A network of doctors from across the country has alleged that emergency urgent authorisation (EUA) approval given to the vaccines — Covishield and Covaxin — is beset with “several irregularities” and asked the Government to make public all the relevant vaccine data.

“This would enable scientists and health workers to make informed choices regarding administration of vaccines for self and community in general,” said the medical professionals under the banner of the Progressive Medicos and Scientists Forum (PMSF).

The doctors have demanded the rollback of approvals for EUA and choice be given to the healthcare workers (HCWs) to choose the vaccine without any fear or riders such as linking vaccinations with travel advisory restrictions.

“Better approach will be to have an option strategy rather than opt out strategy. The continuation or eligibility for working as HCWs should not have any precondition of Covid vaccination, as is being done in a few countries,” said PMSF president Dr Harjit Singh Bhatti in a memorandum to the Government.

Also, the forum said the clinical trials phase-3 data should be evaluated in transparent manner as and when available for India for both vaccines and the decision to grant EUA may be revisited once the phase 3 trials are completed.

The DCGI had early this month gave EUA to the two vaccines developed respectively by Serum Institute of India and Bharat Biotech following which vaccination drive has been launched in the country from January 16.

However, the forum alleged that the whole process of vaccine authorisation has been highly opaque and apparently unscientific.

“The unethical manner in which the clinical trials for Covid vaccine have been conducted in India has cast a shadow on the whole scientific research and innovation in the country. The blatant violations of nearly all procedures of trial have now been well documented but still, the Government went ahead with approval of the vaccines,” it said.

“The HCWs should have the option of choosing between the two vaccines (or from amongst more as and when they come) as the efficacy profile and also safety profile of the two vaccines currently on offer differ widely.

“In case of any Severe Adverse Effect (SAE), the cost of healthcare and indemnity should be covered and a transparent mechanism for same to be established,” it added even as it questioned the inclusion of all HCWs and also all individuals above 50 years of age for priority group of vaccination.

“Current evidence warrants inclusion of only HCW engaged in high-risk procedures and individuals above 65 years age. The ambit of priority groups seems to have been expanded under market dynamics and not based on risk assessments,” said the doctors.