Union health secretary Rajesh Bhushn also said that the Centre has not banned the export of any vaccines. The country’s drugs regulator had on 3 January approved Oxford-Astrazeneca’s COVID-19 vaccine, manufactured in India by Serum Institute of India, and Bharat Biotech’s Covaxin for restricted emergency use.
As India’s coronavirus cases rose to 1,03,56,844, the Union health ministry on Tuesday said it is prepared to introduce the COVID-19 vaccine by 13 January, within 10 days from date of Emergency Use Authorisation, but added that the final decision lies with the government.
The country’s drugs regulator had on 3 January approved Oxford-Astrazeneca’s COVID-19 vaccine, manufactured in India by Serum Institute of India, and Bharat Biotech’s Covaxin for restricted emergency use.
Amid questions being raised by health experts and journalists over the approval to Covaxin in the absence of Phase 3 trial data, the Centre said that all scientific and statutory requirements have been met and regulatory norms followed for granting the authorisation.
Also on Tuesday, UK prime minister Boris Johnson postponed his trip to India in wake of the rising cases of the new virus variant and lockdown in that country. Johnson, who had accepted the invitation as the chief guest for India’s Republic Day parade, indicated that his visit would take place during the first half of this year and before the G7 Summit presided over by the UK.
No ban on export of vaccine, clarifies health ministry
Addressing a press briefing, Union health secretary Rajesh Bhushan said: “Based on the feedback of the dry-run, the Health Ministry is ready to introduce COVID-19 vaccine within 10 days from date of emergency use authorisation,” However, while responding to a question on roll-out, Bhushan said the final decision will be taken by the government.
In response to another question, Bhushan said, “The Union government has not banned the export of any one of the COVID-19 vaccines and this should be absolutely clear.”
Referring to a joint statement issued by the SII and Bharat earlier in the day, Bhushan said neither the Centre nor the vaccine manufacturers are talking on any ban on the export of vacccines.
Sounding a truce after engaging in a war of words, the two companies on Tuesday said they will work together to develop, manufacture and supply the COVID-19 vaccines in India and globally.
In a joint statement on behalf of the two companies, SII CEO Adar Poonawalla and Bharat Biotech chairman and managing director Krishna Ella announced their combined intent to develop, manufacture and supply the COVID-19 vaccines for India and the world. They also noted that the vaccines were a global public health good.
“We are fully aware of the importance of vaccines for the people and countries alike, we hereby communicate our joint pledge to provide global access for our COVID-19 vaccines,” the statement said.
ICMR DG defends Covaxin approval, explains clinical trial mode
In the briefing, Indian Council of Medical Research (ICMR) chief Balram Bhargava said that during a pandemic, restricted emergency use of vaccines is considered based on safety and immunogenicity data while phase three clinical trial is underway.
“The immunogenicity data generated through phase two clinical trial serves as a surrogate for efficacy. The Clinical Trial Rule, 2019, provides for considering phase two results to guide approval,” he said.
The New Drugs and Clinical Trial Rules issued on 19 March, 2019, clearly state that if remarkable efficacy is observed with a defined dose in the Phase 2 clinical trial of investigational new drug for the unmet medical needs of serious and life threatening diseases in the country, it may be considered for grant of marketing approval by the Central Licensing Authority based on Phase 2 clinical trial data, he said.
Industry experts and some Opposition leaders have expressed concern over the absence of Phase 3 trial data on Covaxin. The critics have cautioned that “sidestepping” processes and giving “premature” clearance could risk lives and fuel vaccine hesitancy in India.
Explaining the process followed in giving the nod to the Oxford COVID-19 vaccine and indigenously developed Covaxin, Bhargava said, “The existing pandemic situation, high mortality, available science and lack of definitive treatments were considered by the subject expert committee (SEC) on COVID-19 of CDSCO for granting accelerated approval to these vaccines, and that is in our legal provision.”
“Now the SEC guides the DCGI in the process of decision making for restricted use under emergency situation. Now we have two vaccines,” Bhargava said.
The ICMR chief said animal studies of Covishield in the UK showed that vaccine prevented SARS-CoV-2 pneumonia in monkeys and elicited good immunogenicity in mice.
The Phase one and Phase two clinical trials in 1,077 participants showed an acceptable safety profile, and homologous boosting increased antibody responses. Phase two and three in prime-boost regimen in 560 participants showed it was better tolerated in older adults than in younger adults and has similar immunogenicity across all age groups after a boost dose. The result was published in the Lancet, the ICMR chief said.
