IAVI contributes to WHO proposed framework for evaluating the effectiveness of new COVID-19 vaccines

New vaccines to combat the evolving SARS-CoV-2 virus should be introduced with vaccine equity in mind, say global health experts in a new commentary published in the journal Vaccine. Marion Gruber, Ph.D., vice president, public health and regulatory science, IAVI, joins experts from eight different countries as an author on a report from the Feb. 23 World Health Organization (WHO) meeting, “COVID-19 vaccines: Developing a framework for evaluating new COVID-19 vaccines.” The resulting framework proposal supports developers, regulators, and scientists to rapidly determine which combinations of new and existing evidence may be needed to support WHO Emergency Use Listing of new vaccines.

“Global inequities in vaccine distribution indicate the need for additional vaccines with properties that enhance their deployability,” say the authors. “The continuing spread and evolution of the virus, with new virus variants of concern (VoC) such as omicron exhibiting increased transmissibility and partial evasion of vaccine immune responses, indicates the need for new vaccines with greater breadth and duration of protection, especially against severe disease.”

But conducting placebo-controlled clinical trials of new COVID-19 vaccines — the gold standard — has become much more difficult as more people become infected and vaccinated globally. Different evaluation methods, such as immune response biomarker comparisons, could accelerate new vaccine authorization, particularly when “new vaccines have substantial advantages over existing vaccines in aspects, such as deployability, availability, or cost.” For example, regulators may be willing to authorize new vaccines based on studies comparing the immune responses induced by candidate vaccines with those of licensed, efficacious COVID-19 vaccines. Other scenarios may require developers to generate additional data for consideration, guided by key questions to facilitate rapid decision-making.

Read the full article in Vaccine:

Making more COVID-19 vaccines available to address global needs: Considerations and a framework for their evaluation