Covaxin trials conducted with '200% honesty', says Bharat Biotech MD; new COVID-19 cases under 20,000 for 3rd day
The global efforts to curb the spread of COVID-19 got a boost in the UK, as it became the first country to administer a vaccine against the virus
Hitting out at critics questioning the Drugs Controller General of India's approval for Covaxin in the absence of data from Phase 3 trials, Bharat Biotech managing director Krishna Ella on Monday claimed that clinical trials of the company's COVID-19 vaccine had been carried out with "200 percent honesty."
The approval to COVAXIN has been questioned by industry experts and some Opposition Congress leaders who have expressed concern over the absence of Phase 3 trial data, who have expressed concern that "sidestepping" processes and giving "premature" clearance could risk lives and fuel vaccine hesitancy in India.
At a media conference, Ella said his firm has a track record of producing safe and efficacious vaccines and was transparent with all data.
"We are not just conducting clinical trials in India. We have done clinical trials in more than 12 countries including the UK," he said. "Many people are just gossiping everything in a different direction to just backlash on Indian companies, that is not right for us. We don't deserve that."
"Covaxin addresses an unmet medical need and has generated excellent safety data with robust immune response to multiple viral proteins that persist," he said.
Ella said his company had carried out "200 percent honest clinical trials" and added, "Give me one week's time, I will give you confirmed data."
The global efforts to curb the spread of COVID-19 got a boost in the UK, as it became the first country to administer a vaccine against the virus.
On Monday, the UK began rolling out the Oxford/AstraZeneca vaccine against COVID-19 . The Oxford vaccine, which also has a tie-up with the Serum Institute of India, was first administered to Brian Pinker, an 82-year-old Oxford-born dialysis patient, PTI reported.
Meanwhile, the declining trend in the number of new COVID-19 cases in the country continued for the third consecutive day on Monday. The single-day spike of cases remained below 20,000, as 16,504 new patients were reported, the Union health ministry said.
The total caseload rose to 1,03,40,469, while the recoveries surged to 99.46 lakh, according to the data updated at 8 am. On the other hand, the total toll increased to 1,49,649 with 214 new fatalities.
'Don't accuse Bharat Biotech of inexperience'
In the press conference, Ella also addressed statements from Serum Institute CEO Adar Poonawalla without naming him. Poonawalla had termed vaccines other than that of Pfizer, Moderna, and Oxford-AstraZeneca as "just like water".
Ella said, "Bharat Biotech has manufactured 16 vaccines. Don't accuse us of inexperience. We are a global company."
He added, "We do 200 percent honest clinical trials and yet we receive backlash. If I am wrong, tell me. Some companies have branded me like water." He also said the Bharat Biotech vaccine is not inferior to that developed by Pfizer.
Ella said it was wrong to say Bharat Biotech was not transparent with data and went on to cite the number of publications by the company in comparison with industry peers.
"People should have the patience to read and see how many articles we have published," he said. "We are the only company that has got such extensive experience and publication (in peer reviewed journals)."
The approval by the Indian drug regulator to Covaxin without revealing its efficacy results has been questioned by industry experts and the Congress.
The Bharat Biotech MD added that Covaxin Phase-3 efficacy data will be available by March. No interim analysis of efficacy in Phase 3 has been done so far, he said.
Defending the decision to award Covaxin emergency approval, he said the emergency use authorisation was based on 2019 rules of the Government of India and stated that even the US grants emergency authorisation to a company with good immunisation data.
Bharat Biotech was the first to identify the Zika virus and the first to file global patents for the Zika and Chikungunya vaccines, he said. "It is not correct to say that we are not transparent with data... we don't deserve the backlash."
He further said the company has already produced 20 million doses of Covaxin and is aiming to achieve 700 million doses capacity in four facilities: three in Hyderabad and one in Bengaluru in 2021.
Health experts question govt's claims of COVAXIN's efficacy
Virologist Shahid Jameel said he does believe that eventually Covaxin would turn out to be safe and show more than 70 percent efficacy.
"I say this based on the platform, which is widely used and Bharat Biotech's own track record of successfully making inactivated viral vaccines," he said.
He also said his concerns are based on the processes adopted for approving the vaccine and also on the utterances of people in responsible positions.
"If approval requires both safety and efficacy data for a representative population, Phase 2 safety and immunogenicity do not fulfill that criteria," he said.
"That is why we conduct a Phase 3. It is the closest you get to a population. Where is that data? Vaccines are not drugs. They are given to healthy people. They are prevention not a treatment. Both safety and efficacy is required," he said.
He also questioned what is an approval for a "backup"? "Does this mean that if needed, a vaccine of unproven efficacy would be used?"
He said the biggest concern is that "sidestepping" processes and poor/complex communication will fuel vaccine hesitancy in India.
"There is already evidence of that on account of fast tracked development timescales. Our country has one of the finest immunisation programmes. It will also undermine the global value of India's vaccine industry, which is first rate by any measure," he said.
All India Drugs Action Network (AIDAN) also questioned the claim that Covaxin can work better against the UK strain of the virus which is more transmissible.
"It is not clear if there is any scientific basis to claim that Covaxin will be effective in the context of infection by mutant strains when its efficacy has not been established and is currently unknown against any strain of the virus," the AIDAN said.
"The claim being propagated that the whole virion inactivated vaccine is likely to be effective against mutations of the virus is not being supported by any efficacy from the trial because no data has been generated as yet in the Phase 3 trial," AIDAN said in a statement.
SII's vaccine to be sold to Centre for Rs 300 per shot
The SII-developed vaccine, Covishield, will cost $3-4 per shot (Rs 219-292) for the Indian Government and will be priced at double that rate in the private market once such sales open up, said Poonawalla said on Monday.
