India has a good story to tell when it comes to vaccines -- it produces more than 60 per cent of all vaccines sold across the globe. Why then has India’s final approval of two Covid-19 vaccines kicked up such a storm, with many respected health experts and scientists calling it a hasty decision?
Unless you have been living under the rock the past few days, you probably know the answer. In brief, last weekend, India’s drugs regulator gave the green signal for the emergency use of two coronavirus vaccines. One, called Covishield, is developed by AstraZeneca-Oxford University and is being made in India by Serum Institute of India, the world's largest vaccine producer by the number of doses produced.
The controversy, however, is more about the drug regulator’s emergency approval to the second coronavirus vaccine, the indigenously produced Covaxin, before critical efficacy data of the third phase of clinical trials are out. Covaxin is being made by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research and the National Institute of Virology. Bharat Biotech is a well-known vaccine maker and has a track record of clinical trials in 20 countries.
But Covaxin has completed only two of the three required phases of clinical trials. The vaccine is safe. The critical Phase 3 trial, meant to test efficacy, started last November. The company expects to release the efficacy data by March.
What further complicates the situation is the drug regulator saying that Covaxin would be administered in “clinical trial mode”. This has led to questions about whether those being vaccinated with Covaxin in the immediate future will, in effect, be taking part in a clinical trial.
Why could India’s regulatory authorities not wait for a few more weeks for all the three phases of the clinical trial to be over and approved an indigenous vaccine of proven efficacy?
Till date, there is no convincing answer. Perplexingly, over the past few days, we have also been witnessing bizarre incidents such as the Drugs Controller-General of India not taking any questions from journalists at a press conference, and the two companies which have got the green signal engaging in a temporary slanging match about the merits of their respective vaccines.
All this plays havoc with public trust in oversight mechanisms when there are signs of vaccine hesitancy in the country.
How do we restore trust?
“Transparency breeds trust, and trust is very important during a health crisis like a pandemic,” says virologist Shahid Jameel, director of the Trivedi School of Biosciences at Ashoka University. “Science does not work on beliefs. Science works on data, and we still don’t have data on the efficacy of one of the approved vaccines. Science does not say it has answers to everything but there should be clear communication about what is not known, and this has to be communicated openly and transparently.”
“A common man who does not understand the difference between the different vaccines needs to be told what exactly is known and what is not known,” Dr Jameel adds. “Otherwise, there is a risk of vaccine hesitancy spreading.”
Leena Menghaney, South Asia head of the access campaign at humanitarian organisation Médecins Sans Frontières, also points out that transparency is a key component to building trust. And it is important to adopt it as a public health strategy.
Ms Menghaney cites the example of the European Medicines Agency (EMA), that has set a minimum level of transparency for itself. In many areas, the agency has decided to go beyond what the law requires. During the pandemic, EMA is implementing exceptional measures to maximise the transparency of its regulatory activities on treatments and vaccines for Covid-19 that are approved or are under evaluation. This includes making public the detailed minutes of various committee meetings. In 2019, the World Health Assembly adopted a resolution on improving the transparency of markets for medicines, vaccines and other health products in an effort to expand access. The resolution urges member states to enhance public sharing of information on actual prices paid by governments and other buyers for health products, and greater transparency on pharmaceutical patents, clinical trial results and other determinants of pricing along the value chain from laboratory to patient. A trust deficit can arise due to multiple reasons, acting independently and together.
There is a lesson from India’s victory in the battle against polio. Then too, there was a trust deficit in some quarters, though due to different reasons. While researching a report on a sudden spurt of polio cases in parts of Uttar Pradesh in 2006, I saw firsthand how lack of trust could derail a public health intervention. Official explanations attributed the spike to rumours and fear among the Muslim minority. But a visit to Moradabad, one of the worst affected districts in UP, offered nuanced insights into the reality of traditionally disadvantaged communities that have little contact with the healthcare system. Rumour mongers were exploiting grievances accumulated over years. This was among the most daunting challenges in the global battle against polio.
In a narrow bylane flanked by open sewers in Karula, in the outskirts of Moradabad, I met Muslim families who were convinced that a “geopolitical conspiracy” lurked behind the persistent attempts to give polio drops to their children. Many people told me they wanted to know why the government was so eager to protect their children against polio when it paid no heed to other ailments that struck them. There were rumours about the polio drop making male children impotent.
Frustration and rage at a dysfunctional healthcare system had morphed into irrational fear and distrust of “outsiders”, including health workers and field operatives of international agencies. Muslim clerics in some local mosques in Uttar Pradesh had reportedly opposed the polio vaccine.
Distrust was dispelled through concerted trust-building efforts by civil society, universities like Aligarh Muslim University and Jamia Milia Islamia, health officials and international agencies like Unicef, as Dr Jameel points out. Many respected Imams worked hard to build trust among communities resisting the vaccine.
Trust and transparency during a crisis mean that not only should the political and administrative leadership be decisive, it must also convincingly explain to all groups that whatever is being done is being done in their interest.
Opacity in decision-making, attempts to gloss over mistakes or polarise the populace on any count will punch holes in the trust narrative. We must not let that happen in 2021....