Vetting the vaccines
Twelve medical consultants share their views on the advisability of taking a Covid-19 vaccine
Representational depictions of the Covid-19 vaccines Photos: Jasmine D. Driver
Senior citizens, those suffering from comorbidities and health care workers are the most vulnerable segments of the community, was the consensus amongst the respondents. The doctors also recommended that those who have already developed antibodies to Covid-19 need not be in a rush to take the vaccine.
Could the G6PD enzyme deficiency that several in the community suffer from be a risk factor? Zarir Udwadia believes this deficiency "should not result in a higher incidence of vaccine related adverse effects.” Dr Jehangir Sorabjee, honorary professor and head, Department of Medicine, Bombay Hospital Institute of Medical Sciences, also shares this opinion. He stated, "I don’t know of any vaccines that are contraindicated in persons with G6PD deficiency. There is no reason to suspect that the Covid vaccine would be different in this regard.”
Neither are those suffering from comorbidities necessarily at a greater risk of side effects from the vaccine. In the absence of peer reviewed analytical data on the vaccines in the public domain, the responding doctors were unable to give definitive responses to some of our queries.
Recently the Medicines and Healthcare products Regulatory Agency in the UK has cautioned those suffering from allergies: "Any person with a history of anaphylaxis [an overreaction of the body’s immune system which the National Health Service (NHS) describes as severe and sometimes life-threatening to a vaccine, medicine or food] should not receive the Pfizer/BioNTech vaccine.” As clarified in a NHS leaflet shared by Dr Jehanbux Chichgar, senior physician at PGH and Masina Hospital, "If you are unwell, it is better to wait until you have recovered to have your vaccine but you should try to have it as soon as possible. You should not attend a vaccine appointment if you are self-isolating, waiting for a Covid-19 test or unsure if you are fit and well.”
To guide readers to arrive at an informed judgment, carried below, in alphabetical order, are the professional viewpoints expressed by the doctors to the nine questions posed to them by Parsiana: Chichgar; Dr Aashish Contractor, director, Rehabilitation and Sports Medicine, Sir H. N. Reliance Foundation Hospital; Dr Ketayun Dhunjibhoy, retired chief of laboratories, Lilavati Hospital and Research Centre and ex consultant microbiologist, Jaslok Hospital and Research Centre; Dr Sharukh Golwalla, cardiologist; Dr Pilloo Hakim, ear, nose and throat surgeon; Dr Karl Mehta, consultant pulmonologist at Mallya Hospital, Bangalore where he heads the Hospital Task Force during the pandemic; Dr Behram Pardiwalla, head, Department of Medicine, and director academics, Wockhardt Hospital; Sorabjee; Zarir Udwadia. PGH chose to let Zarir Udwadia speak on their behalf. When they were informed that Parsiana had approached him independently and he had already kindly responded, they requested their consultant chest physician Dr Aditya Agrawal to address our queries. Likewise, consultant chest physician Dr Sonam Solanki was requested by Masina Hospital to respond to Parsiana. We appreciate the cooperation of all these doctors who made time for Parsiana in the midst of their busy schedule. Photographs, where made available, have been included.
Who would be considered the most vulnerable segment of the community regarding Covid?
Agrawal: All patients above 60. Those suffering from comorbidities like chronic bronchitis, heart disease, diabetes or on immunosuppressant drugs (administered so that a body is less likely to reject a transplanted organ or other treatment).
Chichgar: The elderly who constitute the largest segment among Parsis, and patients with comorbidities like those suffering from diabetes, taking dialysis, steroids and those with transplants.
Contractor: The elderly – those over 60 years of age and those with comorbidities, the prime being diabetes, hypertension and obesity.
Dhunjibhoy: Senior citizens with comorbidities, immunosuppressed individuals on chemotherapy or dialysis or patients with uncontrolled diabetes or other comorbidities. Also health care workers who are constantly working with patients need to be covered with the vaccine.
Golwalla: The vaccine is for all, starting with health care workers, followed by senior citizens and those with comorbidities.
Hakim: The elderly above 70 years and those with comorbidities are more susceptible.
Mehta: Health care practitioners, seniors residing in retirement homes/hospitals/old age homes, patients with cancer, chronic ailments (heart, lung, kidneys, diabetes).
Pardiwalla: The elderly and those with comorbidities. Since we are a fast aging majority that would cover a significant portion of our community.
Solanki: Senior citizens, males and people with comorbidities like diabetes, blood pressure, obesity are more likely to get a severe form.
Udwadia: Health care workers, the elderly and those with comorbidities like diabetes, hypertension and chronic lung disease should be considered the top priority groups.
Should Parsis in all age-groups avail of the vaccine as soon as it is made available or should one wait to see the side effects on others?
