India’s COVID-19 battle: Why is there an outcry for Remdesivir and concerns over the effectiveness of vaccines on the virus

An utter disregard to pandemic-related safety measures is reaching dangerous proportions in India and almost seems symptomatic of a new devil-may-care attitude where even a record viral caseload is not making people change their behaviour. Picture the new virus variants landing into the country, new mutations emerging locally and set them against the images of large gatherings for religious events, elections, cricket matches and social functions and it is a no brainer why India is seeing record COVID-19 cases each day. But with new cases now at over 2 lakh a day for three straight days, concerns over what is in-store tomorrow are getting hard to ignore.

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At one end, there are worries around the injections – the availability of vaccine doses, the types of new vaccines, their safety and their ability to deal with the new variants. On the other end, there are concerns around the infection and the manner in which it is unfolding – the changing nature of the virus, its likely resistance to vaccines, and the transmissibility versus the virulence of the virus strains.

Let us try and get answers to some of the important questions:

How safe and effective are the vaccines?

How much should we worry about the virus variants and the ability of the vaccines to deal with them? Based on studies done abroad, Dr Gagandeep Kang, India’s top vaccine scientist and professor at the Christian Medical College, Vellore, tells Financial Express Online: “Of all the strains that we see, we do not need to worry too much.” Among all the variants, there are more concerns around the South African variant – that vaccine experts refer to as B.1.351. It is also found in India as are the other variants – B.1.1.7 (the UK variant) and P.1 (the Brazilian strain) apart from the double mutations seen in India and in other countries. “I don’t think we know for sure that all the vaccines are not working even against the South African variant – which is regarded as the worst of the lot variants in terms of immune escape. However, these kinds of studies need to be done in India also,” says Dr Kang.

Dr Soumya Swaminathan, the chief scientist at the World Health Organisation and the former director-general at the Indian Council of Medical Research (ICMR) says: “All the currently approved vaccines in India and those which have received emergency use listing by the WHO and other stringent regulatory authorities and will also eventually get to India are all very effective in preventing severe disease and death.” She feels “most will probably work against the variants noticed in India also (B.1.1.7, B.1.351, P.1 apart from the double mutations) though more studies are needed on the vaccine efficacy against the different variants.”

Agreeing with the view on the working of the vaccines, Rakesh Kumar Mishra, director of the Centre for Cellular and Molecular Biology (CCMB), a premier Indian research organization based in Hyderabad and focused in the frontier areas of modern biology, says: “because we are not finding any unusually high level of re-infection, it means people who got infected have developed the immunity and are able to resist the infection. Therefore, he sees reason to believe the vaccines are also working and therefore “those who get vaccinated will also get the protection.”

CCMB (and perhaps a couple of other scientific institutions), he says, is currently conducting the in-vitro neutralizing assay to understand the response of vaccines to the double mutations and he feels in another 10 days to a fortnight more clearer picture should emerge on the efficacy of the vaccines on the double mutations.

What details are still missing?

But then, while we need to do the studies in India, the concerns that need to be cleared are about the vaccines that are getting approved. In the Sputnik vaccine, nobody knows till date which of the two presentations – the frozen one or the lyophilized one – has been approved by the Indian drug regulator. For instance, K V Balasubramaniam, an independent consultant and the former managing director of Indian Immunologicals Ltd, explains: “the frozen one needs to be stored at minus 20 degrees centigrade and therefore likely to pose a logistical challenge whereas the lyophilized (for freeze-dried) one can be stored like many other vaccines at between 2 and 8 degrees centigrade, there could be challenges of apparently a short window available for administering the vaccine after the vial has been opened.”

Then, on the other important vaccine in India – Covaxin made by Bharat Biotech and now also by the Maharashtra government undertaking Haffkine Biopharmaceutical Corporation through technology transfer from Bharat Biotech. Vaccine experts point out that the final efficacy study data is still to be shared and that they are all even today basing all their views on only the interim study findings shared so far. Many hope it will be announced soon.

What is the vaccination plan?

Given the rising caseload and the fact that vaccines are the only available defence, the key concern, therefore, is the need for clarity on what the government’s proposed inoculation strategy is: For instance, the key question everyone wants to know is how many people does the government actually want to vaccinate and based on that its assessment of the vaccine doses required and the extent to which the procurement plans for these are in place and the resource allocation made.

How to check transmission?

The idea is to understand, which is the target segment of the population the government is looking at. If the goal is to check the transmission then 45 years and above is not the target population because transmission is more through younger people. However, if the goal is the prevention of severe disease and death then the argument of 45 years and above can hold.

While, ideally, anybody above the age of 18 – at least going by the available vaccines and the applicability based on age currently – should be allowed a vaccine and subsequently, even get to the children too because as the disease settles down, experts say, children could unwittingly become the major modes of transmission.

Why the outcry for Remdesivir is flawed?

Talk to patients getting treated for COVID and in fact, a colleague of this writer is currently in a hospital in Delhi coping with COVID and desperately in need of Remdesivir. Elsewhere in Chennai, there is a patient that has a long list of prescription from a doctor and this includes antibiotics, asthma drugs, paracetamol and even a CT scan. How much of all these medications is justified, we asked Dr Swaminathan and this is what she says: “Unnecessary use of antibiotics or antivirals (including Remdesivir) is not warranted in all cases of COVID-19.” She says, “we have learnt a lot about the clinical management of COVID-19 and it is important that all physicians and hospitals follow evidence-based clinical care guidelines and stick to standard protocols.” The WHO, she says, “has guidelines on the treatment of COVID-19 which are regularly updated based on emerging evidence.” Though she also feels “more research is needed in India and globally on outpatient treatment of patients with drugs like inhaled corticosteroids and nitric oxide, both of which have shown promising early results and need further validation.”

The solution, Dr Gagandeep Kang, feels is having in place a proper protocol that is standardized that both private and public systems follow and deliver evidence-based care and not a random set of treatments that are decided with, in some cases, just with an eye on profits. CMC Vellore, for instance, she points out, has a protocol in place for COVID patients developed by a team that looks at the evidence.