AstraZeneca admits its Covid vaccine can cause blood clots in rare cases

AstraZeneca sells its vaccine in India under the brand name Covishield. It admitted that its vaccine may, in rare cases, lead to side effects including blood clots.

ByChetana Belagere

Published Apr 30, 2024 | 8:02 AMUpdatedApr 30, 2024 | 2:18 PM

covid-19 vaccine

AstraZeneca has admitted for the first time that its Covid-19 vaccine may cause a rare side effect.

The UK-based pharmaceutical firm AstraZeneca made the revelation in court documents, reported The Telegraph. It said its Covid-19 vaccine, in rare cases, led to Thrombocytopenia syndrome (TTS).

Oxford-AstraZeneca’s Covid-19 vaccine was globally sold under the brand names Covishield and Vaxzeria, among others. The company has been facing a lawsuit, alleging that its vaccine has caused serious injuries and deaths.

In India, 1,74,93,57,213 doses of Covishield had been administered. The symptoms of TTS occurred between four and 42 days after vaccination.

Also Read: Covid decreases lung function even months after infection

What is TTS?

Thrombosis with thrombocytopenia syndrome (TTS) is a rare health condition where two serious issues occur together: Blood clots form in the body, and there is a lower than normal number of platelets, the cells that help blood clot to stop bleeding, doctors said.

A blood clot in the blood vessel can cause thrombosis, which can reduce blood flow. Meanwhile, Thrombocytopenia occurs during low blood platelet count in the body.

It’s also called vaccine-induced immune thrombotic thrombocytopenia (VITT) when linked to vaccines.

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AstraZeneca’s version

The Telegraph reported that AstraZeneca made the admission in a legal document submitted to the high court in February.

The company reportedly stated that TTS could happen even if there was no vaccination, hence expert testimony would be required to determine the cause in each case, the report said citing the document.

AstraZeneca has been fighting a class action lawsuit that accused its Covid vaccine, developed with the University of Oxford, which has led to several deaths and serious injuries.

In 2023, Jamie Scott, a father of two, filed the first complaint against the firm. He reportedly mentioned that he developed “a blood clot and bleeding on his brain,” leaving him with a severe brain impairment.

Scott had then blamed his situation on AstraZeneca’s Covid-19 vaccine, which he received in April 2021. However, in May 2023, AstraZeneca had said, in response to Scott’s lawyers that “We do not accept that TTS is caused by the vaccine at a generic level.”

Meanwhile, Scott’s wife Kate told The Telegraph that the entire medical world had acknowledged that the vaccine caused VITT.

“It’s only AstraZeneca that has questioned whether Jamie’s condition was caused by the jab,” the UK newspaper reported.

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Compensation sought

It has been reported that so far 51 cases have been filed in the high court, seeking compensation for damages suffered.

Several countries suspended the Covid-19 vaccine after reports of TTR emerged.

In 2021, more than a dozen countries, mostly in Europe, suspended the use of AstraZeneca’s Covid-19 vaccine over fears that the shot might have caused blood clots in some recipients.

Sweden, Latvia, Germany, Italy, France, Spain, Denmark, Norway, the Netherlands, Portugal, Slovenia, Indonesia, Ireland, Bulgaria, and the  Democratic Republic of Congo, were among those countries that had suspended the UK firm’s vaccine.

Swedish Medical Products Agency reportedly recorded 10 cases of blood clots and one case of low platelet levels in those administered with the AstraZeneca’s vaccine.

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The Australian move

In 2023, the Australian government’s Department of Health and Aged Care in its clinical guidance for Covid-19 vaccine providers said that AstraZeneca’s Vaxzeria was causing TTS. The vaccine is not available in Australia since 21 March 2023.

The department specifically mentions the “rare but serious side effect”.

“There was a link between the AstraZeneca vaccine and a rare but serious side effect called thrombosis with thrombocytopenia syndrome (TTS),” it said in a set of guidelines issued.

Meanwhile, cases of TTS were rare. In Australia, the rate of AstraZeneca-related TTS was estimated to be about 2 to 3 per 1 lakh recipients aged below 60 and about 2 per one lakh above-60 people administered with the same vaccine.

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Symptoms seen in Australia

The Australian Health Department said the symptoms typically occurred between four and 42 days after the first dose was administered.

The Australian government, as per the advice and recommendations from the Australian TechnicalAdvisory Group or Immunisation (ATAGI), recommended an alternative to AstraZeneca for those aged under 60 years.

Symptoms of TTS included severe, persistent headache, blurred vision, confusion or seizure, weakness of face or limbs, shortness of breath or chest pain, severe abdominal pain, leg swelling, and unexpected pin-prick rash or easy bruising at the injection site.

“Patients were urged to seek urgent medical attention if they experienced any symptoms of TTS,” the Australian advisory said.

In India AstraZeneca’s vaccine was sold as Covishield, should we be worried?

