Pfizer’s BioNtech in final stages of approval in India


The US pharmaceutical major Pfizer is in the last phase of getting approval for its COVID-19 vaccine in India.

Albert Bourla, the company’s CEO said that he hopes very soon to “finalize an agreement with the government,” while speaking at the 15th Annual BioPharma & Healthcare Virtual Summit of USA India Chamber of Commerce.

Pfizer is holding talks with the Indian government for supplying its COVID-19 vaccine to the country. The company co-developed the two-shot COVID-19 vaccine, called BNT162b2, along with its German partner BioNTech.

Pfizer’s COVID-19 vaccine may be priced under $10 (around Rs 730) per dose in India, which would be the lowest price for the mRNA-based jab globally, and almost half of the rate in developed markets such as the UK, US and EU.

The vaccine costs $19.5 (Rs 1,423) per dose in US, and around $21 (Rs 1,532) per dose in UK. In the EU, the jab was priced at about $18.9 per dose earlier, but price negotiations are in progress for a higher rate of $23.2 (Rs 1,693) per dose.

“We need to get the approval of this vaccine in India. We are in a good way to get approval. Then we have to have a sign an agreement that will allow us to send doses,” Bourla said. Bourla said that Pfizer will be able to produce 3 billion vaccines by the end of 2021, and 4 billion vaccines in 2022.

The company has also asked for indemnification from the central government. Further, the company has sought certain relaxations in the regulatory regime, including relaxation in requirement of post-approval bridging trials and dispensing the requirement of testing the vaccines in Central Drugs Laboratory.