NEW DELHI: Pfizer is committed to engaging with the Indian government and explore opportunities to make its Covid-19 vaccine, developed jointly with Germany based BioNTech, available for use in the country, the company told The New Indian Express on Sunday.
The company has become the first firm to apply for the emergency use authorization to the Central Drugs Standards Control Organization, days after receiving the regulatory approval for the vaccine’s use in the UK.
It has also sought a waiver from carrying out clinical trials in India under the new clinical trial rules.
The results of a late phase trial of the vaccine in 6 countries on about 41,000 volunteers by the pharmaceutical major has shown 95% efficacy against the infectious disease.
The vaccine based on messenger RNA technology needs to be stored at -70 degree Celsius.
“Pfizer is dedicated to ensuring the availability of this vaccine for use by governments across the world. During this pandemic phase, Pfizer will supply this vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorization or approval,” the company told TNIE in response to queries.
“We remain committed to engaging with the Government of India and explore opportunities to make this vaccine available for use in the country.”
The firm also said that its vaccine approach is based on the principles of ensuring broad access and supplies to governments.
“This is reflected in all aspects of our agreements with various governments with the pricing strategy being an outcome of volume, advanced commitment, equity and affordability principles,” it added.
“We are in discussions with Gavi on behalf of the COVAX Facility to potentially provide doses to the Facility that will support the needs of beneficiary countries. It is our intention to achieve equitable global distribution of vaccine supply in alignment with identified priority populations.”
In India, officials while confirming that talks are on with Pfizer, have also said that owing to the ultracold chain supply the vaccine needs for storage and distribution, it may not be practical for the country to procure it.
The Centre, therefore, is inclined to depend mainly on Covid-19 vaccines developed or at least manufactured in the country such as the ones by AstraZeneca and Oxford University, to be produced by Serum Institute of India and others being indigenously developed.
The price of the vaccine, at $20 per dose, is also way too much for a resource-constrained country like India.
Officials sources in the Union ministry of health and family welfare, meanwhile, also said the company, during the negotiations with the government, has proposed three options for storage that include ultra-low temperature freezer, which are commercially available and can extend shelf life for up to six months.
The second option offered includes specially designed, temperature-controlled shippers in which doses will arrive and can be used for temporary storage units.
“They have also informed us the vaccine vials can be kept in refrigeration units at healthcare facilities for up to five days and can be tracked through thermal censors to ensure their location and temperature,” a ministry official said. “All these factors are being considered as of now.”