AstraZeneca’s admission in court sparked an animated discussion in India, where 1,74,93,57,213 doses of Covishield were administered. The issue even started trending on X

Several netizens voiced their concerns on social media. “Big Pharma used millions of unsuspecting citizens as guinea pigs, in cahoots with Bill Gates and politicians,” Dr Aniruddha Malpani from Mumbai tweeted.

Also Read: Delhi study says no evidence of Covid vaccines increasing heart attack risk

Netizens concerned

Another X handle, Mahua Moitra Fans said: “In the last few days, we saw how companies are putting our life at risk for their business. Products of Patanjali are substandard with misleading claims, spices of MDH and Everest allegedly contain cancer-causing pesticides. Covishield may cause side effects including blood clots,”

The user stressed that the government regulators were responsible for constantly monitoring the product and its quality, “but in NEW India every check is bypassed if a company donates political funds via electoral bonds”.

More people aged between 25 and 45 suffered heart attacks since 2022. “Who is responsible for all these lives,” netizens questioned.

Can an increase in cardiac attacks be linked to this?

Several doctors took to X. Chairman of Cardiology Dr (Prof) Deepak Natarajan who has been practicing clinical medicine for 45 years said, “For four years, I have been harping on this along with other equally or even more dangerous side effects, such as myocarditis, autoimmune disease/cancer.”

Meanwhile, several people tagged Venugopalan Govindan, who has been waging a legal battle after losing his daughter post-vaccination.

He replied to one such post: “We will get justice, even if it takes time. Precious lives haven’t been wasted for nothing. Through their deaths, they will make this world a safer place and will spoil the evil forces’ plans to ruin the peaceful lives of millions.”

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Official data

According to Indian government data, 92,479 citizens had been hospitalised due to Adverse Event Following Immunisation (AEFI) in the country, which meant one out of 23,000 recipients.

Of these 261 were severe and only 2,539 cases were serious. The Indian Parliament was told in 2023 that 1,156 people had died in the country, with Kerala reporting the highest number of casualties.

Officials explained that the number of deaths was minuscule – one death per 2.3 lakh doses.

However, the Union health ministry then said that “mere reporting of deaths and hospitalisations as serious adverse events does not automatically imply that the events were caused due to the vaccine”.

“Only properly conducted investigations and causality assessments can help in understanding if any causal relationship exists between the event and the vaccine,” it said.

Malini Aisola, Co-convenor of All India Drug Action Network, said only a few individuals in India could move courts.

“There is no accountability in India,” she told South First.

“To date, there is no compensation mechanism for people who suffered serious adverse effects or death due to the vaccine. Despite repeated demands, the government had not put in place any mechanism, even though it knew that people would be affected given the scale of the vaccination and ruling several AEFI as related to the vaccine. They did not even issue a warning or ensure early clinical management,” Aisola said.

Also Read: 1,156 died in India after taking Covid vaccine, highest in Kerala, Parliament is told

Who is responsible?

Dr KR Antony, an independent monitor of the National Health Mission and former director of the State Health Resource Centre, felt AstraZeneca should not face any lawsuit seeking compensation.

“At last they have admitted. But they should not face any lawsuit for compensation. Because it was not a deliberate one to cause harm. They used the best technology available with them, then, to save humanity from the pandemic,” he opined.

However, he wanted to fix responsibility. People at the National AEFI committee who bluntly refused to accept that there was a problem should be investigated.

“They adamantly stuck to their pre-drawn conclusion that deaths, strokes, and heart attacks following Covishield vaccination were all coincidence,” he pointed out.

He even said that in many cases, proper postmortem examinations were not done.

Also Read: Covid-19 vaccines and sudden heart attacks: Why are experts divided over ICMR study?

ICMR under fire

Dr Antony criticised the Indian Council for Medical Research for going ahead with an “unscientific conclusion that unprecedented deaths among 15-45-year-olds were due to other factors, based on an ill-conceived methodology”.

He also criticised the government for sidelining science for the sake of political mileage. Public health experts had no say in pandemic control policies, he added.

Meanwhile, Dr B Ekbal, Chairperson of Kerala’s Vaccine Policy Committee, called the finding an ultra-rare possibility of blood clots.

Also Read: India says no legal compulsion to take Covid-19 doses

Benefits outweigh risks

“AstraZeneca, in the court, has acknowledged the ultra-rare possibility of blood clots. Regulatory bodies like India’s Drug Control General of India and the World Health Organisation still consider the benefits of Covishield to outweigh the risks for most people,” he said.

“I have seen the report and all drugs can cause rare side effects. Clots can develop as part of a post-Covid condition/syndrome also,   especially in the elderly with co-morbidity like diabetes or hypertension. Modern genome-based vaccines are safe,” he added.

Dr Chaitanya Goud, a physician in Hyderabad, earlier told South First that Covid-19 vaccines were safe and effective in preventing severe illness, hospitalisation, and death caused by the virus.

He said that in extremely rare cases, some people experienced severe reactions that could be life-threatening. However, the benefits outweighed the risks.

(Edited by Majnu Babu)