2 min read.Updated: 18 Mar 2021, 11:04 PM ISTLeroy Leo
The panel, which involved experts in blood disorders in its review, worked closely with other health authorities, including the UK’s regulator
The Indian government has also backed the vaccine, saying that no such events have been observed in the country
After a preliminary review of the safety data of AstraZeneca plc’s covid-19 vaccine, the European Medicines Agency on Thursday said that the jab is not directly associated with an increase in the overall risk of blood clots, but said that further analysis is required to prove whether there is an indirect link.
“Close safety monitoring of reports of blood clotting disorders will continue, and further studies are being instituted to provide more laboratory data as well as real-world evidence," the EMA said in a statement on Thursday, while adding that the panel which conducted the review—Pharmacovigilance Risk Assessment Committee—will conduct similar reviews of risks for other vaccines as well.
The panel, which involved experts in blood disorders in its review, worked closely with other health authorities, including the UK’s regulator which has overseen administration of the vaccine to around 11 million people.
It observed that the number of blood clot-related events reported after vaccination was lower than that expected in the general population, and came to the conclusion that there is no increase in overall risk of blood clots, but there were some concerns in younger patients.
Despite saying that a casual link—in which the vaccine triggers an effect in the body and indirectly causes a serious side effect—is possible, the regulator said that the benefits of the vaccine in preventing hospitalisation and death from COVID-19 outweighs the extremely small likelihood of developing severe blood clotting disorders.
The regulator said that around 20 million people in the UK and European Union had received the vaccine as of March 16, only 7 cases of blood clots in multiple blood vessels and 18 cases of clots in the vessels draining blood from the brain were observed and reviewed by the EMA.
The review days after France, Germany, Denmark and a few other European countries halted vaccination after reports emerged that the vaccine may be causing blood clots in very rare cases.
However, the EMA and World Health Organization have backed the vaccine both are conducting a review of safety data, with WHO officials last week also saying that the risks of covid-19 infections were still greater than that from the vaccine.
Serum Institute of India manufactures the vaccine under the brand Covishield, which has so far been administered to over 20 million people in India, and has also been exported to other countries through WHO’s Covax facility and the company’s own commercial pacts with some countries.
The Indian government has also backed the vaccine, saying that no such events have been observed in the country, where around 90% of nearly 40 million doses that have been administered are Covishield.
Subscribe to Mint Newsletters
* Enter a valid email
* Thank you for subscribing to our newsletter.
Never miss a story! Stay connected and informed with Mint.
our App Now!!