US pharma major Pfizer said on Thursday that it had offered a not-for-profit price for its vaccine to the government and was in talks with the administration to deploy its jab for India's Covid-19 immunisation programme.
The Pfizer-BioNTech Covid-19 mRNA vaccine has been widely used in the United States and Europe for inoculating large populations and has a tested efficacy of around 95%.
It is a two-dose vaccine but the company said last week that people may need a third dose within 12 months of getting fully vaccinated, which may be the case with others too as scientists attempt to understand the duration of immunity.
"For India, Pfizer has offered a not-for-profit price for its vaccine for the government immunisation program. We continue to be in discussions with the government and remain committed to make our vaccine available for deployment in India's immunisation program," a statement by the company read.
The company said that it was interested in working exclusively with the government.
"During the current pandemic situation worldwide, Pfizer has maintained that its priority would be to exclusively support governments through supply of its vaccine only to governments for their immunisation programs. This would be our approach in India as well," the statement added.
On April 13, India announced that Covid-19 vaccines cleared for use in the US, the UK, the European Union, and Japan will get fast-track approval in India, and would not need prior bridging trial results to seek emergency use authorization (EUA). The trials can be done in parallel to administering the shots to the general population..
The move is expected to potentially boost India's pandemic response when it has recorded the world's worst surge in infections.
At present, there are vaccines by three companies that are approved by regulators identified by the government and are yet to be authorised in India: Pfizer-BioNTech, Moderna and Johnson&Johnson. A fourth vaccine, made by Novavax, has made progress in clinical trials and sought approval from several of these regulators.
Pfizer said it will continue talks with the Indian government on the matter.
"We have noted the recent announcement with regard to the regulatory pathway for global vaccines. We remain committed to continuing our engagement with the government towards making the Pfizer and BioNTech vaccine available for use in the government's immunisation program in the country."
The company also denied some reports citing a price for American vaccines in India. "In all our agreements Pfizer has adopted a distinct pricing structure for high, middle, and low/lower-middle-income countries consistent with our commitment to work towards equitable and affordable access for our Covid-19 vaccine for people around the world," the company said.
Despite being the first company to have applied for EUA of its Covid-19 vaccine on December 7, Pfizer withdrew its application on February after the national drugs controller did not approve its EUA application and sought additional data.
The decision was taken after the central drugs standard control organization (CDSCO) subject expert committee (SEC), on February 3, did not recommend granting approval for want of more data.
The company said Pfizer's priority had been to ensure rapid manufacturing and deployment of the Covid-19 vaccine to cater to the current emergency response scenario.
"We are also mindful of the unique mRNA technology that is being utilized in this vaccine. Given these considerations, Pfizer has created two dedicated supply lines with established vaccine capabilities – one each in US and Europe… This will continue to be the company's strategy for the time being. At this time we are not in discussions for any additional local manufacturing for this vaccine," the company said.
"Once the pandemic supply phase is over and we enter a phase of regular supplies, Pfizer will certainly evaluate all additional opportunities available. We remain committed to working towards equitable and affordable access for our Covid-19 vaccine for people around the world including in India, and we welcome opportunities to collaborate with the government to fight Covid-19," the statement further read.