When contacted, Pfizer said it remains committed to engaging with the Government of India and explore opportunities to make this vaccine available for use in the country.(REUTERS)
When contacted, Pfizer said it remains committed to engaging with the Government of India and explore opportunities to make this vaccine available for use in the country.(REUTERS)

Pfizer seeks emergency use authorisation for Covid-19 vaccine in India

The firm, in its application submitted to the drug regulator, has sought permission to import the vaccine for sale and distribution in the country, besides waiver of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019, official sources said.
By Press Trust of India | Posted by Nilavro Ghosh | New Delhi
UPDATED ON DEC 06, 2020 05:09 AM IST

Pfizer India has become the first pharmaceutical firm to seek from the Drugs Controller General of India (DCGI) an emergency use authorisation for its Covid-19 vaccine in the country, after its parent company secured such clearance in the UK and Bahrain.

The firm, in its application submitted to the drug regulator, has sought permission to import the vaccine for sale and distribution in the country, besides waiver of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019, official sources said.

“Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorization (EUA) for its Covid-19 vaccine in India,” a source said.

“The firm has submitted the EUA application in Form CT-18 for grant of permission to import and market Pfizer-BioNTech’s Covid-19 mRNA vaccine BNT162b2 in the country,” the source said, citing the application.

The UK on Wednesday became the first country to approve the Pfizer/BioNTech vaccine against Covid-19, with the UK regulator Medicines and Healthcare products Regulatory Agency (MHRA) granting a temporary authorisation for its emergency use.

The British regulator said the jab, which claims to offer up to 95% protection against Covid-19, is safe for roll-out.

Bahrain on Friday also announced that it has granted an EUA for the two-dose vaccine made by Pfizer and its German partner BioNTech. The pharma company has already applied to the US FDA seeking EUA for the vaccine.

The extreme low temperature of minus 70 degrees Celsius required for storing the vaccine poses a big challenge for its delivery in a country like India, especially in its smaller towns and rural areas where maintaining such cold chain facilities would be very difficult, top government officials have said.

When contacted, Pfizer said it remains committed to engaging with the Government of India and explore opportunities to make this vaccine available for use in the country.

“During this pandemic phase, Pfizer will supply this vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorisation or approval,” the global pharma major said in a statement.

Five vaccines are in advanced phases of clinical trials in India with the Serum Institute of India conducting phase-3 trial of the Oxford-Astrazeneca Covid-19 vaccine, while the indigenously developed vaccine by Bharat Biotech in collaboration with ICMR has already started the phase-3 clinical trial.

Drug firm Zydus Cadila has received the approval from the DCGI to start the phase-3 clinical trials of the indigenously-developed anti-coronavirus vaccine.

Dr Reddy’s Laboratories and the Russian Direct Investment Fund (RDIF) have announced that they commenced adaptive phase 2 and 3 clinical trials for Covid-19 vaccine Sputnik V in India, Also, Biological E. Ltd has started early phase 1 and 2 human trials of its Covid-19 vaccine candidate.

SHARE THIS ARTICLE ON
Close
Representational image. (Getty Images/iStockphoto)
Representational image. (Getty Images/iStockphoto)

NIA arrests BSF officer for helping cross-border drug smugglers

By Neeraj Chauhan
PUBLISHED ON MAR 03, 2021 09:08 AM IST
Romesh Kumar is the second security person to be arrested in Jammu & Kashmir since January 2020 for allegedly helping terrorists
Close
Senior citizens at BKC in Mumbai waiting for vaccine registration on Tuesday. Photo by Pratik Chorge
Senior citizens at BKC in Mumbai waiting for vaccine registration on Tuesday. Photo by Pratik Chorge

More private hospitals to become vaccine sites, Centre allows states to decide

By hindustantimes.com | Edited by Poulomi Ghosh
UPDATED ON MAR 03, 2021 08:50 AM IST
The Centre has also asked states to not store vaccines or to create a buffer stock, apprehending any future shortage.
Close
A boy sells a water pot for summer days at Sahakar nagar in Pune, India, on Sunday, February 28. (Rahul Raut/HT photo)
A boy sells a water pot for summer days at Sahakar nagar in Pune, India, on Sunday, February 28. (Rahul Raut/HT photo)

