With input from Dr Monica Vasudev

1321: Minutes of Virtual Meeting of CMAAO NMAs on “COVID-19 vaccine safety”

16^th January, Saturday, 9.30am-10.30am

Participants: Member NMAs - Dr KK Aggarwal, President CMAAO, Dr Yeh Woei Chong, Singapore Chair CMAAO, Dr Marthanda Pillai, Dr Ravi Naidu, Malaysia, Dr Alvin Yee-Shing Chan, Hong Kong, Treasurer, CMAAO, Dr Angelique Coetzee, President South African Medical Association, Dr Md Jamaluddin Chowdhury, Bangladesh Medical Association, Dr Tashi Tenzin, Bhutan

Invitees: Dr Russell D’Souza, Australia UNESCO Chair in Bioethics, Dr S Sharma, Editor IJCP Group

Key points from the discussion

• The SARS-CoV-2 virus generates four types of responses in the body: Immunogenic, virogenic, cytogenic and thrombogenic.
• In Norway, 23 people have died following COVID vaccine (Pfizer-BioNTech mRNA vaccine). All of them were elderly and frail individuals. Preliminary report says that these elderly frail people could not tolerate even milder side effects of the vaccine and developed exaggerated cytokine response to the vaccine. This means that the vaccine is also causing immune dysregulation. Norway has now withdrawn vaccination for elderly and frail individuals.
• This defeats the purpose of vaccination. Because it is the elderly and those with comorbidities who need to be protected more.
• If herd immunity is obtained, even with 60% of immunization, this population is going to be protected.
• For elderly and those with comorbid conditions, active vaccines should not be used. Only killed vaccines should be used.
• mRNA is inflammatory and will cause inflammatory reaction.
• If baseline CRP is high before acquiring the infection, this will result in exaggerated inflammatory response.
• Before vaccination, if there is prothrombotic and proinflammatory state, it has to be managed along the same lines. If early signs of inflammation are evident, steroids/anticoagulants should immediately be given.
• A vaccine-induced prothrombotic and proinflammatory state should be urgently and aggressively treated.
• Contraindications to the vaccine should be considered seriously.
• Bhutan is opting for Covaxin (the indigenously developed Indian vaccine by Bharat Biotech).
• Interim results of a phase 1–2a trial of Ad26.COV2.S COVID-19 vaccine (J&J) have been published in the New England Journal of Medicine. Ad26.COV2.S is a recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized SARS-CoV-2 spike protein.
• The trial included healthy adults between the ages of 18 and 55 years (cohort 1) and those 65 years of age or older (cohort 3).
• After the administration of the first vaccine dose in 805 participants in cohorts 1 and 3 and after the second dose in cohort 1, the most frequent solicited adverse events were fatigue, headache, myalgia, and injection-site pain.
• The most frequent systemic adverse event was fever. Systemic adverse events were less common in cohort 3 than in cohort 1 and in those who received the low vaccine dose than in those who received the high dose.
• Reactogenicity was lower after the second dose. Neutralizing-antibody titers against wild-type virus were detected in 90% or more of all participants on day 29 after the first vaccine dose and reached 100% by day 57 with a further increase in titers, regardless of vaccine dose or age group. Titers remained stable until at least day 71. 
• On day 14, CD4+ T-cell responses were detected in 76 to 83% of the participants in cohort 1 and in 60 to 67% of those in cohort 3, with a clear skewing toward type 1 helper T cells.
• Based on the results, the trial concluded that the safety and immunogenicity profiles of Ad26.COV2.S support further development of this vaccine candidate.
• Now second generation vaccines are being talked about, which will cover the whole population, are single dose and will impart longer lasting immunity.
• Mild illness may develop after vaccine; anticipate it and treat it.
• 484 mutation (seen in Brazil, India, South Africa, Japan) is more important than 501 mutation. The 69/70 deletion hinders diagnostics and makes them more unreliable.
• With every mutation, the efficiency of a vaccine may reduce.
• A 10-minute video was also played illustrating what CMAAO has done in terms of educating the public about COVID-19.

Dr KK Aggarwal

President CMAAO, HCFI and Past National President IMA