CME INDIA Presentation by Dr Raj Kamal Choudhary, Associate Professor of medicine, JLNMCH, Bhagalpur.

These days most read stories are about COVID vaccine. Health care professionals and also general public have understood the realities of treatment available. All need new wings to fly uninterrupted. It is possible that you take the first shot of vaccine and start flying like a bird. But news is also coming that Masks will be needed even after vaccination. CME INDIA tried to understand the scenario.

Trials of Vaccine

• Phase 1 trials primarily to test the vaccine’s safety, determine dosages and identify any potential side effects in a small number of people.
•  Phase 2 trials further explore safety and start to investigate efficacy on larger groups.
• The final stage, Phase 3 trials, which few vaccines ever make it to, are much larger, involving thousands or tens of thousands of people, to confirm and assess the effectiveness of the vaccine and test whether there are any rare side effects that only show up in large groups.
•  The World Health Organization lists candidates at various stages of clinical trials.

Vaccine Basics

• A vaccine trains the body’s immune system to recognize some signature viral protein called an antigen. SARS-CoV-2, like other coronaviruses, is named for the crown-like spikes on its surface. There are three proteins on the surface of these viruses: the envelope, membrane and spike, which encapsulate a strand of RNA. This RNA molecule holds the genetic instructions that make up the virus.
• Viruses do not make their own components. Instead, a coronavirus enters into the lung and possibly other respiratory track cells by attaching through to them via its spike protein. Once inside, the viral RNA becomes part of the host cell’s protein production machinery, and produces new copies of viral proteins and RNA which then assemble into thousands of new viruses to spread the disease.
• So, one way to stop a disease is to block the virus from entering the cells. Vaccines do that by training the body to identify and attack the virus before it can infect healthy human cells.
• A vaccine is essentially a pure preparation of one or more key components of the virus – such as the envelope, spike or a membrane protein – that is injected in the body to give the immune system a preview of the virus without causing disease. This preview tells the immune system to seek out and attack the virus containing those specific proteins if the real virus ever shows up.    

Which Vaccine in India?

• Covax Vaccine is the indigenous vaccine of Bharat Biotech, Hyderabad.
• Oxford / Astra Zeneca Vaccine is being manufactured by Serum Institute, Pune.
• The Vaccine will depend on the efficacy result.
• mRNA vaccine interim results better than others, though cold chain is an issue for these.
• India may go for indigenous vaccines, like serum.

CME INDIA Discussion

Dr A K Singh, Endocrinologist, Kolkata asks:

If all vaccines are provided to you free of cost – which one you will take and why?

1. Pfizer
2. Moderna
3. AZ-Oxford/ Covaxin
4. Sputnik V

Dr Meena Chhabra: Pfizer, Will take the first one available then review data of phase 3 in a peer reviewed journal and get re vaccinated

Dr Prabhat Agarwal, Agra: Sputnik

Dr Sanjeev R Pathak, Ahmedabad: Let us wait for full results especially safety results of all phase 3 trials

Dr Shashank Joshi, DM Endo, Mumbai: Will see data of phase 3 fully in a peer reviewed journal before making any decision.

Dr Chandra Bhushan Prasad, Bihar: Pfizer of course, it’s suitable for 60 and above, Biden approval, corona care ambassador 😁

Dr N K Singh: Moderna might be. May be earliest available one.

Dr Keyur Acharya, Intensivist, UK: I think it depends on which one is cheaper, scalable and easy to store. All of them have shown good efficacy (for WHO anything above 50%). I think most of the world will end up with AstraZeneca. 2 shots IM 4 weeks apart and another 1-2 weeks for immunity. Unless other vaccines change their price, storing etc.

Distribution of vaccine comes with its own challenges. From ethical point of view, strategy for global supply and distribution should combine 1) beneficence and 2) social justice.

This would mean followings:

1) Utilitarian approach in order to maximize its overall benefits and

2) Equitable approach to treat individuals in fair manner.

