CHEARS

As every country and its people are looking forward to the vaccine against COVID-19, there are many pharmaceutical and medical companies all over the world are in a race of preparing vaccines against COVID-19.

As the situation is becoming serious day by day, all these companies are trying to make available the vaccine in a very short period involving limited participants in the clinical trials within a short period.

As the vaccine is new and has not involved people with different comorbidities, we cannot expect the vaccine to be safe when used in people from different races, countries, and different morbidities.

There will be many chances of experiencing adverse events following immunization (AEFI).

As we all know that no vaccine is completely safe (or) completely effective. Some of the vaccines are associated with serious adverse events after administration.

So the responsibility of every country is not only to develop a vaccine against a particular disease but also to promote safety after administrating vaccines.

For promoting safety after immunization surveillance known as Vaccine Safety Surveillance (also known as AEFI surveillance) is needed to protect every individual from adverse events following immunization (AEFI).

What is AEFI?

All vaccines used in national immunization programs are safe and effective if used correctly. In practice, however, no vaccine is completely risk-free, and adverse events can occasionally result after an immunization. Adverse events can range from minor side-effects to more severe reactions. They can be a cause of public concerns about vaccine safety.

Adverse event following immunization (AEFI) is any unwanted medical condition which occurs following immunization and which does not necessarily have a causal relationship with the usage of the vaccine. If not rapidly and effectively dealt with, it can undermine confidence in a vaccine and ultimately have dramatic consequences for immunization coverage and disease incidence.

Classification of AEFIs:

o Vaccine product-related reaction.

Ø Example: Extensive limb swelling following DTP vaccination.

o Vaccine quality defect-related reaction.

Ø Example: Failure by the manufacturer to completely inactivate a lot of inactivated polio vaccine leads to cases of paralytic polio.

o Immunization error-related reaction.

Ø Example: Transmission of infection by the contaminated multidose vial.

o Immunization anxiety-related reaction.

Ø Example: Vasovagal syncope in an adolescent during/following vaccination.

o Coincidental event.

Ø Example: A fever occurs at the time of the vaccination (temporal association) but is caused by malaria.

What is Vaccine Safety Surveillance?

Vaccine safety surveillance (also known as AEFI surveillance) A surveillance system designed to collect adverse events temporally associated with receipt of vaccines.

AEFI surveillance (also known as vaccine safety surveillance)A surveillance system designed to collect adverse events temporally associated with receipt of vaccines. This type of surveillance typically relies on health professionals associating an adverse event in an individual as a possible consequence of vaccination and reporting it to the NRA or appropriate authority. Systems are specific to monitoring adverse events associated with vaccine use.

Importance Of Vaccine Safety Surveillance:

AEFI surveillance addresses the needs of immunization programs and National regulatory authorities. The general principles of AEFI surveillance are,

• Detection, correction and prevention of immunization errors,

• Identification of potential problems with specific vaccine lots,

• Prevention of false blame from coincidental events,

• Maintenance of confidence in the program by properly responding to parent/community concerns,

• Identification of signals for unexpected adverse events and generation of hypotheses to be tested by controlled studies,

• Estimation of AEFI rates in local populations,

• Support to formulate and adjust contraindications, risk/benefit equations, and provider and patient information.

Pharmacist in Vaccine Safety Surveillance:

As per the American Society of Health-system Phar¬macists (ASHP) Guidelines, pharmacists have a major role in disease prevention by advocating and adminis¬tering vaccines. These activities are consistent with the preventive aspects of pharmaceutical care and are a part of the pharmacy practice for many decades. Many countries grant the legal authority of pharmacists to administer vaccines after they achieve competency in all aspects of vaccine administration. But in India, phar¬macists play a major role in the storage and transportation of vaccines than administration.

Public awareness of vaccine safety has grown through increased access to information through the internet, television, and other media. As the Pharmacists (Community) are the easily accessible HCPs in the community, they can take the initiative of reporting these events to the NRAs. The pharmacists can maintain a link between the patient and his/her other health care professionals in primary health care settings and can take up the responsibility to report the AEFIs. Consumer reporting of AEFIs also in place in some of the developed countries. Parents may be the right resources to identify different AEFIs and the professional interaction of pharmacists with the consumers may help to improve the rate of AEFI reporting.

In a systemic evaluation of 1,10,000 individual case safety reports(ICSR) received at the National collaborating center- Pharmacovigilance program of India (NCC-PvPI), 15.13% were reported by the Pharmacist and the study described that the ADR reporting by the Pharma¬cists are slowly increasing from 2011.

Pharmacists (clinical) are very well trained in management and prevention of Disease, Monitoring, Reporting, Management, And Prevention of Adverse Events.

As these Pharmacists (clinical) have sound knowledge in the management of adverse events, they should be made available in all the clinical settings to prevent and manage adverse events.

Conclusion: By The Involvement Of Pharmacists, Who Can Monitor, Report, Prevent And Manage Adverse Events, We Can Protect Every Individual Through Vaccine Safety Surveillance.