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Coronavirus News Updates: COVID-19 expert panel recommends emergency use authorisation for Bharat Biotech's COVAXIN

Coronavirus News LIVE Updates: Covaxin has been indigenously developed by Bharat Biotech in collaboration with the ICMR

FP Staff January 02, 2021 22:45:48 IST
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Coronavirus News Updates: COVID-19 expert panel recommends emergency use authorisation for Bharat Biotech's COVAXIN

Representational image. PTI

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LIVE NEWS and UPDATES

Jan 02, 2021 - 22:36 (IST)

Rajasthan imposes night curfew in 13 districts

The Rajasthan government on Saturday imposed night curfew from 8 pm to 6 am in 13 districts in the state. Curfew has been imposed within the urban limits of district headquarter towns in 13 districts – Kota, Jaipur, Jodhpur, Bikaner, Udaipur, Ajmer, Alwar, Bhilwara, Nagore, Pali, Tonk, Sikar and Ganganagar, reports said.

Jan 02, 2021 - 21:54 (IST)

Vaccination dry run conducted "smoothly" in Sikkim

The Sikkim government on Saturday conducted a dry run for COVID-19 vaccination at an urban PHC in Gangtok, a senior health official was quoted by PTI as saying. The dry run was conducted smoothly and strengths and disadvantages were known, State Immunisation Officer Dr P Denzongpa said.

"We are fully prepared to conduct the actual COVID-19 vaccination. We have strengthened our cold storage units. All district hospitals and even PHCs already have the necessary infrastructure in place because of other routine vaccination drives held earlier across the state," Denzongpa told PTI.

The list of first beneficiaries of the COVID-19 vaccine has been prepared, she said.

Jan 02, 2021 - 21:17 (IST)

Bharat Biotech vaccine candidate approved 'especially in context of virus mutation'

The Subject Expert Commitee of the Central Drugs Standard Control Organisation (CDSCO) granted the permission for the emergency use of COVAXIN, emphasising on the "context of infection by mutant virus strains", PTI reported.

The SEC’s recommendations will now be considered by the Drugs Controller General of India (DCGI), who will grant the final approval, News18 reported.

Jan 02, 2021 - 21:13 (IST)

SEC recommends permission to Ahmedabad-based lab to conduct phase 3 trials

After detailed deliberations, the SEC has also recommended for grant of permission to Cadila Healthcare Ltd in Ahmedabad for conduct of phase-3 clinical trial protocol for its vaccine candidate.

Jan 02, 2021 - 20:51 (IST)

CDSCO panel recommends granting approval for Bharat Biotech's Covaxin

An expert panel of India's central drug authority on Saturday recommended granting permission for restricted emergency use of the indigenously developed COVID-19 vaccine Covaxin with certain conditions, a day after giving similar direction for the Oxford COVID-19 vaccine, reports said.

Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on Saturday again deliberated on the emergency use authorisation (EUA) application of the Hyderabad-based pharmaceutical firm after it submitted additional data, facts and analysis subsequent to Friday's review meeting, a source said.

Jan 02, 2021 - 20:22 (IST)

37 UK returnees test positive for COVID-19 in Kerala

Thirty-seven people who returned from the UK to Kerala recently have tested positive for COVID-19, while the state recorded 5,328 new cases and 4,985 recoveries on Saturday, Health Minister KK Shailaja said. While the virus caseload has gone up to 7,71,251, as many as 7,02,576 people have recovered.

At least 2,40,490 people are under observation in various districts, including 11,811 in hospitals. The minister also said the dry run for the COVID-19 vaccine was successfully held and asserted the state was fully prepared to receive and administer the vaccine.

Jan 02, 2021 - 20:01 (IST)

COVID-19 vaccines don't belong to any political party, says Omar Abdullah

COVID-19 vaccines do not belong to any political party, but humanity, National Conference leader Omar Abdullah said on Saturday, hours after Samajwadi Party chief Akhilesh Yadav termed coronavirus vaccines to be rolled out in the country as "vaccine of the BJP". Taking to Twitter, the former Jammu and Kashmir chief minister said, "I don't know about anyone else but when my turn comes I'll happily roll up my sleeve & get a COVID vaccine."

