The indigenous vaccine developed by Bharat Biotech with the Indian Council of Medical Research (ICMR) will be used as a “back-up” only if a large number of people need additional doses to be vaccinated, particularly given the possibility of a surge caused by the UK variant.
And, unlike the Covishield vaccine of the Serum Institute of India (SII), Covaxin will only be used in ‘clinical trial mode’ where consent will be taken and side effects monitored.
On Sunday, the Indian Drug Controller General of India (DCGI) accepted the recommendation of the Subject Expert Committee on the emergency use of Covishield and Covaxin.
Although Covishield is the same vaccine as Oxford-AstraZeneca, which has been approved for emergency use in the UK, there have been concerns about the absence of efficacy data produced during Phase 3 of human clinical trials in the case of Covaxin.
The decision to grant Bharat Biotech emergency approval is focused solely on immunogenicity, the ability to cause an immune response, and the safety data produced in clinical trials in phases 1 and 2.
However, the members of the National Task Force, including Dr. Randeep Guleria, Director of AIIMS, and Dr. Balram Bhargava, Director General of ICMR, stressed that the approval granted to Bharat Biotech is distinctly different from that granted to SII.
Dr. Guleria said: ‘This is like a back-up. If we find that there is no spike in cases, then we stick to the SII until the data from the Bharat Biotech arrives early next month. And if it is found that the data is good enough, then they will obtain the same approval as the SII. The (Covaxin) is a safe vaccine, indirectly, looking at the safety profile, but we don’t know how effective it is. If we need it, they (the regulators) have given, I would say, a green signal to start stockpiling.
Covaxin is also considered by some to be more effective against any mutations as a vaccine that uses a platform used for traditional vaccines in India which targets the entire virus for antigen response.
“It (Covaxin’s approval) says that it should be used in a situation of emergency, which means that, as is the case in the UK, Europe, and the US in the event there is a sudden increase in numbers in the country and given that we do not yet have an anti-viral drug against Covid-19, vaccination can only prevent infection spread, under certain circumstances, if there is an anti-viral drug available,” Dr. Guleria said.
Without evidence of effectiveness, he emphasized the “satisfactory precaution” in the use of Covaxin. “…It will be in the clinical trial mode so that the protection and side effects are closely monitored. It’s not like the normal vaccine commercialization (for commercial use). It would be like an essay in which the side effects are often called up and a database is stored.”
In the absence of evidence on effectiveness, he stressed the “abundant precautions” to be observed in the application of Covaxin. “…It will be in the clinical trial mode so that the protection and side effects are closely monitored. It’s not like the normal vaccine commercialization (for commercial use). It would be like a trial, where the side effects will be called up regularly, and a record will be maintained.
Dr. Guleria however has acknowledged that more data from the laboratory for Covaxin to protect against the latest UK variant is required at this stage.
“Bharat Biotech is using the platform used in other vaccines in our region, using a virus inactivated. The proof is that the antibody response can be more robust because of the use of the whole virus as an antigen… But, we’ll still need more lab evidence to prove this,” he added.
The bottom line is that we will use the SII vaccine if we don’t have a spike in cases. After reading the recommendation, this is what I understand. And, if an emergency is needed, we can use a Bharat Biotech vaccine in the trial mode and take plenty of precautions. If not, we wait 4-6 weeks until the final data has been gone,” says Dr. Guleria.
