Health Ministry Refuses to furnish COVID Vaccine Safety Data

On January 03, the Government of India approved the AstraZeneca-Oxford COVISHIELD vaccine, manufactured by the Serum Institute of India (SII) and COVAXIN, developed by Bharat Biotech and Indian Council for Medical Research (ICMR). Both had been provided green signal for restricted emergency use in “clinical trial mode”, the term which many experts say they have never heard before.

Many were concerned about the safety and efficacy of the two vaccines. Many wondered as to how such approval could be provided, especially for COVAXIN which is yet to provide data on its safety and efficacy from Phase 3 trials. Now, to an RTI filed by me that sought copies of the data and evidence-based on which the approvals were provided, the Union Health Ministry’s Central Drugs Standard Control Organisation (CDSCO), which had finally approved these vaccines, has refused to furnish any information for the same. It claimed exemption under Section 8(1) (d) and (e) of the RTI Act.

The former clause allows a public authority to withhold any information that is in the nature of ‘commercial confidence, trade secrets or intellectual property, the disclosure of which would harm the competitive position of a third party’. And the later clause allows withholding of information that is held by a public authority in a ‘fiduciary relationship’. It must be noted here that both these clauses come with an overriding provision. It says that any information must be provided if ‘the competent authority is satisfied that larger public interest warrants the disclosure of such information’. Not only this, but as per Section 8(2), any and all exemptions provided under the RTI Act can be overridden ‘if public interest in disclosure outweighs the harm to the protected interests’. Further, the CDSCO has simply claimed blanket exemption and has not provided details like which third party will be affected and how. As per many Central Information Commission (CIC) rulings and Court orders, any public authority invoking exemption clauses need to furnish solid reasons for doing so.

Also Read: Questions and Concerns Regarding the Covid 19 Vaccine Roll-out

It is a known fact that Bharat Biotech’s COVAXIN third phase human trials are not yet over. There have been credible media reports of adverse side-effects experienced by some individuals who took a jab of the vaccine, including some that are of serious nature. A few deaths have also occurred, though both the Company and the Health Authorities have denied any link with vaccination. In such a situation, it should be of utmost priority for the Government of India to do all that it can to reassure people about the vaccines and provide answers to all their questions. This will only increase public confidence in the vaccines. However, what we are seeing now is the Government placing private interests above public interest, thus not serving any public good.

In many parts of the country, even healthcare workers are out-rightly refusing to inoculate themselves with COVAXIN, and they cannot be blamed. The responsibility here lies with the Government of India. This also has to be looked at from another angle. For a separate RTI query of mine, the CDSCO said that it has no information on who will be liable for any adverse reactions or deaths due to the vaccines and went on to add that “however, any individual has to assess the risks and benefits before using COVID-19 vaccine”. Now if we look at this response and the other response in toto, they seem to be directly contradicting themselves. Citizens want to do this “assessment” of the vaccines and therefore asked for the data, but the Government says it will not provide. One can only hope now that the CIC and the Courts overrule this stand taken by the Government when I challenge the denial of information.

Saurav Das is an independent journalist and RTI Activist. He tweets at @OfficialSauravD.