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Opinion

Pfizer Approval Based on Global Study May Affect Indian Vaccine Manufacturers: Kang

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Giving Pfizer approval based on its global data, without a bridge study in India, could put domestic vaccine developers and manufacturers at a disadvantage, said clinical scientist and vaccine expert Dr. Gagandeep Kang.

“So far, we have not licensed any vaccine without data from India. However, new clinical trial rules that went into effect last year allow licensing without such data, meaning that Pfizer could receive approval. This could put our manufacturers at a disadvantage, ”Dr. Kang said during a discussion on the race to develop a vaccine for coronavirus disease (Covid-19) at the India International Science Festival.

So far, three companies have requested an emergency use authorization from the Central Drug Standards Control Organization (CDSCO), the country’s main drug regulator.

This includes Pfizer, which has already received emergency approval in the United States and the United Kingdom. However, so far no bridging study has been done on the immune response of Indians. Only 4.3% of the participants in the global vaccine trial were Asian.

The other two companies that have applied for emergency use authorization are Serum Institute of India, which will manufacture 1 billion doses of the vaccine developed by the University of Oxford together with the pharmaceutical company AstraZeneca. A bridge study is underway to measure the immune response produced by Indians to the vaccine in 1,600 participants.

Others, like Russia’s Sputnik V, are also conducting a phase III trial in India.

“I think that the bridging studies that are being carried out should not be called Phase III, as they only look for an immune response in the participants. They are not looking to find the efficacy of the vaccine, “Kang said.

The safety of the vaccine is determined in a small phase I trial, the immune response generated is studied in a slightly larger phase II trial, and the protection provided by a vaccine in the field is measured in a phase III trial.

The third company to apply for the emergency license is Bharat Biotech, which is currently conducting a phase III trial with 26,000 people at 25 sites in the country. More than 13,000 participants have already been recruited. The candidate vaccine was developed by the Indian company in conjunction with the Indian Council for Medical Research.

“We will have real phase III data from Bharat Biotech and ZyCovD, which is about to start the phase III trial,” he said. She added,

Dr Sanjay Rai, head of the department of community medicine at All India Institute of Medical Sciences and one of Bharat Biotech’s Covaxin Principal Investigators, said that people who have already been exposed to natural infection should be excluded from the initial vaccination campaigns.

“We know that people who have had the infection are not susceptible to it for some time and therefore can be excluded from vaccination campaigns at this time. The limited number of vaccines can be given initially to the most vulnerable: those in high-risk groups who have not had the infection. Studies are being done to analyze how long this natural immunity lasts; If we find that it doesn’t last long, they can get the vaccine later, ”he said.

Regarding the new UK variant, Dr Priya Abraham, director of the National Institute of Virology in Pune, said: “Even in the UK strain, the RBD protein is 99% identical to the Wuhan strain, for so the vaccines are likely to be effective. ” said.

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