With input from Dr Monica Vasudev

1377: HCFI Round Table Expert Zoom Meeting on “Adverse events including Deaths following vaccinations”

6^th February, 2021; 11am-12pm

Participants: Dr KK Aggarwal, Dr Ashok Gupta, Dr Suneela Garg, Prof Mahesh Verma, Dr Anita Chakravarti, Dr DR Rai, Mr Bejon Misra, Ms Balbir Verma, Dr KK Kalra, Dr Anil Kumar, Dr Suresh Mittal, Dr S Sharma

Consensus Statement of HCFI Expert Round Table

• Vaccines are universally tested and monitored and are among the safest medical products in use. Although evidence supports the safety of vaccines, there are rare instances where the causal relationship between vaccines and complications, including deaths has been established or plausible theoretical risks exist.
• Vaccines have saved millions of lives. Like any other drug, some adverse events (common, severe, serious) are associated with vaccinations. One should be aware about them and it is also important to know how to tackle them.
• Convert any contraindication to an indication. This will remove vaccine hesitancy. Try to identify vaccine intolerant patients and see how to proceed to give them the vaccine.
• Two patients in Brazil have tested positive for more than one strain of coronavirus. This is a matter of concern.
• India has overall only 25% seropositivity.
• Mutations are causing more mortality. The UK Prime Minister has said that the new UK variant may be more deadly.
• In India, out of 28 lakh vaccinations, 13-16 deaths (between 25 and 56 years of age) have occurred (Uttar Pradesh, Karnataka, Andhra Pradesh, Rajasthan, Telangana, Haryana, Odisha, Kerala and Gujarat); the vaccine taken in each case was Covishield. All had cardiovascular problems or brain stroke.
• In Norway, 33 elderly (≥75 years) and frail individuals died in a short time after receiving the first dose of the vaccine.
• Evidence from South Korea shows that people can die after flu vaccine; 23 persons, out of 13 million people who received the flu vaccine, died after being vaccinated.
• 10 people died in Germany, 79 to 93 years of age.
• A person can develop anxiety, vasovagal attack after seeing the vaccine injection.
• When a vaccine is taken, the antigen-presenting cells (APCs) will present the vaccine antigen 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).
• Different reactions are seen after a 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.
• Before giving the vaccine, ask:

o   Will you develop & tolerate vasovagal reaction? If there is a history of syncope, the vaccine should be given in the lying down position and stay hydrated.

o   Are you prone to develop and tolerate immediate (IgE) and/or delayed (non IgE) allergy? Allergy occurring in the first hour is IgE mediated; if it is occurring after 1 hour and specifically after 6 hours, it is non-IgE mediated allergy. In India, delayed reaction is being seen.

o   If likely (non IgE mediated): pre-load with Montelukast + H1 + H2 blocker. If known IgE allergy: Get absolute eosinophilic count and IgE levels, do a scratch test/intradermal challenge.

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

o   Will you 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.

• For non-IgE mediated reactions, the following protocol comprising of H1 and H2 antihistamines and sometimes montelukast, aspirin, or glucocorticoids will help.

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

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

o   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.

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

o   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.

• Reduce the precipitating factors for CAD - hypertension, fever, tachyarrhythmias, thyrotoxicosis, anemia, polycythemia, hypoxemia and valvular heart disease.
• Ask for a history of cocaine use in young people; even casual use of cocaine may be associated with acute or chronic cardiovascular toxicity. Cocaine can precipitate myocardial infarction.
• Smoking will increase the sympathetic response; it will increase BP by 20 mmHg. A person, who smokes before taking the vaccine and has an underlying heart disease, both can precipitate acute cardiovascular event.
• The amount of alcohol taken the previous night can also precipitate oversympathetic response.
• Frail individuals with comorbid conditions will not be able to tolerate even mild sympathetic overactivity. They need to be premedicated.
• The response to vaccine is the same as with COVID natural infection.
• The AEFI (adverse event following immunisation) definition does not mention the time.
• Every death within 3 months of vaccine should be investigated.
• The long-term effects of the vaccine are unknown.
• We need to prevent post-vaccine complications. They are manageable and preventable.

Dr KK Aggarwal

President CMAAO, HCFI and Past National President IMA