Having a choice of COVID-19 vaccines is just the first step. Besides the logistics and pharmacovigilance to track AEFIs, the other issue is, the choice to take it
With three companies filing for emergency authorisation of their COVID-19 vaccine candidates in India, it seems that we will be spoilt for choice.
But it will be a tough decision for the Central Drugs Standard Control Organisation (CDSCO). Besides evaluating the applications of Pfizer, Serum Institute of India and Bharat Biotech, based on the data available and a rolling review, there are other candidates waiting in the wings.
As Union Minister of Science and Technology, Earth Sciences and Health & Family Welfare, Dr Harsh Vardhan informed, India has about 30 vaccines in different stages of development.
Two of them are in the most advanced stage of development – COVAXIN developed through ICMR-Bharat Biotech collaboration and COVISHIELD from the Serum Institute of India. Both are in the Phase-III clinical trial stage.
India is also hosting clinical trials for most major vaccine contenders. Besides the COVISHIELD trial by Serum Institute of India for the vaccine developed by Oxford University, there is the indigenous DNA vaccine from Zydus Cadila which is in Ph2 trial. Dr Reddy’s Laboratories will be conducting final stage trials and distribute Russia’s SPUTNIK V vaccine in India after receiving regulatory approval.
As per MoH&FW data, India’s active caseload further contracted to 4.03 lakh on December 7, after 138 days, total recoveries surpass 91 lakh, new cases per million population in India in the last week were one of the lowest in the world. The country’s active caseload presently consists of just 4.18 per cent of the total positive cases.
These are comforting numbers. Defying predictions that India would overtake the US by October in terms of total number of cases, India remains second in terms of total cases, third in terms of total global COVID-19 deaths and has the highest number of recovered COVID-19 patients.
But all these numbers hinge on testing strategies.
As per ICMR data, a total of 14,88,14,055 samples were tested for SARS-CoV-2 (COVID-19) up to December 07, with 10,26,399 samples tested on that day, of which 530428 were RT-PCR tests.
While there seems to be a concerted effort to increase the number of gold standard RT-PCR tests over the rapid antigen test (RAT), one hopes that this effort continues. While the RAT has speed as a major advantage, it loses out on accuracy.
Dealing with ‘long COVID’
But with highest number of COVID-19 recoveries, India has to prepare for what’s being called ‘long COVID’.
Dr Saranya Narayan, Technical Director and Chief Microbiologist, Neuberg Diagnostics says that while most people recover in a few weeks, around 10 per cent suffer from prolonged COVID (including symptomatic and asymptomatic). It damages several organs of our body, especially the lungs, heart and brain. The type of pneumonia often associated with COVID-19 can harm tiny air sacs in the lungs resulting in dyspnoea (breathing problems) and cough. It is observed that even in cases with mild symptoms, the patients complain about chronic muscle pain and fatigue. This condition is known as Myalgia. Many studies have highlighted that COVID can lead to memory and cognitive impairment and increase a person’s stress and anxiety level.
Choice of vaccine platforms
As Dr Dhirendra Kumar, Director at National Center For Disease Control, and a senior microbiologist research scientist who works on clinical samples of diarrhoeal patients and diphtheria patients points out, “Vaccine makers have adopted different approaches to develop the COVID vaccine. Currently, the most popular technologies to develop the vaccine includes the synthetic vaccines with RNA, the viral vectors and the protein-based vaccines plus adjuvant.”
He opines that due to the ongoing urgency, it is indeed a good idea to pursue a range of vaccine platforms to solve the crisis as quickly as possible. But also suggests that while we look at the new technologies, it would be best to select a tried and tested platform.
Also, the pertinent question is which amongst them will be an ideal vaccine. Storage and logistics are the biggest challenges in most countries like India, analyses Dr Kumar.
Post vaccination strategy
Unfortunately, vaccination will not be the end, but the beginning of another phase in the battle with COVID-19. The vaccinated population will need to be observed for any side effects, both during the vaccination process, as well as for a long period of time as the ‘first generation’ vaccines are likely not to be the best. Does India have the pharmacovigilance network to monitor for and report adverse events following immunisation (AEFI)?
