How the Covishield controversy began
It all started with a submission made by Astrazeneva in a British court. It said in court documents that its Covid vaccine can cause a rare side effect, the UK’s Daily Telegraph newspaper reported nearly 10 days ago. The pharmaceutical giant is being sued for over £100 million (a little over Rs 1,000 crore) in class action over claims its vaccine caused death and serious injury in 51 cases, according to court documents seen by the Daily Telegraph, a British newspaper.
AstraZeneca is contesting the claims but has accepted, in a legal document submitted to the high court in February, that its Covid vaccine “can, in very rare cases, cause thrombosis with thrombocytopenia syndrome”, which causes people to have blood clots and a low blood platelet count.
One of the claimants is Jamie Scott, a father of two, who was left with a permanent brain injury after developing a blood clot and a bleed on the brain that prevented him from working after he received the AstraZeneca vaccine in April 2021. Lawyers representing families suing the drugs company argue that the vaccine was not as safe as individuals were entitled to expect. They are suing the firm under the Consumer Protection Act of 1987, arguing the maximum £12,000 (more than Rs 12 lakh) payout they could get from the UK-govt-run vaccine compensation scheme is inadequate.
The India angleIn India, the said vaccine was sold under the brand name Covishield manufactured by the Serum Institute of India (SII) in Pune. After the revelation about Astrazeneca’s submission in the UK court, parents of a woman who allegedly died after taking Covishield decided to file a case against SII.Venugopalan Govindan, father of Karunya, who died after taking the vaccine, said the admission by AstraZeneca is “too late” and has come after so many lives have been lost. ” The parents have already filed a writ petition seeking compensation, appointment of an expert medical board independent of the government to forthwith inquire into and investigate the deaths of their daughter, and to share the report of the investigation with them.
A group of parents who lost their children to alleged adverse effects after taking Covishield, believes the number of deaths or serious injury could be much more in India than the government figures even as more parents join in to fight it out in the court.
A plea has been filed in the Supreme Court, seeking setting up of an expert medical panel to study and assess the possible risk factors associated with the vaccine. It calls for a direction to the Centre to implement a vaccine damage payment system to compensate citizens who are severely disabled or deceased as a result of the vaccine.
A doctors’ group has urged the government to review the science behind all Covid vaccines and audit their commercialisation as well as implementation of active surveillance and monitoring mechanisms to ensure vaccine adverse events are identified as early as possible.
What is the chief concern?
At the centre of the controversy is a rare side effect known as Thrombosis with Thrombocytopenia Syndrome (TTS), which AstraZeneca has acknowledged that its vaccine can potentially cause, as per the report by The Telegraph.
TTS is a rare yet serious condition linked to certain COVID-19 vaccines, notably adenovirus vector vaccines like AstraZeneca and Johnson & Johnson’s Janssen vaccine. TTS is marked by the presence of blood clots (thrombosis) along with low levels of platelets (thrombocytopenia), crucial for blood clotting. It often involves unusual clot locations, such as in the brain (cerebral venous sinus thrombosis) or abdomen. Symptoms may include severe or persistent headaches, blurred vision, shortness of breath, chest pain, leg swelling, persistent abdominal pain, and easy bruising or tiny blood spots under the skin beyond the injection site.
While TTS is rare, individuals who have received vaccines associated with TTS should be vigilant for symptoms and seek medical attention promptly if they experience any within a few weeks of vaccination. Early recognition and treatment are essential for managing TTS effectively.
What AstraZeneca and SII say
“Our sympathy goes out to anyone who has lost loved ones or reported health problems,” AstraZeneca has said amid concerns over the side-effects. “Patient safety is our highest priority, and regulatory authorities have clear and stringent standards to ensure the safe use of all medicines, including vaccines.”
The product information relating to the AstraZeneca vaccine was updated in April 2021, with the approval of the UK regulator MHRA, to include the possibility that the vaccine is capable, in very rare cases, of being a trigger for TTS. AstraZeneca points out this update was well documented and publicly available, The Telegraph reported. The vaccine, developed with Oxford University, is no longer used in the UK.
Benefits of the vaccine far outweigh the risks of extremely rare potential side effects, AstraZeneca has told news agency IANS. “From the body of evidence in clinical trials and real-world data, the AstraZeneca-Oxford vaccine has continuously been shown to have an acceptable safety profile,” the statement said. “Regulators around the world consistently state that the benefits of vaccination outweigh the risks of extremely rare potential side effects,” it added.
AstraZeneca has begun the global withdrawal of its COVID-19 vaccine, Vaxzevria, citing a surplus of available updated vaccines since the pandemic began. The company has also decided to withdraw the vaccine’s marketing authorizations within Europe. “As multiple, variant COVID-19 vaccines have since been developed, there is a surplus of available updated vaccines,” AstraZeneca stated. This surplus has led to a decline in demand for Vaxzevria, which is no longer being manufactured or supplied.”
SSI, the Indian manufacturer of AstraZeneca’s vaccine under brand name Covishield, said on Wednesday that it had stopped manufacturing the vaccine and supply of additional doses in December 2021 itself. “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,” an SII spokesperson said. “Consequently, since December 2021, we have stopped the manufacturing and supply of additional doses of Covishield”.
Moreover, SII also said that it had disclosed all rare and very rare side effects of the vaccine, including TTS, in the packaging inserts as well. “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.”
What experts say
“In spite of the uncommon risk of TTS, Covishield, which was used to vaccinate 90% of India’s population, has done well in India,” a senior member of the Covid working group told ET, downplaying worries of unfavorable outcomes.