Phase 3 trials in 11,636 participants from UK and Brazil, with two standard doses, showed vaccine efficacy was 62.1 percent, in case of a low dose followed by a standard dose, the efficacy was 90 per cent. Overall, Covishield efficacy was 70.4 percent and this has been published online last month, he said.
As for Covishield’s phase two and three clinical trial in India, there were 1,600 participants above the age of 18. Their immunogenicity data is being generated, more than half is available. Covishield is safe and immunogenic and the data showed that it is “non-inferior to the UK product,” Bhargava said, adding that this was an important point that led to its approval.
As for Covaxin, Indian studies on animals such as rats, mice, rabbits, hamsters and monkeys showing excellent safety, immunogenicity. It showed robust viral clearance in both the upper and lower respiratory tract in large animals.
The Phase one and Phase two clinical trial on 375 and 380 participants respectively revealed very low adverse events, Bhargava said, adding, “It showed neutralising antibody responses equivalent to human convalescent serum, strong antibody responses to all structural proteins… three months after vaccination.”
The Phase three clinical trial will include 25,800 participants of which 24,000 have been enrolled. There are no safety concerns and (participants) have been given their first dose and more than 5,000 given the second jab, he said.
The ICMR DG said Covaxin animal studies have been published in Nature Communications and High science.” The phase one trial was being published in Lancet Infectious Diseases… and the phase two paper is under review there. They also have the protocol of phase three which is also under review by the British Medical Journal.”
“There is another important publication in the Indian Journal of Medical Research which has compared the large animal data in all vaccine products and has shown the efficacy of this as well,” Bhargava said.
Bhargava said permission for restricted use in clinical trial mode has been allowed for Covaxin, which means consent of participants has to be taken and there has to be a regular follow-up with participants.
Explaining further, he said the manufacturer of Covaxin has been requested by the drug controller to provide the protocol for the clinical trial mode and added that there will be no placebo used.
Drug Controller has requested manufacturers to provide SOPs and protocol for a clinical trial mode which means everyone will give their consent for the vaccine. There will be no placebo. There will be closer follow up: Balram Bhargava DG ICMR pic.twitter.com/OxlGrj6MHF
— ANI (@ANI) January 5, 2021
‘Indian vaccines will have to be stored at 2-8 degree Celsius’
Department of Biotechnology Secretary Renu Swarup said Covaxin and Covishield have robustly undergone immunoassay lab tests. She also said that all Indian vaccines being developed against the coronavirus will have to be stored at 2-8 degrees Celsius as the logistics have been worked out while considering temperature as a factor. The Pfizer and Moderna vaccine require a minus 70 degree Celsius (cold) chain, she said.
The Zydus Cadila candidate has been granted approval to conduct the phase-3 trial while the Biological E candidate is in its phase-1 clinical trial stage. Swarup said Dr Reddy’s Laboratories has partnered with Russia’s Gamaleya Institute and a vaccine is being developed for India targeting storage at 2-8 degrees Celsius.
They (Dr Reddy’s Laboratories) have started phase 2/3 trials in the country. They have completed the first part of the phase 2 trial on 1,000 subjects and they are now looking at interim data which is to be analysed. They also have large global trials, like the Astrazeneca and that data is also being looked at. What they are targeting is for India to try and see how it could be at 2-8 degrees, Swarup said.
Asked about Pfizer not getting approval, Bhushan said the company has been given three opportunities, but it has not appeared before the subject expert committee and added that the panel which is willing to listen to their presentation.
‘Health and frontline workers need not register’
The health secretary said Co-WIN system is made in India and for the world, and the Indian government will actively help whichever country wants to use it.
The health secretary said that healthcare workers and frontline workers need not register themselves as their database has been populated on to the Co-WIN vaccine delivery management system in a bulk manner.
But the provision of registration and editing of data would come in for the priority population groups, he said.
CO-WIN Vaccine Delivery Management System:
— #IndiaFightsCorona (@COVIDNewsByMIB) January 5, 2021
“Then the system electronically allows session allocation… the beneficiary has been vaccinated this will also be digitally captured and he would be given this information digitally that when he has to come for the next dose. They will also get an acknowledgement, a unique health ID would also be generated,” he said.
