COVID-19 Vaccine study

**What are the main findings on COVID-19?

Know from previous studies that COVID-19 seems to affect males and females differently and that males seem to have a more severe disease course. Females seem to encounter but also report more adverse drug reactions than males.

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Vaccine

Vaccine pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding, prevention, and communication of AEFIs (adverse events following immunization), or of other vaccine or immunization-related issues.

Special considerations for vaccine:

• Vaccines are generally given healthy persons, primarily infants and children
• Vaccines are given to large proportions of the population
• Certain immunisations are mandated in certain circumstances
• Vaccines are often administered concomitantly with other vaccines, making investigation of adverse events difficult
• The perception of benefit of vaccines may be small, especially if the incidence of the target disease is low

 

Vaccines are complex biological products usually a mixture of multiple antigens or live organisms, adjuvants, and preservatives.

Benefit/risk profile is dynamic and variable between countries*
Communicaton around issues of vaccine safety are challenging.

 

Monitoring the safety of vaccines requires the involvement of both the National Immunization Programme (NIP) and the National Regulatory Authority (NRA)

Vaccine basics:

Live forms of microorganisms cause a mild form of disease and thereby stimulate an immune response which closely approaches a wild-type infection

 There is the rare potential to revert to fully pathogenic forms and cause disease

 Drug Safety

Drug Safety team have been monitoring the suspected adverse drug reactions that have been shared to the WHO global database.

Team have been producing a report summarising these ADRs which in turn has been shared with the WHO member countries as well as global basis.

In parallel team are preparing for future monitoring of COVID-19 vaccines.

From a research perspective, team wanted to add to the existing knowledge database of COVID-19 with data analysis.

One of those things was a paper that was recently published in Drug Safety on ADR reporting in COVID-19 use vs non-COVID-19 use, with a specific focus on sex differences.