International agencies coordinate regulation of COVID-19 vaccines and medicines

Article written by Gary Finnegan.

Regulators around the globe are aligning their approaches to the approval of vaccines and medicines against COVID-19. Closer cooperation is seen as crucial to the widespread availability of preventative and therapeutic tools for controlling the pandemic.

A series of regulatory workshops, convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), focused on three priorities: responding to emerging COVID-19 virus variants; addressing knowledge gaps regarding vaccines and treatments in pregnant and breastfeeding women; and strengthening collaboration on safety monitoring of vaccines.

The rapid spread of new SARS-CoV-2 variants could mean regulators need to rapidly review data on updated versions of existing vaccines. The European Medicines Against (EMA) and the US Food and Drug Administration (FDA), which co-chaired the workshop, have already begun working with manufacturers to ensure updated vaccines can meet safety standards without conducting new trials in thousands of volunteers.

The question of whether new COVID-19 vaccines and medicines should be offered to women who are pregnant or breastfeeding is also a challenge. Most regulators now allow for vaccination of pregnant women against COVID-19.

Vaccination during pregnancy is not unusual but depends on the kind of vaccine used. Flu vaccines and pertussis are recommended for women during pregnancy whereas live vaccines, such as the MMR jab, are not. The COVID-19 vaccines currently approved by the EMA are not live and are not expected to carry additional risks.

On the wider issue of COVID-19 vaccine safety monitoring, regulators said that rapid exchange of information would help to detect any safety signals and support vaccine confidence. Communicating on safety issues in a consistent way across regions is vital to building and maintaining public trust in vaccines, it was agreed.