Dr Alok Roy, Chair, FICCI Health Services Committee and Chairman, Medica Group of Hospitals points out that the COVID-19 virus has already mutated more than 300 times in less than a year and there can be serious side effects. Even as Government, scientists are working 24×7 from ICMR, health officials must detect that on real time basis.
He suggests that the government should develop an app where all the steps on vaccination can be tracked. If anyone faces some problem, then they can directly convey it through the app and necessary action can be taken. There should also be a campaign to educate the people about the app specifically in the rural areas. The speed and scale of a COVID-19 immunisation programme will determine how India copes with the pandemic.
Fortunately, the government does have a solution.
On November 20, the Health Minister confirmed that the Government is repurposing and ramping up its current national immunisation campaign, which has the capability of a cold storage chain for immunising children from 12 diseases under Mission Indradhanush. “The entire eVIN platform is being repurposed as COVIN Network. All movement of stock can be digitally tracked and those receiving vaccines an also be traced after two to three weeks if the vaccine requires two shots. This will ensure last mile vaccine delivery,” he said.
Deepak Kapur, Chairman, Rotary International’s India National PolioPlus Committee from 2001 has played a major role in making India polio-free, also assures that India’s cold chain is able to maintain vaccines at minus 30-degrees Celsius, and work toward COVID-19 vaccine storage and distribution has already begun. The government is identifying warehouses and preparing its proprietary Electronic Vaccine Intelligence Network (eVIN) that digitises vaccine stocks and monitors cold chain temperatures to ensure quality and efficacy are not lost to temperature variations. Health centres are geo-tagged and sensors in refrigerators and freezers storing vaccines automatically inform a central database when temperatures change, signalling that the equipment needs to be repaired or replaced.
But till the COVIN network also track AEFIs? There have already been instances, one of them in Chennai with the SII/AstraZeneca/Oxford University candidate, of a severe adverse reaction of trial participant. While SII clarified that the reaction was unrelated to the vaccine, it raises the possibility of many more such reactions once emergency and then mass immunisation rolls out.
One solution leading to more dilemmas
Thus having a choice of COVID-19 vaccines is just the first step. Besides the logistics and pharmacovigilance to track AEFIs, the other issue is, the choice to take it.
Do COVID-19 recovered patients, who have antibodies, have the right to defer the use of a vaccination? Especially COVID-19 recovered healthcare workers, who will continue to have high exposure to COVID-19 patients?
Dr Abdul Ghafur believes that the proper strategy would be to prioritise the COVID-19 vaccine to antibody-negative individuals.
As Coordinator, Chennai Declaration on AMR, and Apollo Adjunct Professor, Consultant in Infectious Diseases, at Chennai’s Apollo Cancer Institute, Dr Ghafur has written an open letter to Dr Soumya Swaminathan, Chief Scientist, WHO and other colleagues, asking the WHO to take a formal stand on this issue.
Explaining his strategy, he clarifies that he is not a supporter of the herd immunity strategy through natural infection. He has recovered from COVID, and knows how bad a disease it is. He stresses that he will do anything possible not to get this infection a second time.
As he states in this letter, “I am Covid antibody-positive. I do know that this protection may not last forever. But the probability for me to get reinfected in the immediate future is far lower than my fellow citizens who are antibody-negative. I do know that a vaccine may further boost my immunity and provide me with additional protection. But I do also know that there is an acute shortage of the vaccine and it may take up to two or three years to vaccinate my fellow humans across the world.
I will consider myself selfish if I take the vaccine before my antibody-negative highly vulnerable fellow citizens getting their vaccine shots. I believe this is my ethical responsibility as a social animal.”
He urges that the COVID-19 antibody-positive take a pledge to opt out until the antibody-negative, and vulnerable receive the shots.
As we end 2020, let us hope that with the experience of COVID-19, we get the wisdom to make the right choices in 2021. Both as government/regulators, as well us individuals.