Technical co-ordinator at the Caribbean Public Health Agency (CARPHA) Caribbean Regulatory System Division Dr Rian Extavour has said both regional and international bodies are working to ensure the strictest quality-control measures are in place to monitor the AztraZeneca vaccine.
Extavour was speaking at the Ministry of Health’s virtual press conference on Monday morning.
She said the collection of scientific information begins when the product composition is being put together as early as the animal testing phase.
She said the information from clinical trials in humans is also collected and regulators take that information and apply it to all areas such as quality of manufacturing.
Product labelling, for example, is another important stage in the process. She said, “Each country has to ensure the labelling is suitable for use by healthcare professional.”
Monitoring does not stop there, she said. Even after the product has been approved, monitoring continues.
“Any changes, in terms of quality and efficacy must be given to regulators.”
She said many countries need support in assessing medicines and vaccines and the World Health Organization (WHO) established an emergency use listing pathway, which has been in place after previous outbreaks such as the Ebola virus.
She said WHO convenes assessment experts and leverages experience and expertise from health care professionals around the world. Once a product meets the organisation’s criteria, they will assess its quality, safety, and efficacy data and look at inspection reports.
“Throughout its lifecycle, the product is monitored for safety.”
Any new information on the product noticed by manufacturers in different countries must be shared with WHO.
Extavour said locally, the regulatory body is the Ministry of Health, through the Chemistry, Food and Drug Division, which receives applications. The region also has the assistance of CARPHA’s Caribbean Regulatory System (CRS) which also issues its own reports to help member states.
Another arm of Carpha CRS is Vigicarib, a network that monitors quality and safety and shares information on the adverse effects of different drugs throughout the region. It also shares information on falsified or unregistered medical products with member states.