Several states including Karnataka are poised to begin the first phase of Covid 19 vaccination for health care workers on 16th January 2021. There have been some disturbing events in the past weeks related to EUA to the two vaccine candidates and unethical practices during the ongoing phase 3 clinical trial of Covaxin in Bhopal. These developments have dented public faith and confidence in the vaccination efforts. Karnataka Janaarogya Chaluvali believes that vaccines are among the various public health strategies that have made valuable contributions to reductions in mortality and morbidity. Any action that reduces public trust in vaccination efforts is a serious impediment in the country’s ongoing efforts to improve the health and well-being of citizens. It is in this context that KJC would like to put forth its concerns. We expect that the government of Karnataka will respond to these concerns in a spirit of transparency and accountability, both of which will demonstrate its concern for the safety and well-being of its citizens. We believe it will go a long way in preventing rumor-mongering and misinformation that plagued the government’s containment efforts during the initial days of the pandemic.
Emergency Use Authorization of the two vaccines
Typically Emergency Use Authorization for vaccines is provided only when we are faced with an epidemic where the death rates are very high. This measure was invoked during the Ebola pandemic in Africa because the death rate of Ebola was 40%. In the Covid 19 context, certain countries are seeing a relentless increase or a resurgence of infections and a proportional increase in the number of deaths. Therefore such countries can make a valid case for EUA for whatever vaccines that are in various stages of development.
In contrast to those countries (such as US and UK), the number of infections in India including Karnataka and Bangalore is seeing a downward trend for the past few months.For instance, as of 14th January 2020, India had reported less than 20000 infections for 7 days consecutively. Secondly, in contrast to diseases like Ebola where the death rate was 40%, Covid 19 has a very low death rate. In India the death rate of Covid 19 is 1.4% which can be further reduced by ramping up preventive activities, increasing health systems capacity to manage Covid 19 -related complications.
In such a scenario why is the government rushing headlong into approving vaccines which do not prevent transmission of the SARS CoV2 virus but are expected to reduce the severity of Covid 19 disease and whose efficacy has been highly variable and questionable?
The process followed for Emergency Use Authorization of Covid 19 vaccines in India
Covishield vaccine manufactured by Serum Institute of India has received EUA based on efficacy data of trials conducted in the UK and Brazil. They have not presented data from the Indian arm of the trial that involved 1600 volunteers. Covaxin on the other hand has no data on efficacy at all. Yet it received EUA in clear violation of CDSCO’s own authorization protocol. Therefore it seems quite possible that these vaccines may turn out to have low levels of efficacy or are not efficacious enough to warrant their widespread use. In that case, would it not mean that precious public resources were wasted only because the regulators side-stepped crucial elements in the approval protocol? Would it also not imply that the regulators willfully misled the public and gave them a false sense of security?
What do the two authorized vaccines actually do?
There is little clarity among people about the specific action of the vaccine. Does it protect a person from getting infected in the first place? Or does it prevent transmission from an infected person to others? Or does it prevent the Covid19 disease from progressing to the severe stage?
And whatever kind of protection it affords, there is no information on how long such a protection will last. Will it last for weeks, months or years? If this vaccine provides protection for a very short period, then is it worth the effort and resources spent on it?
Will both Covishield and Covaxin be given?
In an interaction with the media on 13th January 2021, the Health Minister said that the state will soon receive 20000 doses of Covaxin and Covaxin will also be used during the vaccination roll-out. Further, he added that those receiving the vaccination cannot exercise their choice between the two vaccines. An important issue is that it would be unethical to give some covishield which has some level of proven efficacy and some others Covaxin which has no data on efficacy. Further on what basis will the government decide who gets covaxin and who gets covishield. As we understand Covaxin was given EUA by the Subject Expert Committee only as an “abundant caution” which implied that only if there are some problems with Covishield supply or other such issues will Covaxin be deployed. But that does not seem to be the case at least in Karnataka. It is not clear why the state government is so keen on pushing Covaxin which has no data to prove its efficacy.
Covaxin’s EUA in ‘clinical trial mode’
No one seems to understand the meaning of ‘clinical trial mode’. Does this mean that those who take the vaccine are considered to be participants in the phase 3 trial of Covaxin? If that is indeed so, then what kind of clinical trial would it be since most of those who take the vaccine would know what they have taken?
Is participation in the Covid 19 vaccination drive voluntary for health care workers?
As of now, the government maintains that health care workers are being asked to come forward voluntarily to get vaccinated. Does it mean that health care workers can refuse to get vaccinated? If they do exercise this choice then what are the repercussions? Will refusal to participate in the vaccination drive leads to loss of benefits? This question is particularly important in the case of contractual employees and ASHA workers who lack job security.
