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New Delhi: Cyrus Poonawalla, chairman of Serum Institute of India (SII), on Friday expressed apprehension about mixing the covid-19 vaccines, Covishield and Covaxin, saying the efficacy of this approach is still to be proven.

Poonawalla’s comment comes at a time the country’s drug regulator has approved a clinical trial on mixing and matching the two vaccines. “I am against the mixing of two different vaccines. There is no need to mix two different vaccines," he said. Poonawalla was speaking to reporters at an event in Pune organized by the Lokmanya Tilak Smarak Trust.

“If cocktail vaccines are administered and if the result is not good, then SII may say that another vaccine was not good; vice versa, the other company might say that since you mixed Serum’s vaccine, it did not give desired results," Poonawalla said.

Later in the day, he said in a statement to Mint that “for those who have been administered the first dose of a particular vaccine and in case of the unavailability of the second dose of the same, as an alternative, another vaccine can be administered."

That said, the efficacy and the immunogenicity of the combination are dependent on ongoing studies conducted by regulators," Poonawala said.

The Indian Council of Medical Research (ICMR) last week, citing its preprint research, said immunization with a combination of a dose of Covishield followed by the dose of Covaxin is not only safe but also elicits better immunogenicity.

India’s inoculation programme began with the two vaccines on 16 January. Covishield is the in-country version of the Oxford-AstraZeneca vaccine made by Serum Institute. Covaxin is an inactivated whole virus vaccine (BBV152) developed jointly by ICMR-National Institute of Virology (ICMR-NIV) and Bharat Biotech International Ltd.

A group of 18 people in Uttar Pradesh had received Covishield as the first dose, followed by an inadvertent administration of Covaxin as the second dose at an interval of six weeks.

Following this, ICMR conducted a study on the mixing and matching of both vaccines. The apex biomedical research organization maintained that the findings suggest immunization with a mix of an adenovirus vector platform-based vaccine followed by an inactivated whole virus vaccine was not only safe but also elicited better immunogenicity.

Meanwhile, the Central Drugs Standard Control Organisation (CDSCO) has approved a study to be conducted by Christian Medical College (CMC), Vellore, on mixing of Covaxin and Covishield, a government officials said on Wednesday. An expert panel of the drug regulator on 29 July recommended granting permission for conducting the study. The trial will involve 300 healthy volunteers.

At a time clinical trials are being done globally on mixing and matching of covid-19 vaccines, a World Health Organization (WHO) expert panel this week also warned that such studies need cautious interpretation.

“While these studies are encouraging, they require cautious interpretation, given the limited sample sizes and lack of follow up, especially related to safety data, and the uncertain relevance of immunological readouts in relation to clinical impact," the WHO panel said in its interim statement.

During the media interaction, Poonawalla also spoke about Covovax, another covid-19 vaccine being manufactured by SII in India. He said some issues between the US Food and Drug Administration (USFDA) and Novavax are preventing the launch of Covovax in India by October, as planned.

“We can’t launch Novavax’s vaccine unless we get a licence to launch it. The American parent company has some issues with the USFDA that should be cleared by the end of October. We will get the licence only when the company gets one from the FDA. We are trying to obtain the licence ahead of the parent company, but it’s an uphill task," Poonawalla said.

Adar Poonawalla, SII CEO and Cyrus Poonawalla’s son, had earlier said that he is hopeful that Covovax will be launched in October for adults and for children by the first quarter of 2022.

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