Pfizer discussing expedited approval pathway for vaccine with Indian govt, CEO

Pfizer is in discussions with the Indian government to come up with a pathway to secure an expedited approval for its covid-19 vaccines under revised regulations, the company’s chief executive officer Albert Bourla said on Monday.

“We are currently discussing with the Indian government an expedited approval pathway to make our Pfizer-BioNTech vaccine available for use in the country,” Bourla said.

Bourla’s comments come on the back of the Indian government last month allowing fast-track emergency authorisations for covid-19 vaccines that have already been authorized by one of four foreign drug regulators—US Food and Drug Administration, UK Medicines and Healthcare products Regulatory Agency, Japan’s Pharmaceuticals and Medical Devices Agency and European Medicines Agency—or the World Health Organization (WHO). This made vaccines by Pfizer, Moderna and Johnson & Johnson eligible under the process as each has an emergency authorisation.

However, even under the new norms, vaccines that are eligible for use in India will have to start a local bridging trial within 30 days of getting the authorisation. They will also have to conduct a safety review for the first week on 100 vaccinees before mass rollout.

Bourla’s comments were in the context of the massive surge in covid-19 cases in the second wave.

“We are committed to being a partner in India’s fight against this disease and are quickly working to mobilize the largest humanitarian effort in our company’s history,” Bourla said in a letter to the company’s employees in India, adding that the company is also immediately rushing in medicines worth $70 million from US, Europe and Asia which could benefit “hundreds of thousands of patients across India over the next 90 days”.

Pfizer was the first company to apply for an emergency authorisation for its vaccine in India. However, due to lack of adequate data on the local population, the subject expert committee of the Indian regulator asked the pharmaceutical giant to conduct a local bridging study to prove that the messenger RNA vaccine, the latest technology in vaccine technology, was similarly safe and effective in the Indian population as it was in the US, where majority of its global trial was conducted.

Apart from SEC’s directive, the company also faced significant headwind from the Indian government, with some officials saying that the issue of storing the vaccine at -70 degree Celsius was not feasible in India. Besides, the vaccine was priced at $19.5 ( ₹1440) per dose in the US, and while the company said that it would offer its vaccine at a lower price in India, negotiations with the government did not make much headway. Subsequently, Pfizer withdrew its application in early February.

After the change in regulations last month, Pfizer issued another statement expressing its interest in supplying to the government its mRNA vaccine.

In a statement on 23 April, Pfizer said that it has offered to supply its vaccine to the Indian government at a “not-for-profit” price as part of its strategy to provide distinct prices for the vaccine based on the economic profile of the country.

“For India, Pfizer has offered a not-for-profit price for its vaccine for the government immunization programme. We continue to be in discussions with the government and remain committed to making our vaccine available for deployment in India’s immunization programme,” a Pfizer spokesperson said in a statement on Thursday. Live Mint