Plan should encourage “greater good” focussing on public health, social and economic wellbeing. Public health strategy might include intervention at those levels which will allow us to return to normal- workers who cannot work from home, children who have lost priceless time away from education and many more such groups.

Can we distribute by typical mechanisms?

First cum first basis, auction or lottery system and such mechanism would be very unfair and inefficient ways of distributing it. Should marginalized groups either from health perspective or economic perspective be prioritised?  Equally allocating it to essential public service workers would be vital under ethical principle of reciprocity.

How we distribute and allocate vaccine will test our social and ethical abilities, legitimacy of our policies framework.

As a society, are we prepared to discuss, deliberate, plan, implement fair distribution or are we going to plunge in chaotic, unorganised, black market like allocation? Only time will tell!!

Dr Rajkamal Chaudhary, Asso. Prof of Medicine, Bhagalpur: I would like to take which ever vaccine is finally approved by GAVI & WHO. AstraZeneca vaccine, Pfizer, Novavax are going to be safe and has entered 3rd. Phase of Trial, proved finally the vaccine which is not having any complications. Cold chain maintenance of these vaccines will be comparatively easy. We have ILR 2 to 8 degrees C and DF in India – 50 degrees C to keep the vaccines whichever will suit the temperature.

CME INDIA Learning Points:

• Natural infection can provide differing levels of immunity. It is based on the variable viral load different persons are exposed to. At present we do not know how long such immunity lasts in each person.
• A vaccine administers a standardised dose. It is likely to elicits a good immune response and to last longer than a natural infection of variable viral exposure and clinical severity.
• Top Priority to provide vaccine first is definitely healthcare providers who test, trace, treat or counsel persons infected with the COVID-19 due to their repetitive exposure to high viral loads.
• Apart from cold chain, the actual administration of the vaccine, as an intramuscular injection in two doses set 3-4 weeks apart, could be a challenge.
• If there are hotspots of rapidly increasing cases in any part of the country, urgent immunisation of susceptible persons there should be undertaken.
• 2021 has to be the year of discipline and determination to subdue the virus with all the tools.
• If multiple vaccines are procured, how will they be distributed across states? It is a mystery at present

CME INDIA Tail Piece:

• We do not know if people can become infected and transmit even with vaccination. Those who have been vaccinated could continue to asymptomatically and unknowingly shed virus and spread disease.
• The data from the Pfizer/BioNTech and Moderna vaccines are about protection from symptomatic disease. Pfizer reported 170 infections (162 in the placebo group) in 41,000 participants. Moderna, to date, has reported 95 cases (90 in the placebo group) in 30,000 participants.
• It will take 80% coverage to get to herd immunity, and that is not likely to happen until summer 2021
• Every mRNA vaccine is different. The sequence that codes for the stabilised spike may be the same, but when you’re making a vaccine which is either enclosed within a lipid nanoparticle or integrated with it, you’re going to have different levels of stability.
• Making News/Former Pfizer VP: ‘No need for vaccines,’ ‘the pandemic is effectively over’-A equally viral Post. SAGE believes that less than 10% of the population have so far been infected by SARS-CoV-2. VP also told – “well understood that not every person, infected by a respiratory virus, goes on to produce antibodies. And many people, having prior immunity, never get properly infected anyway.”
• EK TAMASHA MERE AAGE: Two faces of a News/30/11/20
  1. 1. AstraZeneca coronavirus vaccine is undergoing trials in India in its partnership with the Pune-based SII. A 40-year-old Chennai-based volunteer, who was a volunteer for the third phase of the vaccine trial, has now sought Rs 5 crore compensation while alleging that the vaccine dose has caused serious neurological and psychological anomalies in his case.
  2. 2. SII slaps Rs 100 crore defamation case on volunteer saying it “malicious and misconceived”. The SII has said in a statement, “It is evident that the intention behind the spreading of such malicious information is an oblique pecuniary motive. The Serum Institute of India, will seek damages in excess of 100 crore for the same and will defend such malicious claims.”

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