New Delhi:

In the wake of pharmaceutical giant AstraZeneca admitting in a UK court that its Covid vaccine can cause blood clots in rare cases, a group of doctors on Thursday expressed deep concern over the safety of the Covishield vaccine manufactured by the Serum Institute of India.

At a press conference, the doctors, under the banner of the Awaken India Movement (AIM), urged the government to review the science behind all Covid vaccines and audit their commercialisation as well as implementation of active surveillance and monitoring mechanism to ensure vaccine adverse events are identified as early as possible.

“The government has wholly ignored the rising number of cases of tragic deaths post-Covid vaccination all the while and continues to promote Covid vaccines as ‘safe and effective’, without scientific investigation and invoking epidemiology,” Dr Tarun Kothari, a radiologist and an activist, said at the press conference.

The world is learning about a side effect of the Covid vaccine called Thrombosis with Thrombocytopenia Syndrome (TTS), he said.

When the COVID-19 vaccines were being administered, not many people were aware that it was being done without the completion of phase-3 trials. Administration of COVID-19 vaccines was started without the manufacturers having complete information and data on the possible short-term or long-term side effects, or fatalities, said Dr Sujata Mittal, a gynaecologist and oncologist.

There is an already low awareness around vaccine injuries, especially in India, she said.

Thousands of women reported abnormalities in their menstrual cycles, which was confirmed much later as a side effect of the vaccine in a study published in September 2022, she added.

“The Awaken India Movement (AIM) has been collecting details of Covid Vaccine deaths covered by media/social media in India and sharing them with various high authorities of the country since 2021, when the vaccination began. The government has failed to respond to our repeated requests to investigate deaths and debilitation from adverse effects of vaccination,” Dr Kothari said.

The AIM urged the government of India to compensate all the victims of Covid vaccines, including their family members, through a mechanism that involves vaccine manufacturers as well.

“We also demand establishing fast track courts and vaccine courts to provide swift justice to the vaccine injured and their families,” Dr Mittal said.

Besides, active surveillance and monitoring mechanisms should be implemented to ensure vaccine adverse events are identified as early as possible and early treatment protocols must be created and widely publicised so that lives can be saved, she stated.

“Review science behind all Covid vaccines and audit their commercialisation,” Dr Kothari said.

The United Kingdom-based AstraZeneca has started global withdrawal of its COVID-19 vaccine, which was provided in India as ‘Covishield’ in partnership with the Serum Institute of India, days after it admitted to rare side effects of blood clotting and lowering of platelet counts.

The withdrawal has been initiated due to a surplus of available updated vaccines since the pandemic, the company said in a statement.

In India, the company’s partner Serum Institute of India said it has stopped the manufacturing and supply of additional doses of Covishield since December 2021 while reiterating that it had disclosed all rare to very rare side effects, including TTS, in the packaging insert in 2021.

AstraZeneca had partnered with Oxford University to develop the COVID-19 vaccine, which was sold as Vaxzevria in Europe. 

(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)

New Delhi:

The Supreme Court will hear a petition on a rare side-effect associated with the COVID-19 vaccine developed jointly by British pharma giant AstraZeneca and Oxford University, manufactured by the Serum Institute of India and sold, in this country, as Covishield. 

A date for the hearing 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. An early hearing of the petition, though, has been ruled out.

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.

Last month AstraZeneca said its vaccine could, in rare cases, cause TTS, or thrombosis with thrombocytopenia syndrome, a condition that leads to blood clots and low platelet count. 

The company is facing class-action lawsuits in the United Kingdom that were triggered by a complaint from Jamie Scott, who claims he suffered a permanent brain injury after a blood clot that formed after he was injected with the vaccine in April 2021.

READ | AstraZeneca Makes Big U-Turn, Admits Covishield Can Cause Rare Side Effects

AstraZeneca initially contested the claim but later told a UK court that “the AZ vaccine can, in very rare cases, cause TTS…”.

There are over 50 cases before the 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

News of a possible side-effect of the Covishield vaccine – widely administered in India – have led to concerns, but medical experts and a fact-check by The Healthy Indian Project indicate the claim is only half-true; i.e., while the risk of TTS is true, the probability is “very rare”.

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.

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

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

The Covishield vaccine uses a viral vector platform rather than mRNA technology. 

This vaccine employs a modified chimpanzee adenovirus, ChAdOx1, to transport the COVID-19 spike protein into human cells. While this cold virus cannot effectively infect recipients, it effectively “teaches” the immune system to defend against similar viruses.

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New Delhi:

Amid concerns over potential side effects associated with the AstraZeneca-Oxford COVID-19 vaccine, the pharmaceutical giant on Tuesday reiterated its commitment to patient safety after acknowledging that the vaccine can, in some rare cases, lead to blood clots and low platelet count. The vaccine, marketed as Covishield in India, was produced by the Serum Institute of India and widely administered in the country.

Although this was not the first time that AstraZeneca admitted to side effects associated with its Covid vaccine, a UK court case involving a 100 million pound class action lawsuit against the pharmaceutical company saw it conceding that the vaccine can indeed cause Thrombosis Thrombocytopenia Syndrome (TTS) in very rare cases.

“Our sympathy goes out to anyone who has lost loved ones or reported health problems. Patient safety is our highest priority, and regulatory authorities have clear and stringent standards to ensure the safe use of all medicines, including vaccines,” AstraZeneca said in a statement. 

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

The World Health Organisation (WHO) has described the vaccine as “safe and effective for all individuals aged 18 and above”, with the adverse effect that has prompted the legal action being “very rare”.

The Serum Institute of India developed the Covishield COVID-19 vaccine using a viral vector platform rather than mRNA technology. This vaccine employs a modified chimpanzee adenovirus, ChAdOx1, to transport the COVID-19 spike protein into human cells. While this cold virus cannot effectively infect recipients, it effectively “teaches” the immune system to defend against similar viruses.