CMAAO CORONA FACTS and MYTH :  Vaccine safety

Author : Dr K K Aggarwal President CMAAO, HCFI, With input from Dr Monica Vasudev

India

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New Delhi, February 11, 2021:

Minutes of Virtual Meeting of CMAAO NMAs on “Vaccine safety” ,Held on 6^th February, Saturday, 9.30am-10.30am

Participants, Member NMAs

Dr KK Aggarwal, President CMAAO

Dr Yeh Woei Chong, Singapore Chair CMAAO

Dr Alvin Yee-Shing Chan, Hong Kong, Treasurer, CMAAO

Dr Marthanda Pillai, India, Member World Medical Council

Dr Marie Uzawa Urabe, Japan Medical Association

Dr Md Jamaluddin Chowdhury, Bangladesh Medical Association

Dr Qaiser Sajjad, Secretary General, Pakistan Medical Association

Dr Lwando Maki, South African Medical Association

Invitees

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

Key points from the discussion

• Two patients in Brazil have tested positive for more than one strain of coronavirus. One of the patients tested positive for the two Brazilian strains P.1 and P.2. The second patient tested positive for P.2 and the B.1.91 strain, which first appeared in Sweden.
• The UK Prime Minister has said that the new UK variant may be more deadly, hence vaccine becomes a priority.
• In India, more than 13 people, between 25 and 56 years of age, have died after taking the covid vaccine (Covishield) after 2.8 million vaccinations across the country. All have been ascribed to cardiovascular problems (MI) or “brain stroke”.
• In Norway, 33 elderly (≥75 years) and frail individuals died short time after receiving the first dose of the vaccine. 13 autopsies were done, which suggest that common side effects may have contributed to severe reactions in frail elderly people.
• In Germany, 10 people died after (several hours to 4 days) taking the covid-19 vaccine (Pfizer-BioNTech). They were aged 79 to 93 and all had antecedent diseases. Investigation of deaths showed that they died of their main diseases.
• When a vaccine is taken, the vaccine antigen is identified by the antigen-presenting cells (APCs) and present it to CD8+ T cells (cytotoxic) and CD4+ T cells.  Th1 cytokines stimulate CD8+ T cells and in turn acquire the ability to attack the infected cells. Th2 response helps in the differentiation of B cells. The activated B cells can produce neutralizing antibodies. However, imbalanced immune responses can cause pulmonary immunopathology, partially due to aberrant Th2 response or antibody-dependent enhancement (ADE). Similar to the cytokine storm, there can be an aberrant vaccine response, which can cause immunoinflammation and thrombotic manifestations in people. So, there can be the same response with a vaccine as natural infection.
• Various reactions seen after vaccine: Allergy to vaccine or any of its ingredients, reactogenicity, reacto-immunogenicity (exaggerated Th1 and Th2 response), antigenicity or immunogenicity, reaction to pre-existing antibodies, development of disease enhancing antibodies/non neutralizing antibodies.

When you are taking a vaccine, ask yourself:

Q) Will I develop & tolerate vasovagal reaction? If you have a history of syncope, get vaccinated in lie down position and stay hydrated.

Q) Will I develop and tolerate immediate (IgE) and or delayed (Non IgE) allergy? If likely (non IgE mediated): pre-load with Montelukast + H1 + H2 blocker. If you have a known IgE allergy: Get eosinophilic count and IgE levels, do a scratch test/ intra dermal challenge.

Q) Will I get exacerbation of my thrombo-inflammation? If baseline CRP >1 mg/L, it will cause rise in CRP, IL-6, IL-1β). In such cases, preload the patient with ACS (aspirin, colchicine and statin). CRP may rise by 30% on day 2. If rise is more or CRP is k> 10 mg/L, then add mefenamic acid or any other immunomodulator.

Q) Will I get oversympathetic response? (abnormal HR variability, 6 MWD/T less than 700 feet or over sympathetic response to walking) pre-load such patients with a β-blocker

Q) Continue all your medicines unless contraindicated on the day of vaccination

• Vaccines can cause 4 types of immunologic reactions: Type 1 (immediate, IgE-mediated), type II (delayed, IgG-mediated), type III (delayed, immune complex deposition and complement activation) and type IV (delayed, T cell mediated).
• The World Allergy Organization has divided into two: Immediate (within 1 hour) and delayed (after 1 hour but usually >6 hours
• After a vaccine, there will be either an immediate reaction (IgE mediated) or a delayed reaction (non-IgE mediated).
• For IgE-mediated reactions: antihistamines and steroids do not prevent anaphylaxis.
• For non-IgE mediated reactions, the following protocol comprising of H1 and H2 antihistamines and sometimes montelukast, aspirin, or glucocorticoids will help.

Q) Cetirizine (10 mg orally) is given 30 to 120 minutes before the start of the procedure.

Q) Famotidine (20 mg IV or orally) is given 30 to 60 minutes before the start of the procedure.

Q)Aspirin (325 mg orally) is given to patients with flushing during their initial reaction. This is administered the night before the procedure and again 1 hour before the start of the procedure.

Q)Montelukast (10 mg orally) is given the night before the procedure and again one hour before the start of the procedure.

Q)When desensitizing to chemotherapy or biologic agents, any premedications (such as steroids) that would be given to a nonallergic patient should be incorporated into the planned pre-medications as well.

• Convert contraindication to indication to remove vaccine hesitancy.
• One way to prevent vaccine-induced adverse events is to anticipate. Allergy reaction with the first dose is non-IgE mediated, which can be prevented by a combination of H1 and H2 blocker and montelukast.
• When persons ≥50 years with comorbid conditions will be vaccinated, lot more thrombotic episodes can be expected.
• In Singapore, so far 150,000 people have been vaccinated; there were 4 anaphylactic reactions. All have recovered. Vaccination for the elderly has started. So far, no mishaps have occurred.
• In susceptible persons, keep temperature and heart rate less than 100; high fever and heart rate in the presence of underlying coronary blockage will precipitate heart attack.
• Reduce exacerbating factors for CAD such as hypertension, fever, tachyarrhythmias, thyrotoxicosis, anemia, polycythemia, hypoxemia and valvular heart disease.

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