covishield-production-halted-in-2021-sii-clarifies-side-effect-disclosure

The recent announcement by AstraZeneca regarding the withdrawal of marketing approval for its COVID-19 vaccine, Vaxzevria (known as Covishield in India), has sparked debate and raised questions in India.

 

The Serum Institute of India (SII), which partnered with AstraZeneca to manufacture Covishield, has issued a statement clarifying its position.

 

An SII spokesperson stressed that production of Covishield had already stopped in December 2021.  

 

This decision, they explained, was driven by a combination of factors. Firstly, a significant portion of the Indian population had already been vaccinated by that time. 

 

Secondly, a sufficient stockpile of Covishield doses had been created. Finally, the emergence of new COVID-19 variants led to a shift in demand towards updated vaccines.

 

AstraZeneca's justification for withdrawal in Europe centers on the current surplus of COVID-19 vaccines.

 

With the development of more recent vaccines targeting emerging variants, the demand for Vaxzevria has declined.

 

AstraZeneca confirmed that Vaxzevria is no longer being manufactured or supplied.

 

The SII statement specifically addressed concerns regarding the disclosure of potential side effects.

 

They asserted that all rare and very rare side effects, including Thrombosis with Thrombocytopenia Syndrome (TTS), were included in the Covishield packaging insert as early as 2021.

 

This transparency ensured that healthcare professionals administering the vaccine were fully informed about potential risks.

 

The news of AstraZeneca's withdrawal coincides with a legal development in the United Kingdom.

 

According to media reports, AstraZeneca reportedly admitted for the first time in a UK court that its vaccines could, in very rare cases, have the potential to cause TTS. 

 

This admission opens the door for potential payouts in a class-action lawsuit.

 

TTS is a rare condition characterized by blood clots combined with a low platelet count, linked to certain adenovirus vector vaccines like Vaxzevria and Johnson & Johnson's Janssen vaccine.

 

The first cases of TTS emerged in Europe soon after the rollout of the AstraZeneca vaccine. These incidents led some European countries to temporarily suspend the use of Vaxzevria.

 

While vaccination with the vaccine eventually resumed, it was not recommended for young women, who appeared to be more susceptible to TTS.

 

The SII statement regarding side-effect disclosure contrasts with the experiences of some in India.

 

While SII included warnings about TTS in the packaging insert, some family members of those who suffered from TTS or other rare side effects allege that the information was not readily accessible to the public during the mass vaccination drives.

 

They claim that individuals receiving the vaccine were not adequately informed about potential side effects.

 

Covishield played a pivotal role in India's fight against COVID-19. Over 79% of the 220 crore doses administered during the national vaccination program were Covishield.

 

Data from the government's Adverse Events Following Immunisation (AEFI) committee reveals that at least 36 cases of TTS were reported in India, with 18 fatalities.

 

Nearly all of these TTS cases occurred in 2021, the first year of the vaccination program.