The TLDR: Over the past week, we have learnt of two participants in two separate vaccine trials—Oxford and Bharat Biotech—who suffered serious complications. That’s all we know. What we don’t know is far more serious: Were these events investigated? Who conducted the investigation? And what were the conclusions? Also: why were the trials not suspended in the interim? The total lack of transparency also reveals a global double-standard—where some lives in some countries are more important than others.

Vaccine #1: Bharat Biotech

The vaccine: is called Covaxin. It uses a dead sample of the virus, which in turn triggers an immune response. Stage I human trials were held on July 15 with 375 volunteers in India. The participants received two shots, fourteen days apart. The adverse event occurred during this stage in August.

The volunteer: We don’t know much about the person other than that he is a 35-year-old male who participated in the trial in Nagpur.

The adverse event: The person developed viral pneumonitis after he was given a dose of Covaxin. 

The outcome: Bharat Biotech says he is fine and his illness was not caused by the vaccine—and that the company has paid for his medical expenses.

Point to note: The vaccine is being developed by Bharat Biotech in partnership with the National Institute of Virology—one of the government institutes that reports into the Indian Council of Medical Research. The ICMR is in charge of all government-sponsored medical research—and is leading India’s effort to fight the pandemic.

Cause for concern

One: Neither Bharat Biotech nor the government authorities revealed this ‘adverse event’ to the public. The company put out a statement only after the story leaked in the Economic Times.

Two: Bharat Biotech claims: “The adverse event was investigated thoroughly and determined as not vaccine related”—and that permission for the phase 2 and 3 trials was given only after reaching this conclusion. However, there is no indication that the trials were temporarily suspended until the investigation was complete. This is routine in vaccine trials. Both AstraZeneca and Johnson & Johnson suspended their trials when one of their trial participants fell ill.

Three: Bharat Biotech’s partnership with ICMR is itself shrouded in secrecy. As one patient rights’ organisation notes: 

“Given the extensive and continuing role of the government in developing this vaccine, the agreement between ICMR & Bharat Biotech should be made public. We do not know whether the government is retaining rights or terms for commercialisation.”

It doesn’t help that the company’s permissions have been fast-tracked without data or explanation. As Firstpost notes:

“Phase 1 of the trials included 375 healthy volunteers while Phase 2 was supposed to have double that number. However, after the event, the Phase 2 trials was only conducted with 380 participants (only five more than the first trials), where the original plan was for double that figure.”

And yet the company recently received approval to begin Phase 3 human trials with 26,000 volunteers—without publicly releasing findings of the Phases 1 and 2.

Vaccine #2: Oxford

The vaccine: It is being developed by AstraZeneca in partnership with Oxford University—and is being manufactured by Serum Institute of India, which is also conducting the human trials in India. We’ve explained how the vaccine works at length here.

The volunteer: A 40-year-old man was administered the dose as part of phase 3 trials held in Chennai. That’s all we know about him.

The adverse event: Here’s the timeline of his illness:

• The volunteer fell sick 10 days after he was given a shot on October 1.
• It isn’t clear if he received the vaccine or the placebo. But follow-up tests revealed antibodies, he was likely administered a dose.  
• On October 11, he reported a severe headache and vomited. 
• After CT scans, Covid tests, and MRI scans, he was shifted to the ICU. 
• He was released after 11 days. The hospital documents say he suffered “acute encephalopathy”—which is a broad term used to describe brain disease. 

The outcome: According to his wife, the person “is still not stable, has severe mood swings, has problems with comprehending and focusing on things, is finding it difficult to even do simple routine things like making online payments, leave alone focusing on work-related matters.” His lawyers claim that he “has to be under medical care for a long time to come.” 

His family has since sent a legal notice to everyone involved in the trial—from the Serum Institute to the Indian Council of Medical Research (ICMR) and Chief Executive Officer (CEO) of AstraZeneca. Their demand: Rs 5 crore in compensation and that the trials be halted asap.

Cause for concern

One: Each time there was an adverse event in Oxford vaccine trials in other parts of the world—the UK and Brazil—they were immediately suspended. AstraZeneca publicly disclosed all details of these events—and the data was analysed by independent investigators. None of this has happened in India. The ICMR says it is looking into “adverse reaction” but has no plans to halt the trials: “There was no immediate cause of concern at this stage.” 

Two: In India, Serum Institute instead recently claimed that the trials are “running smoothly with strict adherence to all the necessary processes and protocols. So far, there are no concerns.” And when faced with a legal notice from the volunteer, it threatened to countersue for Rs 100 crore. Patient rights groups’ are calling it a “blatant attempt at intimidation” and “to divert public scrutiny of its trial.” 

Three: The most alarming bit is that government officials appear to be passing the buck:

“‘In the UK, the sponsor, not the regulator, halted the trial. Investigation found the matter was related to the vaccine. The DSMB (Data and Safety Monitoring Board) will get the data from the sponsor,’ said a government official, adding the lead investigator could not stop the trial without a decision by the sponsor.”

This is patently absurd. When AstraZeneca halted its UK trial, the Drugs Controller General of India (DCGI) issued a show-cause notice to the Serum Institute threatening to suspend the India trials. And yet when it comes to an “adverse event,” the government is staying wilfully mum—refusing to release any data despite repeated inquiries.

Added points to consider: Global experts are unhappy with AstraZeneca’s data from its phase 3 trials in the UK and Brazil. WHO certainly isn’t convinced that it proves that the Oxford vaccine works. And yet, the Serum Institute plans to apply for emergency authorisation in India within two weeks. Oh, and AstraZeneca has refused to comment —a luxury it would not have in the UK or the US.

The bottomline: The other two major vaccines—Pfizer and Moderna—have established 95% efficacy. All the wealthy nations have pre-booked their available vaccines. The UK just bought another 2 million jabs of Moderna. These countries may not care if the Oxford vaccine—which is the only leading candidate for India and the rest of the world—works or is safe. But at the very least, our government should.

Reading list

The Print has the most details on the Oxford vaccine volunteer. Firstpost has the same for the Bharat Biotech case. The Telegraph has the response of patient rights groups on the lack of transparency. Mint looks at how the Oxford vaccine can fix issues with its trial data—we explained these issues here. We also flagged early problems with the ICMR and its attempts to accelerate Bharat Biotech’s trials.