Synopsis: Government has released a Vaccine Fact sheet that contains guidelines for administering both vaccines (Covaxin and Covishield).
- Union Health Ministry has sent a comprehensive fact sheet for both vaccines (Covaxin and Covishield) to all states and immunisation officer.
- The Centre has also asked the states and immunisation officers to disseminate the fact sheet to all programme managers, cold chain handlers, and vaccinators before the rollout.
What is this fact sheet?
The fact sheet contains the general guidelines that should be followed during the initial phase of the Covid-19 vaccination drive, while vaccinating the priority group (3 crore people).
The fact sheet contains the guidelines on the following aspects,
- Physical specifications such as dosage, cold chain storage requirements.
- Specific guidelines on contraindications (a factor due to which the vaccine is to be withheld to certain categories of people)
- Guidelines on adverse events
- Details on special precautions.
Now we will examine in detail, the exceptions, precautions, and possible adverse events that are mentioned in the fact sheet.
First, the general guidelines in the fact sheet contain the following directives to ensure that proper care is taken while administering the vaccine.
- Only people over the age of 18 years are eligible for vaccination.
- Since 2 doses of vaccines are required per person, every Person should be administered the same vaccine in both the dosage. It is to deal with the issue of possible interchangeability.
- While administering the vaccine to a person with a history of any bleeding or coagulation disorder, platelet disorder, clotting factor deficiency, or coagulopathy, it should be done with caution.
- Both Vaccines have to be stored at +2°C to +8°C and needed to be protected from light. If it is found frozen it has to be discarded.
Second, the specific guidelines on contraindications. The three categories of people for whom the vaccine should not be administered. They are,
- Persons who have shown a history of an allergic reaction.
- 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.
Third, guidelines on temporary contraindications. 3 categories of persons for whom vaccination is to be deferred for four-eight weeks. They are,
- Persons showing active symptoms of SARS-CoV-2 infection.
- Covid-19 patients who have been treated with anti-SARS-Cov-2 monoclonal antibodies or convalescent plasma.
- Acutely unwell and hospitalised patients (with or without intensive care) due to any illness.
Fourth, the fact sheet under not contraindicated, specifically mentions that persons suffering from following health conditions can get vaccinated. However, the response to the Covid-19 vaccine may be less in these individuals. They are;
- Persons with a past history of Covid-19 infection.
- Persons with a history of chronic diseases and comorbidities (cardiac, neurological, pulmonary, metabolic, and malignancies).
- Persons with immunodeficiency or HIV, and patients on immune suppression due to “any condition” can be administered with the Covid-19 vaccine.
Fifth, the fact sheet has also separately mentioned the Possible Adverse Reactions for both the vaccines along with the required precautions to be taken during the adverse reaction.
Guidelines provide the list of mild adverse events and rare adverse events that may follow the vaccination from both Covishield and Covaxin. It also provides for the precautions and medication that will be required in the above cases.
For example; In case of Mild adverse events for Covishield like myalgia (deep muscle pain), malaise (a feeling of overall discomfort), common painkiller paracetamol may be used.
How Covid-19 vaccines administered in other countries have performed till now?
Though the overall performance is found to be safe so far, there were few adverse events recorded in a small section of the population. For example, in the case of the US,
- The US Centers for Disease Control (CDC), monitoring by the Vaccine Adverse Event Reporting System detected 21 cases of anaphylaxis (a severe, life-threatening allergic reaction that occurs rarely after vaccination) out of a reported 1,893,360 first doses of the Pfizer-BioNTech vaccine.
- Whereas in the case of Modern’s mRNA vaccine, which was authorized for emergency use in the US, the CDC said data is still limited.