The firm, in its request submitted to the drug regulator, has requested permission to import the vaccine for sale and distribution in the country.
Pfizer India has become the first pharmaceutical company to apply to the Controller General of Drugs of India (DCGI) for an emergency use authorization for its COVID-19 vaccine in the country, after its parent company obtained such authorization in the United Kingdom and Bahrain.
The firm, in its request submitted to the drug regulator, has requested permission to import the vaccine for sale and distribution in the country, in addition to exemption from clinical trials in the Indian population in accordance with the special provisions of the New Drug Rules. and Clinical Trials. 2019, official sources said.
“Pfizer India submitted an application on December 4 to DCGI seeking emergency use authorization (USA) for its COVID-19 vaccine in India,” said a source.
“The company has submitted the US application on the CT-18 form for the granting of permission to import and commercialize the Pfizer-BioNTech BNT162b2 COVID-19 mRNA vaccine in the country,” the source said, citing the request.
The UK became the first country on Wednesday to approve the Pfizer / BioNTech vaccine against COVID-19, and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) granted a temporary authorization for its emergency use.
The British regulator said the jab, which claims to offer up to 95% protection against COVID-19, is safe for implementation.
Bahrain also announced on Friday that it has granted an EUA for the two-dose vaccine made by Pfizer and its German partner BioNTech. The pharmaceutical company has already applied to the US FDA to request the US for the vaccine.
Challenges ahead
The extremely low temperature of minus 70 degrees Celsius required to store the vaccine represents a great challenge for delivery in a country like India, especially in its smaller towns and rural areas where maintaining such cold chain facilities would be very difficult, according to have informed senior government officials. said.
When contacted, Pfizer said it remains committed to working with the Government of India and exploring opportunities to make this vaccine available for use in the country.
“During this pandemic phase, Pfizer will supply this vaccine only through government contracts based on agreements with the respective government authorities and after authorization or regulatory approval,” the world’s leading pharmaceutical company said in a statement.
Five vaccines are in advanced stages of clinical trials in India with the Serum Institute of India conducting the phase 3 trial of the Oxford-Astrazeneca COVID-19 vaccine, while the vaccine developed locally by Bharat Biotech in collaboration with ICMR the phase has already started. 3 clinical trial.
The pharmaceutical company Zydus Cadila has received approval from the DCGI to initiate phase 3 clinical trials of the indigenously developed coronavirus vaccine.
Dr Reddy’s Laboratories and the Russian Direct Investment Fund (RDIF) have announced that they have started phase 2 and 3 adaptive clinical trials for the COVID-19 Sputnik V vaccine in India. Additionally, Biological E. Ltd has started the first phases 1 and 2 of human trials of its COVID-19 vaccine candidate.
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