Agrawal: To wait for some time.
Chichgar: We should wait; the potential side effects are being under-reported.
Contractor: Taking the vaccine is a personal decision but in general those who are most vulnerable should definitely be taking it since the benefits outweigh the risks of taking the vaccine. Once the vaccine is approved by government authorities it should be safe to take.
Dhunjibhoy: None of the short-term, long-term effects of the vaccine are known so the entire community need not get vaccinated in my opinion till more details are known.
Hakim: It may be desirable to wait a while, say four to six weeks to see if there are severe or undesirable side effects.
Mehta: Always good to wait until more details come out with regards to side effects profile.
Pardiwalla: As there have been some doubts about the efficacy of the vaccine, those below 40 should
wait a little longer.
Solanki: Initially people at high risk should take the vaccine. Priority wise it should be first given to senior citizens and subsequently to those who are healthy and children. The side effects profile will always be disclosed.
Udwadia: All age groups should receive the vaccine. To reach herd immunity, 70% of a population must be vaccinated.
What are the greatest risks involved in taking the vaccine?
Agrawal: The most commonly reported are neurological and liver complications.
Chichgar: There can be allergies or neurological complications.
Contractor: From the published data available so far on three vaccines — Pfizer, Moderna and AstraZeneca/Oxford — there do not seem to be any serious side effects.
Dhunjibhoy: This is not known as the results of the trials are not shared in an unbiased way by third-party evaluators. Whatever information is shared by media is information given either by the manufacturing company or politicians. There is always a chance of bias in that evaluation. There are different ways in which the vaccine is prepared by different companies. There is live attenuated vaccine (that use weakened or inactivated germs), there are mRNA vaccines (m=messenger, that teach our cells how to make a protein — or even just a piece of a protein — as an immune response inside our bodies), etc so the data of their trials at different phases is not open to public for review.
Golwalla: The side effects are minimal.
Hakim: A severe allergic reaction or the occurrence of any permanent disabilities.
Mehta: Side effects – most important and most common being allergic reaction. Otherwise vaccines in general have an excellent acceptability rate.
Pardiwalla: The question of efficacy is the biggest risk. In the short term we don’t know how effective it will be; long-term complications are not known. For the simple reason that it has been an accelerated development program, long-term effects will be known only after two years.
Solanki: There are no major risks. Every vaccine has rare side effects. Recent news reports have referred to palsy.
Udwadia: Of course there is always worry about possible side effects from the vaccine especially because two of the front runners use mRNA technology which has never been used before. The initial signal from the Phase 3 trials seems to be reassuring to date, and from what we can tell all three vaccines that have completed Phase 3 trials seems to be well tolerated. Vaccine related side effects are rare but have been reported after any vaccine including those commonly used across the world like the measles vaccine. Minor side effects like fever, pain and inflammation at the site of vaccination have been frequently reported with the Covid vaccines but these are not a concern and often merely tell us that the vaccine is eliciting the appropriate immune response it is meant to. It is also important to distinguish a genuine vaccine related reaction from something coincidental which the patient falsely attributes to a reaction.
Would those with comorbidities be more likely to suffer after effects from the vaccine?
Agrawal: Not really.
Chichgar: Not likely. Immunosuppressed patients should not take vaccines.
Contractor: Not according to the data released so far.
Dhunjibhoy: Again lack of evidence. Trials done on different samples of patients with existing comorbidities is not known or open to the public as yet.
Hakim: Not necessarily.
Mehta: Difficult to comment with no hard data on hand.
Pardiwalla: Arguably they would be the people who will benefit the most. Even if it gives one 40% immunity, I would rather have that situation than no immunity at all.
Solanki: There is no evidence of that. Healthy individuals may also suffer from after effects.
Would there be any long-term after effects?
Agrawal: We do not know.
Chichgar: We do not know at this stage. The virus has only been studied for eight months.
Contractor: The vaccines have been tested only for a few months so that is a difficult question to answer. However, in most vaccine trials the majority of side effects are seen in the first few months and so far the results have been encouraging.
Dhunjibhoy: Not studied as yet as the vaccine is less than a year old as of now.
Hakim: Do not think anyone can be quite sure of that as yet.
Mehta: Difficult to comment with no hard data on hand.
Pardiwalla: Too early to say. The after effects of thalidomide were known only after two years. In epidemiology you do the greatest good for the greatest number of people. Trying to get herd immunity, like they did in Great Britain, caused a lot of problems. In the waiting for herd immunity, a vast majority of the elderly will pass away.
Solanki: It is too early to say. Will have to wait and watch.
Udwadia: Long-term safety of any vaccine, especially one that is so hastily pressed into action, remains uncertain and careful monitoring of all those who receive it is a must, specially watchful monitoring of the elderly, the pregnant and pediatric vaccinated populations are needed and more of these groups need to be included in vaccine trials.
