Oxford, Bharat Biotech's vaccines approved for emergency use; PM hails it as ‘Made in India’ moment

Oxford, Bharat Biotech's vaccines approved for emergency use; PM hails it as ‘Made in India’ moment

Redemption lies for the suffering millions in two vaccines that have been cleared by the drugs regulator for restricted emergency use in the country.

FPJ News ServiceUpdated: Sunday, January 03, 2021, 10:54 PM IST
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Your eternal wait for the prick of a needle is over – a prick that may add years to your life and, more important, change your outlook towards it.

Redemption lies for the suffering millions in two vaccines that have been cleared by the drugs regulator for restricted emergency use in the country.

While UK-based Oxford Institute's Covishield has been developed by the Pune-based Serum Institute, Hyderabad-based Bharat Biotech's Covaxin is an outcome of collaboration with the Indian Council of Medical Research. To that extent, both vaccines are home-spun.

Made in India

Hailing it as a defining moment for the scientific community and frontline Corona warriors, PM Modi tweeted, "It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India! This shows the eagerness of our scientific community to fulfil the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion."

Though the decks have been cleared for a massive inoculation drive, there was no word yet on when the vaccination process will begin.

Allaying all doubts and misgivings that have been reinforced by a misinformation campaign, Drug Controller General of India VG Somani said: ‘‘The vaccines are 110 per cent safe. While Covishield was found to be 70.42 per cent effective, Bharat Biotech's Covaxin is safe and provides a robust immune response.

We'll never approve anything if there was slightest of concern about safety.’’

He, however, acknowledged that some side effects like mild fever, pain and allergy are common to every vaccine.

Both vaccines have to be administered in two doses and stored at temperatures between 2 and 8 degrees Celsius, which makes them ideal for Indian conditions.

Bharat Biotech's Covaxin is still conducting phase three human trials and 22,500 of the 25,800 volunteers have been vaccinated. Its clearance was fast-tracked for "restricted use in emergency situation in public interest". The idea was to have "more options for vaccinations, especially in case of infection by mutant strains," the ministry said, adding that the clinical trials will continue. The latter is

essentially supposed to serve as a back-up vaccine.

Pune-based Serum, which has developed the Oxford vaccine, was granted permission to conduct Phase-2/3 clinical trials on 1,600 participants within the country. The firm had submitted to the expert committee interim safety and immunogenicity data generated from this trial and it was found comparable with the data from the overseas clinical studies.

Taking to Twitter, Serum Institute’s Chief Executive Officer Adar Poonawalla said, "Happy new year, everyone! All the risks @SerumInstIndia took with stockpiling the vaccine have finally paid off. COVISHIELD, India's first COVID-19 vaccine is approved, safe, effective, and ready to roll-out in the coming weeks."

Health Minister Harsh Vardhan termed it as a "watershed moment in India's battle against Covid-19". The World Health Organisation also welcomed the move, saying it will "help intensify and strengthen the fight against the pandemic in the region".

Pfizer had also applied for regulatory approval for its vaccine on December 4 but not much progress has been made after that.

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