Coronavirus India Updates: Drug Regulator Approves Serum, Bharat Biotech Vaccines For Restricted Use
India’s drug regulator approved the Covid-19 vaccines manufactured by Serum Institute of India Ltd. and Bharat Biotech International Ltd. for restricted use in emergency situation.
The approval by the DCGI was given on the basis of recommendations submitted by a Covid-19 subject expert committee of the Central Drugs Standard Control Organisation.
Drugs Controller General of India’s VG Somani said the overall efficacy of the AstraZeneca-Oxford University shot being produced locally by the Serum Institute as ‘Covishield’ was found to be 70.42%. In a statement to the media, Somani said that the interim safety, immunogencity data of Serum’s vaccine was found comparable with overseas clinical studies.
Adar Poonawalla, chief executive officer of Serum Institute, tweeted following the approval saying that the vaccine is ready to roll out in the coming weeks.
On Bharat Biotech’s ‘Covaxin’, the DCGI said the vaccine is “safe and provides a robust immune response.” The approval for this vaccine has been given even as, Somani said, “The clinical trial ongoing within the country by the firm will continue.” Unlike his comment statement on the Serum vaccine, Somani did not offer a data point on the efficacy of ‘Covaxin’.
Ahead of this announcement, the ‘All India Drug Action Network’, a group of non-government organisations, had urged the DCGI on Saturday to reconsider the recommendations of the CDSCO’s Subject Expert Committee to grant restricted emergency use to ‘Covaxin’. “Disturbingly, it appears that no efficacy data for the vaccine candidate were submitted from the Phase 3 trials that are ongoing and being conducted by Bharat Biotech and ICMR,” AIDAN said in a statement.
On its part, Bharat Biotech on Sunday said it has generated excellent safety data with robust immune responses to multiple viral proteins that persist and their goal is to provide global access to populations that need it the most.
There has been concern on the process, from other quarters as well.
“I thought I knew something about the process of licensure of vaccines, but clearly I do not. I do not understand what ‘the grant of permission in emergency situation in public interest as an abundant permission, in clinical trial mode’, means—either you are doing a clinical trial or you are not. As far as I am aware, Covaxin has no clinical efficacy data whatsoever at this time, so I fail to see how the DCGI can consider this an efficacious vaccine,” said Dr. Gagandeep Kang, professor, the Wellcome Trust Research Laboratory, division of gastrointestinal sciences, Christian Medical College, Vellore, told BloombergQuint.
According to Murali Neelakantan, a healthcare laws expert, the issue with using terms like emergency use authorisation and restricted emergency use, that are alien to Indian regulations, is that it causes confusion among doctors and patients about the basis for the approval and the limitations of the data used to grant approvals.
“This lack of transparency could lead to a lack of trust in the vaccine. Contrast this with the U.S. FDA which live streamed the whole regulatory review process and issued a detailed memo on the vaccine, with all relevant data, including restrictions,” said Neelakantan. “The credibility of the regulator is at stake and this is especially telling due to the history of the regulator acting contrary to the regulations in the past. India has had a troubling history of new drug approvals.”
Cadila Gets DCGI Nod To Initiate Phase-3 Trials For Vaccine
Drug firm Zydus Cadila on Sunday said it has received the Drugs Controller General of India’s approval to initiate phase-3 clinical trials of its Covid-19 vaccine ZyCoV-D.
The company will now be initiating phase-3 clinical trial in around 30,000 volunteers, Zydus Cadila said in a statement. ZyCoV-D was found to be safe, well-tolerated and immunogenic in phase-1 and 2 clinical trials, it said.
The phase-2 study of ZyCoV-D had been conducted in over 1,000 healthy adult volunteers as part of the adaptive Phase I/II dose-escalation, multi-centric, randomised, double-blind placebo-controlled study, the drug firm said.
“We are reaching a critical milestone in our vaccine development programme and towards our goal of helping people fight the pandemic with an indigenously discovered, safe and efficacious vaccine,” Zydus Group Chairman Pankaj R Patel said.
The launch of the phase-3 trial will determine the efficacy of the company’s vaccine in preventing Covid-19, which continues to pose a major threat world over, he said.
Track all developments around the Covid-19 outbreak in India here.
Delhi All Set For Covid-19 Vaccine Rollout: Health Minister
Delhi Health Minister Satyendar Jain on Sunday asserted that the city government is all set for the Covid-19 vaccination rollout as soon as any of the two approved by the drug regulator for emergency use arrive.
Interacting with reporters, he said, in the first phase, about three lakh healthcare workers and nearly six lakh frontline workers, totalling about nine lakh, will get the vaccine.
"We are all ready with our preparations, from storage to logistics, and yesterday (Saturday), a dry run was conducted at three sites to assess the preparedness for the vaccination roll-out. Vaccination can begin, soon as the vaccine arrives in Delhi, which we expect in few days," he said.
Delhi recorded 424 fresh Covid-19 cases, the lowest in over seven months. It reported 14 new fatalities on Sunday even as the positivity rate slipped to 0.62%, authorities said. The infection tally in the city stands at over 6.26 lakh and death toll rose to 10,585, they said.
