the big story

WTF is going on with the ICMR?

The TLDR: Last week, the Indian Council of Medical Research wrote a letter to 12 hospitals conducting human trials for a ‘made in India’ vaccine called Covaxin. The demand: get it ready by August 15 (which is—not coincidentally—Independence Day, when the PM traditionally makes his laal kila speech). 

The outlandish deadline had medical experts up in arms. And the ICMR is now in damage control mode. We take a closer look at the council and its role in fighting the pandemic—and whether this incident indicates a serious cause for alarm.

First, tell me what ICMR does

The ICMR is a hallowed institution that is in charge of all government-sponsored medical research—and was first established as the Indian Research Fund Association in 1911. It has led the medical research effort on every major communicable disease we have experienced since then—be it plague, cholera or smallpox. And it’s taken the lead again in our fight against the coronavirus.

So they know what they’re doing, right?

Yes, the ICMR is very good at what it does: medical research. But there is increasing concern that its scientists have turned into babus—addicted to red tape, protective of turf, and susceptible to political pressure. Here are some red flags that have popped up since the pandemic broke:

Lack of testing: The ICMR has dragged its feet on testing from the very start of the pandemic—right when it was critical to stemming the spread. And for many critical months, it did not allow private labs to conduct tests—which created a massive backlog. Even now, its rules for the use of rapid Covid tests restrict their widespread use. Also: Many India-made testing kits are yet to make it to the market because of that famed red tape.

Lack of data: The ICMR gets its Covid numbers from the labs—which have become increasingly sparse on the details. The daily announcements have zero information on the number of serious cases, age or gender, patterns of infection. And that data is not shared with other medical institutions that are on the frontlines either. 

Lack of expertise: The National Centre of Disease Control is actually in charge of surveillance and tracking of infectious diseases at the national, state and local level. And it created the Integrated Disease Surveillance Programme during the big outbreak of SARS just for exactly this purpose. The IDSP published a weekly report of outbreaks on its website—until early February, right before the outbreak! 

The NCDC has since disappeared from the scene, as has its data. The ICMR has instead been left mysteriously in charge. According to leading epidemiologist:

“The ICMR has a task force headed by a paediatrician, a cardiologist, and a pulmonologist. They are clinicians with no background and training in epidemiology but are leading the task force. It has become a rubber stamp for the government’s decisions.”

What’s any of this to do with Covaxin?

The vaccine: Let’s start by telling you about Covaxin. 

• The potential vaccine is being developed by Bharat Biotech India in partnership with the National Institute of Virology—one of the government institutes that reports into ICMR. 
• NIV isolated a strain of the virus to the company—which in turn has created a vaccine that uses an inactive sample. 
• Translation: the virus is dead when it’s injected into the patient. But it will still trigger the body to produce antibodies—which in turn leads to immunity. 

The stages of testing are roughly as follows:

• A potential vaccine is first tested on animals to see a) if it is safe and b) if it triggers an immune response. Then there are multiple rounds of human trials on volunteers. 
• The first round is conducted on a small sample of 10-plus people to check if it is safe for human use. 
• The next round has 100-plus volunteers and focuses on dosage—how much to administer and with what frequency.
• The third round of human trials requires a very large sample size, and is typically conducted in an area with a large number of Covid cases. There is a group that gets the placebo, while the other receives the vaccine. Then you wait and see whether the drug actually protects those who were vaccinated.

Point to note: This process usually takes between 6-10 years—as scientists move carefully from one stage to another! But in the case of the coronavirus, both governments and scientists are rushing to get a vaccine ready by the end of the year—in less than 12 months of sequencing the virus’ genome. 

A second point to note: Only 10% of all potential vaccines successfully pass the human trial stage.

But Covaxin will be ready by August 15?!!

It will certainly take a miracle to make that happen! Covaxin has just successfully gone through the animal trial stage—and has just been approved by the ICMR for human trials. In other words, it hasn’t even conducted that first phase to test whether it is safe for human use. 

Er, what’s ICMR smoking?

We’re not sure:) The letter sent to the 12 hospitals selected for human trials insisted the vaccine had to be ready for “public use” by that date. And it took a distinctly threatening tone: 

“Kindly note that non-compliance will be viewed very seriously [emphasis in the letter]. Therefore, you are advised to treat this project on highest priority and meet the given timelines without any lapse… This is the first indigenous vaccine being developed by India and is one of the top priority projects which is being monitored at the topmost level of the Government.”

To be fair: In its application for human trials, Bharat Biotech laid out a much longer 15-month schedule for its trials. 

This is worrying…

Yes, and it compromises the Indian scientific community and Bharat Biotech—which has delivered more than 4 billion doses of vaccines worldwide, has developed vaccines for H1N1 and rotavirus, among other diseases. In the words of one researcher:

“The (ICMR) letter could turn India into a laughing stock in the vaccine community. India’s vaccines enjoy high credibility worldwide. This letter will provide an unwarranted opportunity to raise questions about the safety and quality of vaccines from India.”

So where are we now?

ICMR has walked back its August 15 deadline. Irony alert: the council defended its original directive as “meant to cut unnecessary red tape” and protect the vaccine trials from “slow file movement” typical of medical bureaucracy.

The bottomline: The reality is that the first vaccine is unlikely to be developed in India. The frontrunner—being developed by AstraZeneca and the University of Oxford—is already at phase III of human trials. But if our national pride requires consolation, one billion doses of this vaccine will be manufactured and distributed by Pune-based Serum Institute. Maybe the PM can talk that up on August 15.

Reading list

• Science Chronicle offers the best, in-depth critique of the ICMR letter—and the problem with speeding up human trials. 
• BBC News offers a good overview of Covaxin and this BBC video offers an excellent summary of what it will take to develop a Covid vaccine. 
• The Telegraph has the pushback from Indian scientists. 
• Caravan did an excellent report on the problems with ICMR, NCDC and testing data. 
• Voice of America has an animated guide to how vaccines are developed. 
• A related must read: Huffington Post flags serious issues with the ventilators bought by the PM-CARES fund.