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COVID-19 Vaccine Updates
With input from Dr Monica Vasudev
1135: HCFI Round Table Expert Zoom Meeting on “What to do when opinion differs regarding usefulness of a particular drug in presence of varying scientific reports!”
31st October, 2020, 11am-12pm
Participants: Dr KK Aggarwal, Dr AK Agarwal, Dr Jayalal JA, Prof Mahesh Verma, Dr Suneela Garg, Dr Anita Chakravarti, Dr RK Mani, Dr Jayakrishnan Alapet, Dr SK Singh, Mr Bejon Mishra, Ms Upasana Arora, Dr KK Kalra, Dr Uday Kakroo, Dr Anil Kumar, Ms Ira Gupta, Dr S Sharma
Consensus Statement of HCFI Expert Round Table
- In almost all countries, there is a second wave of coronavirus infection. South Korea, UK, Russia, Japan, Iran, Hong Kong, Spain, Malaysia, and Australia are experiencing a second wave of the infection. This second wave comes on an average 3-4 months after the first wave; it is denser, bigger and will last longer than the first wave.
- USA is in the midst of a third wave, which is bigger than the second, which was bigger than the first wave. In India, Singapore, New Zealand, Bangladesh, the first wave is still persisting interspersed with spurts of cases.
- The message about the possibility of a second wave should come from the government.
- This observation, akin to “market forecast” in management language, raises an alert that we need to prepare for the next wave. The citizens should be made aware of the dos and don’ts to tackle these waves. Reasons for waves must be identified.
- The treating doctor gets conflicting evidences because of emergence of new research almost every day.
- Conflicting reports about the use of a drug for coronavirus patients has led to a dilemma. Such dilemmas may vary from country to country, WHO vs. country or state to state. For example, the WHO Solidarity trial found that remdesivir had no effect on mortality in hospitalized patients with COVID-19, whereas remdesivir has been approved by the US FDA. The WHO recommends minimum distancing of 3 feet, while the CDC recommends a minimum distance of 6 feet.
- Plasma therapy was perceived to be a “wonder treatment”; there was lot of enthusiasm about it. But then came different opinions and experiences from different countries that it is difficult to believe that it is good or not good. The PLACID trial showed that plasma therapy offered no survival benefits.
- As scientific experts, we have to go into the depths of evidence. We have now realized that plasma therapy is more useful when given in the early stages.
- Every treatment decision should be shared between the patient and the doctor.
- A new drug or therapy has to pass muster through a pyramid of evidence before it is accepted as a treatment. Guidelines are developed based on evidence. Every guideline is only an advisory, not mandatory, unless it is a grade IA evidence, then it becomes a norm/standard. But if it is IIB recommendation or based on experience, then it is not mandatory to be followed as a standard.
- The treating physician should weigh the current evidence available, the last evidence available, and merge the two with the side effects and cost of treatment and based on this, he/she should take the decision. You should be able to support your decision.
- The physician is the best person to decide upon the treatment based on experience, guidelines, evidence and professional autonomy.
- The vaccine may be granted emergency use authorization; hence, a “no-fault compensation” clause should be included as side effects are bound to occur.
- The Consumer Protection Act 2019 has clearly defined product liability as “the responsibility of a product manufacturer or product seller, of any product or service, to compensate for any harm caused to a consumer by such defective product manufactured or sold or by deficiency in services relating thereto”. It is the duty of the government to ensure that any product which is used for commercial purpose, before it is made available for use by the public, the regulatory body should ensure that their license for marketing is based on safety issues. When a product becomes commercial, it comes under scrutiny for safety and efficacy.
Dr KK Aggarwal
President CMAAO, HCFI and Past National President IMA