Recommendation to drug controller for emergency approval to India’s indigenous product against COVID-19
CORRECTION: This story was published on the Down To Earth website on January 2, 2021. One line mentioned that the Oxford vaccine uses the m-RNA platform. In fact, the vaccine uses the adenovirus platform. The line has been removed. The error is regretted
Independent scientists and experts working with the Union government expressed concern at an expert panel’s recommendation to grant emergency approval to Bharat Biotech International Limited vaccine, Covaxin, against the novel coronavirus SARS-CoV-2.
The subject expert committee (SEC) constituted by the Central Drugs Standard Control Organisation gave such a recommendation January 2, 2021 to the Drug Controller General of India, who will take the final call.
Covaxin is India’s first indigenous vaccine manufactured by Bharat Biotech. Indian Council of Medical Research (ICMR) is co-sponsoring it.
The Union Ministry of Health and Family Welfare in a statement said the SEC has recommended Covaxin “for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by mutant strains”.
This, however, has left experts confused. First, the statement did not say anything about the interim efficacy data of phase 3 trials on Covaxin. No such data has been released by Bharat Biotech as well; other vaccine manufacturers that have claimed a certain efficacy did so either through press releases or peer-reviewed papers.
The proposal by Bharat Biotech was discussed in an SEC meet January 1, when the latter asked it to submit the interim efficacy data. In fact, the Clinical Trial Registry of India clearly says that the recruitment of phase 3 trial participants was ongoing.
It is not possible to generate interim results during this stage.
Down to Earth sought clarification on what changed in one day from the Union ministry, but did not get any suitable response.
Covaxin will use an inactivated virus platform — it will inject inactivated or killed virus in the body against which the immune system triggers a response.
The Union government’s statement pointed to the fact that a few COVID-19 vaccines use messenger Ribonucleic acid (mRNA) platform that has spike protein. The United Kingdom recently reported a mutation in the S gene found in the RNA of the virus. So the government statement intended to give the message that since Covaxin does not use mRNA platform, it would work better in the case of mutations.
The chair of National Expert Group on Vaccine Administration for COVID-19, VK Paul, has also made a similar argument in his interviews.
Vaccine expert Gagandeep Kang said: “What data do they have to say this? Is it a part of their trial?”
The reference to ‘mutant strain’ in the government statement was questionable, she said, for it implied if policymakers have concluded that mRNA vaccines do not work.
A senior expert on the Union government’s COVID-19 panels told Down To Earth on the condition of anonymity that the argument of inactivated vaccines providing a better alternative was made out in a couple of meetings.
“However, a prerequisite was the availability of primary efficacy data. Only after that the theoretical hypothesis of inactivated vaccines doing better should have been made out. I am surprised how the government picked up one part of the argument as per its convenience and ignored the other,” the source said.
The source added that the January 2 decision was a move taken in a state of panic. “The number of cases of COVID-19 is coming down in India. If the trend continues, Bharat Biotech will find it difficult to complete the trials due to lack of participants. Also, once SII vaccine gets license, trial participants may decline,” he said.
Both experts said they did not understand what the Union ministry was trying to convey through use of terms such as ‘clinical trial mode’, ‘public interest’ and ‘abundant precaution’ regarding approval to Bharat Biotech vaccine.
Experts also warned that the decision may lead to distrust among people regarding vaccines and that it may become difficult for the Union government to defend it in the international fora.
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