“What if the COVID-19 vaccine has side-effects?”
A very logical question, isn't it? While the end of the pandemic is finally in sight, as India gets ready to kick-off the vaccination programme, there are many who are saying, 'Vaccine leke kuch ulta-seedha ho gaya toh? (What if something goes wrong after taking the vaccine?)’
First, side effects are common in most vaccines – and most vaccines come with these warnings. So, if you are hearing about side effects, IT'S NORMAL.
AND if something happens, the government is preparing a plan for it at each vaccine site. Before taking you through the plan, let's address some common questions.
What Are the Chances of Having Adverse Effects?
The Union Health Ministry, in its briefing, said that an adverse event – which is side effects of the COVID-19 vaccination – cannot be ruled out, and states and Union Territories must prepare for these as part of the vaccination programme.
Even vaccination drives that have kicked-off in the US and the UK have shown side effects in many people, including severe allergic reactions in people with allergies, but very rarely have they been reported to be serious.
Side effects in medical jargon are called Adverse Events Following Immunisation, or AEFIs. According to the Centre's guidelines issued to the states and the UTs, the AEFIs of the COVID vaccine can have three categories:
- Minor AEFIs: These are minor reactions that are common and self-limiting; for example, pain and swelling at the injection site, fever, irritability, malaise, etc.
- Severe AEFIs: These are non-hospitalised cases with increased severity which do not lead to long-term problems but can be disabling. Examples: Non-hospitalised cases of allergic reactions that can be recovered from, high fever, hypotonic experiences or change in physical reactions, sepsis, etc.
- Serious AEFIs: These include Anaphylactic Shock deaths, hospitalisations, clusters, disability or anything that is a cause of media reports/community/parental concern following vaccination.
The government has said that the exact list of expected side effects could be different based on the safety profiles of the vaccines that finally get approved for use.
The top three vaccines that are currently awaiting the government's approval in India are – Pfizer and BioNTech, Oxford-AstraZeneca and Bharat Biotech's Covaxin. So far, the trials of these vaccines have AEFIs in the 'Minor' category or in the 'Severe' category, and the percentage of such cases is not very high.
The cases in the 'Serious' category that required hospitalisation after trials were almost negligible. Some were reported to be not linked to the vaccine. Despite that, the government has asked for more data and analyses of the trials from all the three manufacturers before giving them approval.
What Happens If You Show Side Effects?
Here's how the government is planning and preparing for it:
- Vaccinators are actively being trained to detect, prevent, control, and manage the possible minor or severe AEFIs.
- Every vaccination site will be linked to a designated AEFI management centre.
- The states have been asked to identify at least one AEFI management centre in each block, which can be a primary health centre, a community health centre, a district hospital or even a private health facility that has medical officers and paramedical staff.
- These side effects/adverse events will be registered on the Co-WIN app and website which the government is going to use to mandatorily register people before they get vaccinated for further monitoring and management. Simultaneously, they will also be reported to the concerned medical officers of the block or the area.
- The vaccinators are to counsel all beneficiaries, as to what side effects they should be mentally prepared for, so that they don't panic later.
- There are expected to be more detailed guidelines for those who are supposed to get vaccinated in case they are already allergic to any of the contents in the vaccine or have other preliminary conditions like pregnancy, diabetes, other chronic illnesses, etc.
Now, if the last few minutes of reading has made you a little nervous, don't worry! As multiple experts have told The Quint over the past few months, no vaccine gets approval from the government and is licensed for public use unless and until the benefits aren't proportionately larger than the risks that come along with it.
If there have been adverse events during the trials, it has only helped the vaccine manufacturers and the government prepare themselves to deal with them. So that, you and I, as citizens, can get ready for a better 2021!
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