The more people get vaccinated, the better it will be for the country and the economy, the NC vice president said. "No vaccine belongs to any political party, they belong to humanity & the sooner we get vulnerable people vaccinated the better," he tweeted.

Jan 02, 2021 - 19:26 (IST)

3,218 new COVID-19 cases in Maharashtra, 51 deaths

Maharashtra's COVID-19 tally on Saturday rose to 19,38,854 as the state recorded 3,218 new cases of infection, a health department official said. With 51 fatalities being reported during the day, the toll reached 49,631.

A total of 2,110 patients were discharged after treatment, taking the tally of recovered persons to 18,34,935. With this, there are 53,137 active coronavirus patients in the state now.

Mumbai city reported 593 new cases during the day, which pushed its case count to 2,94,660, while its toll rose to 11,132  with seven patients dying.

Jan 02, 2021 - 19:06 (IST)

One primary contact of UK returnee tests positive for new virus strain in Karnataka

One primary contact of a UK returnee was among 10 people who tested positive for the new strain of coronavirus and all of them are undergoing treatment, Karnataka Health Minister K Sudhakar said on Saturday.

"Ten people have so far been confirmed with the new variant of coronavirus infection... nine of them are returnees from the UK., while one is a contact, the mother of one them. All of them are undergoing treatment and are without any serious health condition. They will recover soon," he said.

Jan 02, 2021 - 18:31 (IST)

Odisha govt to begin lectures for Class 10, 12 from 8 Jan

The School and Mass Education department of the Odisha government on Saturday said that lectures for Class 10 and 12 will reopen from 8 January. Schools will be strictly following the COVID-19 protocol SOP.

Coronavirus News LATEST Updates: An expert panel of India's central drug authority on Saturday recommended granting permission for restricted emergency use of the indigenously developed COVID-19 vaccine Covaxin with certain conditions, a day after giving similar direction for the Oxford COVID-19 vaccine, reports said.

Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on Saturday again deliberated on the emergency use authorisation (EUA) application of the Hyderabad-based pharmaceutical firm after it submitted additional data, facts and analysis subsequent to Friday's review meeting, a source said.

The School and Mass Education department of the Odisha government on Saturday said that lectures for Class 10 and 12 will reopen from 8 January. Schools will be strictly following the COVID-19 protocol SOP.

Nearly 75 health workers underwent dummy vaccination at Bhopal in Madhya Pradesh on Saturday as part of the first dry run of COVID-19 vaccine programme in the state. The mock vaccination programme was conducted at three health centres in the state capital — Gandhi Nagar community health centre (CHC), Govindpura CHC and L N Hospital.

As part of the process, SMSs were sent to the health workers, in which they were asked to come to these health facilities. "After the dummy vaccination shots were given to them, these health workers were asked to wait for 30 minutes at the centres so that they are kept under observation, like in the actual vaccination plan," PTI quoted an official as saying.

Four people who recently returned to Gujarat from the United Kingdom (UK) have tested positive for the new strain of coronavirus , a top state health department official said on Saturday. Results of the 15 samples that had tested positive for coronavirus on arrival in Ahmedabad from the UK are currently pending with the National Institute of Virology (NIV) in Pune.

"All the passengers who had reached Ahmedabad from the UK were screened, and the samples of those who had tested positive for coronavirus were sent to the NIV. We have received intimation that the UK strain of coronavirus has been detected in four such cases," Principal Secretary (Health), Jayanti Ravi told reporters.

Union aviation minister Hardeep Singh Puri said on Saturday that flights from India to UK will resume from 6 January, while services from that country to India will resume from 8 January onwards. "Resumption of flights between India & UK: India to UK from 6 Jan 2021. UK to India from 8 Jan 2021. 30 flights will operate every week. 15 each by Indian & UK carriers," Puri said on Twitter.

