With input from Dr Monica Vasudev

1171: HCFI Round Table Expert Zoom Meeting on “Five COVID-19 vaccines of importance”

21^st November, 2020, 11am-12pm

Participants: Dr KK Aggarwal, Dr AK Agarwal, Prof Mahesh Verma, Dr Narottam Puri, Dr Suneela Garg, Dr Girdhar Gyani, Dr DR Rai, Dr Anita, Dr Suresh Mittal, Ms Upasana Arora, Dr KK Kalra, Dr Anil Kumar, Ms Ira Gupta, Mr Saurabh Aggarwal, Dr S Sharma

Consensus Statement of HCFI Expert Round Table

• Four different patterns of mortality are being seen around the world.
• First pattern is the ‘W’ pattern of mortality around the world. The increase in mortality is proportionate to the rising number of cases.
• The second pattern is seen in North America, Canada, Europe, where cases are increasing, but the mortality is decreasing.
• The third pattern is seen in countries like Russia, India, Bangladesh, Brazil, Pakistan, Iran, Iraq, South Korea, Thailand, and Malaysia, where mortality depends on the number of cases; more the cases, more the mortality and fewer cases, less mortality.
• The fourth pattern is seen in countries like Taiwan, New Zealand, Hong Kong, China, which have reduced their mortality to near zero. 
• Few vaccines may be available for distribution by the end of this year. It will be a challenge to decide, which vaccine to choose.
• There are two types of vaccines: Protein based and non-protein based. Most vaccines use a protein component of the virus, which is immunogenic, and do not require stringent cold chain.
• The non-protein vaccines use the nucleic acid of the virus and require cold chain.
• Serum Institute of India is collaborating with the Oxford-AstraZeneca vaccine, which uses spike protein and the vector is chimp adenovirus. Two cases of transverse myelitis have been reported (not in India) with this vaccine in phase 3 trials.
• The Bharat Biotech vaccine “Covaxin” is an inactivated vaccine (killed with reagent) and an adjuvant is used to increase antigenicity. Although safety will be higher, we do not know the efficacy.
• Sputnik V vaccine is under phase 3 trial by Dr Reddy’s Lab; it has received emergency use authorization in Russia. It contains two vectors: Adenovirus 5 and Adenovirus 26. The phase 2 trial in Russia was successful.
• The Zydus Cadila vaccine is a DNA-based vaccine delivered by a ‘skin patch’. Phase 2 trials have been completed. It is India’s answer to Moderna and Pfizer vaccines. It is easily manufactured and can change the genetic mutations like flu vaccine.
• Biological E vaccine uses RBD of the protein; undergoing phase 1/2 trial.
• Moderna and Pfizer-BioNTech vaccines are nucleic acid based vaccines; >90% efficacy; synthetic vaccine, so chances of side effects are less. Pfizer has asked for EUA in the US. If it is approved, it will be the first vaccine to be approved with full-fledged phase 3 trial.
• The J&J vaccine is also a vector based vaccine.
• India has already started manufacturing of syringes, needles, vials; cold chains are being set up.
• Efficacy is being affected because of cold chain.
• All vaccines are going to be multidose vials and their disposal will be a problem.
• Pfizer vaccine requires temperature of -70^o This is a concern as we do not have this storage in the country.
• Storage and beneficiaries of vaccines need to be decided. How will it reach the last mile? Tier 3 and Tier 4 cities?
• University of Hong Kong is working on a nasal vaccine, which may be more acceptable; still in the primitive stage.
• Two factors to be considered when choosing a vaccine: Disease enhancement (the vaccine should not behave like re-infection) and at least 3 months data on adverse events of special interest (multiple sclerosis, autism, transverse myelitis, Guillian Barre syndrome). The common adverse events of a vaccine are fever, muscle pain, etc.
• All companies manufacturing vaccine have been asked to do animal studies to check for enhancement in mice before approval is given.
• We will be richer by experience when the vaccine comes in India. Will there be an apprehension about the vaccine when it is available?
• Skilled manpower will be required for the vaccine.
• First are nucleic acid vaccines; they are more antigenic and more safe; in second place are vector vaccines.
• Storage temperature needs to be clarified. It is better if they are available in pre-filled form.

Dr KK Aggarwal

President CMAAO, HCFI and Past National President IMA