Can the clause for a ‘compassionate use’ be invoked to fast track Indian corona vaccine trials?

No one in the world has ever created a new vaccine in four months, but then again, nothing is impossible either.

By Pallava Bagla 

India First, and India can do it! Can vaccines be denied to 1.3 billion people? Much is being made out of the effort made by India’s top medical research body to try and expedite the availability of a vaccine against the dreaded novel coronavirus.

With over 700,000 corona cases, India is already ranked number three in the world, and there is no end to the pandemic in sight. Can’t ‘compassionate use’ of a new drug or vaccine be invoked? Public health emergency needs out of the box solutions bereft of usual bureaucratic lethargy, but with zero compromises on science. After all, people who are part of the vaccine trial have rights and need full protection. However, at the same time, patients who are suffering also have human rights. There is a crying need for a safe vaccine since no drug is working against the Covid-19 disease.

There is always a possibility of this, by way of the Indian government invoking WHO’s clause of Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI), an ethical protocol developed by the World Health Organisation to evaluate the potential use of experimental drugs in the event of public health emergencies. Do Indian corona vaccines meet those criteria? That, the ministry of health and family welfare can decide, but no one can doubt that India is struggling with a public health emergency of unprecedented proportions; prime minister Narendra Modi has already called for a ‘war on corona’!

In April, the Indian economy had reached the hospital itself. So much so that a Rs 20 lakh crore immunity booster shot was injected over a week in five doses by the finance minister.

Now, the July 2 announcement indicates that the prime minister wanted India’s corona vaccine to be ready by August 15. Possibly part of the “Modi hai toh mumkin hai” approach. Can it be done? No one in the world has ever created a new vaccine in four months, but then again, nothing is impossible either.

Dr Balram Bhargava, head of Indian Council of Medical Research (ICMR), on July 2, had written to 12 hospitals that have been selected for the corona vaccine trial, “to treat this project with the highest priority” and initiate subject enrolment no later than July 7, so that vaccine can be launched for public health use latest by August 15. The letter also warns that “non-compliance will be viewed very seriously”. This artificial deadline to make possible a profound announcement from the Red Fort on Independence Day by the prime minister that the indigenous vaccine is ready for ‘public health use’ was certainly uncalled for.

Efforts to try and meet the needs of political pronouncements are not the way science works. The failure of Isro’s Vikram lander is a case in point, where insiders claim that the Indian space agency fast-tracked the Chandrayaan-2 mission for garnering political brownie points!

Today, even the worst critics of Bharat Biotech Ltd want Dr Krishna Ella to succeed. Can vaccine trials be expedited without compromising scientific and health rigour, do they really have to cost $1 billion per trial? To bring affordable medicines, vaccines and medical devices into the Indian aatmanirbhar market place, the nexus and cartel of the big pharma that has made drug and vaccine trials completely out of reach for the poor needs to be broken once and for all. The emergency of the pandemic offers one such opportunity. I have been arguing, for the last decade, to bring down the cost of drug trials without reducing the rigour and without lowering the ethical accountability. Modi should announce a new mission on affordable medicines.

I recall the helpless faces of patients who met many of us at All Indian Institute of Medical Sciences (AIIMS), New Delhi a few years back. These patients needed new drugs, but since clinical trials had become exorbitantly expensive and unaffordable, they were dying. The desperation I saw on their faces brought tears to my eyes. Today, 130 crore Indians are desperate for a vaccine against the novel coronavirus.

India is already a global powerhouse for generic drugs and vaccines; can it also conduct ethically correct drug trials? In my opinion, the 21st century New India should shun the attitude that gullible Indians will be made guinea pigs. There are enough independent watchdogs and whistleblowers to ensure that 1.3 billion Indians are not taken for a ride.

Indians who want protection against the novel coronavirus also have rights. No easy choices for the policymakers either decision—to give or not to give— which is a double-edged sword.  If the Zydus vaccine for Covid-19, ZyCoV-D, or Bharat Biotech’s vaccine, named Covaxin, or any of the five other candidates, offers a glimmer of hope, give it an opportunity. After all, we are living amidst an unforeseen health emergency, a pandemic. If, in sheer desperation, the head of ICMR seeks early results, is that wrong? The language of the letter could certainly have been gentler.

On July 4, a statement released by ICMR says “in the larger public health interest”, it is important for ICMR to expedite the clinical trials with a promising indigenous vaccine. All other vaccine candidates across the globe have been similarly fast-tracked. ICMR’s process is, thus, in accordance with the globally accepted norms to fast-track the vaccine. Now, that preclinical studies have been completed successfully, the letter was meant to cut unnecessary red tape, without bypassing any necessary process and speed up recruitment of participants.’

Even the world’s most respected drug regulatory agency the Food and Drugs Administration (FDA) of USA has provisions for ‘compassionate use’, and there have been occasions when drugs and vaccines have been administered with no trials having been done! Merck’s vaccine against Ebola was administered to humans without any regulatory clearance!

“Sometimes called ‘compassionate use’, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available” is the FDA description for such cases.

Today, there can be no doubt that 1.3 billion Indians stare at a nasty future as Covid-19 cases increase almost exponentially. The government and the Central Drugs Control Organisation can always invoke legal provisions which are variously called ‘special access, temporary vaccine or MEURI’.

Incidentally, on June 5, the ministry of health issued a gazette notification on application for import of unapproved new drug for compassionate use for the treatment of patients by hospitals or and medical institutions. Today, when many experts have said the Indian economy is already in the intensive care unit, the government and or the Supreme Court could well be in their rights to ask for ‘compassionate use’ of vaccines that hold promise. Armchair ethicists and bleeding heart activists should also ask potential patients who may be denied the right to a safe vaccine unless it is fast-tracked, keeping safety in mind. Corona haarega, desh jeetega!

The author has reported about pandemics since 1994. Co-author ‘Bridging the Communication Gap in Science and Technology: Lessons from India’