Exclusive: Pfizer says will continue to engage with govt to make its COVID-19 vaccine available in India
In February, had the firm withdrawn an application for emergency-use authorisation of its vaccine in India, after failing to meet the drug regulator’s demand for a local safety and immunogenicity study. Now, as per a new rule, the company is eligible to directly seek EUA from the Drugs Controller General of India.
April 21, 2021 / 01:34 PM IST
Drug maker Pfizer on Wednesday said it would continue engagement with the Central government towards making the Pfizer-BioNTech vaccine part of the government’s immunisation programme in the country.
“As we have stated earlier, during this pandemic phase, Pfizer will prioritise supporting governments in their immunisation programmes and supply the COVID-19 vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorisation or approval,” the company told Moneycontrol.
Pfizer, in February, had withdrawn an application for emergency-use authorisation (EUA) of its COVID-19 vaccine in India, after failing to meet the drug regulator’s demand for a local safety and immunogenicity study.
But circumstances have changed now, with Pfizer becoming eligible to directly seek EUA from the Drugs Controller General of India (DCGI) to import its COVID-19 vaccine, as the government last week waived off the requirement of submitting local bridge trial data upfront for vaccines approved by the USFDA, European Medicines Agency (EMA), UK MHRA, PMDA Japan or those listed with the WHO under Emergency Use Listing. All these regulatory agencies have approved Pfizer vaccine.
Recently, Pfizer signed a deal with South Africa to supply Pfizer-BioNTech COVID-19 vaccine at $10 per dose.
Pfizer’s vaccine is based on genetic material or mRNA. The vaccine is safe with an efficacy of 95 percent after the second dose. The vaccine needs to be taken in two full doses, with a gap of 21 days and storage temperature of -70 degrees Centigrade.