Mangalore Today Interview – January 2021

The first ten days’ experience of the ‘world’s largest vaccination drive’ in India has given several insights. “Vaccine hesitancy” has emerged as the biggest roadblock while the operation as a whole presents a case of speeding up of its implementation.

Though the vaccination drive is underway, risks of new strain and other factors along with too much time to be taken in inoculation of the whole population, unrelenting vigilance against the pandemic and preventing its spread remains as important as ever. Awareness raising programs are necessary to dispel misgivings among the intended recipients of the vaccines. The initial experience suggests that people are under the grip of safety concerns.

The situation is evolving fast, and therefore everyone needs to be informed.

Excerpts from the interview with eminent physician and social activist Dr Srinivas Kakkilaya

Q1. Are the COVID- 19 Vaccines (Covaxin and Covidshield) safe? Are there any serious problems or side effects?

As the trials are not yet completed, there’s no clarity yet, nor is enough data available.

Covishield is nothing but the Oxford – Astra Zeneca vaccine, and several side effects have been identified during the trials conducted in Europe, Brazil and South Africa. These have ranged from simple side effects such as pain at the site of injection, body ache, fever etc., to a few cases of serious neurological problems. As per the product brochure for COVISHILD, and on the basis of the above mentioned trials, the most frequently reported adverse reactions were injection site tenderness (>60%); injection site pain, headache, fatigue (>50%); myalgia, malaise (>40%); pyrexia, chills (>30%); and arthralgia, nausea (>20%). The brochure claims that the majority of adverse reactions were mild to moderate in severity and usually resolved within a few days of vaccination and that by day 7 the incidence of subjects with at least one local or systemic reaction was 4% and 13%, respectively. As per the product brochure, efficacy and safety data of Covishield are currently limited in individuals ≥ 65 years of age and its safety and efficacy in children and adolescents (aged <18 years old) have not yet been established, and there is a limited experience with its use in pregnant women.

For Covaxin, phase III trials are not yet completed and only the data from initial trials are available, with only Phase I report now having been published. The government has allowed the use of this vaccine in clinical trial mode only, meaning, every recipient is taking the vaccine as a clinical trial participant. All those who are receiving Covaxin are made to sign a general consent form. The company released a fact sheet 2 days after the launch of the vaccination drive and enlisted certain conditions, such as pregnancy, use of blood thinners, and unspecified diseases as exclusion criteria. The brochure indicates that all the recipients will have to participate in the programme, being followed up for 3 months after the second dose.

It’s clear therefore that these vaccines are in evolution, and so is the information on their side effects.

Q2. There are reports of deaths after COVID19 vaccination in the country. However, authorities claim the deaths are due to other reasons. Can the Covid-19 vaccine trigger other problems like heart attack, organ failure or any other health problems?

At least 10 deaths have been reported among vaccine recipients, all of them healthcare workers and doctors, occurring within 1-5 days of vaccination. All these deaths have been attributed to heart attacks and stroke and the government authorities have stated, within no time, even before post mortem examination, that these were not related to the vaccination.

As mentioned earlier, it must be noted that the government has granted permission for Covishield vaccine for ‘restricted use in emergency situation subject to certain regulatory conditions’ and for Covaxin ‘for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains’. It’s therefore clear that the vaccination is being done under several restrictions, and in the case of Covaxin, as a clinical trial, virtually making every recipient a trial candidate.

None of the trials being exhaustive, it is really not possible to either link or delink these serious and fatal events to the vaccinations. It is well established now that COVID can trigger vascular events such as heart attacks, strokes, thromboembolism etc. Therefore, the onus of proving that these similar incidents following the vaccinations are unrelated to the vaccines lies entirely with the vaccine makers and the government.

There’s no information yet about organ failures or any other long term consequences of any of these vaccines.

Q3. There are reports of doctors refusing to take the vaccine. What could be reason?

The uptake of these vaccines have ranged from 10-50%, and among those who didn’t take the vaccines, there are not only doctors, but also healthcare workers at every level. If not for the pressures exerted, the uptake could even have been lower. There could be several reasons for this.

1. Most important reason is the failure of the government to inspire confidence in the recipients.

2. Hurried approvals that were questioned by many top scientists as well the media, lack of scientific information on the efficacy and safety of the vaccines, allowing a vaccine to be used in clinical trial mode, thereby making the recipients the subjects of phase III trial for that vaccine, inability of the authorities and vaccine makers to clear the doubts, lack of clear strategy for vaccination of those already infected, confusing statements on alcohol use after vaccination and many other such factors led to the refusal of vaccination.

3. Reports of adverse events added to these concerns, and glitches in the CoWin app and other logistical issues compounded it. As the government had rightly made the vaccination an optional choice for the recipients, nearly half of the enlisted recipients chose to exercise that option not to take the vaccine.

