VAERS - Objectives, Strengths, and Limitations

Introduction

With the surge of new illnesses and diseases, science has always looked for ways to protect and conserve living beings. One such marvel discovery of science was the immunization or discovery of vaccines. Immunization is one of the most important public health measures that can prevent illness and curtail disease spread. Vaccines are considered saviors as they have proved pivotal in combating many fatal diseases. Prophylactic vaccines are of great benefit in keeping society and the community healthy and productive. However, vaccines, like other pharmaceutical preparations, are not entirely risk-free. Vaccine safety is questioned by many in the community giving rise to misconceptions on the vaccine efficacy and hazards and thus hampering the success of the vaccination strategy. In order to ensure vaccine safety and its comprehensive use, a surveillance system was introduced by the U.S. Food and Drug Administration (FDA) known as VAERS (Vaccine Adverse Events Reporting System)

What Is VAERS?

VAERS is a vaccine safety surveillance plan created in response to the National Childhood Vaccine Injury Act of 1986 (NCVIA). It is one of the principal vaccine safety programs initiated and co-managed by the CDC (Centers for Disease Control and Prevention) and the FDA. VAERS is a nationwide primary warning system that helps identify the safety problems with a particular vaccine. Any adverse event pertaining to a vaccine can be reported to VAERS, which will be investigated and acted upon by the FDA and the CDC. Certain key points to be understood about VAERS:

• It is a passive surveillance program to detect unusual or adverse events related to a vaccine.

• It depends on the vaccination reports of individuals who have taken it.

• It accepts reports from any individual, health care professional, patient, or pharmaceutical firm.

• It is mandatory by law for vaccine manufacturers and healthcare professionals to report any adverse vaccine effects.

• VAERS is not authorized to scrutinize or conclude that the vaccine caused any adverse event; thereby, a report to VAERS is not conclusive but can be investigated by the FDA and CDC.

• Other vaccine safety monitoring systems can follow up on VAERS reports.

What Is the Objective of VAERS?

VAERS cannot authorize or conclude that a particular vaccine is responsible for an adverse event; instead, it can heads-up the CDC and FDA to investigate and conduct more research regarding vaccine safety. The main objectives of VAERS are:

• To identify new, rare, or infrequent adverse events.

• To monitor the rise of known adverse effects.

• To identify patient risk factors that may increase the possibility of adverse effects.

• To assess if the adverse events occurring are with a particular batch of vaccine or localized to a particular cluster or area.

• To identify any mistakes while vaccinating by the health care professionals.

• To deliver a global safety monitoring system that would be effective in a national emergency or a pandemic.

Who Can Report to VAERS?

VAERS is a passive reporting system that accepts data from any individual, like patients, caregivers, parents, healthcare individuals, and vaccine manufacturers. Healthcare workers and vaccine manufacturers are required by law to report any known adverse events to VAERS. Patients can take the help of healthcare professionals to complete the reporting, and also it will prevent the duplication of data.

How Does VAERS Work?

Once the vaccines are licensed and authorized, various systems continually monitor their safety and effectiveness. In addition, various clinical trials and studies assess its effectiveness in a larger population. VAERS is a passive reporting system that relies on vaccine reports from individuals to assess safety. The data collected by VAERS are potential signals that postulate an early warning sign concerning the vaccine's safety. Once a signal is identified by VAERS, the FDA, and CDC can act upon them by analyzing and conducting more studies to be more conclusive. Any vaccine adverse event can be reported to VAERS through the online portal. They re-authenticated by correlating the reports with the patient's medical record. The data is globally accessible and publicly available; however, to protect patient privacy and confidentiality, patient details and other personal information are not included. Multiplicity and duplicity are checked before submitting a report as the patient, and the health care provider may submit the same adverse event of the patient that could lead to false counts. The information collected is classified based on the seriousness describing mild, moderate, or severe and fatal adverse events. The reports are reviewed below:

• Mild events such as fever, soreness, and irritability.

• Permanent disability.

• Requiring hospitalization.

• Life-threatening conditions.

• Congenital disabilities.

• Death.

The report pertaining to vaccine adverse events includes

• The type of vaccination received.

• Demographic information and date when the vaccine was given.

• Patient medical history.

• The adverse event that occurred and its details. (When it started, how it started and progressed, and the current adverse event status.)

• Similar history of an adverse event following any vaccination.

What Are the Strengths and Limitations of VAERS?

Strengths:

• VAERS is an early nationwide warning system reporting vaccine safety.

• It accepts reports from any individual.

• The information obtained is followed-up and researched by the medical scientist. The data from VAERS forms the basis for further studies.

• The data is publicly available and accessible universally.

• Patient privacy is protected.

Limitations:

• It is a passive reporting system where the adverse events data collected is being reported by someone else.

• Possibility of errors and lack of details when the adverse event is reported.

• VAERS data cannot conclude that the vaccine itself causes the adverse event.

• Coincidental death and such adverse events could be misinterpreted as caused by the vaccine. Hence a causal relationship cannot be concluded.

• Media intervention and public awareness can intervene in the number of reports.

• Since the reports submitted to VAERS are voluntary, they may be subjected to biases.

• Minor adverse effects can go unreported as patients only report grave events.

Conclusion

Even though vaccines are tested in laboratories and on many volunteers before legalizing and authorizing their usage on the general population, it is not sufficient to identify the rare or infrequent side effects. VAERS is an effective monitoring system to advocate vaccine safety and promptly report adverse events. Therefore, the government should encourage healthcare professionals to educate their patients about VAERS and report any adverse events irrespective of their seriousness. This would pave the way for further studies and research and thus prevent any fatalities and may also help improve the efficacy of the vaccine in question.