The indigenous vaccine developed by Bharat Biotech with the Indian Council for Medical Research (ICMR) will be used as a ‘backup’, only if the country needs additional doses to vaccinate large numbers of people, particularly given the possibility of an increase sudden triggered by the UK variant. And, unlike the Serum Institute of India (SII) Covishield vaccine, Covaxin will be used only in ‘clinical trial mode’, where consent will be taken and side effects monitored, the AIIMS and ICMR heads, part of the National Covid-19 task force, he told The Indian Express.
On Sunday, India’s regulator, the Comptroller General of Drugs of India (DCGI) approved the recommendation of the Committee of Experts on the subject for emergency use of Covishield and Covaxin. While Covishield is the same vaccine developed by Oxford-AstraZeneca, which was approved for emergency use in the UK, in the case of Covaxin, concerns have been raised about the lack of efficacy data, generated during the Phase 3 from human clinical trials. The decision to grant emergency approval to Bharat Biotech is based solely on immunogenicity, ability to elicit an immune response, and safety data generated in Phase 1 and Phase 2 clinical trials.
However, members of the national task force, including AIIMS Director Dr. Randeep Guleria and ICMR Director General Dr. Balram Bhargava, emphasized that the approval given to Bharat Biotech is clearly different from that of the IBS.
Said Dr. Guleria: “This is like a backup. If we find that the cases are not increasing, then we stick to IBS, until the Bharat Biotech data comes in early next month. And if that data is found to be good enough, it will get the same approval as the SII. Indirectly, looking at the safety profile, that (Covaxin) is a safe vaccine, although we don’t know how effective it is. They (the regulators) have given, I would say, a green signal to start stocking in case we need it. “
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As a vaccine using a platform used for traditional vaccines in India, targeting the entire virus for antigenic response, Covaxin is also considered by some to be more effective against any mutation.
“(Covaxin’s approval) says it can be used in an emergency situation, which means that because of what is happening in the UK, Europe and the US, in case there is a sudden increase in the number of cases in the country, and considering that we do not yet have any anti-viral medicine available against Covid-19, whether vaccination can prevent the spread of an infection, only in such circumstances – when there is a need to vaccinate a large number of people, that cannot be done using the IBS vaccine alone: Bharat Biotech could administer the vaccine, ”said Dr. Guleria.
During the vaccination test at GTB Hospital, Delhi, on Saturday.
In the absence of efficacy data, he emphasized the “abundant caution” that should be observed in the use of Covaxin. “… This will be in clinical trial mode, so there is a very close monitoring from the point of view of safety and side effects. It will not be like the usual marketing of a vaccine (for commercial use). It will be like a test, where they will be called frequently about side effects and a database will be maintained. “
The director of AIIMS compared the scientific rationale behind the authorization of Covaxin with granting approval to repurposed drugs such as hydroxychloroquine and remdesvir to treat symptoms arising from Covid-19. “We are looking at two things: safety and efficacy. If you have data that the vaccine is safe, or any drug is safe, then I would say that if necessary, we can consider using it without knowing that it would work at 20 percent or 80 percent. This is what was done even when hydroxychloroquine or remdesivir or even convalescent plasma was approved, ”Dr. Guleria said. “With regard to this vaccine, there are data that show good immunogenicity and safety.”
During the drill in Chandigarh
Dr Bhargava, ICMR director who co-developed Covaxin with Bharat Biotech, said: “In terms of efficacy data, we have done extensive work at NIV, Pune. Small animal studies, large animal studies, and monkey challenge studies have been conducted. And a big bronchoscopy study done at the ICMR for 14 days (in monkeys), where samples were taken every day and efficacy was examined, “he said.
“In the data from the Phase 1 human trials, which included 375 patients and the 380 Phase 2 participants, we did not find any cases of someone contracting Covid-19,” said Dr. Bhargava, adding that even in Phase 3, there are no security concerns. had reported 22,500 participants.
Bharat Biotech had announced the start of phase 3 trials on November 16. On Sunday, the government press release said phase 3 trials had started on 25,800 volunteers, of whom 22,500 had received the first dose. Covaxin is injected twice intramuscularly, 27 days apart. Interim security data is expected next month.
Dr Bhargava said that Covaxin’s potential to mount resistance against the new mutant strain was a key factor in granting emergency approval. “It is now present in 34 countries. Some of the vaccines only target the spike protein of the virus, and they may not be effective. From that perspective, we are looking at a whole virus vaccine (Covaxin), which can potentially have benefits, ”he said.
However, Dr Guleria conceded that more laboratory data on Covaxin is required at this point to provide protection against the new UK variant. “Bharat Biotech uses an inactivated virus, using the platform deployed in other vaccines in our country. The evidence that is being presented is that because the entire virus is being used as antigen, the antibody response may be more robust to deal with any mutation … However, we will need more laboratory data to be able to confirm this. ” he said.
“The bottom line is, if we don’t have any increase in cases, then we would use the IBS vaccine. That is what I understand after reading the recommendation. And, if there is an emergency need, in clinical trial mode and taking plenty of precautions, we can use the Bharat Biotech vaccine. Otherwise, we wait four to six weeks for the final data to be released, ”Dr. Guleria said.
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