Pfizer, Serum Institute and Bharat Biotech apply for EUA in India: Here’s what might happen next | Latest News India - Hindustan Times
close_game
close_game

Pfizer, Serum Institute and Bharat Biotech apply for EUA in India: Here’s what might happen next

Hindustan Times, New Delhi | Byhindustantimes.com | Edited by Karan Manral
Dec 08, 2020 02:27 PM IST

America’s Pfizer was the first firm to apply for EUA in India. Serum Institute and Bharat Biotech, both Indian firms, followed next.

Hopes for an early vaccine for the coronavirus disease (Covid-19) in India have been rekindled after three firms, within days of each other, applied for emergency use authorisation (EUA) of their respective vaccine candidates in the country. While America’s Pfizer Inc was the first to apply on December 4, Pune-based Serum Institute of India (SII) and Hyderabad-based Bharat Biotech International Limited applied on December 6 and 7 respectively.

Vials labelled "COVID-19 Coronavirus Vaccine" are placed on dry ice in this illustration taken, December 4, 2020. REUTERS/Dado Ruvic/Illustration
Vials labelled "COVID-19 Coronavirus Vaccine" are placed on dry ice in this illustration taken, December 4, 2020. REUTERS/Dado Ruvic/Illustration

Click here for full Covid-19 coverage

Hindustan Times - your fastest source for breaking news! Read now.

While SII will manufacture in India the Oxford University-AstraZeneca vaccine candidate, Covishield, Bharat Biotech’s candidate, Covaxin, is the country’s first, and thus far only, indigenously developed vaccine candidate. According to reports, the EUA applications of all three companies will be reviewed on Wednesday.

Here’s what is likely to happen next:

1. The US Food and Drug Administration (FDA) describes EUA as “mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current Covid-19 pandemic.” For approval for full-time use, a company needs to submit, among other information, data on the vaccine candidate’s efficacy.

Also Read | Emergency use authorisation for Covid-19 vaccines explained

2. In India, the power to grant EUA lies with the Central Drugs Standard Control Organisation (CDSCO). However, there are no provisions for EUA under India’s drug regulations. In such a scenario, processes to obtain EUA here are not clearly defined. However, CDSCO had granted permission for the use of drugs like remdesivir and favipiravir in June, and itolizumab in July.

3. Since there are no fixed rules for granting EUA in India, the minimum efficacy that a candidate needs to have to be granted permission for use in emergency cases is not yet known. In FDA’s case, the agency says it would consider a EUA application only if the vaccine candidate has shown at least 50% efficacy in phase 3 trials. Additionally, the data should have been generated from more than 3,000 participants.

4. In terms of how long it might take for a vaccine candidate to be granted EUA in India, Dr VK Paul, NITI Aayog member, told NDTV it might take 90 days for an EUA application to be reviewed and permission to be granted. The Drugs Controller General of India (DCGI) is the department within CDSCO which grants such approvals.

5. Globally, Pfizer has filed for EUA in the United States and the application is likely to be reviewed this week. The United Kingdom on Tuesday initiated the use of Pfizer’s vaccine candidate in emergency cases. Bahrain, too, has granted EUA for the US firm’s vaccine.

Unveiling Elections 2024: The Big Picture', a fresh segment in HT's talk show 'The Interview with Kumkum Chadha', where leaders across the political spectrum discuss the upcoming general elections. Watch now!

Get Current Updates on India News, Election 2024, Mukhtar Ansari Death News Live, Bihar Board 10th Result 2024 Live along with Latest News and Top Headlines from India and around the world.
SHARE THIS ARTICLE ON
Share this article
SHARE
Story Saved
Live Score
OPEN APP
Saved Articles
Following
My Reads
Sign out
New Delhi 0C
Friday, March 29, 2024
Start 14 Days Free Trial Subscribe Now
Follow Us On