20^th March, 2021, 11am-12noon

Participants: Dr KK Aggarwal; Dr AK Agarwal; Dr KK Kalra; Dr DR Rai; Dr Anita Chakravarti; Dr Jayakrishnan Alapet; Mr Bejon Misra; Mrs Upasana Arora; Dr Ashok Gupta; Dr Anil Kumar; Ms Ira Gupta; Dr S Sharma

Consensus Statement of HCFI Expert Round Table 

• The vaccine contains the original virus gene and therefore will behave similar to how a virus will act when it enters the body. The vaccine will cause, in addition, allergy not seen with the virus.
• More than 20 million doses of AstraZeneca vaccine have been administered in Europe and other countries. In India, 27 million doses of the Covishield vaccine (manufactured by Serum Institute of India) have been given.
• Some concerns have been raised about the vaccine following reports of thromboembolism from all over the world, including in India. So far, no direct causal link has been found between the vaccine and the events.
• The review committee concluded that the benefit-risk balance of the medicine remains positive, and there is no association with thromboembolic disorders overall…But there is a need to educate the healthcare professionals and the person receiving the vaccine that they should immediately report if they observe symptoms of thromboembolism, and especially signs of thrombocytopenia and cerebral blood clots, such as easy bruising or bleeding, and persistent or severe headache, particularly beyond 3 days after vaccination. Adequate information should be available on the leaflet as a warning.
• Covishield is like a fixed dose combination drug as it contains two viruses in one formulation.
• Vaccine can cause anaphylaxis type 1 hypersensitivity reaction, which can be immediate IgE mediated or it can be non-IgE mediated, which is complement mediated and occurs after 6 hours.
• It can also cause type 3 reaction (Arthus reaction) with skin, joint and kidney involvement.
• It can cause type 4 local skin reactions, as seen in tuberculin test after 72 hours at the site of injection.
• The protein in the virus and the vaccine is the same. Therefore, it is a biosimilar drug.
• Anaphylaxis can occur after the vaccine. Anaphylaxis is always to a protein. So, the mRNA will not cause anaphylaxis. It is the other ingredients (polysorbate 80) that will cause anaphylaxis. After taking the COVID vaccine, do not take any other injection at least for the next 4 days.
• The vaccine can cause allergic non-IgE-mediated reaction after 6 to 8 hours - angioneurotic edema, rash, urticaria.
• It can cause type 4 reactions in the arm at the local site of injection, after 48hours till 7^thday, in the form of redness, swelling, rash. Delayed local injection-site reactions to vaccine may occur, though they are uncommon (T-cell mediated hypersensitivity) (NEJM).
• Vaccine may precipitate underlying allergy and inflammation: post-vaccine rheumatoid arthritis, dye allergy (eczematous rash), herpes zoster, Bell’s palsy, transverse myelitis.
• Vaccine can precipitate inflammation: anal fistula precipitated after vaccine, painful lymphadenitis, episcleritis and left eye conjunctivitis.
• Vaccine can cause thrombosis; 60 cases of deaths due to myocardial infarction have been reported. Arterial thrombosis has been reported more often in India; in European countries, pulmonary embolism is reported more often.
• Low platelet count with skin rash (purpuric rash) has been reported. Falling platelets with rising CRP is suggestive of a triad of thrombosis, bleeding and low platelet (pro-thrombotic state) e.g. – thrombotic thrombocytopenic purpura (TTP), DIC, hemolytic uremic syndrome, post-COVID vaccine.
• Post-COVID post-vaccine systemic inflammation may occur with very high fever, very high CRP.
• Rashes in feet, Raynaud’s like phenomenon, rash on venous ulcers in a patient of venous varicosities have been reported.
• Spike protein in the vaccine can convert a normal state to proinflammatory state, proinflammatory to inflammatory, proinflammatory to inflammatory to thrombotic and prothrombotic to thrombotic state.
• Such reactions are expected with the vaccine. As doctors, we must list possible side effects and prevent/treat them.
• Weigh the risks versus benefits in high risk and susceptible individuals; minimize their risks and prevent complications.
• Clots will occur more with vector vaccines and may be more reactogenic. The adenovirus also provokes the immune system by switching on the cell’s alarm systems. The cell sends out warning signals to activate immune cells nearby. By raising this alarm, the Oxford-AstraZeneca vaccine causes the immune system to react more strongly to the spike protein.
• S protein antibodies will be much higher with Covishield, but Covaxin will also generate antibodies against N-terminal domain (NTD).
• A large scale study from Denmark has shown that reinfection rate is only 0.65%. So far, anybody who has developed reinfection has not died.
• Inadequate antibodies after the vaccine may cause disease enhancement, if infection occurs.
• If baseline CRP is high, it may further rise after the vaccine. Manage it appropriately and accordingly, or take precautions before taking the vaccine.
• Not taking the vaccine is not the solution; taking precautions is the answer.

Dr KK Aggarwal

President CMAAO, HCFI and Past National President IMA