Pfizer applies for emergency use authorisation in India for COVID-19 vaccine!
Galatta | Dec 06, 2020, 05:56 pm
After waiting for a very long time of seeing the bleak devastation being wreaked across the world by the COVID-19 Novel Corona Virus Pandemic, which has already claimed over 1.5 million lives across the world, people were given a big hope with the announcement that a couple of vaccine candidates were nearing the end stage. Pfizer and BioNTech jointly developed a vaccine candidate and it returned 95% efficacy in the Phase 3 trials, following which the company applied for and got Emergency Authorisation, from the United Kingdom government. Just earlier today, it was also announced that the vaccine was ready to rollout in Britain, from the coming week and that 800,000 doses would be distributed in the first week of immunisation.
Now, in what comes as great news for Indians, Pfizer has applied for Emergency Use authorisation of its COVID-19 vaccine, in India too. After Pfizer obtained the clearance for emergency use in the UK and Bahrain, Pfizer India has applied for the same, from the Drug Controller General of India, making it the first Indian pharmaceutical company to do so. The company has sought permission to import the vaccine and to sell and distribute it, across India. Pfizer India has also requested for the waiver of clinical trials on the Indian population, in accordance with the special provisions of the New Drugs and Clinical Trials Rules, 2019.
UK's regulator Medicines and Healthcare products Regulatory Agency (MHRA), granted temporary authorisation for the emergency use of Pfizer-BioNTech's COVID-19 vaccine, on Wednesday and Bahrain also granted EUA for this vaccine, last Friday. Pfizer has also applied for EUA, from USA too. However, the extreme storage requirements might make it difficult for the vaccine to be distributed across the smaller villages and towns of India, as it needs to be stored at -70 degree Celsius. Earlier, the Pharma giant Pfizer had stated that during the Pandemic phase, Pfizer will supply their vaccine only through government contracts, based on agreements with the respective government authorities and following regulatory approval! Stay tuned for updates...