PHARMACOVIGILANCE: THE BACKBONE OF DRUG SAFETY WITH SPECIAL REFERENCE TO THE MONKEYPOX VIRUS

Himanee Takzare and * Dr. D. K. Jain

ABSTRACT

Pharmacovigilance is essential for guaranteeing the safety and effectiveness of vaccines and treatments, especially during the monkeypox crisis. Since monkeypox has recently spread outside of endemic areas, it is imperative to employ antivirals such as Tecovirimat and Brincidofovir as well as immunizations like Modified Vaccinia Ankara (MVA-BN, JYNNEOS) as soon as possible. These emergency therapies require robust post-marketing surveillance to detect adverse drug reactions (ADRs) and ensure public safety. Some challenges include a lack of real-world safety data, inconsistent global reporting methods, and underreporting of ADRs. Pharmacovigilance supports regulatory compliance, aids in risk-benefit evaluations, and encourages public health communication in the fight against vaccine reluctance and misinformation. International collaboration, particularly between the FDA, EMA, and WHO, is necessary to harmonize reporting standards and exchange safety data. Furthermore, advanced technologies like artificial intelligence and big data analytics, which allow for the early detection of safety signals, enhance pharmacovigilance capabilities. This analysis highlights pharmacovigilance's critical role in safeguarding public health and managing the monkeypox outbreak through continued monitoring and international cooperation.

Keywords: Pharmacovigilance, Monkeypox, Vaccine Safety, Adverse Drug Reactions, Public Health, Regulatory Compliance.