After admitting side effect, AstraZeneca withdraws COVID vaccine: What’s going on?

After admitting side effect, AstraZeneca withdraws COVID vaccine: What’s going on?

FP Explainers May 8, 2024, 12:11:15 IST

After admitting that its vaccine causes a rare side effect, AstraZeneca is withdrawing the jab across the world. The UK-headquartered company has said that its decision was for ‘commercial reasons’, as other alternatives have superseded its COVID-19 shot. Is there more to it?

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After admitting side effect, AstraZeneca withdraws COVID vaccine: What’s going on?
A woman receives an AstraZeneca vaccine against in Huelva, Spain in March 2021. The pharma company has now announced that it is withdrawing its vaccine worldwide. File photo/Reuters

How safe is the AstraZeneca COVID-19 vaccine? It is a question that is being asked too often these days. Now the vaccine has been withdrawn worldwide.

The move comes weeks after the UK-headquartered pharmaceutical giant admitted that Oxford-AstraZeneca’s novel coronavirus shot caused a rare side effect, triggering panic. Jointly developed by the firm and Oxford University, the vaccine is manufactured by the Serum Institute of India (SII) and sold as Covishield.

So what’s going on? We explain.

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Why has AstraZeneca withdrawn its vaccine?

AstraZeneca has said that its vaccine has been removed from the markets for commercial reasons, according to a report in The Telegraph. The vaccine will no longer be manufactured or supplied as there are newer vaccines that have been adapted to target newer variants of COVID-19.

The pharma company will withdraw marketing authorisations in the UK and other countries where it has regulatory approval, reports The Telegraph. It would first proceed to withdraw the vaccine, also sold as Vaxzevria, within Europe.

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

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

A medical worker holds a vial of AstraZeneca COVID-19 vaccine at a vaccination centre in Ronquieres, Belgium. The company has said it is withdrawing the jab for commercial reasons. File photo/Reuters

“The authorisation of the anti-Covid vaccine Vaxzevria by AstraZeneca will be withdrawn and the process has already officially started with the European Commission. This is in line with the expectations that no-longer-used and updated vaccines will be withdrawn, as per our indication,” Marco Cavaleri, head of vaccines at the European Medicines Agency, the body which is responsible for drug and medicine safety within the EU was quoted as saying by The Telegraph.

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According to Cavaleri, all “monovalent vaccines”, which dealt with the original COVID-19 strain – the Wuhan virus – are expected to be withdrawn in time.

Also read: AstraZeneca vaccine’s side effects. Why Covishield takers shouldn’t worry

Which countries used the AstraZeneca vaccine?

The AstraZeneca vaccine was authorised for use for those aged 18 and above. Two jabs of the vaccine were given at least three months apart. The vaccine was distributed to at least 70 countries.

“According to independent estimates, over 6.5 million lives were saved in the first year of use alone and over 3bn doses were supplied globally,” the statement by AstraZeneca said.

The vaccine was used in the UK. However, the government to a large extent stopped giving the shots by September 2021. Until then, 50 million doses were delivered in the UK.

The country replaced it with Pfizer and Moderna jabs for the booster campaign, which started at the end of 2021.

In high-income countries, the use of the vaccine became limited. It was perceived that mRNA vaccines like those manufactured by Pfizer and Moderna were more effective than AstraZeneca. The vaccine’s reputation was questioned after some people who took it developed blood clots, according to a report in The Conversation.

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Also read: AstraZeneca's COVID vaccine windfall: What's behind quiet departure to other profit zones?

In March 2021, Canada suspended AstraZeneca for those under 55 after recommendations from its immunisation advisory panel which cited concerns over blood clots. In April 2021, Denmark became the first European country to stop using the vaccine. Norway followed in its footsteps.

In Australia, it was not available for use since March 2023. The country started phasing out its use from June 2021 because of the availability of other vaccines, reports The Guardian.

A woman receives a dose of AstraZeneca’s Covishield vaccine, produced by the Serum Institute of India, during a vaccination campaign at a medical centre in Mumbai, in September 2021. File photo/Reuters

In India, Covishied was widely used during the pandemic and reportedly 1.75 billion (175 crore) doses were delivered. The Serum Institute of India stopped manufacturing the vaccine in December 2021. In April last year, it started remaking the doses as COVID-19 cases rose in the country.

SII CEO Adar Poonawala said in April last year that the vaccine manufacturer would make six to seven million doses available in 90 days. “Just as a precaution, at risk we have done it so that people have Covishield as a choice if they want it,” he was quoted as saying by news agency PTI.

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In February 2021, South Africa suspended its AstraZeneca inoculation programme over concerns the shot did not work nearly as well against the new variant of the coronavirus.

However, the vaccine was used widely in other developing countries. By March 2022, of the jabs administered in Ghana, 57 per cent were those developed by AstraZeneca.

How safe is the AstraZeneca vaccine?

AstraZeneca recently admitted in court documents that the vaccine causes side effects such as blood clots and low blood platelet counts.

A report in The Telegraph on 28 April spoke about a class action suit brought against the company. “AstraZeneca has admitted for the first time in court documents that its Covid vaccine can cause a rare side effect,” it said.

The side effect was identified as a condition called Thrombosis with Thrombocytopenia Syndrome (TTS), which translates to blood clots and low levels of platelets, a type of blood cell that prevents bleeding.

TTS has been linked to at least 81 deaths in the UK and hundreds of serious injuries. Fifty-one cases have reportedly been filed so far in the UK with victims and grieving relatives seeking damages estimated to be worth up to £100 million, reports The Telegraph.

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A healthcare worker prepares to administer a dose of Covishield, in Santiago, Dominican Republic. AstraZeneca admitted that its vaccine causes a rare side effect. File photo/Reuters

In India, parents of a young woman who died allegedly after receiving Covishied are planning to sue SII and AstraZeneca. Venugopalan Govindan lost his 20-year-old daughter Karunya in 2021. He said that AstraZeneca’s admission about the side effect was “too late” and came after “so many lives have been lost”.

In an online post, he said the Serum Institute should have stopped the vaccine supply after the 15 European countries had restricted its usage over deaths from blood clots.

However, experts emphasise that the side effect is rare. According to Dr Raman Gangakhedka, a former scientist of the Indian Council of Medical Research (ICMR), a very small number of people may face the risk of Covishield. “Only seven to eight individuals out of 10 lakh who receive the Covishield vaccine face the risk of experiencing” the rare side effect Gangakhedkar told News18.

“The risk is highest when you get the first dose. It lowers with the second dose and is lowest with the third," he said.

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Has AstraZeneca withdrawn its vaccine because of the side effects?

AstraZeneca has insisted the decision to withdraw the vaccine is not linked to the court case or its admission that it can cause TTS. It said the timing was pure coincidence, reports The Telegraph.

A worker leaves the AstraZeneca research facility in Loughborough. The company has begun the worldwide withdrawal of its Covid-19 vaccine. File photo/Reuters

“As multiple, variant Covid-19 vaccines have since been developed, there is a surplus of available updated vaccines. This has led to a decline in demand for Vaxzevria, which is no longer being manufactured or supplied. AstraZeneca has therefore taken the decision to initiate withdrawal of the marketing authorisations for Vaxzevria within Europe,” the company said in a statement.

“We will now work with regulators and our partners to align on a clear path forward to conclude this chapter and significant contribution to the Covid-19 pandemic.”

With inputs from agencies

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