https://www.cidrap.umn.edu/mpox/who...nostics-fda-approves-acam2000-mpox-prevention
WHO seeks to expand mpox diagnostics; FDA approves ACAM2000 for mpox prevention
Lisa Schnirring
Today at 2:02 p.m.
Mpox
The WHO made a similar pitch to mpox vaccine companies on August 9 and has already received applications for EUL from two manufacturers, Tedros said. WHO listing is usually required for UNICEF and Gavi, the Vaccine Alliance, to buy vaccine for low-income countries, but the WHO recently said the groups could go ahead and buy vaccine as the WHO reviews the EUL applications.
DR Congo mpox challenges as Kenya reports another case
In his comments today, Tedros said the outbreak of clade 1b mpox is occurring in one of the poorest, least stable areas of the Democratic Republic of the Congo (DRC), which is complicating the response. "Despite these challenges, hundreds of WHO personnel are on the ground in DRC and the other affected countries, working with our partners to stop transmission and bring these outbreaks under control," he said.
Hundreds of WHO personnel are on the ground in DRC and the other affected countries.
Tedros said he met with the DRC's president this week to discuss the situation, and he lauded his leadership in battling the outbreaks, which came with a commitment of $10 million toward the response. Tedros said he is optimistic that close cooperation with the DRC can stem the outbreaks over the next 6 months, but he said what the region needs more than anything else is a political solution to long-running instability, especially in the eastern DRC, where clade 1b is spreading.
In other developments, Kenya’s health ministry today confirmed its third mpox case, which involves a 30-year-old woman in Nairobi, the country’s capital, who had recently traveled to Uganda.
FDA green-lights use of ACAM2000 for mpox
Emergent BioSolutions yesterday announced that the US Food and Drug Administration (FDA) has approved an expanded indication for its ACAM2000 smallpox/mpox vaccine for use in people at high risk for mpox infection. The company said the approval is based on safety data in people and data from a well-controlled animal study that suggested the vaccine was effective for preventing mpox.
The company filed for the expanded indication for the live replicating vaccinia virus vaccine in October 2023.
ACAM2000 is given as a single dose by scarification, which means it is delivered percutaneously with a bifurcated needle, pricking the skin several times in the upper arm with a droplet of vaccine. The FDA first approved ACAM2000 in 2007 as a smallpox countermeasure.
This expanded indication for ACAM2000 comes at a critical time.
Emergent BioSolutions is one of the companies that has filed an expression of interest for EUL with the WHO. Joe Papa, the company's president and chief executive officer, said, "This expanded indication for ACAM2000 comes at a critical time as the global health community comes together to ensure an effective and cohesive response to the recent upsurge in mpox cases."
WHO seeks to expand mpox diagnostics; FDA approves ACAM2000 for mpox prevention
Lisa Schnirring
Today at 2:02 p.m.
Mpox
In rapidly evolving mpox developments, the World Health Organization (WHO) yesterday invited makers of mpox diagnostic tests to submit interest in applying for emergency use listing (EUL), and today the agency received its first response from a manufacturer, WHO Director-General Tedros Adhanom Ghebreyesus, PhD, said today at a media briefing.The WHO made a similar pitch to mpox vaccine companies on August 9 and has already received applications for EUL from two manufacturers, Tedros said. WHO listing is usually required for UNICEF and Gavi, the Vaccine Alliance, to buy vaccine for low-income countries, but the WHO recently said the groups could go ahead and buy vaccine as the WHO reviews the EUL applications.
DR Congo mpox challenges as Kenya reports another case
In his comments today, Tedros said the outbreak of clade 1b mpox is occurring in one of the poorest, least stable areas of the Democratic Republic of the Congo (DRC), which is complicating the response. "Despite these challenges, hundreds of WHO personnel are on the ground in DRC and the other affected countries, working with our partners to stop transmission and bring these outbreaks under control," he said.
Hundreds of WHO personnel are on the ground in DRC and the other affected countries.
Tedros said he met with the DRC's president this week to discuss the situation, and he lauded his leadership in battling the outbreaks, which came with a commitment of $10 million toward the response. Tedros said he is optimistic that close cooperation with the DRC can stem the outbreaks over the next 6 months, but he said what the region needs more than anything else is a political solution to long-running instability, especially in the eastern DRC, where clade 1b is spreading.
In other developments, Kenya’s health ministry today confirmed its third mpox case, which involves a 30-year-old woman in Nairobi, the country’s capital, who had recently traveled to Uganda.
FDA green-lights use of ACAM2000 for mpox
Emergent BioSolutions yesterday announced that the US Food and Drug Administration (FDA) has approved an expanded indication for its ACAM2000 smallpox/mpox vaccine for use in people at high risk for mpox infection. The company said the approval is based on safety data in people and data from a well-controlled animal study that suggested the vaccine was effective for preventing mpox.
The company filed for the expanded indication for the live replicating vaccinia virus vaccine in October 2023.
ACAM2000 is given as a single dose by scarification, which means it is delivered percutaneously with a bifurcated needle, pricking the skin several times in the upper arm with a droplet of vaccine. The FDA first approved ACAM2000 in 2007 as a smallpox countermeasure.
This expanded indication for ACAM2000 comes at a critical time.
Emergent BioSolutions is one of the companies that has filed an expression of interest for EUL with the WHO. Joe Papa, the company's president and chief executive officer, said, "This expanded indication for ACAM2000 comes at a critical time as the global health community comes together to ensure an effective and cohesive response to the recent upsurge in mpox cases."