Covaxin approval: Embargoed information

We are in a euphoric mood. An “Atmanirbhar Bharat” has demonstrated to the world that we are not only a pharmaceutical but also a vaccine giant. Two of our vaccines are declared to have met required safety and efficacy standards and approval given for their `Restricted Emergency Use’. The Drug Controller General of India (DCGI) granted approval based on the recommendations made by Subject Expert Committee (SEC).

The august technical body has to make its recommendation based on undisputable facts and figures which can be peer-reviewed and challenged by competent professional colleagues. That is the norm internationally among the scientific community for centuries. Then why such a secrecy on the clinical trial results?

One among the various spin-offs from this Covid pandemic is the global solidarity in sharing information on gene sequencing, epidemiological patterns, testing, containment strategies as well as treatment protocols. In vaccine development, testing, administration etc, this positive trend is not to be compromised. India should not be blamed for such an opacity in vaccine trials.

We have seen so many drugs and treatment protocols originally suggested were later replaced or thrown off from the recommendations. Hydroxyquinoline, Azithromycin, Oseltamivir, Lopinavir/Ritonavir, Remdesivir, Convalescent Plasma, Monoclonal antibodies like Tocilizumab etc, were disappearing from the regimes globally as randomised controlled trial results were reviewed. Only high flow nasal oxygen, low molecular weight heparins as anticoagulants and Corticosteroids in severe cases proved to be beneficial for Covid patients.

Why can’t vaccinology be free from political jingoism? We have seen how Director General of ICMR quickly withdrew his statement of launching Covid vaccine on August 15, 2020. Now, UP Chief Minister is announcing the launch of vaccination on Makar Sankranti.

The 70.4% efficacy of Covishield (Astra-Zeneca- Oxford-SII vaccine) is an average based on trials on 23,745 global participants, mainly in Brazil and UK, but we don't know the results of specific trial among 1,600 Indian volunteers. The DCGI claims that the safety and efficacy results among Indian volunteers are comparable to the global results. It may be true fully or partially. Everything is trust-based under a patriarchal benevolence of the ruling government.

Covaxin, produced by Bharat Biotech, was injected to 22,500 volunteers safely up to date, but there is no mention about efficacy data in the press release. Phase-3 trials are currently ongoing and it is too early for the data to meet the criterion for an interim analysis. Even the recruitment of originally planned volunteers are not complete.

The only human data available on safety and immunogenicity is from 755 participants in Phase 1 & 2 trials. The objective of a bridging study to assess the vaccine candidate in an Indian population would be undermined if the data generated from the Indian trial is not reviewed in the process of regulatory approval. On what basis Restricted Emergency Use Authorisation was recommended by SEC to DCGI is a mystery.

This would amount to rolling out an untested and unproven vaccine to the public which is unethical. Who will be accountable to the reporting of severe adverse events, if it occurs in large proportions? Isn’t this premature sanction of approval for Covaxin, a violation of the criteria in the draft regulatory guidelines for development of Covid-19 vaccines published by Central Drugs Standard Control Organisation on September 21, 2020?

We do not know what the efficacy estimates for the different dosing regimens and dosing schedule that was followed during the trial and that will be recommended for future. Is it a single dose or two doses, four weeks or 12 weeks after first dose? In any case, it should align with the principles of rational use of medicines and medical technology including vaccinology. Without data, any orders on dose or schedule are irrational.

The vaccine roll out plan has prioritised health staff, police and front line service providers to be immunised first. When doctors and nurses have to take the lead to organise immunisation sessions and receive themselves the new vaccine still in Phase-3 trial, they need to be taken into confidence by providing full information on the status of risk versus benefit of the vaccine. They need to be the first converted before they attempt converting others to accept the vaccine.

The government is planning a massive communication campaign to overcome the possible vaccine hesitancy. No print, electronic or social media campaign, however expensive, is going to succeed without evidence-based scientific information. Professionals should back up the campaign with conviction. Already, medical staff have started losing faith in the autonomy of our scientific decision-making bodies. Sooner the government realises it, the better.

Under the norms of Rights of the Patient, the individuals who get vaccinated should get detailed information about the vaccine for an informed consent. The providers should disclose that this vaccine candidate is under authorisation for a Restricted Emergency Use and as of now, there is lack of finalised efficacy data as it is still in Phase-3 trial.

After taking informed consent, the individual gets vaccinated and she/he should get the benefit of provisions under the law that apply to clinical trial participants such as compensation for adverse events, ethics committee oversight etc. Norms and modalities of payment of such compensation must be clear at the outset.

When India is going to be the global vaccine manufacturing hub of the world with its technical capacity and infrastructural strength, we need to maintain global standards of quality and efficacy of vaccine. Any dubious measures like withholding efficacy data is going to sabotage our marketing potential. We need to capitalise on our existing negotiating power built on credibility.

The decision to approve an incompletely-studied vaccine, even under accelerated process, and probably with good intentions, raises more questions than answers. This censoring of data or veiled wall leading to murkiness, gives scope for rumours. Openness and transparency in sharing information will minimise vaccine hesitancy and boost the image and credibility of a democratic nation like ours.

(The writer is a consultant in public health in Kochi and an Independent Monitor for National Health Mission)