Jain on Saturday had tweeted that the positivity rate had been below 1% for the past 11 days, and fresh cases were the lowest since May 17.
Jan. 3 India Covid-19 Update
The death toll in India due to the coronavirus fell to the lowest in seven months, just as the South Asian nation prepares to roll out an inoculation programme to stem the world’s second-worst outbreak.
India reported 217 deaths due to the Covid-19 in the last 24 hours, taking the total toll tally to 1.5 lakh, according to the Health Ministry’s update as of 8 a.m. on Jan. 3, 2021. The nation has reported less than 300 one-day fatalities for nine straight days.
The country also added 18,177 fresh infections in a day, taking the total tally of confirmed cases to 1.03 crore. This includes 99.3 lakh patients who have recovered.
Total confirmed cases: 1,03,23,965
Total number of active cases: 2,47,220
Total patients cured/discharged/migrated: 99,27,310
Total deaths: 1,49,435
Number of fresh cases in last 24 hours: 18,177
One-day recoveries: 20,923
One-day deaths: 217
According to the Indian Council of Medical Research, a total of 17.48 crore samples have been tested as of Jan. 2, 2021. Of these, 9.58 lakh were screened just on Saturday.
The nation with 1.3 billion people is only behind the U.S. in the number of confirmed infections. New cases continue to fall in India, with daily additions less than 30,000 since Dec. 14.
The slower pace of adding fresh infections and an improved recovery rate pushed active cases in India below the 3-lakh-mark for the first time since Dec. 22. That’s just 2.4% of the total caseload. India’s active cases had crossed 10 lakh in mid-September.
Recoveries, on the other hand, now account for more than 96% of the total confirmed cases.
All Indian states and union territories started conducting a dry run of its vaccine delivery system and identify potential hurdles on Jan. 2. The Health Ministry has reviewed preparedness and asked state governments to ensure the effectiveness of the programme.
The world’s second-most infected country plans to inoculate 300 million people in the first phase by August, including health care and front line workers, police and military troops and those with co-morbidities and above the age of 50.
Globally, the coronavirus cases have topped 84.5 million, with more than 1.8 million deaths.
The U.S. reported at least 267,550 new coronavirus cases on Jan. 2, the worst day since the pandemic began. The country’s death toll is nearing 350,000, more than India and Brazil combined.
German Health Minister Jens Spahn is seeking to extend the country’s coronavirus restrictions beyond Jan. 10 because infection rates remain too high.
Coronavirus clusters in Australia’s two most-populous states, however, may be coming under control. Victoria reported three new cases in the past 24 hours, while New South Wales said it detected eight locally transmitted cases in the same period compared with seven the day before.
The U.K. government has drawn up plans to allow people to receive two different Covid-19 vaccines as part of the two-dose treatment to protect against the coronavirus. More than 800,000 Russians have received the Covid-19 vaccination.
Read more on global scenario here:
Health Workers First To Get Covid-19 Vaccine In Punjab: Minister
Around 1.60 lakh health workers in Punjab will receive a Covid-19 vaccine in the first phase, Health Minister Balbir Singh Sidhu said on Sunday.
According to Principal Secretary (Health) Hussan Lal, data regarding 1.60 lakh healthcare workers have already been uploaded on the CoWin portal — an online platform for monitoring the delivery of Covid-19 vaccine.
After health workers, Lal said vaccine will be administered to around three lakh frontline workers, including policemen, paramilitary forces, sanitation workers and disaster management volunteers. Thereafter, people above 50 years and those aged below 50 with co-morbid conditions will be covered under the inoculation drive.
To a question on the timeframe of the vaccination drive, Lal said it will depend upon the availability of vaccine. The state, according to him, has the capacity to administer 4 lakh vaccines in a day.
The state has around 4,000 trained vaccinators. "If we get a large number of doses, then we can also use doctors, pharmacists, dental doctors and nurses as vaccinators," he said, adding the state has enough storage capacity for Covid-19 vaccine.
A state-level vaccine store has been set up in Chandigarh, officials said.
Punjab has already conducted a dry run for vaccination in Ludhiana and Shaheed Bhagat Singh Nagar. The mock drill of the distribution and administration of Covid-19 vaccine was being conducted in Patiala on Sunday.
Punjab has so far witnessed 1.67 lakh coronavirus cases and 5,364 deaths.
Assam's Covid-19 Toll Climbs To 1,051
Assam reported two more deaths due to Covid-19, pushing the death toll to 1,051, while the coronavirus tally mounted to 2,16,289 with 38 fresh cases, the National Health Mission said in a bulletin.
The overall positivity rate stood at 3.58% against total testing of 60,38,661 samples so far, it said.
The state reported 80 single-day recoveries, taking the total count to 2,12,069, the NHM said late on Saturday.
Assam now has 3,166 active cases and the patients are being treated at different hospitals and Covid Care Centres across the state, while some are in home isolation.
The bulletin said 1,347 more Covid-19 patients have died, but the state government's Death Audit Board has not included them in the tally of fatalities caused by the virus, as they had other ailments, too.