WHO Declares Monkeypox a Global Health Emergency
- by Marco Cáceres
- Published
- Infections
On Aug. 14, 2024, the World Health Organization (WHO) declared monkeypox (mpox) a public health emergency of international concern (PHEIC). “Today, the Emergency Committee met and advised me that in its view, the situation constitutes a public health emergency of international concern. I have accepted that advice,” said WHO Director-General Tedros Adhanom Ghebreyesus,1 2 3 who added:
The detection and rapid spread of a new clade of mpox in eastern [Democratic Republic of the Congo], its detection in neighboring countries that had not previously reported mpox, and the potential for further spread within Africa and beyond is very worrying.1
According to the WHO, there have been more than 14,000 cases of mpox reported in the DRC and 524 deaths so far in 2024. The U.S. Centers for Disease Control and Prevention (CDC) has confirmed 1,634 mpox cases have been reported in the U.S. this year.3
“What we’re seeing is tip of the iceberg,” said Dr. Dimie Ogoina, professor of medicine and infectious diseases at Niger Delta University in Nigeria. “We need concerted international action to stem this recent, novel outbreak,” said Gregg Gonsalves, global health activist and epidemiologist at Yale University. In a special report published in The Vaccine Reaction last month questioning whether public health officials are preparing to bring back widespread vaccinia virus (smallpox) based vaccinations,
Barbara Loe Fisher noted that a researcher (Dr. Placide Mbala-Kingebeni) in Africa had warned that the “mutated clade is more virulent and better adapted for human-to-human transmission, allowing it to spread silently between individuals and potentially sustain itself globally.”2 4 5 6The WHO previously declared mpox a PHEIC on July 23, 2022. That epidemic, which ran through May 11, 2023, infected some 100,000 people in 116 countries, killing about 200. COVID-19 was also declared a PHEIC by the WHO on Jan. 30, 2020. That pandemic lasted through May 5, 2023.4 7 8 9
FDA Grants EUA for JYNNEOS Mpox Vaccine
On Aug. 9, 2022, the U.S Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for an mpox vaccine known as JYNNEOS (also known as Imvamune or Imvanex), manufactured by biotechnology firm Bavarian Nordic A/S of Hellerup, Denmark. The vaccine, designed to be given in two doses four weeks apart, is authorized for “prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.” JYNNEOS is made using weakened (attenuated) live vaccinia (smallpox) virus.3 10 11
The most common injection site reactions to the JYNNEOS vaccine are pain, redness, swelling, induration (thickening and hardening of skin) and itching. The most common systemic adverse reactions include muscle pain, headache, fatigue, nausea and chills. The incidence of cardiac adverse events following vaccination with JYNNEOS is unknown. A study published in the journal Vaccine last year noted that the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended that people with “underlying cardiac risk factors should be counseled about the theoretical risk for myopericarditis” after getting the vaccine.11 12
Bavarian Nordic, whose stock soared 17 percent the day after the WHO’s emergency declaration, has confirmed it has 500,000 doses of its JYNNEOS vaccine in stock and can supply 10 million doses to countries in Africa by the end of 2025. “We have inventory and we have the capabilities. What we’re missing are the orders,” said Paul Chaplin, CEO of Bavarian Nordic.13 14
ACAM2000 Mpox/Smallpox Vaccine Also Available
The FDA has also licensed an mpox/smallpox vaccine known as ACAM2000, produced by Emergent BioSolutions, Inc. of Gaithersburg, Maryland. The live virus vaccine is designed to be administered in one dose. Based on clinical studies, myocarditis (inflammation of the heart muscle) and/or pericarditis (inflammation of the tissue around the heart) occurs in 1 in 175 adults who receive the ACAM2000 vaccine for the first time.15 16
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