Coronavirus News LIVE Updates: 'All risks paid off', says SII chief Adar Poonawalla after DCGI grants authorisation to vaccine
12:51 (IST)
Coronavirus News LATEST Updates
Ready to roll out COVID-19 vaccine in India: Serum Institute of India
Serum Institute of India (SII) on Sunday said it is ready to roll out Covishield vaccine in the country in the coming weeks after receiving approval from the Indian drug regulator.
The Pune-based vaccine major has entered into a collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine. The company has already stockpiled around 50 million dosages of the vaccine and aims to produce up to 100 million dosages per month by March next year.
The approval by the DCGI was given on the basis of recommendations submitted by a COVID-19 subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).
"After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and accordingly, vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in emergency situation," DCGI Dr VG Somani told a press conference.
This paves the way for the roll-out of at least two vaccines in India in the coming days. The Oxford-AstraZeneca vaccine has already been approved by the UK government.
12:31 (IST)
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Vaccines are safe and immunogenic: DCGI
The Drugs Controller General of India in a press release stated that the interim data suggested that the vaccines are safe to use.
- The vaccines are safe and immunogenic with three doses when administered intra-dermally.
- For each person, Bharat Biotech's Covaxin and Oxford Astrazenenca's Covishield vaccines have to be administered in 2 doses.
- Apart from these two vaccines, the drug regulator also allowed Cadila Healthcare to conduct its phase 3 trials.
- All three vaccines have to be stored at 2-8° C.
12:20 (IST)
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Congress leaders raise concern over grant of permission for restricted use of vaccine
Senior Congress leader Anand Sharma on Sunday raised concerns over India's drugs regulator granting permission for the restricted use of Bharat Biotech's COVID-19 vaccine and asked the government to explain why mandatory protocols and verification of data has been dispensed with.
Sharma, who heads the Parliamentary panel on Home Affairs which dealt with the issue at length, said the issue of granting authorisation to the vaccine use needs to be taken carefully as no country has dispensed with the mandatory phase 3 trials and verification of data.
As per submissions made before the expert panel, phase 3 trials have not been completed and therefore, the data on safety and efficacy has not been reviewed, which is a mandatory requirement, he said.
"The Health ministry needs to give cogent reasons for dispensing with the mandatory protocols and requirements in this case since it involves the health and safety of those frontline workers who will be vaccinated under the restricted category," he told PTI.
"The DCGI statement is puzzling and the government must must reveal the final data of global efficacy trials and the final trials in UK which has been shared officially by UK's MHRA following a government to government agreement signed between the two countries which should be put in public domain to avoid any confusiuon on the proven efficacy of the vaccine," Sharma also said.
12:06 (IST)
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WHO welcomes first emergency use authorisation to vaccines in South-East Asia Region
“WHO welcomes the first emergency use authorization given to COVID-19 vaccine in the WHO South-East Asia Region. This decision taken today by India will help intensify and strengthen the fight against COVID-19 pandemic in the Region. The use of vaccine in prioritized populations, along with continued implementation of other public health measures and community participation will be important in reducing the impact of COVID-19," said Dr Poonam Khetrapal Singh, Regional Director WHO South-East Asia Region.
11:57 (IST)
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Cadila Healthcare to conduct Phase-3 trails for vaccine candidates
As per a press release by DCGI, it has also granted permission to Cadila Healthcare for conducting phase-III clinical trial of their COVID-19 vaccine candidate.
11:38 (IST)
Coronavirus News LATEST Updates
Decisive turning point: PM congratulates SII and Bharat Biotech
In a series of tweets, Prime Minister Narendra Modi on Sunday congratulated Serum Institute and Bharat Biotech on getting the DCGI’s approval. “A decisive turning point to strengthen a spirited fight! DCGI granting approval to vaccines of @SerumInstIndia and @BharatBiotech accelerates the road to a healthier and COVID-free nation. Congratulations India. Congratulations to our hardworking scientists and innovators. DCGI approves restricted emergency use of Serum Institute, Bharat Biotech's COVID-19 vaccines,” PM Modi said.
"It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India! This shows the eagerness of our scientific community to fulfill the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion," PM Modi said in a another tweet.
It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India! This shows the eagerness of our scientific community to fulfil the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion.
