Coronavirus Live News Updates: US FDA rejects EUA for Covaxin, recommends Biologics Licence Application route for approval

13:27 (IST)

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SC directs postponement of INI CET 2021 by a month

The Supreme Court on Friday directed the All India Institute of Medical Sciences (AIIMS) to postpone the INI CET 2021 exam for at least a month, reports LiveLaw. 

"Considering that many of the candidates intending to appear in the exam are in covid duty and in remote areas, we are of the opinion that June 16 date is arbitrary. We direct the exam to be postponed by one month, Needless to say exam can be held anytime after the expiry of one month," Bar&Bench quotes the top court as saying. 

The exam was scheduled to be held on 16 June. The INI CET Exam is conducted for admissions to higher studies in the field of medicine/post graduate studies.

13:09 (IST)

Coronavirus live updates

US FDA had earlier communicated that no new EUAs will be given for COVID vaccines, says Bharat Biotech

 

On US FDA rejecting Ocugen's EUA application for Bharat Biotech's Covaxin, the Hyderabad-based firm said the FDA Had earlier communicated that no new EUAs will be approved for COVID-19 vaccines. "With good herd immunity and significant percentage of the population vaccinated, the pandemic is reducing in the United States. The US FDA had earlier communicated that no new EUA’s will be approved for covid vaccines.  All applications have to follow the biological license application process, with is the standard process for vaccines. Data from an additional clinical trial will be required to support the marketing application submission for Covaxin," Bharat Biotech said.

 

The company also claimed that no vaccine manufactured or developed from India has ever received EUA or full licensure from US FDA.  It added that Covaxin has received EUA’s from 14 countries with more than 50 countries in process. "When approved, it will be a Great Leap Forward for vaccines Innovation and manufacturing from India," Bharat Biotech said.

12:38 (IST)

Coronavirus live updates

US FDA rejects EUA for Covaxin, 'suggests' Biologics Licence Application route for approval 

 In a setback to Bharat  Biotech's COVID-19 vaccine Covaxin, the US Food and Drug Administration has "recommended" Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixing hopes of Emergency Use Authorisation.

 

Ocugen in a statement on Thursday announced that as recommended by the FDA,it will pursue submission of a biologics licence application (BLA) for Covaxin. BLA is a "full approval" mechanism by the FDA for drugs and vaccines.

 

PTI

12:32 (IST)

Coronavirus live updates

India records 91,702 new COVID-19 cases, 3,403 fresh fatalities

The daily COVID-19 count in India remained below the one-lakh mark for the fourth consecutive day with the country reporting 91,702 fresh cases, while the daily positivity rate dropped to 4.49 percent, according to the Union Health Ministry data updated on Friday. With the fresh cases, the total tally of cases has climbed to 2,92,74,823. The COVID-19 toll climbed to 3,63,079 with 3,403 fresh deaths, the data updated at 8 am showed

The active cases further declined to 11,21,671 comprising 3.83 percent of the total infections, while the national COVID-19 recovery rate has improved to 94.93 percent. A net decline of 46,281 cases has been recorded in the COVID-19 caseload in a span of 24 hours.

PTI

Coronavirus LATEST News Updates: In a setback to Bharat  Biotech's COVID-19 vaccine Covaxin, the US Food and Drug Administration has "recommended" Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixing hopes of Emergency Use Authorisation.

 

The daily COVID-19 count in India remained below the one-lakh mark for the fourth consecutive day with the country reporting 91,702 fresh cases, while the daily positivity rate dropped to 4.49 percent, according to the Union Health Ministry data updated on Friday.

With the fresh cases, the total tally of cases has climbed to 2,92,74,823. The COVID-19 toll climbed to 3,63,079 with 3,403 fresh deaths, the data updated at 8 am showed

The active cases further declined to 11,21,671 comprising 3.83 percent of the total infections, while the national COVID-19 recovery rate has improved to 94.93 percent. A net decline of 46,281 cases has been recorded in the COVID-19 caseload in a span of 24 hours.

Also, 20,44,131 tests were conducted on Thursday taking the total cumulative tests conducted so far for detection of COVID-19 in the country to 37,42,42,384.

The daily positivity rate was recorded at 4.49 percent . It has been less than 10 percent for the 18th consecutive day, the ministry said, adding the weekly positivity rate has also declined to 5.14 percent.

Recoveries continue to outnumber daily new cases for 29th consecutive day. The number of people who have recuperated from the disease surged to 2,77,90,073, while the case fatality rate has increased to 1.24 percent, the data stated. Cumulatively, 24,60,85,649 COVID-19 vaccine doses have been administered so far under the nationwide vaccination drive.

India's COVID-19 tally had crossed the 20-lakh mark on 7 August, 30 lakh on 23 August, 40 lakh on 5 September and 50 lakh on 16 September . It went past 60 lakh on 28 September, 70 lakh on 11 October, crossed 80 lakh on 29 October, 90 lakh on 20 November and surpassed the one-crore mark on 19 December. India crossed the grim milestone of 2 crore on 4 May.

The 3,403 new fatalities include 1,915 from Maharashtra, 358 from Tamil Nadu, 194 each from Karnataka and Kerala.

A total of 3,63,079 deaths have been reported so far in the country including 1,03,748 from Maharashtra, 32,485 from Karnataka, 28,528 from Tamil Nadu, 24,748 from Delhi, 21,597 from Uttar Pradesh, 16,642 from West Bengal, 15,367 from Punjab and 13,285 from Chhattisgarh.

The ministry stressed that more than 70 percent of the deaths occurred due to comorbidities. "Our figures are being reconciled with the Indian Council of Medical Research," the ministry said on its website, adding that state-wise distribution of figures is subject to further verification and reconciliation.

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