After AstraZeneca covid-19 vax recall worldwide, Serum says it stopped manufacturing jabs in Dec 2021

New Delhi: The Serum Institute of India (SII) on Wednesday said it has stopped making and supplying covid-19 vaccine Covishield after AstraZeneca, the British drugmaker that helped develop the vaccine, announced it too was withdrawing its version of the jab worldwide.

Both companies cited lack of demand for their move. The vaccine used in Europe is called Vaxzervia.

The development follows the launch of a class action suit in the UK over allegations that the UK vaccine caused blood clots in a large number of covid-19 patients—a side-effect that AstraZeneca admitted could happen, but only rare cases. 

Nothing undisclosed

The SII said it had disclosed all rare to very rare side effects, including Thrombosis with Thrombocytopenia Syndrome, in the packaging insert in 2021.

Also read |  AstraZeneca to withdraw sales of Covid-19 vaccine globally

In India, Covishield, a vaccine developed by AstraZeneca and Oxford University, was manufactured by the SII and extensively administered.

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

Committed to transparency

“We fully understand the ongoing concerns and it's crucial to emphasize our commitment to transparency and safety. From the outset, we have disclosed all rare to very rare side effects, including Thrombosis with Thrombocytopenia Syndrome, in the packaging insert in 2021. Despite the challenges faced during the global pandemic, the safety of the vaccine remains paramount. Regardless of whether it's AstraZeneca's Vaxzervria or our own Covishield, both vaccines have been instrumental in saving millions of lives worldwide. We commend the collaborative efforts of governments and ministries in facilitating a unified global response to the pandemic,” the vaccine manufacturer said.

Also read |  Bharat Biotech releases statement amid Covishield blood clot row: ‘Covaxin was developed with…’

A senior Indian government official added, “In the last one-and-a-half-year, around 400,000 covid-19 vaccines were used (in India). Right now, there’s no vaccine available in the market. Even if one tries to get the vaccine, they will not find it. If fact, after September 2022 when free booster doses were offered, the government did not procure even a single dose of vaccine. Similarly, there is no availability of the vaccine in the private market. It was only indicated to the private sector, if they wish to purchase vaccine or not. So, there’s no point of recalling the vaccine in India when there is no stock.” 

No rise in severity

“Only a few private hospitals which have the remaining stocks available with them are conducting vaccination,” said the official.

As of 8 May, India had 810 active covid-19 cases. In the last 24 hours, 12 people were vaccinated.

According to the government's covid group, INSACOG, JN.1 covid-19 sub-variant is in circulation at present. However, no increase in disease severity or hospitalization has been observed with this sub-variant.

Queries sent to the health ministry remained unanswered. 

Also read |  Covishield vaccine side effects: Ex-ICMR scientist says only 7 in 10 lakh may face risk

Reuters adds: AstraZeneca said on Tuesday it had initiated the worldwide withdrawal of its covid-19 vaccine due to a "surplus of available updated vaccines" since the pandemic.

The company also said it would proceed to withdraw the vaccine Vaxzevria's marketing authorizations within Europe.

"As multiple, variant covid-19 vaccines have since been developed there is a surplus of available updated vaccines," the company said, adding that this had led to a decline in demand for Vaxzevria, which is no longer being manufactured or supplied.

The Anglo-Swedish drugmaker has previously admitted in court documents that the vaccine causes side-effects such as blood clots and low blood platelet counts.

The firm's application to withdraw the vaccine was made on 5 March and came into effect on 7 May, according to The Daily Telegraph, which first reported the development.