With input from Dr Monica Vasudev

1320: HCFI Round Table Expert Zoom Meeting on “COVID-19 vaccine - Indications and contraindications”

16^th January, 2021, 11am-12pm

Participants: Dr KK Aggarwal, Dr Anita Chakravarti, Prof Mahesh Verma, Mr Bejon Misra, Ms Upasana Arora, Dr KK Kalra, Dr Suresh Mittal, Ms Ira Gupta, Dr S Sharma

Consensus Statement of HCFI Expert Round Table

• Two vaccines – Covishield and Covaxin have been approved based on the recommendation of the Expert group.
• The Health Ministry has issued guidelines regarding precautions and contraindications for COVID vaccine.
• The COVID-19 vaccine is approved (EUA) for 18 years and above. Co-administration of other vaccines is not allowed (there should be a gap of at least 14 days). Interchangeability of COVID vaccine is not permitted. Many questions need to be answered such as if a person develops anaphylaxis to one vaccine, can he be given the other vaccine? What about persons younger than 18 years with comorbidities?
• The vaccine is contraindicated in persons with history of allergies and anaphylaxis to a previous dose of vaccine, any vaccine, drugs, and food allergy. This means that at least 10% of the population with history of allergies will be out of the vaccine indications.
• Temporary contraindications (vaccination deferred for 4-8 weeks after recovery) include persons having active symptoms of SARS-CoV-2 infection. But this does not define the symptoms or the duration of symptoms. Another temporary contraindication is “acutely unwell and hospitalized patients due to any illness”, which also needs to be clarified.
• As per a newspaper report, persons who suffer any adverse reaction to the vaccine will be given compensation. But the amount of compensation has not been clarified.
• There is an allergic response to the vaccine along with viral response, inflammatory response and thrombotic response.
• Norway has reported 23 deaths of elderly frail individuals following COVID vaccination (Pfizer mRNA vaccine).
• mRNA is known to be inflammatory. Killed vaccine is known to be safe for elderly, frail and those with comorbid conditions.
• All those who have natural risk factors for natural virus infection (e.g. uncontrolled diabetes) may develop mild inflammatory reactions after vaccine, which they cannot tolerate.
• Reactions caused by mRNA vaccine are not necessarily caused by mRNA. The other components used such as nanoparticles, PEG may be responsible.
• Inactivated vaccines are safe.
• Assess the person, especially the elderly, before vaccination. After vaccination, anticipate and treat mild inflammatory reaction. Check for rise in CRP.
• High CRP on day zero means proinflammatory and prothrombotic state; start anticoagulants. Give steroids if any signs of cytokine release on Day 3.
• All precautions to be taken should be in place at the vaccination center and all citizens should be made aware of these precautions.
• If you take the vaccine, assess your expected response. There is likely to be a foreign body local response (redness, pain, fever on day 1), which is a typical response to a viral protein.
• If the virus is replicative, there is Th1 response by Day 2, which disappears by Day 7, i.e., lymphocytes should become normal. By Day 4, CRP should become normal.
• Exaggerated inflammatory response means rise in CRP and ferritin. If there is a sudden rise in CRP after vaccination, do not wait for symptoms to develop, especially in elderly fragile people and/or persons with comorbid conditions.
• For Covishield AEFI, the Health Ministry has mentioned that “very rare events of demyelinating disorders have been reported following vaccination with this vaccine without the casual relationship establishment". It should be given with caution to individuals with thrombocytopenia.
• Interim results of a phase 1–2a trial of Ad26.COV2.S COVID-19 vaccine published in the New England Journal of Medicine show that the inflammatory response (CD4 –Th1 and CD8 – Th2) comes on Day 15.
• Serial CRP measurements should be done following COVID vaccination. If CRP is rising, this may suggest an inflammatory response. More studies are required to validate this hypothesis.

 Dr KK Aggarwal

President CMAAO, HCFI and Past National President IMA