covaxin: Ideal time for booster dose for Covid vaccine is 6 months after 2nd dose: Bharat Biotech MD | India News
NEW DELHI: Bharat Biotech CMD Krishna Ella on Wednesday blamed the negative campaign against Covaxin in India, particularly in the media, for the delay on part of World Health Organisation (WHO) in granting emergency approval for its ‘made-in-India’ Covaxin.
Hinting at politics as a possible factor behind the negative publicity, Ella recalled how Covaxin, soon after it was taken by the Prime Minister to express confidence in Indian science, innovation and ‘atma-nirbhar’ capabilities, was labelled by some as a “BJP vaccine” or “Modi vaccine”.
In a Q&A session at the Times Now Summit 2021 here, Ella indicated that the nasal Covid vaccine being developed by Bharat Biotech could be taken in lieu of the second dose of Covaxin or to protect previously infected persons.
Spelling hope for a mask-free future, he said that nasal vaccine was more effective in preventing transmission of the virus as compared to an injectable vaccine, which does not reach upper lungs, and could eliminate the need for a vaccinated individual to continue wearing the mask.
He indicated that the Phase 2 trials of the nasal vaccine are done and data was being analysed. “We should expect in 3-4 months,” he said adding that Bharat Biotech was also talking to the government about using the Cowin platform for doing clinical trials.
Ella said a booster dose would be ideal at six months after receiving the second dose of vaccine, but added that a final decision was up to the government.
Probed on the long-drawn scrutiny by WHO on Covaxin, Ella said “the negative things (said about Covaxin) in the country put WHO in a little awkward position”. He said WHO wanted to be sure if it was doing right or wrong and so reviewed data more intensely, with every small issue becoming a major one.
“I think probably we are the only vaccine in WHO that has gone through so much scrutiny…We have gone through more scrutiny because of our internal systems also,” he said.
Ella rued how the anti-campaign on Covaxin — as part of which even a suicide in Bhopal was projected as vaccine-induced death and scientific journals were asked to probe – based on own projections, interpretations and ideas delayed the publications as well as WHO pre-qualification process. He said that the people, instead of criticising, could have just approached Bharat Biotech for the truth.
“But (people) making own opinion…it not only hurt us, but also the future of start-ups in the country. If somebody wants to be against the political system of the country, they can take a different angle but not on healthcare. We are neutral, we want India to succeed. We want the people to be benefited,” said the scientist-entrepreneur.
On WHO withholding approval for emergency use of Covaxin in pregnant women, Ella said though more than a million expectant mothers had been administered Covaxin safely in India, WHO was really looking at data in a clinical mode. “We are on the job. We will finish it in the next 2-3 months,” said Ella.
On bringing a vaccine for children, Ella said Bharat Biotech was the only company in the world to have done clinical trials among those between 2 and 18 years of age.
“Safety and immunogenicity is well established in this population right now. We have submitted the data to the data controller but WHO, unless the national regulatory authority approves it, will not approve,” he said.
Hinting at supply issue as one of the major constraints behind the government’s lack of decision on approval, he said: “May be government is thinking that if it is approved then every child has to vaccinated in the country. Are their enough supplies?…But for us it is a global competition…So I think the Indian government should recognise. We need quick indication from India so that we can move WHO,” said Ella.
Dismissing talk of shortcuts in grant of emergency nod to Covaxin, Ella clarified that though the approval process was hastened, no provision of the Indian law or ‘Schedule Y’ rule was violated. “If anything had been violated, I would have gone to jail by now,” he said.
The Bharat Biotech boss said that unlike other companies like Pfizer and Oxford, etc that are not into R&D and licenced the vaccine, Bharat Biotech developed the vaccine from scratch. “Had I been in the US and done all this thing, I would have been better recognised,” he said with a grin.
Hinting at politics as a possible factor behind the negative publicity, Ella recalled how Covaxin, soon after it was taken by the Prime Minister to express confidence in Indian science, innovation and ‘atma-nirbhar’ capabilities, was labelled by some as a “BJP vaccine” or “Modi vaccine”.
In a Q&A session at the Times Now Summit 2021 here, Ella indicated that the nasal Covid vaccine being developed by Bharat Biotech could be taken in lieu of the second dose of Covaxin or to protect previously infected persons.
Spelling hope for a mask-free future, he said that nasal vaccine was more effective in preventing transmission of the virus as compared to an injectable vaccine, which does not reach upper lungs, and could eliminate the need for a vaccinated individual to continue wearing the mask.
He indicated that the Phase 2 trials of the nasal vaccine are done and data was being analysed. “We should expect in 3-4 months,” he said adding that Bharat Biotech was also talking to the government about using the Cowin platform for doing clinical trials.
Ella said a booster dose would be ideal at six months after receiving the second dose of vaccine, but added that a final decision was up to the government.
Probed on the long-drawn scrutiny by WHO on Covaxin, Ella said “the negative things (said about Covaxin) in the country put WHO in a little awkward position”. He said WHO wanted to be sure if it was doing right or wrong and so reviewed data more intensely, with every small issue becoming a major one.
“I think probably we are the only vaccine in WHO that has gone through so much scrutiny…We have gone through more scrutiny because of our internal systems also,” he said.
Ella rued how the anti-campaign on Covaxin — as part of which even a suicide in Bhopal was projected as vaccine-induced death and scientific journals were asked to probe – based on own projections, interpretations and ideas delayed the publications as well as WHO pre-qualification process. He said that the people, instead of criticising, could have just approached Bharat Biotech for the truth.
“But (people) making own opinion…it not only hurt us, but also the future of start-ups in the country. If somebody wants to be against the political system of the country, they can take a different angle but not on healthcare. We are neutral, we want India to succeed. We want the people to be benefited,” said the scientist-entrepreneur.
On WHO withholding approval for emergency use of Covaxin in pregnant women, Ella said though more than a million expectant mothers had been administered Covaxin safely in India, WHO was really looking at data in a clinical mode. “We are on the job. We will finish it in the next 2-3 months,” said Ella.
On bringing a vaccine for children, Ella said Bharat Biotech was the only company in the world to have done clinical trials among those between 2 and 18 years of age.
“Safety and immunogenicity is well established in this population right now. We have submitted the data to the data controller but WHO, unless the national regulatory authority approves it, will not approve,” he said.
Hinting at supply issue as one of the major constraints behind the government’s lack of decision on approval, he said: “May be government is thinking that if it is approved then every child has to vaccinated in the country. Are their enough supplies?…But for us it is a global competition…So I think the Indian government should recognise. We need quick indication from India so that we can move WHO,” said Ella.
Dismissing talk of shortcuts in grant of emergency nod to Covaxin, Ella clarified that though the approval process was hastened, no provision of the Indian law or ‘Schedule Y’ rule was violated. “If anything had been violated, I would have gone to jail by now,” he said.
The Bharat Biotech boss said that unlike other companies like Pfizer and Oxford, etc that are not into R&D and licenced the vaccine, Bharat Biotech developed the vaccine from scratch. “Had I been in the US and done all this thing, I would have been better recognised,” he said with a grin.
