Global pharma major Pfizer on Thursday said it remains committed to engaging with the Indian government to explore opportunities to make Pfizer/BioNTech vaccine available in the country.
The U.K. on Wednesday became the first country to approve the Pfizer/BioNTech vaccine against COVID-19 with the UK regulator Medicines and Healthcare products Regulatory Agency (MHRA)granting a temporary authorisation for its emergency use.
“Right now we are in discussions with many governments around the world and remain committed to engaging with the Government of India and explore opportunities to make this vaccine available for use in the country,” a Pfizer spokesperson said in a statement.
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Pfizer is committed to ensuring everyone has the opportunity to have access to the vaccine, and is working closely with governments, it added.
“During this pandemic phase, Pfizer will supply this vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorisation or approval,” the statement said.
The U.K. regulator, MHRA has granted a temporary authorisation for emergency use of COVID-19 mRNA vaccine.
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This constitutes the first Emergency Use Authorisation following a worldwide phase 3 trial of a vaccine to help fight the pandemic, Pfizer said on Wednesday.
“As we anticipate further authorizations and approvals, we are focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world,” Pfizer Chairman and Chief Executive Officer Albert Bourla said on Wednesday.
In November, NITI Aayog member (Health) V.K. Paul, who also heads the National Task Force on COVID-19, had said the arrival of the Pfizer vaccine in the country might take some months.
“The arrangement of cold-chains for storing the vaccine developed by Pfizer at a low temperature of minus 70 degrees Celsius is a big challenge and it will not be easy for any nation. But then, if at all it has to be obtained, we are examining what we need to do...and will work out a strategy,” he had said.
Currently in India, Pune-based Serum Institute of India has said that it will apply for emergency use licensure for AstraZeneca-Oxford vaccine in two weeks.
Phase-3 clinical trial of the indigenously-developed vaccine candidate of Bharat Biotech and the Indian Council of Medical Research (ICMR) is also underway.
While vaccine candidate of Zydus Cadila has completed the phase-2 clinical trial , pharma major Dr. Reddy’s Laboratories has started the combined phase 2 and 3 clinical trials of the Russian COVID-19 vaccine, Sputnik V, in India.
Another domestic firm Biological E Ltd has also started early phase 1 and 2 human trials of its COVID-19 vaccine candidate.