EBOLA/EVD [to 25 July 2015]
Public Health Emergency of International Concern (PHEIC); “Threat to international peace and security” (UN Security Council)
Ebola Situation Report – 22 July 2015
:: There were 26 confirmed cases of Ebola virus disease (EVD) reported in the week to 19 July: 22 in Guinea and 4 in Sierra Leone. Liberia reported no new cases. For the second consecutive week more than half of all cases were reported from the capitals of Guinea and Sierra Leone, Conakry and Freetown. By contrast, other recent hotspots of transmission such as Boke in Guinea and Kambia in Sierra Leone have now reported no cases for 18 and 9 days, respectively. There are also indications of a continuation of the improvements in contact tracing and case investigation seen in recent weeks, with all but 2 cases arising among registered contacts of previous cases, including all 13 of the cases reported from the Guinean capital Conakry. This is the highest proportion of cases to arise among contacts since the beginning of the outbreak. However, one of the 2 cases reported from Freetown arose from an unknown source of infection, and is considered to represent a high risk of further transmission. In addition, 2 cases, both from Guinea, were identified as EVD-positive only after post-mortem testing of community deaths….
COUNTRIES WITH WIDESPREAD AND INTENSE TRANSMISSION
:: There have been a total of 27 705 reported confirmed, probable, and suspected cases of EVD in Guinea, Liberia and Sierra Leone (figure 1, table 1) up to 19 July, with 11 269 reported deaths (this total includes reported deaths among probable and suspected cases, although outcomes for many cases are unknown). A total of 22 new confirmed cases were reported in Guinea and 4 in Sierra Leone in the week to 19 July…
European Medicines Agency [to 25 July 2015]
First malaria vaccine receives positive scientific opinion from EMA
Mosquirix to be used for vaccination of young children, together with established antimalarial interventions
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive scientific opinion for Mosquirix (Plasmodium falciparum and hepatitis B vaccine), for use outside the European Union (EU).
The malaria vaccine Mosquirix, also known as RTS,S/AS01, was submitted to EMA under a regulatory procedure (Article 58) that allows EMA to assess the quality, safety and efficacy of a medicine or vaccine and its benefit-risk balance, although it will not be marketed in the EU. This means that EMA can help facilitate access to new medicines for people living outside the EU.
Mosquirix is intended for use in areas where malaria is regularly found, for the active immunisation of children aged 6 weeks to 17 months against malaria caused by the Plasmodium falciparum parasite, and against hepatitis B. After decades of research into malaria vaccinations, Mosquirix is the first vaccine for the disease to be assessed by a regulatory agency.
The CHMP highlighted in its opinion that Mosquirix is for use in line with official recommendations that take into account the risk of Plasmodium falciparum malaria in different geographical areas and available malaria control interventions. These recommendations will be defined by the World Health Organization (WHO) and regulatory authorities in the non-EU countries where the vaccine would be used.
As in all Article 58 procedures, the CHMP worked closely with other experts, including from WHO and regulatory authorities from the relevant countries. In its assessment, the CHMP applied the same rigorous standards as for medicines to be marketed within the EU…