Virologists weigh the ethical pros and cons of the unprecedented race against time to develop an antidote for the novel Coronavirus
Medical experts and virologists have expressed concern over AstraZeneca, which is working in collaboration with the Oxford University to develop a COVID-19 vaccine, seeking exemption from liability and asking for indemnity from possible side-effects of their vaccine for four years.
Delhi-based Dr Jacob Puliyel, erstwhile member of The National Technical Advisory Group on Immunisation (NTAGI), said, "Actually, AstraZeneca should ask for indemnity if vaccine produces a reaction and doesn't work against the disease, because that is what the trials are showing. The government should compensate and the company should take profits. It is a brilliant business model and any government fooled into signing such indemnification deserves what it gets.
Dr Jacob Puliyel, former member, NTAGI
Dr Jacob added, "The trial itself was a matter of concern as the drug produced so much reaction that they changed the study protocol midway to add paracetamol for the recipients. This has been reported in the Lancet (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31604-4/fulltext). Its effect was studied on 10 people given two doses. The second dose did not increase cellular immunity needed for protection against COVID-19. This was discussed brilliantly in this week's Highwire programme (https://thehighwire.com/watch/)."
"Conventionally, developing new vaccines takes over a decade. From what I know, this is the first time an indemnity clause is being introduced. It is questionable and against medical ethics. Any adversity will erode 'vaccine confidence' and increase the incidence of 'vaccine-preventable diseases', especially in developing countries," said a pharma expert.
Also Read: Coronavirus outbreak: Maharashtra reports 9,509 new COVID-19 cases, 260 deaths
Representation pic/Getty Images
Dr Wiqar Shaikh, senior allergy and asthma specialist, said, "AstraZeneca has sought indemnification against both side effects and mortality. In the US, the Public Readiness and Emergency Preparedness (PREP) Act 2005 exempts pharma companies from liability. Only exception is when a victim can prove wilful misconduct by the manufacturer. No such act exists in India."
"It is imperative that a pharma company demonstrate the effectiveness and safety of a vaccine before introducing it for India's 1.36 billion people. Such blanket indemnity to any company is not acceptable," Dr Shaikh.
Stuti Galiya, solicitor
Dr Ketan Vagholkar, professor of surgery at D Y Patil Medical College, said, "Indemnification of a vaccine in evolution is unheard of. The COVID-19 vaccine is still not fully developed. Therefore, its protective efficacy, short-term and long-term side effects/complications are yet to be defined."
Dr Vagholkar added, "This impulsive measure indicates growing pressure from governments of developed nations to allow indemnification as a damage-control measure to cover up their mistakes. It appears there is a rat race among pharma giants to develop a vaccine without a sound scientific basis for financial benefits. Patients will be helpless sufferers of this indemnity concept," Dr Vagholkar said.
Dr Ketan R Vagholkar, professor of surgery at D Y Patil Medical College
'No problem with indemnity'
Globally acclaimed virologist Dr T Jacob John, from Vellore, Tamil Nadu told mid-day that technically, such indemnification is called 'hold harmless exemption' from any legal liability, in case anything goes wrong in India.
"If someone is making a donation, it is presumed that the intent was good and not to cause any harm. Any legal complication arising out of such action is usually exempted for the country or the donor."
Dr T Jacob John, virologist
Dr John added, "While the Oxford University and AstraZeneca won't be liable for side effects, any Indian company, procuring or manufacturing the said vaccine, won't have the exemption. The Drug Controller General of India hence had directed that the COVID-19 vaccine trial should have a repeat phase 2 in India before going for phase 3. This is called a 'bridging study' to ensure safety and efficacy."
No law for compensation
Solicitor Stuti Galiya told mid-day, "Most countries have specific vaccine compensation programs for compensation to victims in case of injury, harm or death. In India, there is no specific law. The only option for an aggrieved party is to file legal proceedings under general laws."
Galiya added, "The courts have in various cases stressed that the possibility of side effects in any vaccine cannot be completely ruled out. Under the Constitution, it is the government's responsibility to meet such eventuality or liability-related claims. In case of medical negligence in handling, health care providers can be taken to court under consumer protection laws."
"Since the COVID-19 situation is unique, it is important that India draws insights from other countries that have compensation laws," Galiya said.
10
No. of years it normally takes to develop a vaccine against infectious viruses
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