The world's largest vaccine manufacturer, SII, has a licence to produce the shot and has already manufactured close to 50 million doses.
Poonawalla added that the company will start selling the Covishield to the Indian government and GAVI countries in the first stage, followed by the private market.
"We want the vaccine to be affordable and accessible to all. The government of India will receive it at a far more affordable price of $3-4 since they will be buying in a larger volume," he said.
"The efficacy results of the vaccine are quite high if it is administered in 2-doses within a gap of 23 months," Poonawalla said.
The Centre has been coordinating with the states and union territories to prepare for the vaccination drive and a country-wide dry run was successfully held on 2 January.
NITI Aayog member VK Paul said India has enough stockpile of the COVID-19 vaccine for inoculation of priority groups, including healthcare workers and frontline workers, in the first phase.
Paul, who is also the chairman of National Expert Group On Vaccine Administration for COVID-19 (NEGVAC) further said the government will soon announce its plans for the purchase and distribution of COVID-19 vaccine.
"Our first phase (of vaccination) comprises priority groups with a high risk of mortality and our healthcare and frontline workers. For them, we believe, we have enough ( COVID-19 vaccine) stockpile," he said. Paul noted that "three to four months from now, there will be other vaccines and the stockpile will be even bigger.
8 UK returnees in Maharashtra, 3 in Karnataka test positive for new strain
As many as eight returnees from the UK in Maharashtra and three in Karnataka have tested positive for the mutated strain of COVID-19 , respective state governments said on Monday.
Maharashtra health minister Rajesh Tope said that of the eight, five are from Mumbai and added that contacts of all the COVID-19 patients with the UK strain are being traced.
"Of 4,000 returnees from the UK, 43 people have tested positive for COVID-19 , out of which eight have the new variant," Tope said in a televised message, citing results of their swab samples.
"The protocol to treat them is different and they have been isolated from the other COVID-19 patients," he said. The new coronavirus variant found in the UK is said to 70 percent more infectious than the first one.
Out of the eight, five are from Mumbai and one each from Pune, Thane and Mira Bhayandar.
In Karnataka, the total number of people infected by the new strain rose to 10, state health minister K Sudhakar said.
He also said 75 people who returned from the UK were yet to be traced and the Home department and the city corporation authorities have assured to locate them soon.
On tracing of the other returnees from the UK, where the new strain has been detected recently, he said three of them have given foreign addresses and efforts were on to reach them.
Over 500 centres to be set up for Phase 1 of vaccination drive in Delhi
Work is underway in full swing to set up centres for COVID-19 vaccination in the National Capital with 500 such units to come up in the first phase. This, as the storage facility is being equipped with freezers to hold vaccines in a temperature range of 2-8 degrees Celsius.
Delhi health minister Satyendar Jain on Sunday had welcomed the approval given for emergency use of two COVID-19 vaccines, and asserted that the city government was all set for the vaccination drive as soon as any vaccine arrives.
A total of 1,000 vaccination centres will be set up. And,500-600 centres will be set up in the first phase, for which work is underway in full swing, officials said.
"We are all ready with our preparations, from storage to logistics, and on Saturday, a dry run was conducted at three sites to assess the preparedness for the vaccination roll-out. Vaccination can begin as soon as the vaccine arrives in Delhi, which we expect in a few days," Jain said on Sunday.
As part of the first phase, about three lakh healthcare workers and nearly six lakh frontline workers will get the vaccine. The city government has announced that the vaccine will be provided to people in Delhi for free-of-cost.
'Pivotal moment' says UK health secretary
The UK's inoculation drive is being undertaken as a phased vaccination programme by the National Health Service (NHS).
The Oxford jab is the second vaccine approved for rollout in the UK after the Pfizer/BioNTech vaccine.
Health Secretary Matt Hancock said it was a "pivotal moment" in the UK's fight against the virus, as vaccines will help curb infections and then allow restrictions to be lifted.
Music teacher and father-of-three Trevor Cowlett, aged 88, and professor Andrew Pollard, a paediatrician working at OUH who also pioneered the Oxford jab, were among the first to be vaccinated on Monday.
"The Oxford vaccine is a triumph of British science and I want to thank everyone involved in its development and production," said UK prime minister Boris Johnson.
"We know there are challenges still ahead of us over the coming weeks and months, but I'm confident this is the year we will defeat coronavirus and start building back better," he said.
Professor Pollard, director of the Oxford Vaccine Group and chief investigator of the Oxford Vaccine Trial, said: "It was an incredibly proud moment for me to have received the actual vaccine that the University of Oxford and the AstraZeneca teams have worked so hard to make available to the UK and the world.
COVID-19 caseload details
The COVID-19 active caseload remained below 3 lakh for the 14th consecutive day.
There are 2,43,953 active cases of coronavirus infection in the country, which comprise 2.36 percent of the total caseload, the ministry stated.
According to the ICMR, 17,56,35,761 samples have been tested up to 3 January, with 7,35,978 samples being tested on Sunday.
The 214 new fatalities include 35 from Maharashtra, 26 from West Bengal, 25 from Kerala, 16 from Uttar Pradesh and and 14 each from Delhi, Chhattisgarh and Madhya Pradesh.
A total of 1,49,649 deaths have been reported so far in the country including 49,666 from Maharashtra followed by 12,156 from Tamil Nadu, 12,107 from Karnataka, 10,585 from Delhi, 9,792 from West Bengal, 8,403 from Uttar Pradesh, 7,115 from Andhra Pradesh and 5,376 from Punjab.
With inputs from PTI
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