High maximum temperatures to persist for another 4-5 days: IMD

By HT Correspondent | Edited by Smriti Sinha
PUBLISHED ON MAR 03, 2021 08:17 AM IST
A feeble Western Disturbance as a cyclonic circulation over north Pakistan is persisting. Under its influence, isolated rainfall/snowfall is likely over Jammu, Kashmir, Ladakh, Gilgit, Baltistan, Muzaffarabad, Himachal Pradesh and Uttarakhand on March 3 and 4
Close
A health worker (L) takes a mouth swab sample from a journalist for a Covid-19 nucleic acid test.(AFP)
A health worker (L) takes a mouth swab sample from a journalist for a Covid-19 nucleic acid test.(AFP)

Covid-19 LIVE: Tokyo to seek an extension of emergency, says report

By hindustantimes.com, New Delhi
UPDATED ON MAR 03, 2021 08:58 AM IST
As the vaccination drive in underway, more than 265 million have been immunised against the Covid-19.
Rahul Gandhi interacted with economist Kaushik Basu and shared what he thinks of Emergency, his father's assassination.
Rahul Gandhi interacted with economist Kaushik Basu and shared what he thinks of Emergency, his father's assassination.

Emergency was a mistake, says Rahul Gandhi; talks about father, Prabhakaran

By hindustantimes.com | Edited by Poulomi Ghosh
UPDATED ON MAR 03, 2021 09:05 AM IST
"It was more painful to see my father walking towards his death, as a son knowing that he is not going to come out of what he is fighting," Rahul Gandhi said on his father's death.
Close
A man holds the flags of India and the US. (REUTERS)
A man holds the flags of India and the US. (REUTERS)

India-US ties greatest testament to Gandhi-King legacy, says Indian diplomat

PTI, Washington
PUBLISHED ON MAR 03, 2021 06:46 AM IST
Consul General of India in Chicago Amit Kumar said this at the first Gandhi King Legacy Roundtable Summit organized by the US Congressional Multi Advisory Task Force of Congressman Danny K Davis in cooperation with Metropolitan Asian Family Services on February 26.
Close
In many participating countries, it is the first time that large-scale polling of public opinion has ever been conducted on the topic of climate change.(Pixabay)
In many participating countries, it is the first time that large-scale polling of public opinion has ever been conducted on the topic of climate change.(Pixabay)

Climate crisis to cost $100 billion to Indian firms in next 5 years: Report

By Jayashree Nandi
UPDATED ON MAR 03, 2021 06:16 AM IST
The report, titled “Building Back Greener”, said the numbers were based on responses by 42 of 220 Indian companies that responded to investor requests and disclosed climate data.
Close
Delhi chief minister Arvind Kejriwal.(ANI)
Delhi chief minister Arvind Kejriwal.(ANI)

Delhi Assembly session next week: Govt may table state budget on March 9

By HT Correspondent, New Delhi
UPDATED ON MAR 03, 2021 05:47 AM IST
  • For 2020-21, Delhi had pegged budgeted revenue receipts (excluding borrowings) at 55,309 crore. Revised estimates for the year will be mentioned in the upcoming budget (2021-22) and actual revenue receipts for the year will reflect in the budget after that.
Close
A couple waits to get their first dose of a Covid-19 vaccine, at Bandra Kurla Complex (BKC) in Mumbai.(Satish Bate / HT Photo)
A couple waits to get their first dose of a Covid-19 vaccine, at Bandra Kurla Complex (BKC) in Mumbai.(Satish Bate / HT Photo)

Long wait times, glitches in Co-WIN slow vaccine drive

By Rhythma Kaul, Hindustan Times, New Delhi
PUBLISHED ON MAR 03, 2021 05:41 AM IST
Close to five million registrations — which officials estimate could include 10 million people — took place in the 24 hours after the government began accepting sign-ups.
Close
“What do you think? Is a woman a chattel that we can pass such an order? Is a wife a chattel that she can be directed to go with you?” asked an SC bench of justices Sanjay Kishan Kaul and Hemant Gupta while hearing the man’s petition.
“What do you think? Is a woman a chattel that we can pass such an order? Is a wife a chattel that she can be directed to go with you?” asked an SC bench of justices Sanjay Kishan Kaul and Hemant Gupta while hearing the man’s petition.

