Transparency activist Saket S Gokhale has moved the Bombay High Court against the Drugs Controller General of India urging the urgent publication of the “safety and efficacy data submitted by Bharat Biotech for ‘Covaxin”. In his petition, Gokhale says that while claims of Covaxin being safe are abundant, the company has not made the findings available in the public domain.
In a press note issued by the Centre on January 3, the authorities claimed that the DCGI approved Covaxin for “restricted use in an emergency situation”. However, they added that while Phase I and II studies provided robust results, the Phase III trials are ongoing. Calling into question how the government can approve something without final proof of its efficiency and safety.
The second issue concerning the vaccine is the consent letter that the participant has to sign before receiving the vaccination. “In phase 1 and phase 2 clinical trials, Covaxin has demonstrated the ability to produce antibodies against COVID-19. However, the clinical efficacy of Covaxin is yet to be established and it is still being studied in phase 3 clinical trial. Hence, it is important to appreciate that receiving the vaccine does not mean that other precautions related to COVID-19 need not be followed,” says the consent form.
Gokhale, in his plea, claims that a lack of information regarding the results of the final phase impedes an individual from giving consent. Informed consent is possible when all information is provided to the subject, and anything less than that is an unethical practice. Gokhale states that such a lack of information can cause two issues. Firstly, the subject could take the vaccine and open up to risks, or secondly, remain unvaccinated and become susceptible to Covid-19.
“This incident is one example showing the potential threat to life for recipients of Covid-19 vaccines, especially when the efficacy and safety data of the vaccines have not been released in the public domain for scrutiny by independent experts which would only help in providing better feedback and making the final vaccine safe,” the plea states.
The consent form goes on to say that the Central Licensing Authority has granted permission for the sale or distribution of Covaxin for restricted use in an emergency situation in the public interest as an abundant precaution, in clinical trial mode. However, it adds. “In case any adverse events or serious adverse events, you [the subject] will be provided with a medically recognised standard of care in the government designated and authorised centres/hospitals. The compensation for serious adverse events [SAE] will be paid by the sponsor (BBIL) if the SAE is proven to be causally related to the vaccine.” Such a statement questions their claim of being “safe and efficient”.
For those of you wondering about the SAE, Norwegian officials had claimed that 23 people had died a short time after receiving the Pfizer/BioNTech vaccine in the country. The Norwegian Medicines Agency conducted an autopsy on all bodies and revealed that at least 13 had died from the severe reactions contributed by the common side effects. However, they had added that the risk extended to severely sick, elderly, and frail people. “For those with the most severe frailty, even relatively mild vaccine side effects can have serious consequences. For those who have a very short remaining life span anyway, the benefit of the vaccine may be marginal or irrelevant,” the authorities told media. However, the vaccine maker had said that the number of incidents is so far not alarming and in line with expectations, as reported by international media.
On another note, resident doctors of RML Hospital in Delhi have written to the Medical Superintendent regarding their vaccination with Covaxin. “The residents are a bit apprehensive about the lack of complete trial in case of Covaxin and might not participate in huge numbers…We request you to vaccinate us with Covishield which has completed all stages of the trial before its rollout,” the letter says.
All of this is happening while Prime Minister Narendra Modi had told Indians that the “Made in India vaccines are completely safe”.