"We Disclosed All Rare Side-Effects": Covid Vaccine Maker Amid Safety Row

SII's statement comes as AstraZeneca faces an avalanche of class-action lawsuits in the United Kingdom after one patient claimed he had a brain injury following his vaccination in April 2021.

'We Disclosed All Rare Side-Effects': Covid Vaccine Maker Amid Safety Row

SII's Covishield and Bharat Biotech's Covaxin were India's two main COVID-19 vaccines (File).

New Delhi:

Amid widespread concern over Thrombosis with Thrombocytopenia Syndrome - a rare side-effect of the Covishield COVID-19 vaccine - the Serum Institute - which manufactured the drug that was developed by British pharma giant AstraZeneca - stressed on Wednesday that all its product packaging had "disclosed all rare to very rare side-effects", including TTS. The vaccine's safety "remains paramount", the company said, pointing out the drug, as Covishield, had been "instrumental in saving millions of lives worldwide".

"We fully understand the ongoing concerns and it is crucial to emphasise our commitment to transparency and safety. From the outset, we disclosed all rare to very rare side-effects, including Thrombosis with Thrombocytopenia Syndrome, in the packaging insert in 2021."

The SII also distanced itself from the December 2021 decision to discontinue production of the AstraZeneca vaccine, sold in India as Covishield, indicating that was due to "diminished" demand.

"With India achieving high vaccination rates in 2021 and 2022, coupled with the emergence of new mutant strains, the demand for previous vaccines diminished significantly. Consequently, since December 2021, we have stopped the manufacturing and supply of additional doses of Covishield."

READ | AstraZeneca Drops Covid Vaccine Weeks After Rare Side Effect Report

Underlining  challenges faced by pharma firms and vaccine makers during the pandemic, the company referred to "collaborative efforts of governments in facilitating a unified global response to the pandemic".

SII's statement comes as AstraZeneca faces an avalanche of class-action lawsuits in the United Kingdom; this was after one patient claimed he suffered a permanent brain injury, following a blood clot that formed after he was injected with the vaccine in April 2021.

Fact Check | Are Indians Who Got Covishield Vaccine Susceptible To TTS?

AstraZeneca initially contested the claim but later told a UK court that "the AZ vaccine can, in very rare cases, cause TTS...", a medical condition that causes blood clots and low platelet counts in human beings and has been linked to over 80 deaths in the UK alone.

There are over 50 cases before UK courts with claimed damages up to 100 million pounds.

In a statement issued last week AstraZeneca expressed sympathy for those who have lost loved ones or reported health problems, but reiterated its commitment to patient safety and adherence to "stringent standards to ensure the safe use of all medicines..."

READ | "Sympathy Goes Out...": AstraZeneca Amid Side Effects Concerns

Earlier today the company initiated a global withdrawal of the vaccine. 

According to British publication The Telegraph, the company has attributed the withdrawal to commercial reasons, i.e., to a "surplus of available updated vaccines" for COVID-19.

READ | AstraZeneca Drops Covid Vaccine Weeks After Rare Side-Effect Row

Experts expect all monovalent vaccines, i.e., those that deal with the original Covid strain, to be withdrawn and replaced with updated vaccines that deal with a wide range of strains.

Meanwhile, in India the Supreme Court has agreed to hear a petition on the rare side-effect attributed to the vaccine. 

A date has not been set but Chief Justice DY Chandrachud acknowledged the issue, which includes demands for an expert panel to investigate the side-effect and for the government to provide compensation for families of those who may have died after taking the drug.

READ | Supreme Court Agrees To Hear Plea Over Covishield Side-Effect Concern

Specifically, the petitioner has demanded the expert panel probe both the side-effect and other potential risks, and that this investigation be monitored by a retired Supreme Court judge. The petition claims instances where those who took the vaccine also became disabled and wants directions to the government to provide compensation for them too.

Medical experts have pointed out that side-effects are a not uncommon feature of most, if not all, vaccines, even those that have been in use for decades, and these are "usually very minor and of short duration", according to the World Health Organization.

Regulatory agencies worldwide, including the WHO, continue to maintain that the benefits of vaccination far outweigh the risks posed by exceedingly rare side effects.

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