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India experts 'looking into' adverse events

Denmark, Norway and Iceland put Astra Covid vaccine on hold

National expert panel in India has begun an exercise to 'take a closer look' at the incidence of hospitalisations or deaths after vaccination with Covishield

G.S. Mudur, Reuters New Delhi Published 12.03.21, 02:25 AM
AstraZeneca told Reuters in a written statement the safety of its vaccine had been extensively studied in human trials and that peer-reviewed data had confirmed it was generally well tolerated.

AstraZeneca told Reuters in a written statement the safety of its vaccine had been extensively studied in human trials and that peer-reviewed data had confirmed it was generally well tolerated.

Denmark, Norway and Iceland on Thursday suspended the use of AstraZeneca’s Covid-19 vaccine shots following reports of the formation of blood clots in some people who had been vaccinated.

A national expert panel in India has begun an exercise to “take a closer look” at the incidence of hospitalisations or deaths after vaccination with Covishield, the AstraZeneca vaccine made in India by the Serum Institute, an advisor to the panel told The Telegraph on Thursday night.

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India has not suspended the use of the vaccine.

“We’re aware of the temporary suspension by some countries. We’ve initiated an exercise to examine the incidence of hospitalisations or deaths, if any, involving thrombo-embolic (clotting-related) events,” said Narendra Arora, advisor to the national panel on adverse events following immunisation (AEFI).

The European medicine regulator EMA said the vaccine’s benefits outweighed its risks and could continue to be administered.

Denmark suspended the shots for two weeks after a 60-year-old woman, who was given an AstraZeneca shot from the same batch used in Austria, formed a blood clot and died, Danish health authorities said.

Their response was also prompted by reports “of possible serious side effects” from other European countries.

“It is currently not possible to conclude whether there is a link. We are acting early, it needs to be thoroughly investigated,” health minister Magnus Heunicke said on Twitter.
The vaccine will be suspended for 14 days in Denmark.

“This is a cautionary decision,” Geir Bukholm, director of infection prevention and control at the Norwegian Institute of Public Health (FHI), told a news conference. The FHI did not say how long the suspension would last.

“We... await information to see if there is a link between the vaccination and this case with a blood clot,” Bukholm said.

Iceland on Thursday suspended jabs with the vaccine as it awaited the results of an investigation by the EMA. Italy said on Thursday it would suspend the use of an AstraZeneca batch. Austria had earlier stopped using a batch of AstraZeneca shots.

Some health experts said there was little evidence to suggest the AstraZeneca vaccine should not be administered and that the cases of blood clots corresponded with the rate of such cases in the general population.

AstraZeneca told Reuters in a written statement the safety of its vaccine had been extensively studied in human trials and that peer-reviewed data had confirmed it was generally well tolerated.

In New Delhi, Arora, the national expert panel member, said the Indian exercise would seek to determine whether there had been any spike in thrombo-embolic events among vaccinated people compared with the natural background rate of such events expected in the same age band as those vaccinated.

For instance, if the natural background rates for thrombo-embolic events among people aged 60 to 70 is 4 and the panel finds 3 such events occurred among those within that age band who received vaccinations, these would be considered natural.

But suppose the panel detects 6 or 7 events, it could demand further investigations.

More than 18 million people in India have received Covishield among the 26 million vaccinated across the country so far. The Union health ministry has said that none of the deaths probed so far has been linked causally to the vaccines.

Covaxin

The Centre has said Bharat Biotech’s indigenously developed Covaxin is out of the “clinical trial mode” and has been granted the regular restricted emergency use authorisation just like Covishield, adds PTI.

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