The Hindu (Visakhapatnam)

AstraZenec­a submission over COVID vaccine nothing new, say doctors

- Bindu Shajan Perappadan

Following pharmaceut­ical company AstraZenec­a’s admission in U.K. court documents that its vaccine against COVID-19 has the potential to cause Thrombosis with Thrombocyt­openia Syndrome (TTS), a rare side e“ect associated with blood clotting, doctors in India said this is not new informatio­n and that they are “well aware of the warning which has been available in India as an insert with the vaccine since the time it was introduced for general public here”.

They added that any adverse event associated with the vaccine would have occurred within 21 days to a month of the rst dose.

A report in British newspaper The Daily Telegraph stated that in a legal document submitted to the High Court in London in February for a group action being brought by 51 claimants, AstraZenec­a admitted that the vaccine developed

Doctors say any adverse event would have occurred within a month of the first dose.

with the University of Oxford to protect against COVID-19 may cause TTS in “very rare cases”.

“It is admitted that the AZ vaccine can, in very rare cases, cause TTS. The causal mechanism is not known. Further, TTS can also occur in the absence of the AZ vaccine (or any vaccine). Causation in any individual case will be a matter for expert evidence,” the newspaper quoted the legal document.

The consequenc­es of TTS are potentiall­y lifethreat­ening including strokes, brain damage, and heart attacks.

Both the Union Health Ministry and COVID-19 vaccine Covishield’s manufactur­er Serum Institute of India on Tuesday issued no statement regarding the developmen­t. The Oxford– AstraZenec­a COVID-19 vaccine is sold under the brand name Covishield in India.

Product informatio­n

In India, the product informatio­n with the vaccine clearly mentions TTS in its special warnings and special precaution­s for use section while adding that a “majority of the events occurred within the rst 21 days following vaccinatio­n and some events had a fatal outcome”.

Doctors here said that the court admission now is “no secret”.

Rajeev Jayadevan, cochairman of the National Indian Medical Associatio­n (IMA) COVID Task Force, said: “The court admission is nothing new. In fact, these are well documented facts validated since early 2021 (soon after vaccine rollout). The World Health Organisati­on (WHO) wrote about it in May 2021 and updated it in 2023.”

He added that clotting was an issue for persons who were administer­ed the rst dose of the vaccine and in the rst month afterwards.

“Therefore, in 2024, people are not at risk of TTS. Also, heart attacks and strokes we see in practice are not caused by TTS, which is an exceptiona­lly rare immunologi­cal reaction that leads to clots in certain locations,” he added.

“The clotting side e“ect of this vaccine is already known and is extremely rare. This is not the rst time AstraZenec­a admits risk of clotting events (again rarest side e“ect) associated with COVID,” Cyriac Abby Philips, hepatologi­st from Kerala, wrote in a social media post.

(With PTI inputs)

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