Monkeypox: A Global Health Emergency with Evolving Challenges
Innvocept Global Solutions
A boutique CRO that supports conduct of cost effective clinical studies (Phase II-IV and RWE Studies)
Monkeypox (Mpox) is a viral disease caused by the monkeypox virus, which belongs to the Orthopoxvirus genus in the Poxviridae family. It primarily spreads between individuals through close contact with their bodily fluids, lesions, or contaminated materials. It can also be transmitted from surfaces and objects that an infected person contaminates. Additionally, transmission from infected animals to humans is also possible. (1)
Monkeypox - Global Scenario
The World Health Organization (WHO) has declared mpox a public health emergency due to a surge in global cases and the identification of a new clade, 1b. The outbreak, which originated in the Democratic Republic of Congo in 1970, has now spread internationally, raising significant concern. The WHO has reported over 99,176 cases and 208 deaths. The 2024 outbreak is now impacting a broader demographic, including women and children. (2)
Monkeypox - Indian Scenario
India's first case was detected in Kerala in 2022 when a traveller from the UAE tested positive. The virus soon spread within the country, including cases in Delhi among individuals who had not travelled internationally recently. As of March 2024, India has recorded a total of thirty cases. Despite the ongoing global outbreak affecting over 100 countries, no new cases have been reported in India recently. (3)
In response to the outbreak, the Indian Council of Medical Research (ICMR) has been conducting a serosurvey since the previous year to evaluate mpox exposure in high-risk groups. The Ministry of Health and Family Welfare (MOHFW) has issued guidelines to three major government hospitals in Delhi—Vardhman Mahavir Medical College (VMMC) Safdarjung, Ram Manohar Lohia (RML) Hospital, and Lady Hardinge Medical College—to help manage and prevent monkeypox. (4)
Treatment and Vaccination
As with most viral illnesses, the goal of treating mpox is to take care of the rash, manage pain and prevent complications. Getting a mpox vaccine can help prevent infection. The vaccine must be given within 4 days of contact with someone who has mpox (or within up to 14 days if there are no symptoms).(4)
Ongoing Clinical Trial
Tecovirimat (TPOXX) and Brincidofovir (Tembexa) are antiviral drugs developed for smallpox treatment, with funding from the National Institute of Allergy and Infectious Diseases (NIAID) and Biomedical Advanced Research and Development Authority?(BARDA). Tecovirimat, approved by the FDA in 2018, is available in oral and intravenous forms and was tested in nonhuman primates infected with monkeypox virus. Brincidofovir, approved in 2021, is an oral medication with approval based on animal studies involving rabbitpox and ectromelia viruses. Both drugs underwent extensive preclinical and clinical testing supported by NIAID and BARDA. NIAID continues to explore new antiviral compounds for treating mpox and other pox viruses.
Several significant clinical trials are currently focused on, aiming to evaluate treatments, vaccines, and other interventions.
Key trials include:
A. STOMP Trial in the US
The STOMP trial, started in September 2022 aims to include participants with severe mpox or those at high risk, including individuals with immune deficiencies, inflammatory skin conditions, pregnant individuals, and children, who will receive tecovirimat in an open-label arm. The study seeks to determine if tecovirimat accelerates the healing of mpox lesions compared to placebo.
B. PALM Trial in the Democratic Republic of Congo
In the Democratic Republic of Congo, NIAID and the National Institute for Biomedical Research (INRB) are conducting the PALM trial to assess tecovirimat in adults and children with mpox. It is a Randomized, Placebo-controlled, Double-blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Adult and Pediatric Patients with Monkeypox Virus Disease.(5)
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Vaccine Development and Approval
Vaccination is a crucial strategy in controlling and preventing monkeypox outbreaks. Several vaccines have been developed and tested to provide protection against the virus:
A. Smallpox Vaccine
Historically, the smallpox vaccine, which was used to eradicate smallpox, has shown cross-protection against mpox. This is because the smallpox and monkeypox viruses are closely related. However, the smallpox vaccination program was discontinued after the eradication of smallpox in 1980, and the population's immunity to smallpox has waned over time.
B. Jynneos (Imvamune/Imvanex)
Jynneos, developed by Bavarian Nordic, is a newly approved vaccine for preventing mpox. It's a modified vaccinia Ankara (MVA) vaccine, which is also used for smallpox prevention. Clinical trials have demonstrated its safety and effectiveness against mpox. Jynneos is made from a weakened live vaccinia virus and cannot cause smallpox, mpox, or any other infectious disease. The Food and Drug Administration (FDA) has approved Jynneos for adults aged 18 and older at high risk of smallpox or mpox infection. The Centers for Disease Control and Prevention (CDC) recommends it for specific laboratory workers and emergency response team members who might be exposed to orthopoxviruses. Those who have had the smallpox vaccine in the past might only need a single dose. Booster doses are advised every 2 or 10 years if the person continues to be at risk of exposure to smallpox, mpox, or other orthopoxviruses.
C. ACAM2000
Another vaccine used for smallpox, ACAM2000, also provides protection against mpox. It is a live attenuated smallpox. While effective, it is associated with higher risks of side effects compared to newer vaccines like Jynneos. (1,6)
Key challenges in managing this outbreak include limited vaccine supplies, inadequate testing, and the need for a balanced response to multiple health threats. The availability of vaccines is constrained, with WHO emergency use vaccine approval still weeks away, and large-scale manufacturing and distribution will take additional time. Vaccines and treatments developed for smallpox are effective against mpox, but equitable access remains critical. Post-exposure vaccination with the modified vaccinia Ankara vaccine is sometimes recommended. To address these challenges, there is a call for continued research and a collaborative, adaptable approach to public health emergencies, ensuring preparedness for future outbreaks. (7)
Preventing Monkeypox Infections
Prevention of monkeypox relies on several key strategies:
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