Giving more information on Co-WIN, Bhushan said it has the facility for automated session allocation, Aadhaar authentication to prevent malpractice, creation of Unique Health ID for willing beneficiaries, reporting and tracking of adverse events following immunisation, if any, SMSes in 12 languages to guide beneficiaries and vaccinators, QR code-based vaccination certificate issued after all doses, DigiLocker integrated for data retrieval and storing QR code-based certificate and a 24×7 Helpline including IT professionals.
“In case of an adverse event, to ensure its real-time reporting there is a provision in Co-WIN vaccine delivery management system,” he said.
‘No untoward cluster of UK strain’
NITI Aayog member (Health) Dr VK Paul said an optimistic scenario is emerging with the pandemic situation in India consistently improving in terms of active cases and new deaths declining.
“Let’s hope this trend will continue. In terms of the new UK mutant issue, this mutation has entered this country and 71 have been isolated which shows our capacity to mount that kind of a scientific investigation. But at the same time we have not seen the emergence of any untoward cluster in the country as of now which is reassuring so far,” Paul said.
Earlier in the day, the health ministry had put the number of cases of the UK virus strain at 58, with 20 more found to be infected with the variant. All these persons have been kept in single room isolation in designated health care facilities by respective state governments, it said.
The mutated UK strain was detected in eight samples at National Centre for Disease Control (NCDC), New Delhi, 11 in the Institute of Genomics and Integrative Biology (IGIB), Delhi, in one sample in the National Institute of Biomedical Genomics (NIBMG), Kalyani (near Kolkata), 25 in the National Institute of Virology in Pune, three in the Centre for Cellular and Molecular Biology (CCMB)in Hyderabad and ten were sequenced in the National Institute of Mental Health and Neuro Sciences Hospital (NIMHANS)Bengaluru.
India records lowest daily cases in six months
Giving COVID-19 figures in the briefing, Bhushan said the average COVID-19 recovered cases exceeded average daily new cases for last five weeks. “Daily positivity rate of COVID-19 is continuously declining and has been less than 3 percent from 23 December 23, 2020 to 5 January, 2021,” he said.
“India’s cumulative COVID-19 positivity rate has declined to 5.87 percent; last week positivity rate was recorded at 1.97 percent,” he said.
— PIB India (@PIB_India) January 5, 2021
Bhushan said of the total active COVID-19 cases presently, 43.96 percent patients are in healthcare facilities, while 56.04 percent are in home isolation.
In a statement issues earlier, the Union health ministry had said India’s COVID-19 active caseload stands at 2,31,036 and accounts for a “paltry”2.23 percent of the overall caseload. “A net decline of 12,917 cases has been recorded in the total active cases in a day,” the ministry
India recorded 16,375 new cases of coronavirus on Tuesday, the lowest in over six months,taking the country’s COVID-19 caseload to1,03,56,844. The toll increased to 1,49,850 with 201 deaths, the health ministry’s data updated at 8 am showed. The tally of recovered cases stands at 99,75,958.
The ministry said 82.62 per cent of the 29,091 new recoveries were contributed by 10 states and UTs. Maharashtra reported the highest number of 10,362 single-day recoveries, while Kerala recorded 5,145 and Chhattisgarh 1,349.
Ten states and UTs have contributed 80.05 percent of the new cases. Maharashtra reported 4,875 cases in the last 24 hours. Kerala recorded 3,021 new cases, while Chhattisgarh registered 1,147 daily cases.
The ministry said 70.15 percent of the 201case fatalities reported in a span of 24 hours are from 10 states and UTs. Maharashtra registered 29 deaths, West Bengal reported 25 and Punjab 24. said.
Johnson postpones India visit
Meanwhile, UK prime minister Boris Johnson spoke to Prime Minister Narendra Modi to express his regret over not being able to visit India as planned for the Republic Day on 26 January, said a statement.
“In light of the national lockdown announced last night, and the speed at which the new coronavirus variant is spreading, the prime minister said that it was important for him to remain in the UK so he can focus on the domestic response to the virus,” a Downing Street spokesperson said.
The two leaders underlined their “shared commitment” to the bilateral relationship, and to continuing to build on the close collaboration between India and the UK including in response to the pandemic.
Johnson’s call with Modi came a day after he addressed the nation in a televised address to plunge the country into a new stay-at-home lockdown as his medical chiefs warned that the National Health Service (NHS) was under threat of being overwhelmed by the rising infection rates.
The new rules are expected to stay in place until mid-February with a review planned based on vaccine rollout data and infection rates.
With inputs from PTI
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