16 Oct Adverse reaction management for COVID vaccine programs
by Dr. Suman De
New virus + new vaccine = new ways of dealing with immunization. The worldwide push for vaccination against COVID-19 is going to be unlike any vaccine program we’ve experienced before. The COVID-19 vaccine development has been done at record speeds, but this leaves many questions and potential side effects we’re still uncovering through clinical trials and may continue to discover as the immunization is rolled out globally. Ultimately, the testing can not account for every possible outcome for every demographic that will be vaccinated. Thus, this creates a potential for any unseen and possible adverse reactions.
Typically, adverse reactions with vaccines range from local, systemic to allergic/anaphylactic. The local reactions are most commonly mild physical side effects like soreness, pain, swelling or redness, etc. anticipated immediately after a shot and often referred to as ‘hypersensitivity reactions.’ These are necessarily not a contraindication to receive the follow-up dose, and they subside gradually without any clinical or therapeutic interventions. The systemic reactions, like fever, rash, headache, myalgia, etc., usually vary with certain vaccine recipient factors like age, trait, body’s immediate biological response to the new drug, etc. These can be easily treated or managed at home and are also not any contraindication to taking the following dose of the same vaccine. The extreme is the rare, severe allergic reactions, like anaphylactic, neurological, or immune-mediated events, namely seizures, hypotonicity, paralysis, arthropathy, etc. Such reactions require immediate medical attention. Irrespective of the type of reactions, every adverse event needs to go through comprehensive case management and evaluation.
However, not any or all adverse reactions are always attributed as a reaction to the new drug. There is also room for adverse reactions due to improper vaccine storage; drug expiry; wrong dosage; inappropriate route, site, or technique of administration; or any contraindications not elicited or ignored at the time of inoculation. These are all possibilities that we accept with any vaccine in favor of long-term health and disease prevention. Hence, considering the novelty of this COVID vaccine and a few still unknown, our vaccine programs need to be better administered with the right directives and equally equipped with the advanced tools for prompt adverse reaction management and data analytics to gain insights for proactively managing cases and deciding on every safety aspect of the vaccine.
Dealing with the COVID-19 Vaccine Unknowns
The COVID-19 vaccine is going to be at a considerable disadvantage compared to any other vaccine. With existing vaccinations, they’ve had time in the market—time to build community awareness, clinical knowledge, and overall acceptance into the mainstream. Their effectiveness is, for the most part, unquestioned. The COVID-19 vaccine, however, is not going to have those years of credibility on its side. Yet, it’s an immunization we must get shared with the masses as quickly as possible to establish herd immunity within communities to fight out the deadly virus. The urgency to deliver vaccination and the potential for public hesitation are equally high, creating an administrative nightmare.
Providers and Public Health Departments Clinics need to overcome the many yet-to-be-seen features regarding the COVID-19 vaccine to the best of their ability to maintain credibility in their safe administration. If a clinic fails to deliver immunizations according to CDC and ACIP recommended best practices and vaccine product-specific clinical guidelines, makes too many mistakes, or has too many adverse events, this can trigger detrimental effects on public opinion.
However, with case management and continuous monitoring, clinics can prove their credibility even in the face of the unknown by…
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Dr. De is Infosys Public Services’ Head for Government Healthcare Solutions. In this capacity, he is responsible for the ideation and development of next-generation solutions for public health agencies. He has vast experience in the public health domain, and his previous work experience ranges from involvement with Govt. of India’s National pulse polio immunization program in collaboration with the World Health Organization and various other public health projects conducted by international organizations like UNICEF, Indian Public Health Association, etc. He has been recognized as a subject matter expert (SME) in healthcare for his contribution to the industry through thought leadership, points of view, articles, workshops, running webinars, and speaking sessions. Dr. De is a graduate in medicine from India and holds a Masters in Healthcare Administration from a premier business school in India. He is the recipient of several awards of excellence in recognition of his work for the healthcare industry.