Wife not husband’s chattel, can't be forced to live with him, says Supreme Court

By Utkarsh Anand, Hindustan Times, New Delhi
UPDATED ON MAR 03, 2021 05:31 AM IST
At the core of the dispute is an April 2019 order on restitution of conjugal rights, passed in favour of the man under Section 9 of the Hindu Marriage Act (HMA) passed by a family court at Gorakhpur.
Close
The December 2 order required states and Centre to install high-definition CCTVs with night vision, audio recording and storage facility of a minimum period of 12 months to 18 months. (HT Illustration).
The December 2 order required states and Centre to install high-definition CCTVs with night vision, audio recording and storage facility of a minimum period of 12 months to 18 months. (HT Illustration).

SC tells states to install CCTVs in police stations, probe agencies in 5 months

By Abraham Thomas
PUBLISHED ON MAR 03, 2021 12:55 AM IST
  • Court-appointed amicus curiae senior advocate Siddhartha Dave prepared a chart indicating unsatisfactory response from states as well with some proposing to achieve compliance of Court’s December 2, 2020 order by end of 2023.
Close
The Supreme Court. (HT archive)
The Supreme Court. (HT archive)

SC backs taxpayers in software royalty case

By Utkarsh Anand, Hindustan Times, New Delhi
PUBLISHED ON MAR 03, 2021 12:25 AM IST
  • The judgment, which involved approximately 500 crore in tax revenue, will impact companies such as IBM India Ltd, Samsung Electronics Co Ltd, Hewlett Packard India, Mphasis Ltd, Sonata Software Ltd, and GE India, among others.
Close
A police team in the village in Anoopshahar area of Bulandshahr district where the girls' body was found.(HT PHOTO)
A police team in the village in Anoopshahar area of Bulandshahr district where the girls' body was found.(HT PHOTO)

5 days after 12-year-old girl disappeared in UP’s Bulandshahr, body found in pit

By S Raju
PUBLISHED ON MAR 03, 2021 12:02 AM IST
  • The girl's family lodged a complaint three day after she went missing.
Close
Experts say that one develops immunity against the virus 14 days after the second shot of the vaccine which is taken after a minimum of 28 days of the first shot. (ANI PHOTO) (Image used for representation).
Experts say that one develops immunity against the virus 14 days after the second shot of the vaccine which is taken after a minimum of 28 days of the first shot. (ANI PHOTO) (Image used for representation).

Barely 22 days after taking first jab of vaccine, medico dies of Covid-19

PUBLISHED ON MAR 03, 2021 12:01 AM IST
  • Shubhendu Shubham, 23, a 2016-batch student of Patna’s Nalanda Medical College Hospital (NMCH), had taken the first shot of Covaxin in the first week of February, but tested positive for the viral infection later last month before he could take the second shot
Close
Civil society members and corporators from Srinagar during a candle light protest outside Krishna Dhaba, whose owner's son Aakash Mehra succumbed to injuries, 11 days after he was shot.(ANI)
Civil society members and corporators from Srinagar during a candle light protest outside Krishna Dhaba, whose owner's son Aakash Mehra succumbed to injuries, 11 days after he was shot.(ANI)

Srinagar market desolate after death of eatery owner's son in militant attack

By Ashiq Hussain
PUBLISHED ON MAR 02, 2021 11:13 PM IST
  • For the past 13 days, the Durga-Nag market at Dalgate in Srinagar has been desolate and locals and traders in grief
Close
SHARE
Story Saved
OPEN APP