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Pfizer Seeks Emergency Use Authorisation For Its COVID-19 Vaccine In India

Five vaccines are in advanced phases of clinical trials in India with the Serum Institute of India conducting phase-3 trial of the Oxford-Astrazeneca COVID-19 vaccine and Bharat Biotech in collaboration with ICMR is conducting the phase-3 clinical trial of vaccine

Pfizer Seeks Emergency Use Authorisation For Its COVID-19 Vaccine In India
Highlights
  • We will supply the vaccine only through government contracts: Pfizer
  • Pfizer vaccine is required to be stored at minus 70 degrees Celsius
  • UK became the first country to approve the Pfizer vaccine against COVID-19

New Delhi: Pfizer India has become the first pharmaceutical firm to seek from the Drugs Controller General of India (DCGI) an emergency use authorisation for its COVID-19 vaccine in the country, after its parent company secured such clearance in the UK and Bahrain. The firm, in its application submitted to the drug regulator, 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, official sources said.

Also Read: Department Of Biotechnology’s Expert Committee Tracking Developments Related To COVID-19 Vaccine: Official

Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorization (EUA) for its COVID-19 vaccine in India. 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 said.

The UK on Wednesday (December 2) became the first country to approve the Pfizer/BioNTech vaccine against COVID-19, 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.

Also Read:  No Vaccine Can Give 100 Per Cent Immunity From Any Disease, Say Experts Treating COVID-19 Patients

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 its smaller towns and rural areas where maintaining such cold chain facilities would be very difficult, top government officials have said.

When contacted, Pfizer said it remains committed to engaging with the Government of India and 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 trial of the Oxford-Astrazeneca COVID-19 vaccine, while the indigenously developed vaccine by Bharat Biotech in collaboration with ICMR has already started the phase-3 clinical trial.

Drug firm Zydus Cadila has received the approval from the DCGI to start the phase-3 clinical trials of the indigenously-developed anti-coronavirus vaccine. 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.

Also Read: WHO Chief Urges Global Leaders To Invest In COVID-19 Vaccines

(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)

NDTV – Dettol Banega Swasth India campaign is an extension of the five-year-old Banega Swachh India initiative helmed by Campaign Ambassador Amitabh Bachchan. It aims to spread awareness about critical health issues facing the country. In wake of the current COVID-19 pandemic, the need for WASH (WaterSanitation and Hygiene) is reaffirmed as handwashing is one of the ways to prevent Coronavirus infection and other diseases. The campaign highlights the importance of nutrition and healthcare for women and children to prevent maternal and child mortality, fight malnutrition, stunting, wasting, anaemia and disease prevention through vaccines. Importance of programmes like Public Distribution System (PDS), Mid-day Meal Scheme, POSHAN Abhiyan and the role of Aganwadis and ASHA workers are also covered. Only a Swachh or clean India where toilets are used and open defecation free (ODF) status achieved as part of the Swachh Bharat Abhiyan launched by Prime Minister Narendra Modi in 2014, can eradicate diseases like diahorrea and become a Swasth or healthy India. The campaign will continue to cover issues like air pollutionwaste managementplastic banmanual scavenging and sanitation workers and menstrual hygiene

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