Firm working with regulators to implement changes
KUALA LUMPUR: Biopharmaceutical company AstraZeneca is actively collaborating with health regulators to implement changes in its Covid-19 vaccine.
In a statement yesterday, AstraZeneca said it was already working to understand individual cases, epidemiology and possible mechanisms that could explain the extremely rare events that led to a certain number of its vaccine recipients facing extreme blood clots with low platelets.
“Today, the United Kingdom’s Medicines and Healthcare products Regulatory Agency and European Medicines Agency had completed their assessment of the extremely rare blood clotting cases with low platelets of more than 34 million people inoculated with the AstraZeneca Covid-19 vaccine in the UK and Europe Union.
“There have been requests from the regulators for updates to the UK and EU labels. Neither agency identified any risk factors, such as age or gender, or a definite cause for these extremely rare events.
“However, they came to the view that these events have a possible link to the vaccine and requested that they be listed as an extremely rare potential side effect.
“Overall, both of these reviews reaffirmed the vaccine offers a high level of protection against all severities of Covid-19 and these benefits continue to far outweigh the risks,” said the company.
AstraZeneca said the World Health Organisation (WHO) was quoted as saying that based on current information, a causal relationship was considered plausible but was not confirmed.
“It said that further specialised studies are needed to fully understand the potential relationship between vaccination and possible risk factors.
“WHO noted that despite the concerning side effects, the cases under assessment are very rare, with low numbers reported among the almost 200 million individuals who have been inoculated with the AstraZeneca vaccine around the world.”