Further, the health minister has also said that those getting vaccinated cannot choose between the two vaccines being deployed. Somehow this does not seem to fit with the idea of voluntary participation. What problem does the government foresee if health care workers were to exercise such a choice? Is it concerned that many people may not opt for one particular vaccine? Even if that were to be the case why should it be a source of concern for the government?
What are the various adverse events observed so far?
Fact- a sheet of Covishield mentions the “very common”, “common” and “uncommon” side -effects as follows:
“Very common side-effects that may affect more than 1 in 10 people are tenderness, pain, warmth, redness, itching, swelling, or bruising where the injection is given, generally feeling unwell, fatigue, chills, headache, nausea, and joint pains”.
“Common side-effects that may affect up to 1 in 10 people are a lump at the injection site, fever, vomiting, and flu-like symptoms such as high temperature, sore throat, runny nose, cough, and chills”.
“Uncommon side-effects affecting up to 1 in 100 people are feeling dizzy, decreased appetite, abdominal pain, enlarged lymph nodes, excessive sweat, and skin rashes”.
However, one trial participant from Chennai has sued SII because he developed acute encephalopathy ten days after the vaccine shot. However, SII and the hospital where the trial was being held have rubbished the complaint and have said that they have received a clean chit from their Ethics Committee and the condition the trial participant suffered was not due to the vaccine. But they do not explain what then caused the condition. Similarly, one person is reported to have died during the Covaxin trial in Bhopal. And several CSOs have registered their protest against Bharat Biotech for unethical practices in recruiting participants who were victims of the Bhopal gas disaster. But Bharat Biotech has not taken ownership of any of these lapses. While such incidents raise concerns about vaccine safety, it is the response of vaccine manufacturers that is a cause for greater concern.
What does one do if one suffers a serious and “uncommon” adverse event?
The Covidshield fact sheet provides a toll-free number of SII to call in case of any adverse events. But that information is grossly inadequate. A toll- free number will not ensure immediate medical help in case of an emergency.
In the first phase of the vaccine roll-out, it is the health care workers who are getting the vaccine shot. In case of a serious “uncommon” adverse event, where should the health care worker report to for immediate medical treatment?
What are the systemic measures to monitor and respond to adverse events following vaccination?
There seems to be very little information in the public domain about the systemic measures to record, monitor and respond to adverse events. It is important that the government make public the systemic checks and balances it has put in place to ensure the safety of those getting vaccinated?
One understands that the state government has to form a state and district level Adverse Events Following Immunization (AEFI) committees which include clinicians from various specialities. Have such committees been formed by the state government? If so who are the members of the State-level and district level committees? Has the government planned for a separate portal where all such crucial information can be made available? What is the reporting structure and how is the information passed on to the AEFI committees?
What kinds of measures has the government put in place in case of a serious adverse event with long- term consequences?
Even though the vaccine manufacturers have not reported any serious adverse event, one cannot rule out the possibility of their occurrence. In case of serious adverse event:
- Whose responsibility is it to take cognizance of and respond to immediately? Will it be the state government, the vaccine manufacturer or the central government?
- In case a health care worker suffers a serious adverse event that requires long- term treatment will she/ he be given paid leave for the duration of the treatment?
- Will she/ he be provided free care and treatment?
- For those on contract or ASHA workers, will their job be secure for the duration of the treatment?
- In case of harm that causes permanent disabilities that prevent them from earning a living are there any provisions for compensation?
- What are those compensations being made available?
- Whose responsibility is it to provide those compensations?
Observations in one site on 16th January 2021 revealed that there is no informed consent process. There seemed to be an individualized process of providing a written fact sheet about the vaccine and related information. Health care workers scheduled to take the vaccine were not aware of which of the two vaccines they were receiving. There was no written consent that was taken from those scheduled to take the vaccine. When asked, the officers in charge felt there was no need for that. They are free to refuse so there is no need for any written documentation of consent, they opined. However, they also agreed that there were a lot of fears and worries among the health care staff and they were doubtful whether or not they would have at least 50 people on the site.
Given that there are so many unanswered questions, we urge the government to take serious cognizance of the issues raised here and ensure that this critical information is included in the informed consent forms so that the person who is getting vaccinated is able to make an informed choice about whether or not to get vaccinated. Further, we call upon the state government to provide clarification about compensation measures for a serious adverse event.
The author is a convener of Karnataka Janarogya Chaluvali ( Campaign for healthcare Karnataka) and a Health Activist. She also holds a Ph.D. in Public Health from NIMHANS.