More Concern over AstraZeneca Vaccine: “It is Safe,” Says British PM

Manas Dasgupta

NEW DELHI, Mar 16: Amidst rising complaints of the United Kingdom-based AstraZeneca-developed vaccine causing blood clotting and more European countries blocking its use, the British prime minister Boris Johnson defended its safety and claimed that it worked “extremely well.”

“Covishield,” approved by the Drugs Controller General of India (DCGI) for emergency use is the Indian version of AstraZeneca vaccine and is one of the two vaccines being widely used in the country.

Germany, Italy and France on Monday joined others in suspending the vaccine, dealing a potential blow to the global immunisation campaign against a disease that has killed more than 2.6 million people.

After AstraZeneca repudiated the allegation of blood clotting from its vaccine last week, the World Health Organization and the European Medicines Agency had insisted that the shot was safe and that there was no link between it and reported blood clots.

However, after fresh controversy generated by Germany, Italy and France, the WHO chief said the agency’s vaccine safety experts would meet Tuesday to discuss the AstraZeneca jab after a number of countries halted its use over blood clot fears.

“WHO’s advisory committee on vaccine safety has been reviewing the available data, is in close contact with the European Medicines Agency, and will meet tomorrow,” Tedros Adhanom Ghebreyesus told a press briefing.

The European Medicines Agency said it would hold an “extraordinary meeting’ on Thursday on the AstraZeneca vaccine after key countries suspended its use over blood clot fears, adding that the benefits of using the jab still outweighed the risks.

The EMA said in a statement that it would “further review the information” on the jab Tuesday, and had “called an extraordinary meeting on Thursday…. to conclude on the information gathered and any further actions that may need to be taken,” media report said.

The British prime minister on Tuesday echoed assurances that the jab was not harmful. “That vaccine is safe and works extremely well,” Johnson said. “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.

Fears have grown in some countries over the safety of the AstraZeneca vaccine after several cases of blood clots or brain haemorrhages in people after receiving the inoculation, with a small number of deaths reported.

But AstraZeneca and medical experts in Britain have said there was no evidence of clots being caused by the jab or that they are occurring in greater numbers or frequency than in the general population.

The vaccine was developed by AstraZeneca and the University of Oxford in Britain, where more than 11 million doses have been administered, without any major problem.

Claiming that Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) which was “one of the toughest and most experienced regulators in the world,” did not see any reason to worry about the AstraZeneca vaccine. “They see no reason at all to discontinue the vaccination programme… for either of the vaccines that we’re currently using,” he said.

“We continue to be very confident about the programme and it’s great to see it being rolled out at such speed across the UK,” he said.

Amidst the concern the AstraZeneca vaccine was causing to some European and other countries, an Indian pharmaceutical company, the Hyderabad-based Gland Pharma has signed an agreement to supply 252 million doses of Sputnik V Covid-19 vaccine developed in Russia.

A company spokesman said on Tuesday that it had entered into an agreement with the Russian Direct Investment Fund (RDIF) to supply up to 252 million doses of Sputnik V Covid-19 vaccine. The company “will be leveraging its manufacturing capabilities for the production of Sputnik V Covid-19 vaccine,” Gland Pharma said in a regulatory filing.

The agreement will see the company utilising its Drug Substance and Drug Product facilities at its sites in Hyderabad. The production is expected to commence from the third quarter of 2021 for estimated delivery starting from the fourth quarter of 2021, it added.

“Under the terms of the agreement, Gland Pharma will first undertake technology transfer of the drug substance to its manufacturing facilities,” the filing said.

After successful technology transfer, the company will then undertake manufacturing of drug substance and drug product filling into vials under aseptic conditions, it added.