After a difficult few days for the AstraZeneca Covid-19 vaccine rollout, the European Medicines Agency offered fresh support for the shot’s safety last Thursday. However, after looking at cases of rare blood clots, the agency couldn’t conclusively rule out the risk.
The regulator reached a “clear scientific conclusion” that the AZ vaccine is “safe and effective,” EMA executive director Emer Cooke disclosed during a briefing. The protection the vaccine offers against Covid-19 “outweighs possible risks,” she noted.
With thousands losing their lives to Covid-19 in Europe, it’s important to continue vaccinations, Cooke added.
Still, after a speedy review of data after countries halted vaccinations, the regulator couldn’t eliminate a possible link to blood clots linked to thrombocytopenia, or low levels of blood platelets. With that possible risk looming, the agency is raising awareness of the problem so doctors and patients are aware of what to look for.
With more awareness, people can “spot and mitigate” any likely side effects, Cooke noted. Further, the agency is launching “targeted observational studies” to learn more about the vaccine.
About 20 million people have received the shot so far, EMA says, and the agency has reviewed seven cases of blood clots in multiple vessels. The agency has reviewed another 18 cases of cerebral venous sinus thrombosis, or clots in the vessels draining blood from the brain.
EMA notes that a “causal link with the vaccine is not proven, but it is possible and deserves further analysis.” In the meantime, shot recipients should inform their doctor of pain in the chest, breathlessness, severe headache, persistent bleeding, swelling or coldness in an arm or leg, or bruising EMA added.
EMA’s latest endorsement of the vaccine’s risk-benefit profile came after similar proclamations from authorities at the World Health Organization and the U.K.’s Medicines and Healthcare products Regulatory Agency.
Sometime last week, several countries in Europe and beyond stopped the use of the vaccine amid multiple reports of blood clots following vaccination.
AstraZeneca has stood by the vaccine, affirming that patient safety is the firm’s “highest priority.”
“Regulators have clear and stringent efficacy and safety standards for the approval of any new medicine, and that includes Covid-19 Vaccine AstraZeneca,” a spokeswoman remarked. “The safety of the vaccine has been extensively studied in Phase III clinical trials and peer-reviewed data confirms the vaccine has been generally well tolerated.”
Apart from the safety concerns, the pharma company is also facing supply challenges. In recent days, the company cut its European first-half supply target to 100 million doses – down from 300 million earlier. With that supply cut, Europe is now leaning more on the Pfizer/BioNTech vaccine.