MHRA concluded that there is no evidence that blood clots in veins are occurring more than expected in the absence of vaccination
New Cambridge R&D Centre and Global HQ. (Credit: AstraZeneca.)
The UK’s Medicines Health Regulatory Authority (MHRA) and the EU’s European Medicines Agency (EMA) confirmed the safety and efficacy of AstraZeneca’s Covid-19 vaccine.
Recently, the Netherlands and other European nations suspended the use of AstraZeneca’s Covis-19 vaccine, based on possible side effects reported.
MHRA has reviewed a few thromboembolic events in more than 11 million people who received Covid-19 Vaccine AstraZeneca in the UK.
The UK regulator said that the vaccine provides superior benefits in preventing the Covid-19, compared associated risks, and suggested people continue taking the vaccine shots.
MHRA, following the scientific review, concluded that there is no evidence that blood clots in veins are occurring more than expected in the absence of vaccination.
The regulator is currently reviewing five very rare and specific type of blood clot in the cerebral veins, called sinus vein thrombosis, along with lowered platelets, called thrombocytopenia, reported in the UK.
MHRA said: “This has been reported in fewer than one in a million people vaccinated so far in the UK, and can also occur naturally – a causal association with the vaccine has not been established.”
The Pharmacovigilance Risk Assessment Committee (PRAC) of EMA stated that there was no increase in the overall risk of blood clots in people vaccinated with AstraZeneca’s Covid-19 vaccine.
PRAC also concluded that no evidence has been found to link very rare cases of serious thromboembolic events, with the vaccine, but requires further analysis.
Also, there was no evidence of a problem associated with specific batches of the vaccine or to particular manufacturing sites.
AstraZeneca is planning to implement the PRAC recommendations, including the product information update, to facilitate the safe delivery of the vaccine.
Also, the company would continue its work together with health authorities to ensure the appropriate use of its Covid-19 Vaccine AstraZeneca.
AstraZeneca chief medical officer Ann Taylor said: “Vaccine safety is paramount and we welcome the regulators’ decisions which affirm the overwhelming benefit of our vaccine in stopping the pandemic.
“We trust that, after the regulators’ careful decisions, vaccinations can once again resume across Europe.”