How soon will we have a treatment for Covid-19? All of us want an answer to this.
Dr Shashi Tharoor posed this question to Dr Kiran Mazumdar−Shaw, a leading figure in the pharmaceutical industry and one of the few people with access to information and updates in this regard, during an online public interaction with her on the topic. In the interaction, Shaw outlined what Covid-19 is, how it affects us, its treatment stages, prophylactics, cures, the vaccines under development, and the impact of all this on the Indian pharmaceutical industry.
While pointing out that with no official cure or vaccine available, all sorts of household remedies, homeopathic, ayurvedic and even allopathic medicines are gaining traction to fight against the virus, Dr Tharoor said he was sipping a “kadha (a herbal drink)” which was a concoction of ginger, turmeric, and lemon, to build immunity. On his doctor’s advice, he said he had also taken a prophylactics course of the much−discussed Hydroxychloroquine (HCQ). Dr Shaw joked that she too was taking HCQ, but there was a scientific reason why the Indian Council of Medical Research is using it as a prophylactic.
What is the Covid-19 Virus?
Dr Shaw mentioned that a lot is now known about the Covid-19 virus. It is a type of RNA Coronavirus, similar to what we had in the past with SARS and MERS. It enters the body through our nasal passages and reaches the lungs. In the Coronavirus images, you see spike proteins that the virus uses to invade the cells. This is the scientific rationale behind why some doctors are still prescribing HCQ. In theory, HCQ inhibits the ACE receptor on the epithelial cells of the lungs and prevents the spike proteins from entering the cells.
How Does Covid-19 Affect People?
Some people get a mild form of the illness; others move into a severe phase. Few become critical, and some unfortunately succumb to it.
In severe and unmanageable cases, the human immune response starts producing antibodies against the virus on getting infected. Initially, this is a weak response, but if the illness persists, it activates the adaptive immune or myeloid system. Compare this to calling the cavalry into battle. The myeloid system produces cytokines, which are like poison darts.
A hyperactive myeloid immune system causes a lot of inflammation as it fights the Covid-19 virus.
A cytokine storm builds up, but cytokines poison darts also start poisoning your body. Such a situation can lead to organ failure and other aspects generally not seen in severe respiratory ailments. We now know that it is vital to control the myeloid immune system and lower the cytokine and inflammatory response. This allows your lymphoid system to start producing more antibodies and attack the virus.
Treatment for the Covid-19 Infection
If people get mild versions of the disease, at the early stage, a product like Remdesivir, an antiviral, might help. It will start attacking the virus, and the virus might be destroyed.
But if a body is in the hyper activation phase of the adaptive immune system, you have to treat the patients very differently. You have to use antibodies. Many antibody treatments are currently being tested. One of the antibody treatments at Biocon is certainly showing a lot of promise. Doctors who have used these kinds of drugs have seen some amazing recoveries.
Some doctors are treating the cytokine storm with low molecular weight heparin to fight blood clots. Others are using low−cost steroids like Dexamethasone. We now also have a better understanding of the oxygen drop and safe ventilator use for the patients of Covid-19.
Dr Shaw stated that she was a big believer in plasma therapy. Convalescent patients who have recovered from Covid-19 produce the right neutralizing antibodies to kill the virus. When you take the plasma of convalescent patients and infuse it into patients who are very serious or critical, you are giving them some antibodies to fight the infection.
Plasma therapy seems to be showing positive results during trials in Kerala, Maharashtra, and Delhi.
“I think we are already getting a good understanding of medicines and how to manage patients better. While we may not be able to stop the infection, I think our treatment will prevent many deaths,” she said. Dr Tharoor then turned the conversation to vaccines. He posed two important questions: (i) What is a realistic timeframe for a vaccine? (ii) How is the vaccine development progressing in India?
Currently there are 124 ongoing vaccine programs in the world, of which 14 are in India, Dr Shaw said. Globally ten programs have entered human clinical trials. Four Indian vaccines are expected to begin human clinical trials by the end of this year.
How Long will a Vaccine Protect You?
Companies are using different technologies to develop vaccines. The exciting one for India is the Oxford vaccine group being supported by AstraZeneca. They claim the vaccine will be available by September 2020.
However, one concern is that this vaccine showed a great response with monkeys, but a month later, when the vaccinated monkeys were challenged with the virus, they all got infected. So, the critical question is, for how long does the vaccine protect you?
“We need real−world evidence. Right now, all the vaccines that are under trial are being given to healthy humans. You have not given vaccines to people who are actually in a community where there has been a spread. Vaccine trials take long because they have to be tested in various permutations/combinations of situations,” warned Dr Shaw. She further added that while to say that a vaccine was going to be available in September 2020 was not a lie, but it wasn’t the entire truth either. Many questions needed to be answered for the complete truth to emerge: Are you protecting the people who are getting the vaccine? When does one need a booster shot? Will this vaccine protect a person for a year, for two years? These are the data points that need to be known to feel safe about the vaccine.
Dr Shaw expressed her disappointment with WHO in that it was not playing the role it ought to play, according to her, in evaluating and validating various claims. For instance, there’s a race for the first vaccine in the world. Moderna, a company in the United States, is developing a messenger RNA based vaccine for the first time. They have skipped animal trials and claim to be getting compelling immune responses. But we still don’t know the safety aspect and whether it’s going to last for a long time. We don’t have a reliable regulator who’s looking at all these claims and telling people what is believable and what is not. She hoped that at least ICMR would be asking such questions during vaccine development in India.
The Industry Rising to the Challenge
Pointing out that Biocon had done a lot of cutting−edge work, Dr Tharoor asked Dr Shaw if her company and India could play a significant role as a global pharmacy in the era of Covid-19.
Dr Shaw opined that health sciences and healthcare are the new economic frontiers for India after IT, pointing out that India is one of the largest vaccine producers globally, and the largest producers of generic drugs in the world. Biocon is trying to be the biggest bio−similar or bio−generic producer in the world, she added, so we have a global scale in healthcare. What we need to do now is to unlock the innovation.
The industry is rising to the challenge. Initially, India was short of RT−PCR tests, but small biotech companies swung into action and within a few weeks, indigenous test kits were developed for RT−PCR. And so, our testing ability has increased significantly, Dr Shaw said, expressing the confidence that we can develop novel and innovative antivirals.
(Disclaimer: This is a report based on an interview. Any information contained herein is not and should not be considered as medical advice, suggested treatment, or a medical fact. Please consult a doctor or a medical practitioner for any medical advice required.)