India Opens Doors For Leading Global Vaccines, Green Flags Emergency Use: All You Need To Know

To tackle the massive surge in coronavirus cases in the country, the Health Ministry has now decided to expand the ongoing vaccination programme in the country.

In a massive push to India’s vaccination programme, following a comprehensive approach to tackle the COVID-19 pandemic, the Centre has given emergency use approval for COVID-19 vaccines which have been developed and are being manufactured in foreign countries and have been granted emergency approval for restricted use by USFDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO (Emergency Use Listing).

A release issued by the Press Information Bureau states that “the first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunization programmes within the country.”

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Which global COVID-19 vaccines can now be available in India?

Besides Covishield manufactured by Serum Institute of India and Covaxin manufactured by Bharat Biotech and Russian Sputnik V vaccine which has been granted DGCI approval for use in India, the following vaccines too may soon be available in the country.

Vaccines approved by US FDA

  • Pfizer-BioNtech
  • Janssen
  • Moderna

Vaccines approved by EMA 

  • Comirnaty
  • Moderna
  • Vaxzervia
  • Jansasen

Vaccines approved by UK MHRA

  • Pfizer-BioNTech
  • Moderna
  • Oxford/AstraZeneca

Vaccines approved by PMDA Japan

Comirnaty

Emergency Use Listing Vaccines approved by WHO

  • Pfizer
  • AstraZeneca/Oxford – manufactured by Serum Institute of India and SkBio
  • Janssen

The Centre said the vaccines would be “granted emergency use approval in India, mandating the requirement of post-approval parallel bridging clinical trial in place of conduct of local clinical trial as per the provisions prescribed under Second Schedule of the New Drugs & Clinical Trials Rules 2019.”

So far, India has approved two vaccines – Serum Institute of India’s Covishield and indigenously developed and manufactured Bharat Biotech’s Covaxin.

On Monday, the centre also gave the emergency use authorization approval to Sputnik V vaccine developed in Russia. Dr. Reddy’s Laboratories will be manufacturing it in in India.

Centre’s approval comes following the decision arrived at during the meeting of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) chaired by Dr. V K Paul, Member (Health), Niti Aayog, on April 11.

The decision comes at a time when the country is battling the second wave of the pandemic. India recorded a whopping tally of 1,61,736 COVID-19 cases in the last 24 hours. The total COVID-19 count in the country has shot up to 13,689,453 cases.

“This decision will facilitate quicker access to such foreign vaccines by India & would encourage imports including import of bulk drug material, optimal utilization of domestic fill and finish capacity etc., which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability for domestic,” the PIB release said.

India is now the 2nd worst-hit nation in terms of total COVID-19 cases and 3rd-worst-hit country in terms of active cases. On Tuesday, India also witnessed 880 fatalities due to covid-19 in a single day.

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