If one has already been infected by Covid or has sufficient antibodies should s/he be vaccinated against Covid?
Agrawal: Wouldn’t know this until we have more data.
Chichgar: One should not take the vaccine if antibodies are present. Immunity is believed to last only for 90 days; it is not like measles where one gets life immunity after getting the disease.
Contractor: Those who have antibodies could wait a little longer since they have protection for the time being at least. However, in my view, those with antibodies too should eventually get vaccinated.
Dhunjibhoy: Ideally if there are antibodies against the Covid-19 virus in a patient who has in the recent past been infected then the vaccine is not indicated in such a person.
Golwalla: Even those who have already had Covid antibodies need the vaccine. The duration of protection is not yet known.
Hakim: Probably yes at a later date as the immunity developed through infection does not appear to be permanent.
Mehta: Ideally not required as long as s/he has sufficient antibody levels. However studies have shown the antibodies may be present for up to five months post infection. Difficult to comment with no hard data on hand.
Pardiwalla: This is a moot point. Antibodies last for a very short time. If you have had it, re-check your antibodies. If short on antibodies, take the vaccine.
Solanki: There is a chance of re-infection so all people should take the vaccine but such individuals will not be high priority.
Udwadia: Those already infected should not be in a rush to get the vaccine as they already have natural protective antibodies. However since it is unclear how long-lasting and protective their natural antibodies will be, they too should eventually be vaccinated.
If Covid symptoms were to surface after vaccination, would treatment options be reduced?
Agrawal: Not really.
Chichgar: If vaccination is successful, treatment would not be required. We don’t know how long the immunity will last.
Contractor: No, the options would still be available.
Dhunjibhoy: This is what is claimed but there is no supportive evidence in public forum.
Hakim: It appears that if the infection does occur it would be less in severity post vaccination.
Mehta: Difficult to comment with no hard data on hand.
Pardiwalla: My answer is a vehement no.
Solanki: Very unlikely. The standard line of treatment recommended by doctors would help.
Udwadia: No vaccine is 100% protective though some of the available vaccines reached a remarkable 90-95% protective effect. If a vaccinated patient gets infected then of course they can still be treated for Covid and would have the same treatment options.
Which would be the best place/person to approach for taking the vaccine?
Agrawal: We could run a program at the PGH. It would bring the community together.
Chichgar: It is my suggestion (I will have to speak to the management) that we do it at the PGH especially for the free OPD (Out Patients Department) patients and let Dr Cyrus Poonawalla (founder of the Serum Institute of India that is manufacturing the vaccines for AstraZeneca-Oxford) give us the vaccine at a concessional rate. If we vaccinate successfully, we can save on costs that would otherwise be incurred on admitting free and concessional Covid patients.
Contractor: This will probably be decided by the government. I would advise you to discuss your options with your family doctor who knows your health history the best.
Dhunjibhoy: The best person would be the treating medical doctor who knows the patient’s constitution, who has tested the patient before giving the vaccine and found the patient to be the right candidate for the vaccine.
Golwalla: Vaccination centers as per government recommendations.
Hakim: Take the advice of a senior physician.
Mehta: I would advise it to be taken at a hospital.
Pardiwalla: Entirely up to the government. A certain priority will be determined: medical people, armed forces, etc, seniors, then down the line as per the policy rolled out by the government. No individual will have a say on this.
Solanki: A hospital would be the best place. If the government permits private hospitals then there would be no need to go to a government hospital.
Udwadia: Universal polio vaccination across the Indian subcontinent has been one of India’s great public health success stories. So we already have in place the manpower and infrastructure to vaccinate a huge population. All the current vaccines need two doses, three weeks apart, thus doubling the complexity. It’s going to be a truly herculean task to roll out the vaccine across the country.
After taking the vaccine should one rest for a few days or observe any other precautions?
Agrawal: Rest, yes. Watch for fever, runny or stuffy nose, giddiness, breathlessness.
Chichgar: Not required.
Contractor: Yes, that would be a good idea if you get any symptoms. A mild fever, pain, swelling and redness at the site along with body ache are common side effects. One should not worry about these, because in fact this is an indication of the body mounting an immune response to the vaccine.
Dhunjibhoy: Expected minor/major adverse reactions need to be explained to the vaccinee but this data is not open to the public as yet.
Golwalla: Continue with normal activities after vaccination.
Hakim: Rest is probably not required. The usual self-protection and precautions already being applied such as the use of a mask and washing hands should be continued.
Mehta: Difficult to comment with no hard data on hand. Typically, after vaccines, no restrictions are recommended. The only precaution is that NO person with an active infection should receive any vaccine.
