US-based vaccine major Pfizer’s India unit has approached the Drugs Controller General of India (DCGI) for emergency use authorisation (EUA) for its COVID-19 vaccine. Following the development, Pfizer India has become the first pharmaceutical firm in the country to seek EUA for its COVID-19 vaccine.
Notably, the company’s parent entity has already secured similar clearances in the UK and Bahrain.
The company has sought permission to import the vaccine for sale and distribution in the country, besides waiver of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019.
“Pfizer India submitted an application on December 4 to the DCGI seeking emergency use authorization (EUA) for its Covid-19 vaccine in India,” sources said.
“The firm has submitted the EUA application in Form CT-18 for grant of permission to import and market Pfizer-BioNTech’s Covid-19 mRNA vaccine BNT162b2 in the country,” a source added, citing the application.
UK, Bahrain granted EUA
The UK on Wednesday became the first country to approve the Pfizer/BioNTech Covid-19 vaccine, with the UK regulator Medicines and Healthcare products Regulatory Agency (MHRA) granting a temporary authorisation for its emergency use. The British regulator said the jab, which claims to offer up to 95 per cent protection against COVID-19, is safe for roll-out.
Bahrain on Friday also announced that it has granted an EUA for the two-dose vaccine made by Pfizer and its German partner BioNTech. The pharma company has already applied to the US FDA seeking EUA for the vaccine.
Ultra-cold temperatures required for vaccine storage
The extreme low temperature of minus 70 degrees Celsius required for storing the vaccine poses a big challenge for its delivery in a country like India, especially in smaller towns and rural areas where maintaining such cold chain facilities would be very difficult, top government officials said.
What Pfizer said?
When contacted, Pfizer said it remains committed to engaging with the Indian government to explore 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 respective government authorities and following regulatory authorisation or approval,” the global pharma major said in a statement.
Five vaccines are in advanced phases of clinical trials in India with the Serum Institute of India conducting phase-3 trials of the Oxford-Astrazeneca Covid-19 vaccine, while the indigenously developed vaccine by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) has also started the phase-3 clinical trial.
Drug firm Zydus Cadila has also received approval from the DCGI to start phase-3 clinical trials for its vaccine candidate.
Dr Reddy’s Laboratories and the Russian Direct Investment Fund (RDIF) have announced that they commenced adaptive phase 2 and 3 clinical trials for Covid-19 vaccine Sputnik V in India. Also, Biological E. Ltd has started early phase 1 and 2 human trials of its Covid-19 vaccine candidate.
96.44 lakh COVID-19 cases, 1.4 lakh deaths
The health ministry on Sunday informed that 36,011 fresh cases of COVID-19 have been reported in India in the past 24 hours. The addition of the fresh cases has taken the COVID-19 case tally to 96.44 lakh.
So far, the biggest single-day surge of 97,894 COVID-19 cases was reported in India on September 17. The second-highest surge of 97,570 COVID-19 cases was recorded on September 12. It is followed by 96,551 cases reported on September 11.
Notably, India has already surpassed Brazil in terms of cases. It is now the second-worst hit nation due to the coronavirus pandemic after the US.
Also, 482 COVID-19 related deaths were reported by the ministry during this period. The addition of the fresh fatalities has taken India’s death toll due to the deadly virus to 1,40,182.
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