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WHO advisors extend Ebola emergency, European regulators conditionally approve vaccine
Filed Under:
Ebola; VHF
Lisa Schnirring | News Editor | CIDRAP News
| Oct 18, 2019
In a pair of major Ebola developments today, an emergency committee for the World Health Organization (WHO) recommended extending the public health emergency of international concern (PHEIC) for the ongoing outbreak in the Democratic Republic of Congo (DRC), and European drug regulators conditionally approved Merck's VSV-EBOV vaccine.
Meanwhile, three new Ebola infections were confirmed in the DRC today, raising the outbreak total to 3,233, according to the WHO's online Ebola dashboard.
PHEIC continuation reflects ongoing insecurity worries
The WHO's emergency committee met for the fifth time today to discuss outbreak developments. When the group last met in July, it recommended declaring a PHEIC under International Health Regulations. The group heard updates from the DRC, Uganda, and Tanzania, as well as from global health officials.
Along with a continuing slowdown in cases over the past several weeks, the number of affected health zones has dropped and the epidemic is centered in the Biakato Mine area of the Mandima health zone, an area challenging for outbreak responders due to its remote locations and insecurity problems, partly related to the presence of both legal and illegal mines.
According to a statement from the WHO, the group got the latest risk assessment from the WHO, which says the risk of Ebola spread is still high at the national and regional levels, but low at the global level. The committee also received updates on preparedness in neighboring countries and on the Ebola vaccine campaign.
They learned that funding is still a problem, especially for preparedness in nine surrounding countries for which only $4.5 million of $66.6 million has been pledged by donors. The committee praised neighboring countries' efforts to boost preparedness, but they said they are deeply concerns about the lack of sustained financial support for the activities.
More than a year into the outbreak, access and security issues pose obstacles to final efforts to eliminate Ebola, and the group's view is that the event still constitutes a PHEIC. They recommended a few changes in the temporary recommendations they made in earlier meetings, including establishing community awareness activities in areas in the outbreak region that haven't had transmission, and stepped-up active surveillance.
At a media telebriefing afterward, WHO director-general Tedros Adhanom Ghebreysus, PhD, said he accepted the group's recommendation and that the emergency committee will meet again in about 3 months to assess if the conditions still warrant a PHEIC.
"This remains a dangerous and complex outbreak. We need the full force of our partners to bring the outbreak under control," he said.
Tedros said he is pleased by the progress since the group's last meeting, including that no countries have imposed travel or trade restrictions, expanded screening and contact tracing, and that no forward transmission has occurred in Goma or Uganda. He urged caution in interpreting the continued drop in cases, especially given the rural, difficult-to-reach location of the recent cases. "We must treat every case as if it's the first," Tedros added.
EMA nod paves way for full licensing
In another key development, the European Medicines Agency (EMA) recommended conditional approval for Merck's VSV-EBOV vaccine, which will be authorized under the ERVEBO brand name and indicated for active immunization of people 18 years and older to protect against Ebola.
As the next step, the European Commission will consider authorization on an accelerated basis, and if approved, the vaccine will be cleared for use in 28 countries that are part of the European Union, was well as in European Economic Area countries including Iceland, Liechtenstein, and Norway.
The US Food and Drug Administration (FDA) is currently reviewing the vaccine.
Roger Perlmutter, MD, PhD, president of Merck Research Laboratories, said in a statement today, "Our work would not have been possible without the efforts of countless numbers of people, especially those from the World Health Organization and many other government and non-governmental organizations, who have worked tirelessly on the development of this important vaccine." He added that a top priority is achieving registration of the Merck manufacturing site in Germany that makes the vaccine.
In a statement today, the WHO said today's EMA announcement marks a major milestone and that while the EC decides on licensing, it will move towards prequalifying the vaccine.
Tedros said in the statement that the EMA's conditional authorization is a triumph for public health.
"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," he said.
The WHO said a unique feature of the EMA review was that WHO and African regulators actively participated through a cooperative arrangement put in place by the WHO, which it said will help speed the vaccine's registration in the most at-risk countries.
The WHO said it is working a plan with Gavi, the Vaccine Alliance, and other partners to establish vaccine stockpiles to prepare for future outbreaks. Today's announcement won't impact current vaccine activities in the DRC, and the WHO projected that licensed doses will be available in the middle of 2020.
At today's media briefing, Mike Ryan, MD, the WHO's executive director of health emergencies, said having a licensed vaccine will reduce logistical barriers and allow manufacturers to move to full-scale manufacturing, two factors that are expected to improve the supply of VSV-EBOV.
Latest cases include probable infections
Aside from three new lab-confirmed cases reported today, the WHO's online dashboard reflects two more probable cases, putting the overall outbreak total at 3,233. Health officials are still investigating 443 suspected cases.
One more person died from Ebola, lifting the fatality count to 2,157.
Meanwhile, the DRC's Ebola technical committee (CMRE) in its latest daily update had locations for the single Ebola case reported yesterday, a patient from Mabalako. It also noted that four of the most recent deaths were all from Mabalako, one that occurred in the community and three that happened in the Ebola treatment center.