— Narendra Modi (@narendramodi) January 3, 2021
We reiterate our gratitude to doctors, medical staff, scientists, police personnel, sanitation workers and all Corona warriors for the outstanding work done, that too in adverse circumstances. We will remain eternally grateful to them for saving many lives.
— Narendra Modi (@narendramodi) January 3, 2021
11:25 (IST)
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Happy new year, tweets SII chief after DCGI grants authorisation to Covishield
Serum Institute of India CEO Adar Poonawalla on Sunday said the Oxford-AstraZeneca COVID-19 vaccine 'Covishield' is ready to roll out in the coming weeks.
Poonawalla's remarks came soon after after India's drugs regulator approved Covishield for restricted emergency use.
Happy new year, everyone! All the risks @SerumInstIndia took with stockpiling the vaccine, have finally paid off. COVISHIELD, India's first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks. pic.twitter.com/TcKh4bZIKK
— Adar Poonawalla (@adarpoonawalla) January 3, 2021
11:18 (IST)
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Prioritising COVID-19 UK variant threat while conducting vaccine trails: DCGI
The DCGI on Sunday said that Bharat Biotech's ongoing clinical trial will continue across the nation and the threat of the UK's new strain is being prioritised while doing so. The firm is set to conduct its phase 3 trials in another 26,000 patients across the country.
11:11 (IST)
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DCGI grants emergency use authorisation for Covishield and COVAXIN
The Drugs Controller General of India (DCGI) has granted emergency use authorisation for the Serum Institute of India (SII)’s ‘Covishield’ and Bharat Biotech’s ‘COVAXIN’ vaccines against COVID-19, the disease caused by the novel coronavirus. This comes after clearances from the Subject Expert Committee (SEC).
Both the Covishield and COVAXIN vaccines will be administered in two doses, the DCGI chief said.
11:07 (IST)
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Subject expert committee recommends restricted used of 2 vaccines: DGCI
Subject Expert Committee has recommended allowing restricted use of COVID-19 vaccines developed by Serum Institute of India and Bharat Biotech, said the DCGI on Sunday during the media presser.
11:03 (IST)
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DCGI begins briefing media
LIVE at 11 am: Press Conference by Drugs Controller General of India
— PIB India (@PIB_India) January 3, 2021
Watch on PIB's
📍: National Media Centre, New Delhi
YouTube: https://t.co/7aARy0crqA
Facebook: https://t.co/imJr864fiT
10:48 (IST)
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Telangana logs 394 new COVID-19 cases, 3 deaths push toll to 1,549
Telangana recorded 394 fresh COVID-19 cases, taking the total positives to over 2.87 lakh while three fatalities pushed the toll to 1,549, the state government said on Sunday.
Greater Hyderabad Municipal Corporation (GHMC) accounted for the most number of cases with 81, followed by Rangareddy and Medchal Malkajgiriwith 36 and 31 respectively, it said in a bulletin, providing details as of 8 pm on 2 January.
The total number of cases stood at 2,87,502 while recoveries were 2,80,565. As many as 5,388 patients are under treatment and 40,190 samples were tested on Saturday.
Cumulatively, over 69.91 lakh samples have been tested. The samples tested per million population was over 1.87 lakh, the bulletin said.
-PTI
10:21 (IST)
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Bharat Biotech recruits 23,000 volunteers for COVID-19 vaccine trials
Bharat Biotech has successfully recruited 23,000 volunteers, and continued progress towards achieving the goal of 26,000 participants for Phase-3 clinical trial of its COVID-19 vaccine Covaxin across multiple sites in India, it said.
The Phase III human clinical trials of Covaxin began mid-November, targeted to be done in 26,000 volunteers and it is the country's first and only Phase III efficacy study for a COVID-19 vaccine, and the largest phase III efficacy trial ever conducted for any vaccine in India, a press release from the vaccine maker said on Saturday night.
Thanking volunteers for their participation in the trials, Suchitra Ella, Joint Managing Director of Bharat Biotech said, the volunteering spirit is a great morale boost for India and the world.
"We thank all the principal investigators, doctors, medical staff & the hospitals for their cooperation and support in taking the phase III trials forward in 26,000 volunteers in India. We continue our progress towards achieving the goal of 26,000 participants for Phase-3 clinical trials of Covaxin," she said.