Q4. Reports say that the vaccine may not protect from infection for long period? How long the vaccine can save anyone from infection?

For Covishield, phase III trials have been done on about 24000 volunteers, whereas Covaxin has only entered phase III trials. The available data is only from these studies and it is not long enough to comment on the duration of protection yet.

Q5. With so many uncertainties and side effects of COVID19 vaccination, is it prudent to stay away from vaccine?

That decision is to be taken by the individuals themselves, it’s unfair for anyone to advise either way.

Q6. The vaccines were developed so quick with minimum trial and put to use within a year of the virus outbreak. Does this mean a political urgency to save the face of the central government’s failures? Is there any possibility of political interest in the urgent Vaccine administration? Do you think it is political / publicity stunt?

There are three sides to this issue. One is the scientific and technological prowess of our times that has successfully demonstrated our ability to identify, sequence, recombine, and develop nucleic code based RT-PCR tests and also vaccines on many different platforms such as recombinant, inactivated, DNA, plasmid, and the most novel mRNA. Second is the interests of businesses and funding agencies in trying to make quick profits in quick time, trying to make profits out of human misery. Third, of course, is the political showmanship, trying to gain personal and/or political mileage out of the scientific feats and business deals.

It has been very clear from the very beginning, in every decision that was made with regard to this new pandemic, in most countries including India and the US, that political leaders took their own decisions and disregarded scientists and experts. Such decisions have cost our country and our people very dearly and for long term. We see a very similar pattern with regard to the vaccines as well. When the vaccine makers of our country were asked to expedite the trials in June 2020, many top scientists opposed the move and questioned the intentions, and one senior scientist resigned. And now, when 3 meetings of the subject expert committee of CDSCO were held in 4 days, even without prior notice, and approvals were granted hurriedly, without even completion of phase III trials, very respected scientists and experts, such as Drs Gagandeep Kang, Vineeta Bal, Shahid Jamal, Jacob John, have openly questioned these decisions and have gone to the extent of declaring that they wouldn’t take these vaccines at this stage and have even compared it with Hitlerian methods. All these facts indicate that the great achievements of science and technology have been trumped by business and political interests, completely sidelining scientific methods and ethical standards, and ignoring the safety and health of ordinary citizens. Such hijacking of science and technology and disregard of ethics and safety will result in loss of confidence and credibility of science itself and will do immense harm to the reputation of these very vaccine makers.

Such loss of credibility is already very evident in the fact that nearly half of the enlisted recipients among HCWs have not taken the vaccine and the govt has started threatening penal action against what it calls as rumour mongers; added to this, some supporters of the govt, including some doctors, are invoking nationalism, patriotism, valour etc., to shore up support for vaccination and even spreading fake messages in the name of some top scientists to mislead the people to get vaccinated.

Q7. Leaving politics, what is your advice to public – to take or leave Covid-19 Vaccine?

As I have stated above, politics, nationalism, jingoism etc., have been brought into what should have been a purely scientific and medical effort by politicians and their cronies. If enough evidence was available about the efficacy and safety of these vaccines, and about the need for such emergency use authorisation, these questions and problems wouldn’t have arisen at all.

Consider these: The government and its agencies have very clearly stated that the actual number of cases in India may be 90 times the reported cases, amounting to 65-70% of the population and that the transmission of corona virus has already declined in most parts of the country. That would mean that more than 100 crore Indians have been infected with the virus by now, meaning that the control measures didn’t work and the infection spread very widely. Yet in the same breath, the same government claims that India has shown to the world the way to control the spread of corona virus! If indeed about 70% are infected, so many Indians would have developed immunity with the naturally acquired infection and at that level, as per all the literature, herd immunity would have set in, leading to natural decline in transmission, which is being witnessed now. If that’s the case, there obviously is no ‘emergency’ about corona virus transmission in India any more, but then, the government hurriedly grants approval for ‘emergency use’ of vaccines in a situation where the country is close to herd immunity according to the statements of the very same government! Moreover, the government hasn’t been able to provide all the information on the safety and efficacy of the vaccines, nor has provided any firm opinion on the need for vaccination for those who are already infected, and it makes the vaccination optional, but in the same breath, threatens penal action!

Under these circumstances, one needs to be skeptical about the entire exercise of vaccination and should remember that it is only optional and not mandatory to take the vaccine. As has been stated by the best scientists and virologists of our country, a safe and effective vaccine, so proved in multicentric, large scale, ethically conducted trials, and approved for public use by the WHO, if and when becomes available, may be useful for those who are most vulnerable to severe COVID, such as the elderly and persons with co-morbidities, who have remained uninfected through community spread until then.