See also:
Oct 18 WHO statement on Ebola emergency committee deliberations
Oct 18 Merck statement
Oct 18 WHO statement on EMA announcement
WHO online Ebola dashboard
Oct 17 CMRE daily report
WHO advisors extend Ebola emergency, European regulators conditionally approve vaccine
Filed Under:
Ebola; VHF
Lisa Schnirring | News Editor | CIDRAP News
| Oct 18, 2019
In a pair of major Ebola developments today, an emergency committee for the World Health Organization (WHO) recommended extending the public health emergency of international concern (PHEIC) for the ongoing outbreak in the Democratic Republic of Congo (DRC), and European drug regulators conditionally approved Merck's VSV-EBOV vaccine.
Meanwhile, three new Ebola infections were confirmed in the DRC today, raising the outbreak total to 3,233, according to the WHO's online Ebola dashboard.
PHEIC continuation reflects ongoing insecurity worries
The WHO's emergency committee met for the fifth time today to discuss outbreak developments. When the group last met in July, it recommended declaring a PHEIC under International Health Regulations. The group heard updates from the DRC, Uganda, and Tanzania, as well as from global health officials.
Along with a continuing slowdown in cases over the past several weeks, the number of affected health zones has dropped and the epidemic is centered in the Biakato Mine area of the Mandima health zone, an area challenging for outbreak responders due to its remote locations and insecurity problems, partly related to the presence of both legal and illegal mines.
According to a statement from the WHO, the group got the latest risk assessment from the WHO, which says the risk of Ebola spread is still high at the national and regional levels, but low at the global level. The committee also received updates on preparedness in neighboring countries and on the Ebola vaccine campaign.
They learned that funding is still a problem, especially for preparedness in nine surrounding countries for which only $4.5 million of $66.6 million has been pledged by donors. The committee praised neighboring countries' efforts to boost preparedness, but they said they are deeply concerns about the lack of sustained financial support for the activities.
More than a year into the outbreak, access and security issues pose obstacles to final efforts to eliminate Ebola, and the group's view is that the event still constitutes a PHEIC. They recommended a few changes in the temporary recommendations they made in earlier meetings, including establishing community awareness activities in areas in the outbreak region that haven't had transmission, and stepped-up active surveillance.
At a media telebriefing afterward, WHO director-general Tedros Adhanom Ghebreysus, PhD, said he accepted the group's recommendation and that the emergency committee will meet again in about 3 months to assess if the conditions still warrant a PHEIC.
"This remains a dangerous and complex outbreak. We need the full force of our partners to bring the outbreak under control," he said.
Tedros said he is pleased by the progress since the group's last meeting, including that no countries have imposed travel or trade restrictions, expanded screening and contact tracing, and that no forward transmission has occurred in Goma or Uganda. He urged caution in interpreting the continued drop in cases, especially given the rural, difficult-to-reach location of the recent cases. "We must treat every case as if it's the first," Tedros added.
EMA nod paves way for full licensing
In another key development, the European Medicines Agency (EMA) recommended conditional approval for Merck's VSV-EBOV vaccine, which will be authorized under the ERVEBO brand name and indicated for active immunization of people 18 years and older to protect against Ebola.
As the next step, the European Commission will consider authorization on an accelerated basis, and if approved, the vaccine will be cleared for use in 28 countries that are part of the European Union, was well as in European Economic Area countries including Iceland, Liechtenstein, and Norway.
The US Food and Drug Administration (FDA) is currently reviewing the vaccine.
Roger Perlmutter, MD, PhD, president of Merck Research Laboratories, said in a statement today, "Our work would not have been possible without the efforts of countless numbers of people, especially those from the World Health Organization and many other government and non-governmental organizations, who have worked tirelessly on the development of this important vaccine." He added that a top priority is achieving registration of the Merck manufacturing site in Germany that makes the vaccine.
In a statement today, the WHO said today's EMA announcement marks a major milestone and that while the EC decides on licensing, it will move towards prequalifying the vaccine.
Tedros said in the statement that the EMA's conditional authorization is a triumph for public health.
"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," he said.
The WHO said a unique feature of the EMA review was that WHO and African regulators actively participated through a cooperative arrangement put in place by the WHO, which it said will help speed the vaccine's registration in the most at-risk countries.
The WHO said it is working a plan with Gavi, the Vaccine Alliance, and other partners to establish vaccine stockpiles to prepare for future outbreaks. Today's announcement won't impact current vaccine activities in the DRC, and the WHO projected that licensed doses will be available in the middle of 2020.
At today's media briefing, Mike Ryan, MD, the WHO's executive director of health emergencies, said having a licensed vaccine will reduce logistical barriers and allow manufacturers to move to full-scale manufacturing, two factors that are expected to improve the supply of VSV-EBOV.
Latest cases include probable infections
Aside from three new lab-confirmed cases reported today, the WHO's online dashboard reflects two more probable cases, putting the overall outbreak total at 3,233. Health officials are still investigating 443 suspected cases.
One more person died from Ebola, lifting the fatality count to 2,157.
Meanwhile, the DRC's Ebola technical committee (CMRE) in its latest daily update had locations for the single Ebola case reported yesterday, a patient from Mabalako. It also noted that four of the most recent deaths were all from Mabalako, one that occurred in the community and three that happened in the Ebola treatment center.
See also:
Oct 18 WHO statement on Ebola emergency committee deliberations
Oct 18 Merck statement
Oct 18 WHO statement on EMA announcement
WHO online Ebola dashboard
Oct 17 CMRE daily report