In 2022, Mpox, a disease caused by a virus in parts of Africa and spread mainly through close contact – especially sexual contact between men – has spread to developed countries, including the United States. The US has seen more than 30,000 cases and nearly 58 deaths. Despite two vaccines being available there is not nearly enough vaccination coverage even for high risk populations. Fortunately, the health authorities accepted the vaccination strategies that my colleagues and I had recommended for COVID such as early doses and fractional dosing. For example, a few small lessons (eg here and here) suggested that 1/5 doses delivered intradermally may be effective and thThe FDA, EMA, and the UK have all recommended this fractional dosing strategy. As a result, the US was able to vaccinate about 800,000 people and the epidemic ended (environmental immunity and other prevention methods also played a role).
Unfortunately, a new strain of Mpox is now spreading in the Democratic Republic of the Congo and neighboring countries. Here’s the crazy part: despite declaring Mpox a public health emergency on August 14, the WHO has not approved any vaccines for Mpox. You might be thinking, “Who cares what the WHO approves?” After all, the FDA, EMA, and UK have all granted emergency approval. But here’s the catch: WHO accreditation is important to GAVI, a vaccine alliance that provides vaccines to developing countries. Without WHO approval, GAVI is reluctant to provide vaccines to Congo. To add insult to injury, Congo itself endorsed the Jynneos and LC16 policies. However, the WHO refuses to authorize and GAVI to offer these drugs, citing vague concerns about safety and efficacy.
Stephanie Nolen at the NYTimes has an excellent piece on this mess:
Three years after the last global outbreak of mpox, the WHO still has not officially approved the vaccines – although the United States and Europe have – and has yet to issue an emergency use license that would speed up access.
One of these two accreditations is needed for UNICEF and Gavi, an organization that helps to vaccinate developing countries, buy and distribute mpox vaccines in low-income countries like Congo.
While high-income countries rely on their drug regulators, such as the Food and Drug Administration in the United States, many low- and middle-income countries rely on the WHO to judge which vaccines and drugs are safe and effective, a process called. eligibility.
But the agency is taking serious risks, worried about the need to protect its credibility and not being ready to act quickly in emergencies, says Blair Hanewall…
In addition, no one has followed another practice that my colleagues and I have recommended for COVID (Operation Warp Speed), namely pre-market commitment. So vaccine manufacturers have been twiddling their thumbs and not preparing for mass production. (The Congo would also be at fault for not buying more on its own account.)
All of this means that once the WHO approves it and vaccines begin to flow, we will still be in dire need of techniques like fractional dosing.
A tip of the hat: Ben H. and special thanks to Witold Wiecek.
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