With UK and Bahrain to be the first and the second country to approve Pfizer-BioNTechvaccine, developed against covid-19, India has also approved Pfizer India to roll out the vaccine in the country seeking emergency authorization use.
Pfizer is the parent company of Pfizer India and Pfizer India is now the first Pharmaceutical firm who is approved by the Drug Controller General of India, DCGI, for the covid-19 vaccine.
The application regarding the Emergency Use Authorisation, EUA, for the vaccine in India, Pfizer India submitted their application to DCGI on 4th September in the Form CC-18, for import and market in India.
While MHRA has granted temporary authorization of the vaccine in the UK, which was announced on 2nd December 2020, Bahrain also granted permission for the Pfizer-BioNTech vaccine.
When Vaccination Will Start In India?
India’s death toll mounted to 482 new deaths with 4,03,248 active covid-19 cases and 91,00,792 recovered cases.
Prime Minister, Mr. Narendra Modi, during the recent “all-party meeting”, announced that the covid-19 vaccines will soon roll out in next few weeks.
As soon as the government receives a green signal from the scientists, the vaccination process will start in India.
The permission to import the vaccine in the country for sales and distribution was granted to the company without any requirement of clinical trials on Indian locals.
What Is The Pfizer’s Aim?
The company and its scientists are committed towards providing the vaccine to All the Nations and eradicate the pandemic causing infection.
The company has insured that the vaccine will only be supplied on the basis of the agreement through government contracts.
Approval, authorization, and regulation permission from government authorities has also been taken care of.
What Are The Requirements For Storing The Vaccine?
The first hurdle that the government will have to jump over is that the vaccine can only be stored at an extremely low temperature that is at -70°C for storage.
Another challenge is the delivery of the vaccine in India where it will be difficult to maintain the cold chain facilities in rural and smaller towns or areas.
Aren’t there other vaccines available?
In India, five vaccines are under clinical trials in advance phases.
- The Serum Institute of India, in partnership with Oxford, is currently conducting a phase III clinical trial and is called the AstraZeneca COVID-19 vaccine.
- The vaccine developed by Bharat Biotech has also started their Phase II clinical trials which is in collaboration with ICMR.
- Sputnik V, covid-19 vaccine, is in the adaptive Phase II and III clinical trials which is developed by Dr. Reddy’s Laboratories and the Russian Direct Investment Fund, RDIF.
- Zydus Cadila, a drug firm, has also received approval from DCGI for the Phase III clinical trials.
- Phase I and II, early human trials, have also started by Biological E. Ltd, on candidates.