Dr Kameshwar Prasad, emeritus professor of neurology at AIIMS, has told TOI that TTS is rare, but if it happens, it is usually serious,
particularly when major vessels are involved in thrombosis. “We were members of a committee which developed a WHO guideline where the frequency of this condition has been estimated as less than 1 to 7 per lakh vaccines. Estimates of the risk of TTS following Covishield vaccination range from 1 case per 26,500 after the first doses of Covishield administered (reported in Norway) to 1 case per 261,000 doses of Janssen [vaccine] administered (reported in the US),” he said.
Dr Prasad said that TTS mostly occurs from day 3 to day 30 after the first dose of vaccine. “Beyond 30 days, there are very very few cases reported. If the first dose did not have this complication, it’s very unlikely that the second dose would cause TTS. In any case, after one month of vaccination, there is a negligible chance that TTS will develop, certainly after three months. Now that more than a year has passed since the last vaccine dose of Covid for most people from India, there is no need to worry about TTS,” he said. He advised people not to hesitate to take vaccines rolled out by the government. “It is done after it is certain that the benefits outweigh the risks. Risks may not be more than moving on a road,” he said.
The WHO has said that the recent epidemiological data suggests that the cumulative incidence of TTS is higher following the initial dose of the COVID-19 vaccine than subsequent doses.
Former Indian Council of Medical Research (ICMR) scientist R Ganga Ketkar, who was at the helm of affairs during the Covid pandemic, said symptoms of TTS – a serious adverse event that causes blood clots – can only occur within five to 30 days of receiving a Covid vaccine and not now. “The benefits of the vaccine outweigh the risks,” Ketkar has told ET. “People should not worry as the number of cases are pretty small and TTS develops within 5-30 days after receiving the vaccine and not now.” He said as the number of doses increases, the risk of TTS goes down.
A study conducted by physician-scientists from Assam Medical College Hospital (Dibrugarh), supported by ICMR-recognised multidisciplinary research laboratory, has revealed that 55% of Covishield vaccine recipients experienced only minor side effects like fever and headache. These symptoms occurred within a week of getting inoculated with the first dose. Researchers confirmed no long-term adverse effects after a year. “In our study, we found that 55% experienced minor adverse events such as fever, headache, body ache and pain at the injection site. The remaining 45% of the recipients had no adverse events at all. After the second dose, only 6.8% showed minor adverse events following immunisation (AEFI). Most importantly, no participant showed any major adverse events during the entire one year period of study,” associate professor of pathology at AMCH, Gayatri Gogoi, the principal investigator of the study done in Assam’s Dibrugarh district, has told TOI.
The study was conducted from July 2021 when the first Covishield vaccine for the public was introduced and participants were followed up till June 2022 after receiving the approval of the Institutional Ethics Committee to conduct the same. This data of research findings was recently accepted for publication in a well-known PubMed indexed journal named Journal of Family Medicine and Primary Care.
Besides experts, the government too has downplayed the frequency of the risks associated with the vaccine. Union Health Minister Mansukh Mandaviya said in March that ICMR has done a detailed study which shows that COVID-19 vaccine is not responsible for heart attacks, and an individual’s lifestyle and factors such as binge drinking could be among underlying causes. “If someone has a stroke today, they think it is because of the Covid vaccine. ICMR has done a detailed study that the (Covid) vaccine is not responsible for heart attacks.”
Amid the controversy over the side effects of the AstraZeneca vaccine, Bharat Biotech has asserted that its Covid-19 vaccine, Covaxin, is safe and devoid of any side-effects The company stated that Covaxin was developed with a single-minded focus on safety first, followed by efficacy. Covaxin is India’s first indigenous Covid vaccine.
India’s vaccine politics
Political parties have questioned the government about the health concerns related to the vaccine. “The opposition Congress on Wednesday alleged that the BJP government at the centre did not follow the guidelines of the World Health Organisation (WHO), and demanded that the relatives of those who died due to heart attack or similar reasons after taking the Covishield vaccine against coronavirus should be paid compensation. Doctors associated with the Gujarat BJP, however, said a study by an expert panel in the state had established that there was no direct link between COVID-19 vaccines and blood clotting which can lead to heart attacks,” PTI reported.
Samajwadi Party president Akhilesh Yadav Friday said the lives of the people of the country have been put in danger by the Covid vaccine and demanded that the heart-related tests like ECG should be made free for those who have taken the vaccine.
Months before the AstraZeneca controversy, Union minister Rajeev Chandrasekhar hit out at senior Congress functionaries, claiming that they kept pushing the case for foreign vaccines in India during the pandemic. His statement came days after Pfizer CEO Albert Bourla faced questions over the efficacy of the company’s vaccines.
The minister claimed that Pfizer tried to bully India into accepting conditions of indemnity. “Just to remind all Indians that Pfizer tried to bully the Govt of India into accepting conditions of indemnity. And Cong trio of Rahul, Chidambaram n Jairam Ramesh kept pushing foreign vaccines during Covid,” he tweeted. According to the indemnity clause, the company could not be held responsible or prosecuted under Indian law in case of any severe side-effect or even death on taking their vaccine.
The Pfizer vaccine is not available in the country. India ran its massive vaccination campaign against Covid-19 with two key vaccines — Covishield and Covaxin. Covishield is manufactured by the Serum Institute of India while Covaxin is manufactured by Bharat Biotech.
(With inputs from TOI and PTI)
