With input from Dr Monica Vasudev

1467:    HCFI Round Table Expert Zoom Meeting on “Covishield vaccine halted in some European Countries: Evidence-based or knee jerk reaction?”

13^th March, 2021, 11am-12pm

Participants: Dr KK Aggarwal, Dr Shashank Joshi, Dr Suneela Garg, Dr DR Rai, Mrs Upasana Arora, Ms Balbir Verma, Dr KK Kalra, Dr Ashok Gupta, Dr Anil Kumar, Ms Ira Gupta, Dr S Sharma

Consensus Statement of HCFI Expert Round Table

• If the reactogenicity is uncontrolled, inflammation is likely.
• Delayed local injection site reaction to vaccine is uncommon; they are likely due to T-cell mediated hypersensitivity.
• Mantra: In susceptible high risk (proinflammatory and/or procoagulative) individuals, reactogenic vaccines can trigger transient thromboinflammation, lasting for first few (up to four) days.
• Muscle COVID vs. COVID disease: Vaccine-induced disease is non-pulmonary. In muscle COVID, non-replicable dose of the gene is injected, whereas in COVID disease, the gene is replicable. Vaccine is a fixed dose, whereas in the disease, the dose is variable. In vaccine, the acute inflammation lasts for up to four days, whereas in the disease, the inflammation lasts for 10 days or more.
• Individuals with microalbumin in urine, CRP >1 and 6MWT <200 m are high risk.
• Acanthosis nigricans is procoagulative or prothrombotic state.
• This vaccine is going to be more reactogenic than mRNA vaccine.
• Reactogenicity is different from allergenicity and immunogenicity.
• Cases of disease enhancement are being seen. If vaccine is given in the presence of non-neutralizing antibodies, these patients may develop some degree of non-pulmonary disease enhancement presenting with high grade fever and high CRP.
• Considering the large coverage of Covishield, the reported ADRs seem to be reasonably less. Direct cause-effect relationship has not been established.
• The Indian vaccination program perhaps has the largest pharmacovigilance database, but there is a need to simplify the system and make it single point reporting, harmonize the ADR reporting and make it hassle-free and digital.
• Maharashtra is in the second surge. In Maharashtra, the Vidharbha and Marathwada regions were less exposed during the first surge. There were gatherings, no masking, and no physical distancing and total lack of adherence to COVID appropriate behavior protocol. In Amravati, Akola, clusters of cases were seen. Whole buildings were affected.
• There is an unusual strain, which is spreading rapidly, but it has good recovery and case fatality rate is very low. Testing frequency had dramatically come down. In Mumbai local trains, physical distancing is not possible and masking was scanty. Hence, double masking is being recommended.
• About 80% of cases in Maharashtra are asymptomatic. They do not home isolate despite stamp. In some districts, institutional quarantine is being done even for asymptomatic cases otherwise they become spreading points.
• Gut COVID is seen more; patients are coming with diarrhea. Sewage may be a source of infection.
• Contact tracing has been increased to 1:30.
• The positive signals are asymptomatic infection, faster recovery, younger age and lower death rates.
• Usually Maharashtra precedes the country; what is happening here, it is likely to happen in the rest of the country. Maharashtra is in the same stage as Europe was 2-3 months back. Rapid vaccination is the answer. Citizens have to take responsibility.
• Dissemination of findings of investigation of death after vaccine is important, whether related to the vaccine or not. Precautions to be taken by susceptible persons should be more widely disseminated.

Dr KK Aggarwal

President CMAAO, HCFI and Past National President IMA