-PTI
10:15 (IST)
Coronavirus News LATEST Updates
'Can't trust a BJP vaccine,' says Akhilesh Yadav
Samajwadi Party president Akhilesh Yadav on Saturday termed the anti- COVID-19 vaccine to be rolled out in the country a "vaccine of the BJP" and said he would not take the shot, prompting a sharp reaction not only from the ruling party but also from NC vice-president Omar Abdullah.
While the ruling BJP accused Yadav of "insulting" doctors and scientists, Abdullah said vaccines don't belong to any political party, but humanity.
Hours later after terming the anti-Covid vaccine as a “vaccine of the BJP”, Yadav, however, said in a tweet that he had full faith in scientists but not in the “taali and thali wali” unscientific thinking of the BJP.
10:03 (IST)
Coronavirus News LATEST Updates
Thane district's COVID-19 count rises by 333, toll by 7
With the addition of 333 coronavirus positive cases, the infection tally in Thane district of Maharashtra climbed to 2,43,871, an official said on Sunday. These new cases were reported on Saturday, he said.
As seven patients succumbed to the infection during the day, the death toll went up to 5,974 in the district, where the mortality rate is 2.45 percent, he added. So far, 2,34,005 patients have recuperated from the infection, which took the recovery rate to 95.95 percent.
There are 3,892 active cases in the district at present, the official said.
09:52 (IST)
Coronavirus News LATEST Updates
India reports over 18,000 new cases; tally now at 1.03 cr
India recorded 18,177 new COVID-19 cases in a day, while 99,27,310 people have recuperated so far pushing the national recovery rate to 96.15 percent on Sunday, according to the Union Health Ministry data.
The total coronavirus cases mounted to 1,03,23,965 and the death toll climbed to 1,49,435 with the novel coronavirus virus claiming 217 lives in a span of 24 hours in the country, the data updated at 8 am showed. The COVID-19 case fatality rate stood at 1.45 percent.
There are 2,47,220 active cases of coronavirus infection in the country which comprises 2.39 percent of the total caseload, the data stated.
According to the ICMR, a cumulative total of 17,48,99,783 samples have been tested up to 2 January with 9,58,125 samples being tested on Saturday.
09:48 (IST)
Coronavirus News LATEST Updates
DCGI to brief media at 11 am today
The Drugs Controller General of India (DCGI) will brief the media at 11.00 am today on the COVID-19 vaccine. At least two vaccine candidates are awaiting final emergency use authorisation from the DCGi.
The Drug Controller General of India (DCGI) will address a press conference at 11 am and it is expected that the drug controller watchdog may announce the approval of emergency use of two vaccines. #CoronaVaccine pic.twitter.com/gc4aQZIo0O
— All India Radio News (@airnewsalerts) January 2, 2021
09:46 (IST)
Coronavirus News LATEST Updates
85 people test positive in Chennai's ITC Grand Chola hotel
About 85 people, including staff members of ITC Grand Chola in Chennai's Guindy area, have tested positive for COVID-19 since 15 December last year, a senior official said on Saturday. Of the total of 609 samples collected till date, 85 were found to be positive.
Following this, the Greater Chennai Corporation has been instructed to carry out saturation testing of all the guests at the hotel, Health Secretary J Radhakrishnan said.
ITC Grand Chola, in a release, said all events at the property have been conducted in adherence to the norms mandated by the authorities.
Additionally, only 50 percent capacity of the hall is used to ensure maximum distancing and safety, it said.
09:44 (IST)
Coronavirus News LATEST Updates
India first country to successfully culture UK virus variant, says ICMR
The Indian Council of Medical Research on Saturday said that it has successfully isolated and cultured the new variant of the coronavirus identified in the United Kingdom. The top medical body claimed that no other country has so far reported success in this area.
Culture is the process by which cells are grown under controlled conditions, generally outside their natural environment.
Coronavirus News LATEST Updates: Serum Institute of India CEO Adar Poonawalla on Sunday said the Oxford-AstraZeneca COVID-19 vaccine 'Covishield' is ready to roll out in the coming weeks. Poonawalla's remarks came soon after India's drugs regulator approved Covishield for restricted emergency use.
