COVID-19: WB Doctors Forum Lists Concerns about Vaccine, Resents Dilution of Protocol

Kolkata, January 19: Despite the Ministry of Health and Family Welfare issuing FAQs and a fact-sheet about the COVID-19 vaccination drive, doctors from West Bengal have issued caution and demanded transparency “on a number of issues”.

The Health Services Association - West Bengal (HSA-WB)  has written to the Directorate-General of Health Services under the health ministry, conveying its concerns which also included reservations about the timing.

The Joint Platform of Doctors, West Bengal (JPD-WB) is the umbrella organisation which includes the Association of Health Service Doctors, West Bengal, the West Bengal Doctors Forum, Shramajibi Swasthya Udyog, HSA-WB and Doctors for Democracy.

The organisation wrote that the vaccination campaign began at a time when relevant surveillance data “indicates development of positive sero-prevalence of SARS-CoV-2 antibodies in substantial proportion of the Indian population”. The doctors said that a significant proportion of the population has showed antibodies against the novel coronavirus.

Of the two vaccines approved for use by New Delhi, Covishield, manufactured by the Pune-based Serum Institute of India (SII) and the Indian Council of Medical Research (ICMR) had announced the completion of phase III trials. While granting permission for its use on January 2, the ongoing clinical trial within the country was allowed to be continued. The second product is Covaxin, developed by ICMR and the National Institute of Virolgy of Pune and manufactured by Hyderabad-based Bharat Biotech. Its official mandate contains a note of caution which reads: “restricted use in emergency situation in public interest”.

HSA-WB’s letter mentioned that the detailed pathophysiological mechanism of the genesis of COVID-19 has not been arrived at yet. It said that the diverse ways the virus is presenting itself was “highly intriguing”. The doctors said that thorough knowledge of this aspect was essential for the development of vaccines. They added that the relationship between the infection and the host’s immune response is also complicated. The outcomes of a virus infection is shaped by the interplay between various viral-host interactions. For SARS-CoV-2, the doctors said, it was unclear if any form of immune enhancement could play a role in infection or the vaccines under development.

About Covishield, the doctors said that it was a vaccine based on a weaker version of the common cold virus or the adenovirus found in chimpanzees. The viral vector has the genetic material of SARS-CoV-2. The vaccine will penetrate the muscle cells in the upper arm where the vaccine will be injected and will create spike proteins in human muscles. Antibodies and memory cells are then made in the body against those spike proteins which end up giving us immunity.

Dr. Arnab Sengupta, associated with the Institute of Post Graduate Medical Education and Research, has pointed out that while there is data from Europe and Latin America about its safety and efficacy, data from the Indian subcontinent is meagre. India is a tropical, multi-racial, multi-ethnic country with huge anthropological variations. It has been seen that immunological behaviour and response varies with race, ethnicity and many other external and internal variables – known and unknown. Our climate is also significantly different from the temperature zone the European countries are situated in.

“Accordingly, a carefully conducted country-wide, population-based clinical trial is the only time-tested methodology to promote an externally administrable drug/vaccine for mass intervention,” their letter said.

Dr. Sengupta told NewsClick that in the trial phase it was found that “an erroneously administered half-dose of Covishield is more effective – 90% against 62% – than the so-called correct dose as per submitted protocol.” Asked about the erroneously administered half dose, he said the process involved random selection and some errors might have crept in while measuring biochemical estimates. He called the higher efficacy of the lower than the standard dose a “curious” instance which remains unexplained till date.

The HSA-WB letter has observed: “...the role of prophylactic vaccination either for prevention of the disease or for reduction of severe form of disease remains highly empirical. The rationale for mass vaccination remains grossly inadequate. It is rather worrying that the time-tested protocols of population-based interventional studies are diluted in one go, in the name of emergency (sic)”.

“It is really difficult to understand the sense of exigency on the part of the government that is being overtly manifested in promoting ... half-baked vaccines to control Corona. This is to be recognised that public health is a serious issue and an agency of people’s representative cannot act in haste and promote a drug / vaccine without proper evaluation of efficacy and short & long-term safety (sic),” the letter concluded.

The JPD-WB advisory dealt with a host of related issues – dosage and schedule, side effects, new mutant viruses, use during pregnancy and lactation. It has demanded that basic human rights should be respected, has said that vaccine should be given only after written informed consent given by the recipient, that there shall be no political or state pressure or directive regarding collection of relevant information. It said that if the government wants observers to share collected information, it should be submitted to a recognised international organisation; all immunisation information should be available to the public in real time online and there should be a neutral surveillance system.

The Centre has allotted Covishield for West Bengal and the expectation among medical practitioners is that the vaccine will be used throughout. The turnout in the state for the vaccine has been about 65%, but higher in Kolkata. The state health authorities have attributed the lower turnout to snags in the CoWIN app. They said the listed persons either received the intimation quite late or did not receive it altogether. There were instances of people opting out voluntarily.

Dr. Manas Gumta, from the College of Medicine and Sagore Dutta Hospital – a designated COVID-19 treatment centre in the state – lamented that the vaccine rollout had been haphazard despite all the preparation.

Dr Gumta attributed the unexpected situation to the coWIN app crashing. He said that those originally listed were replaced by new recipients who received the relevant information late. Later, in place of those who had been prioritised, names of the District Magistrate office staff members and panchayat members found their place. It led to protests by nurses and other health workers. “The inevitable consequence will be a delay in completion of the first dose and by the time it is through it will be time for the second dose,” Dr. Gumta told NewsClick.