Forced Consent and No Transparency Can Create a Backlash against Vaccines

The drug regulator’s hurried emergency clearance to Bharat Biotech’s Covaxin in clinical trial mode has been followed by the government making it integral to its mass vaccination drive. It has bought 1.1 crore doses of the Serum Institute-Oxford-AstraZeneca vaccine and another 55 lakh doses from Bharat Biotech. According to the government, neither states nor individuals will have a choice with regard to vaccines. Besides, those vaccinated with Covaxin are being “asked” to sign a consent form that says they “voluntarily” agreed to participate in a Covaxin clinical trial.

There is a push-back on the ground already. The numbers on the second day of the vaccine drive have dropped. Sections, such as resident doctors associations in certain hospitals, have expressed unhappiness over this mode of “voluntary” participation in a clinical trial. It has also added to vaccine anxiety and possible adverse effects from vaccines. 

Given the scale of a mass vaccination campaign, some adverse effects are to be expected. Some effects are normal in any vaccination, such as mild fever, inflammation at the site of the injection, etc., and some could simply be coincidences. From the 3.81 lakh health care workers who have been immunised, only 580 people reported an adverse event, only seven needed hospitalisation, and two have died. The post mortem results of one of those who have died shows he had pneumonia at the time of vaccination. According to vaccine guidelines, in his condition, he should not have been vaccinated at all.

Unfortunately, a high-decibel campaign for taking credit can result in overlooking basic safety norms required for mass vaccination. Again, we have a top-down messiah Modi type of government that led to the lockdown and untold miseries for the people without the benefit of containing the Covid-19 pandemic. This has been the problem with the Modi government’s purely administrative model of handling every problem as if it is a law-and-order issue. Pandemic control is a public health issue and requires involving all tiers of governance, from the central to the state, and even the local governments. It also needs to treat the people whose health it is trying to protect not as subjects to be bullied into submission but as partners in this vaccination drive. 

Public health experts and immunologists have raised serious questions regarding the Central Drugs Standard Control Organisation (CDSCO)’s emergency use clearance to the ICMR-NIV-Bharat Biotech vaccine along with Serum Institute-Oxford-AstraZeneca’s vaccine. Their criticism is that the drug regulator, CDSCO, violated its own guidelines under pressure from the BJP government to clear a “nationalist” vaccine—Bharat Biotech’s Covaxin—along with clearing Serum Institute-Oxford-AstraZeneca’s Covishield. The fig leaf for this clearance was that its emergency use was to be in a “clinical trial mode”. 

The drug regulator gave no details about what clinical trial means, and no further guideline on the way it was to be implemented. Neither did its parent Health Ministry elaborate how it proposed to carry out mass vaccination in a clinical trial mode.

Government officials including Union Health Minister Harsh Vardhan have now clarified that in their view both vaccines have “equal efficacy” and will be used interchangeably. How they have determined the efficacy of Covaxin without Phase 3 trial data is unfathomable. The government has also made clear that approximately 3-3.5 crore frontline health workers and 27-30 crore citizens in the high-risk category (those above 50 years or with pre-existing health conditions) who are being vaccinated will be given no choice. Neither will the state governments. Take it or leave it are the only choices, if they can be called choices. 

Serum Institute-Oxford-AstraZeneca has submitted Phase 1 and 2 trial data from India and Phase 3 trial data from other countries. Under current pandemic conditions, most country regulators have deemed this as sufficient for emergency use clearance. ICMR and National Institute of Virology, Pune, had developed the basic inactivated virus for Covaxin and given it to Bharat Biotech for further vaccine development. Bharat Biotech has conducted Phase 1 and 2 trials proving that it is safe and produces strong antibody reactions in the body. The Phase 3 trials are in an advanced stage and the preliminary efficacy data—the purpose of Phase 3 trials—are currently awaited.

Why did the drug regulator not wait a few extra weeks for the preliminary data of the Phase 3 trials to become available? Such hasty and shoddy steps damage the credibility of India’s science institutions. This will further sully an image that is already dented by cow-science, Vedic mathematics, and plastic surgeries and flying chariots in India in ancient times. Further, the anti-vaccination conspiracy theorists (anti-vaxxers), hitherto an exclusive preserve in the US, have now gained some followers in other parts of the world including India. Any attempt to force people into taking a particular vaccine could result in increasing existing vaccine anxiety, harming the vaccination campaign in the same way that the forced sterilisation campaign did during the 1975 Emergency.

What harm would have been caused by waiting the few weeks before the Phase 3 data is here, especially as current Indian figures for new Covid-19 cases are low? Second, clinical trials are conducted with volunteers. The current vaccination drive makes it mandatory for frontline health workers—either take the vaccine we give you and sign the consent form as voluntarily participating in this clinical trial; or get no vaccine. This is not the informed consent that clinical trials call for, but coercing consent. Third, on what basis are government spokespersons claiming equal efficacy for both vaccines? Phase 3 trials are primarily for finding out the efficacy of a vaccine, which Bharat Biotech is yet to submit.

Again, immunologists are not questioning that the vaccine, in all likelihood, will prove to have the desired efficacy—greater than 50%— as set out by almost all regulators in the world. Bharat Biotech is also using an inactivated whole virus. This is one of the oldest vaccine technologies available and therefore very well-proven, unlike vaccine technologies such as the mRNA vaccines from Pfizer-BioNTech and Moderna. Covaxin is similar to the Sinovac and Sinopharm vaccines that have been successfully tried and accepted by many regulators based on Phase 3 clinical trial data.

There have been attempts by western news agencies to muddy the waters regarding the Chinese and Russian vaccines. This is very much a part of the vaccine nationalism of news agencies, or their desire to advance the case of their own pharma companies. In spite of this anti-China campaign, many regulators—in Turkey, United Arab Emirates, Indonesia, Malaysia—have approved vaccines from China based on trials in their own or other countries, and started their mass vaccination drives.

There is a confusion about what, in terms of numbers, constitutes a good vaccine finding. The key finding of the Sinovac and Sinopharm trials is that these vaccines see virtually no deaths, prevent hospital admission by 100% and drop the need to visit a doctor by a whopping 78%. The 50.4% efficacy rate that has been widely reported for the Sinovac vaccine are for one mild symptom and RT-PCR confirmation of the infection. Each of these figures is important in its own right. According to Esper Kallas at the University of São Paulo’s main campus, who ran one of the major vaccine sites, any vaccine that cuts down deaths by 100% and does not need most of us to see a doctor is to be celebrated in pandemic times. 

The hurried emergency use clearance with only Phase 1 and 2 data for Covaxin raises the question of why not similar clearances to other vaccines? According WHO’s Landscape of Covid-19 Candidate Vaccines, there are 20-odd vaccines currently in Phase 3 trial, including one from another Indian company, Zydus Cadila. The Russian Gamaleya vaccine has tied up with Dr Reddy’s Laboratories and also has preliminary efficacy data from its Phase1 and 2 trials in India and Phase 3 trails from elsewhere. Are all of them to be cleared on the same basis? Or is such clearance reserved only for our “indigenous” vaccine? Or is it to declare that we have scientific prowess equal to other countries like the US, Russia, China and the UK? 

The government would do well to ponder on Sanjay Gandhi’s sterilisation drive and the damage it did to India’s family planning programme. Before the 1975 Emergency, the sterilisation rates of men and women were roughly equal. Today, 93% of sterilisation is of women and only 7% of men. The shift away from men is a backlash to the forced sterilisation during Emergency which never got rebalanced. A forced vaccination campaign can do lasting damage to vaccines, the most critical component of any public health policy