agency said Wednesday.
In the European Union, The European Medicines Agency has found a “strong association” with blood clots. While the regulator has not issued any age guidance, it is likely that the bloc’s health ministers will recommend limiting the use of people over the age of 60, Ansa in Italy said without citing the source.
The warnings dealt another blow to the vaccine developed by Astra in conjunction with Oxford University and continued to blacken its global launch, despite insistence from regulators that the product’s benefits outweigh its risks, that clots are rare and that the shot should be to remain a vital tool in pandemic combat.
“We need to use the vaccines we have to protect ourselves from the devastating effects” of Covid-19, which causes thousands of deaths every day across the EU, said Emer Cooke, EMA’s executive director. “When millions of people receive these vaccines, very rare events can occur.”
Governments are keen to step up vaccination campaigns as Europe fights a third wave of the virus. Italy, France and Germany have recently imposed fresh blockades, and the launch of inoculation in the EU has lagged far behind those in the UK and US
Vaccine concerns focus on an unusual type of blood clot in the brain called cerebral venous sinus thrombosis. There have also been some cases of clots in the abdomen and arteries, which have occurred along with low levels of platelets in the blood. Patients should be alert to symptoms that include chest pain, swelling of the legs, abdominal pain, and difficulty breathing two weeks after vaccination, according to the EMA.
“These clotting disorders are very rare side effects,” Sabine Straus, head of EMA’s safety committee, said in a briefing. June Raine, chief executive of the MHRA in the UK, also pointed out that such events are unusual.
Astra said it was studying individual cases to understand “the epidemiology and possible mechanisms that could explain these extremely rare events.” He is also working with regulators on their request to introduce new labels on his photos, a statement said.
EU health ministers are meeting to try to reach a common position on vaccination, according to Portugal, the country holding the rotating EU presidency. Individual countries may come up with different recommendations based on their own epidemic situation, EMA’s Cooke said.
Astra shares fell 1.2% on trading in London on Wednesday. While the company has pledged not to take advantage of the vaccine during the pandemic, some analysts have expressed concern that it is proving to be a distraction for its top management.
The vaccine has been the subject of controversy in the EU. Prior to health issues, the doctor was involved in a battle with the block after a production issue led to delivery delays.
Now, the company will need to conduct additional research on side effects, including laboratory studies to better understand the impact of the vaccine on coagulation, the EMA said. The universities of Utrecht and Erasmus in the Netherlands will also analyze the risk at the request of the EMA, with data expected in the next few months.
The parallel pill
The EMA safety group did not identify a “definitive cause” or patient profile that would be most at risk, although younger women appear to be most affected. Based on closely monitored rates in Germany so far, brain clots are likely to occur in one person vaccinated per 100,000, according to the agency.
The UK regulator has set the risk at around 4 in a million, with a “slightly higher incidence” in younger adults.
Asked if the risk is acceptable for otherwise healthy people, Peter Arlett, head of EMA analysis, drew a parallel with the birth control pill, in which women voluntarily take a drug estimated to cause blood clots in four out of 10,000 estimated over a year.
Jonathan Van-Tam, the UK’s deputy medical officer, said the new age recommendation would not slow the country’s inoculation campaign.
“It is a correction of the course, but it is nevertheless at full speed for the UK vaccine program,” he said.
– With the assistance of James Paton, Alex Morales, Chris Reiter, Nikos Chrysoloras, Joao Lima and Chiara Albanese
(Updates on the report on the EU recommendation, AstraZeneca statement)