Prime Minister Narendra Modi called DCGI’s emergency approval for 2 vaccines in India a “decisive turning point” in the country’s fight against the virus and expressed gratitude for all frontline workers in “adverse circumstances.”
The Drugs Controller General of India (DCGI) has granted emergency use authorisation for the Serum Institute of India (SII)’s ‘Covishield’ and Bharat Biotech’s ‘COVAXIN’ vaccines against COVID-19, the disease caused by the novel coronavirus. This comes after clearances from the Subject Expert Committee (SEC)
The development comes after the subject expert committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) recommended Oxford-AstraZeneca’s vaccine, which is being manufactured by the Serum Institute of India (SII) as Covishield, for emergency use and Covaxin for restricted use.
India recorded 18,177 new COVID-19 cases in a day, while 99,27,310 people have recuperated so far pushing the national recovery rate to 96.15 percent on Sunday, according to the Union Health Ministry data.
The total coronavirus cases mounted to 1,03,23,965 and the toll climbed to 1,49,435 with the novel coronavirus virus claiming 217 lives in a span of 24 hours in the country, the data updated at 8 am showed. The COVID-19 case fatality rate stood at 1.45 percent
An expert panel of India's central drug authority on Saturday recommended granting permission for restricted use of Bharat Biotech-developed indigenous COVID-19 vaccine Covaxin in emergency situation, especially in the context of infection by mutant strains, officials said.
The recommendation for Bharat Biotech's vaccine came a day after the panel cleared the Serum Institute of India's emergency use athorisation application for the Oxford-AstraZeneca vaccine Covishield.
This paves the way for the roll-out of at least two vaccines in India in the coming days, while two more are in advance stages of development.
At a press conference in New Delhi, Union minister Prakash Javadekar said India was probably the only country where four vaccines were in the pipeline.
Asked about some religious figures raising doubts over vaccines, Javadekar said "our vaccine is effective" and the rest of the world was also using it. He added that vaccines are introduced after tests and those that would be brought in would be safe.
Union Health Minister Harsh Vardhan appealed to people on Saturday not to be misguided by "rumours" regarding the safety and efficacy of the coronavirus vaccine, and said, "We will not compromise on any protocol before approving a vaccine."
The Union Health Ministry on Saturday said the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has recommended granting permission to the Serum Institute of Institute (SII) for restricted emergency use of Covishield in India, subject to multiple regulatory conditionalities.
"The SEC of CDSCO met on January 1 and 2 and made the recommendations for the consideration and final decision of the Drugs Controller General of India (DCGI)," the ministry said.
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The SEC again deliberated on the emergency use authorisation (EUA) application of Bharat Biotech on Saturday after it presented the updated data, justification and requested for consideration of their proposal in the wake of incidence of new mutated coronavirus infection.
It recommended "grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains, to Bharat Biotech," the health ministry stated.
According to sources, the committee, however, stated that the firm shall continue the ongoing phase 3 clinical trial and submit data emerging from the trial as and when available.
The committee noted that the vaccine is an inactivated whole virion, coronavirus vaccine, having potential to target mutated coronavirus strains, a source said. The data generated so far demonstrates a strong immune response (both antibody as well as T cell) and in-vitro viral neutralisation.
While granting the restricted emergency use approval for the Oxford COVID-19 vaccine on Friday, the panel had 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 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 events 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, according to the recommendations.
Thereafter, the firm should submit the safety data as per the provisions and standard procedures.
According to sources, the recommendations stated that the vaccine should be supplied along with fact-sheet and separate leaflet for the guidance of the healthcare provider.
The Serum Institute of India, the world's largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield.
According to sources, the firm had presented the details of the conditions and restrictions under which AstraZeneca was granted emergency use authorisation in the UK and the revised fact sheet and prescribing information in Indian context as required by the committee.
SII had applied to the Drugs Controller General of India (DCGI) for EUA for Oxford COVID-19 vaccine on December 6, while the Hyderabad-based Bharat Biotech had sought the nod for its indigenously developed Covaxin on December 7.
Pfizer had applied for regulatory approval for its vaccine on December 4 has not yet turned for deliberation.
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.
from Firstpost India Latest News https://ift.tt/386FyaT
FP Staff
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