Pardiwalla: Two or three days’ rest is recommended as with any other vaccine. Check for fever. No other precautions. However if there are any symptoms, you have to consult your doctor.
Solanki: If there are symptoms like body ache then rest would be advisable.
Udwadia: Rest after vaccine is needed only in those who develop fever or an inflammatory reaction.
Additional remarks
Dhunjibhoy: Viruses are known to mutate. The vaccine for use must be efficacious for use on any new mutants found in the virus. Also country to country, climate to climate, in different ethnic populations there could be variables and that need to be studied in detail before thinking of mass usage and also deciding on price. It is always better to tread slowly, cautiously than be the first one to start administering the first available vaccine. Testing of vaccine in all three phases of the trial need to be done carefully without any bias with a huge lot of population samples. The logistics for administration of the vaccine need to be worked out too. It is reported that some vaccines need to be stored at -70°C. How will the -70°C vaccine be thawed in a tropical country or a temperate country before administration? There are multiple factors to be studied and understood before starting the mass administration of the vaccine. At present there are a lot of lacunae in the information.
Mehta: A vaccine provides the recipient with antigen material, in this case viral proteins, to a host (patient). This foreign protein triggers an immune response providing antibodies, memory B-cells, in order to prepare the host for subsequent exposure to the specific infection. In some cases, like small pox, the virus gets eradicated and humans are no longer infected. In some cases like chicken pox, one may still get infected in spite of receiving the vaccine. However, the occurrence of severity of infection and complications are a lot less.
The clinical data and other necessary information has not been made public yet the reason being that the pharmaceutical companies are awaiting DGCI (Drugs Controller General of India) emergency approval. Being a front line healthcare professional actively treating Covid-19 patients, I am not going to be taking the vaccine unless I know all details especially the side effects profile and details of why certain trials were delayed.
Sorabjee: I think the Parsi community needs to fall in line with the national and international recommendations and guidelines for the general population.No special genetic considerations would apply. There will, of course, be concerns about a rapidly developed vaccine but risking Covid over a vaccine is certainly the wrong approach both for the individual and as a public health measure. Regarding specific points you mention, there are no clear-cut answers to many of them as the science stands today with the short-term data we have in hand. Rather than risk a generalization, it would be best for persons to discuss options with their family physicians who would know their individual clinical situations better.
Udwadia: The rollout of a vaccine against the SARS-CoV-2 virus in less than a year from the start of the Covid pandemic must rank as a mind-boggling scientific feat. All other vaccines have taken several years to reach this stage.
With over 50 vaccine candidates for Covid-19 currently in trial, the World Health Organization (WHO) has introduced regulatory procedures and policies to ensure safety and efficacy, according to its website who.int that sums up their efforts.
In the interests of safety, Covid-19 vaccines have to go through a rigorous, multi-stage testing process, including large (phase III) trials that involve tens of thousands of people, including people at high risk. These trials are specifically designed to identify any common side effects or other safety concerns.
Once clinical trials indicate that a Covid-19 vaccine is safe and effective, further evidence is required through a series of independent reviews. These include regulatory review and approval in the country where the vaccine is manufactured, before WHO considers a vaccine product for prequalification. The Global Advisory Committee on Vaccine Safety will also review all the safety evidence. Additionally, an external panel of experts convened by WHO analyzes the results from clinical trials, along with evidence on the disease, age groups affected, risk factors for disease, and other information, and accordingly recommends whether and how the vaccines should be used. Ultimately officials in different countries decide whether to approve the vaccines for national use and develop policies on how to use the vaccines based on the WHO recommendations.
After a Covid-19 vaccine is approved, WHO coordinates with vaccine manufacturers, health officials in a country, and other partners to continuously monitor safety concerns. Currently, there is no evidence that any previously used vaccines will protect against Covid-19 although scientists are studying whether some vaccines – such as the Bacille Calmette-Guérin (BCG) which is used to prevent tuberculosis – are also effective for Covid-19. The flu vaccine is not considered a protection against Covid-19 hence both should be taken, preferably a week apart.
Like most other vaccines, it is anticipated that Covid-19 vaccines too will not be 100% effective but WHO is striving to ensure that the two-dose regimen that most Covid-19 vaccines are adopting will be as effective as possible. While some people may still get Covid-19 despite having a vaccination, it is hoped the infection would be less severe. Ultimately, the impact of Covid-19 vaccines on the pandemic will depend on several factors such as the effectiveness of the vaccines; how quickly they are approved, manufactured, and delivered; and how many people get vaccinated.
According to statistics shared by England’s National Health Survey, "Fewer than one in 100 people who are infected will die from Covid-19, but in those over 75 years of age this rises to one in 10.”