"This schedule is valid till 23 Jan 2021. Further frequency will be determined after review," he added. Earlier, Puri had announced on Friday that only 30 flights per week will operate between India and the UK when services resume from 8 January and that this arrangement will continue till 23 January.

The government will give priority to 1 crore healthcare workers and 2 crore frontline workers when India begins the rollout of the COVID-19 vaccine.

Each passenger arriving from the UK would have to bring his or her COVID-19 negative report from a test done 72 hours prior to the journey, the health ministry said.

While reviewing preparations for the exercise, the health minister also appealed to everyone to not believe in rumours and emphasised that the COVID-19 vaccine was safe.

The total confirmed coronavirus cases in India have risen to 1,03,05,788 on Saturday after 19,079 fresh infections were registered in a day, said the Union health ministry.

With the death of 224 more COVID-19 patients in the past 24 hours, the toll due to the novel coronavirus in India reached 1,49,218, the Union health ministry said on Saturday.

The COVID-19 dry run is being conducted in 116 districts across 259 sites. Some 96,000 vaccinators have been trained for this, the health ministry had said.

An expert panel on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on Friday recommended grant of permission for restricted emergency use of Oxford COVID-19 vaccine Covishield in India, subject to certain regulatory provisions, official sources said.

As for Bharat Biotech, the Subject Expert Committee (SEC) on COVID-19 of the CDSCO asked the firm to expedite volunteer recruitment for the ongoing clinical trial and said it may conduct interim efficacy analysis for further consideration of restricted emergency use approval for its vaccine Covaxin, they stated.

The SEC, which earlier had sought additional safety, immunogenicity and efficacy data from SII and Bharat Biotech, deliberated on their applications seeking emergency use authorisation (EUA) for their shots on Wednesday, and met again on Friday to review the matter.

While granting emergency use approval for the Oxford COVID-19 vaccine, the panel imposed certain regulatory provisions, including that the shot is indicated for active immunisation in individuals of 18 years or more to prevent the disease and that it should be administered intramuscularly in two doses at an interval of 4 to 6 weeks.

Further, the SII should submit safety, efficacy and immunogenicity data from the ongoing clinical trials in the country and across the globe for review at the earliest. Also, the Pune-based firm should submit the safety data including the data on adverse event following immunisation (AEFI) and adverse event of special interest (AESI) with due analysis every 15 days for the first two months and monthly thereafter till the completion of the ongoing clinical trial in the country.

The Pune-based Serum Institute of India (SII), the world's largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield.

While considering Bharat Biotech's application, the SEC noted that the ongoing clinical trial is a large one with 25,800 subjects of which 22,000 have been enrolled, including subjects with comorbid conditions, which has demonstrated safety till date but efficacy is yet to be demonstrated.

"After detailed deliberation, the committee recommended that the firm should try to expedite the recruitment and may perform interim efficacy analysis for further consideration of restricted emergency use approval," an official source said.
Pfizer's application was not deliberated, sources said.

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday had approved the COVID-19 vaccine developed by scientists at Oxford University and produced by AstraZeneca for human use.

"In terms of safety, Covishield was well tolerated with respect to solicited adverse events. Majority of solicited reactions were mild in severity and resolved without any sequelae. Therefore, Covishield is safe and can be used effectively for prevention of COVID-19 in the targeted population. Thus, the benefit to risk ratio strongly supports the widespread use of Covishield," the EUA application signed by Prakash Kumar Singh, Additional Director, Government and Regulatory Affairs at Serum Institute of India (SII), had stated.

SII had applied to the Drugs Controller General of India (DCGI) for EUA for Oxford COVID-19 vaccine on 6 December, while the Hyderabad-based Bharat Biotech had sought the nod for its indigenously developed Covaxin on 7 December.

Pfizer had applied for regulatory approval for its vaccine on 4 December.

Updated Date:

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