Shots have shown 90% efficacy; vaccine supply only through Govt contracts
Pfizer Inc has become the first company to seek emergency use approval of its Covid-19 vaccine candidate in India after getting clearance in the UK and Bahrain.
The company said pricing of the vaccine will depend on the amount ordered and advance commitments with countries.
“Our 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,†the Pfizer told a news agency.
The shots have shown 90 per cent efficacy in trials. Pfizer has sought emergency use authorisation for its Covid-19 vaccine from the Drugs Controller General of India (DCGI).
“Pfizer will supply this vaccine only through Government contracts based on agreements with respective Government authorities and following regulatory authorisation or approval,†the company said.
Addressing concerns about distribution, the company also said it will utilise GPS-enabled sensors in every thermal shipper that will allow Pfizer to track the location and temperature of doses across their pre-set routes.
The main concern for developing countries like India has been the vaccine’s ultra cold storage requirements. Pfizer’s mRNA technology needs storage at -75 degrees Celsius (plus-minus 15 degrees) and this calls for storage and distribution infrastructure.
The company, however, said it has “experience of working with customers in all markets to help ensure successâ€. It also highlighted that “detailed logistical plans and tools to support effective vaccine transport, storage and temperature monitoring†has been developed.
The development is significant since Prime Minister Narendra Modi, during an all-party meet on Friday, cited experts to say that India could have the first coronavirus vaccine in weeks and that eight vaccines will be manufactured in India.
Pfizer, in its application submitted on December 4, has sought permission to import the vaccine for sale and distribution in India. It also sought the waiver of clinical trials on Indian population as per the special provisions under the New Drugs and Clinical Trials Rules, 2019, to get instant approval for emergency use, according to yet another report.
AIIMS Director Dr Randeep Guleria had earlier said that India was in talks with Pfizer-BioNTech regarding its Covid-19 vaccine candidate. He said no such communication had been initiated with Moderna for its experimental Covid-19 vaccine.
The UK has already approved Pfizer and BioNTech coronavirus candidate on December 2 after the Medicines and Healthcare Products Regulatory Agency (MHRA) found the shot safe. The country has already ordered 40 million doses of the Pfizer vaccine to vaccinate its 20 million population. After the UK, Bahrain has also approved the vaccine for ‘emergency use’. Bahrain’s drug regulatory body said the approval was granted after a thorough analysis and review of all available data.
