Major milestone for WHO-supported Ebola vaccine
The European Medicines Agency (EMA) has recently announced that they are recommending a conditional marketing authorization for the rVSV-ZEBOV-GP vaccine, which has been shown to be effective in protecting people from the Ebola virus. The EMA is the European agency responsible for the scientific evaluation of medicines developed by pharmaceutical companies. This represents a crucial step before the European Commission decision on licensing. The World Health Organization (WHO) will also move towards prequalification of the vaccine.
“The conditional authorization of the world’s first Ebola vaccine is a triumph for public health, and a testimony to the unprecedented collaboration between scores of experts worldwide,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “My deepest gratitude is to the studies’ volunteers, researchers, health workers in Guinea, other countries and the Democratic Republic of the Congo who have put themselves at risk to ensure people are protected with this vaccine.”
The WHO has spent the last five years fast tracking research and development on various potential Ebola vaccines. This recent EMA review is unique in that the WHO and African regulators were closely involved to help accelerated registration for the countries that are most at risk.
There are 8 vaccines undergoing clinical evaluation. WHO continues to work with partners towards an internationally coordinated governing mechanism to ensure access according to risk criteria, and manage supply and stockpiles, especially as supply will remain limited until a full manufacturing capacity is established or other vaccines are licensed.
This announcement will not have an immediate effect on how the vaccine is accessed or administered in the Democratic Republic of the Congo, as licensing has not yet occurred, and licensed doses will only be available mid-2020. The vaccine will continue to be used in the country under a research protocol (also known as “expanded access” or “compassionate use”), and with the ring vaccination strategy.
In the current Ebola outbreak in the Democratic Republic of the Congo, more than 236,000 people have been vaccinated with rVSV ZEBOV GP donated by Merck to WHO, including more than 60,000 health and front-line workers in the Democratic Republic of the Congo and in Uganda, South Sudan, Rwanda and Burundi.
“This vaccine has already saved many lives in the current Ebola outbreak, and the decision by European regulator will help it to eventually save many more,” said Dr Tedros, WHO Director-General. “I am proud of the role WHO has played, from supporting the research, to conducting the trial in Guinea in 2015.”