The Serum Institute, producer of the Covishield COVID-19 vaccine developed by AstraZeneca, addressed concerns about Thrombosis with Thrombocytopenia Syndrome (TTS), a rare side effect. They stated that all packaging had transparently listed rare side effects, including TTS, emphasizing the vaccine’s crucial role in saving millions of lives globally. The company reaffirmed the vaccine’s safety as a top priority amidst ongoing scrutiny.

“We acknowledge the persistent concerns, underscoring our unwavering dedication to transparency and safety. Since the beginning, we have openly disclosed all rare to very rare side effects, including Thrombosis with Thrombocytopenia Syndrome, in the package insert from 2021.”

SII also mentioned halting Covishield production since December 2021 due to the emergence of new mutant variant strains, leading to a substantial decrease in demand for previous vaccines, the company explained.

“Due to India’s successful vaccination drive in 2021 and 2022, alongside the emergence of new mutant strains, demand for earlier vaccines notably declined. As a result, we ceased production and distribution of additional Covishield doses since December 2021.”

Highlighting the obstacles encountered by pharmaceutical companies and vaccine manufacturers amid the pandemic, the company emphasized the importance of governments’ collaborative efforts in enabling a coordinated global response to the crisis.

During the peak of the pandemic, Covishield constituted the predominant share of vaccines administered. SII’s announcement coincides with AstraZeneca confronting numerous class-action lawsuits in the UK. These legal actions ensued subsequent to a patient alleging a permanent brain injury resulting from a blood clot post-vaccination with AstraZeneca’s vaccine in April 2021.

Initially, AstraZeneca disputed the assertion but subsequently acknowledged to a UK court that “the AZ vaccine can, in very rare instances, lead to TTS,” a condition associated with blood clots and decreased platelet counts, linked to over 80 fatalities in the UK alone. Presently, more than 50 cases are pending before UK courts, seeking damages amounting to up to 100 million pounds.

In a statement released last week, AstraZeneca conveyed condolences to individuals who suffered losses or health issues, reaffirming its dedication to patient safety and adherence to rigorous standards to guarantee the safe usage of all medications.

Today, the company commenced a worldwide recall of the vaccine. As reported by The Telegraph, AstraZeneca cited commercial factors, specifically an excess of updated COVID-19 vaccines, as the reason for the withdrawal.

Covishield Pulled Worldwide

Experts anticipate the withdrawal of all monovalent vaccines designed for the original COVID strain, to be replaced by updated vaccines targeting a broader range of strains. In India, the Supreme Court has agreed to consider a petition regarding the rare side effects associated with the vaccine. Chief Justice DY Chandrachud acknowledged the matter, which involves requests for an expert panel to investigate the side effects and for the government to offer compensation to families of individuals who may have passed away after receiving the vaccine. A specific hearing date has yet to be scheduled.

Covishield Pulled Worldwide

The petitioner has requested an expert panel to investigate both the specific side effects and potential risks associated with the vaccine, with the stipulation that the investigation be overseen by a retired Supreme Court judge. The petition highlights cases where vaccine recipients have experienced disability and calls for government-directed compensation for them as well.

Medical experts emphasize that side effects are a common occurrence with most vaccines, including those with decades of use, typically being minor and short-lived, as per the World Health Organization. Regulatory bodies globally, including the WHO, maintain that the benefits of vaccination greatly outweigh the risks posed by extremely rare side effects.

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