Countries like Denmark, Norway and Iceland have temporarily suspended the rollout of the company's vaccine in their respective geographies.
The Indian authorities including the National Committee for Adverse Event Following Immunization (AEFI) have now decided to expand the review of adverse reactions and will now analyse about 19,500 mild cases,
Drug major AstraZeneca has termed its COVID-19 vaccine safe amid various nations suspending its rollout due to the cases of blood clots in certain people who received the jab.
Countries like Denmark, Norway and Iceland have temporarily suspended the rollout of the company’s vaccine in their respective geographies.
The AstraZeneca/Oxford COVID-19 vaccine, which is being produced by Serum Institute of India, is part of the COVID-19 vaccination drive in India. Both, Covishield (AstraZeneca/Oxford) and Covaxin (Bharat Biotech) are currently being administered in the country as part of the drive.
“Following a recent concern raised around thrombotic events, AstraZeneca would like to offer its reassurance on the safety of its COVID-19 vaccine based on clear scientific evidence. Safety is of paramount importance and the company is continually monitoring the safety of its vaccine,” the drug major said in a statement on Monday.
A careful review of all available safety data of more than 17 million people vaccinated in the European Union (EU) and the UK with COVID-19 vaccine AstraZeneca has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in any defined age group, gender, batch or in any particular country, it added.
AstraZeneca noted that so far across the EU and the UK, there have been 15 events of DVT and 22 events of pulmonary embolism reported among those given the vaccine, based on the number of cases the company has received as of March 8.
“This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines. The monthly safety report will be made public on the European Medicines Agency website in the following week, in line with exceptional transparency measures for COVID-19,” it added.
Furthermore, in clinical trials, even though the number of thrombotic events was small, these were lower in the vaccinated group, it said.
There has also been no evidence of increased bleeding in over 60,000 participants enrolled, it added.
“The nature of the pandemic has led to increased attention in individual cases and we are going beyond the standard practices for safety monitoring of licensed medicines in reporting vaccine events, to ensure public safety.
“In terms of quality, there are also no confirmed issues related to any batch of our vaccine used across Europe, or the rest of the world,” AstraZeneca Chief Medical Officer Ann Taylor said.
Additional testing has, and is, being conducted by the company and independently by European health authorities and none of these re-tests have shown cause for concern, she added.
During the production of the vaccine more than 60 quality tests are conducted by the drug firm its partners and by more than 20 independent testing laboratories, Taylor noted.
“All tests need to meet stringent criteria for quality control and this data is submitted to regulators within each country or region for independent review before any batch can be released to countries,” she added.
The company is keeping this issue under close review but available evidence does not confirm that the vaccine is the cause, she noted.