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Sunday, April 11, 2021

Explained: The controversy around Oxford-AstraZeneca’s vaccine for Covid-19

The vaccine, which is being produced and distributed in India as Covishield by Serum Institute of India (SII), is also expected to undergo a review by the nodal adverse event following immunisation body this week.

By: Explained Desk | New Delhi |
Updated: March 17, 2021 10:56:30 am
A doctor prepares the AstraZeneca vaccine at a Pharmacy in Edgeware, London, Tuesday, March 16, 2021, as Britain continues use of the vaccine. (AP Photo/Frank Augstein)

Amid rising concerns over its safety and efficacy, two more European countries Tuesday suspended the use of Oxford-AstraZeneca’s Covid-19 vaccine in a further blow to the European Union’s vaccination drive. This comes even as the EU’s health authority said the benefits of the vaccine outweigh the risks.

Sweden and Latvia joined the list of other European nations that have halted the use of the British drugmaker’s Covid-19 vaccine after reports that some people who got a dose developed blood clots.

The vaccine, which is being produced and distributed in India as Covishield by Serum Institute of India (SII), is also expected to undergo a review by the nodal adverse event following immunisation body this week.

The AstraZeneca vaccine is one of four vaccines authorised for use in the European Union. According to the World Health Organisation, the vaccine, which is developed in partnership with Oxford University, against Covid-19 has an efficacy of 63.09 per cent against symptomatic Covid-19 patients. Longer dose intervals within the 8 to 12 weeks range are associated with greater vaccine efficacy, the health agency states.

This vaccine has undergone review by the European Medicines Agency (EMA) and consequently meets WHO’s criteria for Strategic Advisory Group of Experts on Immunization (SAGE) consideration.

“The EMA has thoroughly assessed the data on the quality, safety and efficacy of the vaccine and has recommended granting a conditional marketing authorisation for people aged 18 and above,” the WHO website states.

Which countries have suspended the use of AstraZeneca?

Denmark was the first country to halt its use last week after reports of blood clots in some people, including one person who developed multiple clots and died 10 days after receiving the dose.

Even as the authorities noted that it cannot be concluded whether there is a link between the vaccine and the blood clots, they said the suspension could last for at least two weeks while the cases were investigated.

Norway, Iceland, Bulgaria, Ireland, France, Italy, Spain and the Netherlands followed suit. Countries outside Europe such as Thailand and Congo also halted the rollout of AstraZeneca’s vaccine.

AstraZeneca covid 19 vaccine, france A man leaves a vaccination center while a poster reads “No vaccination with AstraZeneca vaccine today” in Saint-Jean-de-Luz, southwestern France, Tuesday, March 16, 2021. France is among the European countries which has halted the use of AstraZeneca vaccine. (AP Photo/Bob Edme)

However, Thailand’s health authorities have decided to go ahead with the vaccine, with Prime Minister Prayuth Chan-ocha and members of his Cabinet receiving the first shots on Tuesday.

On Tuesday, Sweden, Latvia and Germany joined the list, saying that they are halting the use of the vaccine until the EMA decides on its status following a meeting this week.

Meanwhile, British Prime Minister Boris Johnson has defended the safety of the AstraZeneca coronavirus vaccine. “That vaccine is safe and works extremely well,” Johnson wrote in The Times newspaper. “It is being made in multiple places from India to the US, as well as Britain, and it is being used around the world,” he added.

Canadian Prime Minister Justin Trudeau also weighed in favour of the vaccine. “Our health experts … collect data continuously and they assure us that all the vaccines offered in Canada are safe and effective, including those from AstraZeneca,” Reuters quoted Trudeau as saying.

“We are obviously watching what is happening with a specific batch in Europe. We can reassure all Canadians that no AstraZeneca doses came from the same batch,” he added.

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What does WHO say?

The World Health Organisation has appealed to countries not to pause vaccination campaigns, emphasizing that even as the investigation is underway, systems meant to protect public health were working.

“This does not necessarily mean these events are linked to Covid-19 vaccination, but it’s routine practice to investigate them, and it shows that the surveillance system works and that effective controls are in place,” Reuters quoted WHO Director General Tedros Adhanom Ghebreyesus as saying.

European Medicines Agency, astraZeneca, covid 19 vaccine The exterior of the European Medicines Agency, EMA, is seen in Amsterdam, Netherlands, March 16, 2021. The EMA and the World Health Organization say the data available don’t suggest the vaccine caused the clots and that people should continue to be immunized. (AP Photo/Peter Dejong)

The WHO is also going to hold a meeting today to discuss the vaccine. However, the health agency has maintained that it was unlikely to change its recommendations for widespread use of the vaccine. “As of today, there is no evidence that the incidents are caused by the vaccine and it is important that vaccination campaigns continue so that we can save lives and stem severe disease from the virus,” WHO spokesman Christian Lindmeier said as quoted by Reuters.

Dr Soumya Swaminathan, WHO’s chief scientist, noted that around 300 mn doses of Covid-19 vaccines have been injected around the world, and there is no documented death linked to any one of them. The rates at which blood clots have occurred in people who received the AstraZeneca vaccine shot “are in fact less than what you would expect in the general population”, she said.

WHO Assistant Secretary-General Dr Mariângela Simao said the agency is working very closely with the EMA, and with national regulatory authorities in Europe and other regions, in assessing the adverse effects of the AstraZeneca vaccine and other vaccines, the United Nations said in a report.

While its investigation is ongoing, the EMA has maintained that the benefits of the AstraZeneca vaccine in preventing Covid-19 “outweigh the risks of side effects”.

What does AstraZeneca say?

AstraZeneca has said a review of safety data of 17 million people vaccinated with its Covid-19 vaccine has shown no evidence of an increased risk of blood clots.

“A careful review of all available safety data of more than 17 million people vaccinated in the European Union and UK with Covid-19 Vaccine AstraZeneca has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia, in any defined age group, gender, batch or in any particular country,” the company said.

The drugmaker said there have been only 37 reports of blood clots among the more than 17 million people who have received the vaccine across the EU and Britain, which may have been just a coincidence.

How is this going to affect India?

The Oxford-AstraZeneca vaccine, known as Covishield, is being produced and distributed in India as Covishield by Serum Institute of India (SII) — the world’s largest vaccine maker. The other vaccine in use as part of the ongoing immunisation programme is the indigenously made Covaxin by Bharat Biotech.

Amid rising concerns over the possible side-effects of the coronavirus vaccines, the National Adverse Event Following Immunisation (AEFI) committee is expected to review this week data related to side-effects of both Covishield and Covaxin to ensure they are not linked to blood clots.

A preliminary review conducted towards the end of last week prima facie reflected no cause for concern, according to the head of one of the Covid-19 task forces of the Indian Council of Medical Research (ICMR).

“It (the review and concern) is being seen irrespective of the vaccine, for both the vaccines, basically. It is not like it is being done solely for the AstraZeneca/Covishield vaccine. It is also being seen for Covaxin,” Dr N K Arora, executive director for the INCLEN Trust and head of the operations research group in ICMR’s National Task Force for Covid-19, told The Indian Express.

This is because “these are features of Covid-19 disease,” Dr Arora said.

As part of the review, India is expected to look at all adverse events, including serious ones like deaths and hospitalisations following vaccination, for instances of blood clotting, as per a report by AFP on March 13.

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