Two days before the rollout of the Covid-19 vaccination drive, the Union Health Ministry has sent to all states and immunisation officers, a comprehensive fact sheet for both vaccines — Covaxin and Covishield — that will be used during the initial phase of vaccinating a priority group of 3 crore people.
What is this fact sheet?
It contains general information on the vaccine platform, physical specifications, dosage, cold chain storage requirements, and specific guidelines on contraindications (a factor due to which the vaccine is to be withheld to certain categories of people) as well as adverse events that may happen following vaccination. The fact sheet also details special precautions.
The Centre has asked the states and immunisation officers to disseminate the fact sheet to all programme managers, cold chain handlers, and vaccinators before the rollout. The communication comes on the directions of the national drug regulator CDSCO, which, while granting accelerated approvals, had directed manufacturers Serum Institute of India (Covishield) and Bharat Biotech (Covaxin) that the vaccines should be supplied along with the fact sheet and a separate leaflet for the guidance of the healthcare provider.
So, what are the general guidelines?
# The vaccination is only for people over the age of 18 years.
# The vaccines are not interchangeable: the second dose will have to be of the same vaccine that was administered as the first dose.
# The vaccine should be given with “caution” to persons with a history of any bleeding or coagulation disorder — platelet disorder, clotting factor deficiency, or coagulopathy.
# Vaccinators have to store both vaccines at +2°C to +8°C; protect them from light; and discard the vaccine if found to be frozen.
And what are the specific guidelines on contraindications?
The vaccine cannot be administered to people who belong to any of three categories:
# Persons with a history of an allergic reaction to a previous dose of a Covid-19 vaccine (this would mean those who have taken a dose in a country where vaccination has already started);
# People who show an immediate or delayed onset of an allergic reaction to vaccines or injectable therapies, pharmaceutical products, and food items;
# Pregnant and lactating women. Since they have not been part of any clinical trial so far, women who are “pregnant or not sure of their pregnancy” and “lactating women” should not receive the vaccine at this time.
The fact sheet also deals with temporary contraindications.
What are these temporary contraindications?
For certain circumstances under the category of temporary contraindications, vaccination is to be deferred for four-eight weeks after recovery. This covers three categories:
# Persons showing active symptoms of SARS-CoV-2 infection
# Covid-19 patients who have been given anti-SARS-Cov-2 monoclonal antibodies or convalescent plasma
# Acutely unwell and hospitalised patients (with or without intensive care) due to any illness.
What health conditions are not contraindicated, meaning the vaccines can be given regardless?
# Persons with a past history of Covid-19 infection can be administered with vaccine.
# Persons with a history of chronic diseases and comorbidities — cardiac, neurological, pulmonary, metabolic, and malignancies — are also included.
# Persons with immunodeficiency or HIV, and patients on immune suppression due to “any condition” can be administered with the Covid-19 vaccine. The fact sheet states, however, that the response to the Covid-19 vaccine “may be less in these individuals”.
What are the possible adverse reactions mentioned?
These are dealt with separately for either vaccine.
MILD ADVERSE EVENTS: For Covishield, the fact sheet says a few mild adverse events can happen following immunisation —injection site tenderness; injection site pain; headache; fatigue; myalgia (deep muscle pain); malaise (a feeling of overall discomfort); pyrexia (an abnormal elevation of body temperature); chills; arthralgia (pain in the joint); and nausea.
In such cases, the fact sheets says the common painkiller paracetamol may be used “to provide symptomatic relief from post vaccination adverse reaction”.
RARE ADVERSE EVENTS: The nerves in the body are covered with a protective layer called myelin — like a network of electric wires that helps transmit messages from the brain smoothly through the body. Conditions that damage myelin are called demyelinating disorders. The fact sheet says “very rare events of demyelinating disorders” have been reported following vaccination with Covishield, “without the causal relationship establishment”.
It adds that Covishield should be given with “caution” to individuals with thrombocytopenia, a medical condition characterised by abnormally low levels of platelets.
And what about common adverse events with Covaxin ?
MILD ADVERSE EVENTS: Among mild adverse events following immunisation, the fact sheet includes: injection site pain; headache; fatigue; fever; body ache; abdominal pain; nausea and vomiting; dizziness-giddiness; tremor; sweating; cold; cough; and injection site swelling.
RARE/SERIOUS EVENTS: None are listed. Bharat Biotech, the manufacturer, has said no serious adverse event has been reported in either phase 1 or phase 2 trials — or in the ongoing large phase 3 trials with 25,800 participants, it has said.
Bharat Biotech has also said that chloroquine and corticosteroids, both used as repurposed drugs in Covid-19 clinical management, “may impair antibody response” likely to be triggered by the vaccine.
How have vaccines performed on safety so far in countries that have begun?
Wherever Covid-19 vaccines have been used anywhere in the world, they have been found to be generally safe so far.
In a small section, an adverse event called anaphylaxis has been recoded. This is a severe, life-threatening allergic reaction that occurs rarely after vaccination. According to the US Centers for Disease Control (CDC), monitoring by the Vaccine Adverse Event Reporting System detected 21 cases of anaphylaxis— out of a reported 1,893,360 first doses of the Pfizer-BioNTech vaccine that were administered between December 14 and 23. That is 11.1 cases per million doses. Of these, 71% occurred within 15 minutes of vaccination.
The CDC said that 175 case reports had been identified for further review as possible cases of a severe allergic reaction. “Twenty-one cases were determined to be anaphylaxis (a rate of 11.1 per million doses administered), including 17 in persons with a documented history of allergies or allergic reactions, seven of whom had a history of anaphylaxis,” the CDC said. “Of the remaining case reports that were determined not to be anaphylaxis, 86 were judged to be non-anaphylaxis allergic reactions, and 61 were considered non-allergic adverse events,” it said.
On Modern’s mRNA vaccine, the other one authorised for emergency use in the US, the CDC said data is still limited. “Vaccination with Moderna Covid-19 vaccine commenced on December 21, 2020, and through December 23, 2020, an estimated 224,322 first doses of the vaccine had been administered; one report that met the Brighton Collaboration case definition criteria for anaphylaxis had been submitted to VAERS,” the CDC said.
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