1214: HCFI Round Table Expert Zoom Meeting on “Vaccine update”

12^th December, 2020, 11am-12pm

Participants: Dr KK Aggarwal, Dr AK Agarwal, Dr Jayakrishnan Alapet, Dr Suneela Garg, Dr YK Gupta, Dr Anita Chakravarti, Dr Ashok Gupta, Dr Alex Thomas, Mr Bejon Misra, Ms Upasana Arora, Dr Anil Kumar, Ms Ira Gupta, Dr S Sharma

Consensus Statement of HCFI Expert Round Table 

• Graphs of the top 15 countries in the world show that India, Argentina and Poland are still experiencing the first wave of the infection. The remaining 12 countries have seen more than one wave; of these, the second wave is shorter than the first wave only in Brazil and Colombia.
• Various questions arise: Will India have a second wave? Will the second wave be bigger or smaller than the first wave? Will vaccine change pattern? Are all the waves same? Countries where contact tracing is very strong show multiple waves.
• A vaccine will soon be available and several questions need to be answered.
• Can healthcare workers or doctors refuse COVID-19 vaccination? What will be the court’s stand if the patient files a case against a doctor saying that he/she was not vaccinated against COVID-19?
• There are no laws that either requires an employee to be vaccinated against COVID-19 or that protect an employee who refuses the vaccination.
• There is a law in the US where employers can fire employees who do not take the flu vaccine. This has been challenged three times in the US Supreme Court. Exemption was given on religious, medical grounds.
• Will a similar situation occur with COVID-19 vaccine?
• Can a patient insist that he would take treatment from only a COVID vaccinated doctor?
• Employees who refuse vaccination will still need to take measures to protect patients and other employees from infection.
• The situation with COVID-19 vaccine is different from influenza vaccines. There are plenty of data on effectiveness and side effects of influenza vaccines, but there is very little evidence of short- or long-term effects of the COVID-19 vaccines.
• Is an employer exempt from paying workers’ compensation to an employee who refuses to be vaccinated and then contracts the virus while on the job?
• Can a prospective employer require COVID-19 vaccination as a pre-condition of employment?
• Is it within a patient’s rights to receive an answer to the question? Has my HCW been vaccinated against COVID-19? If a hospital allows employees to refuse vaccination and keep working and an outbreak occurs, and it is suggested through contact tracing that unvaccinated workers infected patients, will a court hold the hospital liable for patient’s damages?
• Is informed consent required before any vaccination? Anaphylaxis has been reported yesterday.
• Herd immunity: On 31^stAugust, as per GOI, 7% of population had developed antibodies. In last 3 months, the rise has been 10 times. For every symptomatic case, there are 30 asymptomatic cases. Herd immunity will develop.
• Before the issue of refusal comes up, other questions need to be addressed such as what will be the precise indications of the vaccine? Safety profile has to be defined.
• Vaccination is an individual choice.
• Vaccine will not be given to immunocompromised people, antenatal women and children below 12 years of age. All synthetic mRNA vaccines are highly inflammatory.
• Patients with history of severe allergy/anaphylactoid reaction should not take the Pfizer vaccine.
• The UK government has granted legal indemnity to Pfizer protecting them from civil lawsuits due to any unforeseen adverse events due to COVID-19 vaccine.
• Consent is not required as the vaccine is not for research purpose. It should be mandated as it is for national interest. The vaccine might be brought under the UIP.
• CDC says the vaccine may benefit if people have already had COVID. WHO has not defined any selection criteria.
• We are 1327 million people and approximately 800 million people will be vaccinated. This does not include children below 12 years and we have also excluded people who will have antibodies. People who currently have the infection are also excluded from the trial. Apparently healthy people have been included in the trial. 
• No drug is introduced in the market unless full risk-benefit analysis is done, which is a continuous process. Even after this, there is always a possibility of side effects. For this, there are pharmacovigilance and AEFI programs.
• For emergency approval, limited experimental/clinical data is available and looking at the urgency of the public health situation, it is decided based on what is the perceptible risk; what is the anticipated risk and benefit. It has not undergone complete risk assessment. Consent is required. There is a right to refuse this type of vaccine, which has been given emergency use authorization. But it is advisable to note the cause of refusal.
• Ideally, everyone in the country should be given the vaccine excluding those who are not eligible because of allergic reaction. There has to be adequate supply chain.
• Interchangeability of the vaccine has been ruled out.
• Compensation in clinical trial is a rule. If a person dies in a clinical trial, he/she is entitled to compensation as per rule given in the regulations issued in March 2019.
• When compassionate use/emergency use, the compensation clause is not applicable. The state or sponsor is not responsible as it is after consent. Whether compensation should be given, a policy regarding this is yet to be established. A policy is not a law and can be challenged. So, it has to be in the form of an ordinance. A “no-fault compensation” should be brought in the law.
• Vaccines are for the benefit of the society. Guidelines need to be examined; there should be no loopholes.

Dr KK Aggarwal

President CMAAO, HCFI and Past National President IMA