Yellow Fever [to 23 July 2016]
http://www.who.int/emergencies/yellow-fever/en/
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Yellow Fever – Situation Report – 21 July 2016
Full Report:
http://apps.who.int/iris/bitstream/10665/246242/1/yellowfeversitrep-21Jul16-eng.pdf?ua=1
Summary:
Angola: 3682 suspected cases
In Angola, as of 15 July 2016 a total of 3682 suspected cases have been reported, of which 877 are confirmed. The total number of reported deaths is 361, of which 117 were reported among confirmed cases. Suspected cases have been reported in all 18 provinces and confirmed cases have been reported in 16 of 18 provinces and 79 of 125 reporting districts.
Mass reactive vaccination campaigns first began in Luanda and have now expanded to cover most of the other affected parts of Angola. Recently, the campaigns have focused on border areas.
Mass vaccination campaigns were completed in several districts in Benguela, Huambo, Huila, Kwanza Norte, Lunda Norte, Malange and Uige provinces. All districts continued with house to house immunization campaigns and routine vaccination.
Democratic Republic of the Congo: 1798 suspected cases
For the last four weeks the national laboratory in the Democratic Republic of The Congo (DRC) has been unable to confirm or discard any suspected cases of yellow fever due to technical issues and corrective actions are underway. According to the latest available information (as of 11 July), the total number of notified suspected cases is 1798, with 68 confirmed cases (as of 24 June) and 85 reported deaths. Cases have been reported in 22 health zones in five of 26 provinces. Of the 68 confirmed cases, 59 were imported from Angola, two are sylvatic (not related to the outbreak) and seven are autochthonous.
In DRC, surveillance efforts have increased and vaccination campaigns have centred on affected health zones in Kinshasa and Kongo Central. Reactive vaccination campaigns started on 20 July in Kisenso health zone in Kinshasa province and in Kahemba, Kajiji and Kisandji health zones in Kwango province.
The risk of spread
Two additional countries have reported confirmed yellow fever cases imported from Angola: Kenya (two cases) and People’s Republic of China (11 cases). These cases highlight the risk of international spread through non-immunised travellers…
Seven countries (Brazil, Chad, Colombia, Ghana, Guinea, Peru and Uganda) have reported yellow fever outbreaks or sporadic cases not linked to the Angolan outbreak…
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Fractional dose yellow fever vaccine as a dose-sparing option for outbreak response
WHO Secretariat information paper
WHO reference number: WHO/YF/SAGE/16.1
Published: July 2016 ::39 pages
[Excerpts]
1. Preamble
This document represents the World Health Organization (WHO) Secretariat position on the use of yellow fever (YF) vaccine in the context of supply shortages in response to the current outbreak in Africa in 2016. The development of this paper was led by the WHO Initiative for Vaccine Research with contributions to specific sections from the WHO Departments of Pandemic and Epidemic Diseases, Essential Medicines, and Immunization Vaccines and Biologicals. The evidence and the proposed recommendations, reflected in this document, has been discussed with YF experts and reviewed by the WHO Strategic Advisory Group of Experts (SAGE) on Immunization. SAGE and the YF experts provided input to this paper. The recommendations were vetted by SAGE, but they don’t represent a formal SAGE recommendation. The paper will be updated as additional data become available. A full review on the use of fractional dose YF vaccine will be conducted by SAGE in October 2016….
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12. Ethical considerations
In emergencies the international community has a collective duty of care to ensure that effective affordable measures are available to those most in need. The duty of care principle demands that effective vaccinations against disease threats should be available to those at risk. Emergencies often require rapid decision-making under uncertain and unconventional situations, but ethical principles need to be adhered to even in these situations.
In the face of shortages, a usual strategy is prioritization among different population groups. Another is to use a dose-sparing approach in order to cover as much of the population as possible. Both options could also be combined. The best of these options should be chosen based on a rigorous public health and ethical analysis.
A number of ethical issues arise when choosing a dose-sparing approach:
Risk-benefit considerations
First, the risk of harm to populations and individuals needs to be analysed (the ‘first do no harm’ principle). These risks and possible mitigating actions to minimize them should be explicitly discussed. Second, there should be robust evidence for benefit, i.e. for non-inferiority in comparison to the full dose. In addition, the dose-sparing strategy should be considered based on robust evidence for its benefit.
The obligation to produce and share data
In public health emergencies there is an ethical duty to produce and rapidly share all relevant data. The use of lower doses of vaccine as an emergency measure entails an ethical obligation to learn as much as possible as quickly as possible. Even if the dose-sparing approach is not designed as a research project, research components should be embedded to use this opportunity to gain new knowledge. Ideally, protocols should be submitted for pre-approval so that the final ethics review can be expedited.
Distributive justice and equity
Unless there is scientific necessity and evidence for doing so (e.g. based on safety or futility), the immunization programmes should not discriminate against any population groups. Special measures should be taken to facilitate the access of vulnerable groups, such as children and pregnant women.
Transparency, trust, public engagement
The vaccination strategy should be well communicated by national policy-makers to the public health officials, the public and the media. Special effort should be made to ensure that media understand well the rationale for the dose sparing strategy and become real partners in disseminating the messages of the vaccine programmes. Public engagement will facilitate uptake and trust in the programme.
Informed consent
During mass vaccination campaigns, consent is normally presumed (implicit consent), with a possibility to opt out. This means that information about the vaccine must be disseminated widely in an accessible format, and that it is ensured that members of the public know that they can opt out of vaccination, if they so wish. If mass vaccination campaigns are being planned with the lower-dose vaccine, it is an ethical requirement to provide minimum additional information, i.e. that a lower than usual dose will be used but that it is considered as safe and effective as the normal dose.
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13. Recommendations
1. Fractional dose YF vaccination, an off-label use of the product, should be considered in response to an emergency situation in which current vaccine supply is insufficient. Fractional dose vaccination should be used for vaccination campaigns in response to an outbreak or in settings where the extension of the outbreak is imminent and should not be used for routine immunization. As soon as the vaccine supply situation normalizes, fractional dose should be replaced by full dose vaccination. Fractional dose vaccination is an off-label use of the product.
2. Under no circumstances should YF vaccine be reconstituted in a different volume of diluent than that recommended by the manufacturer, and no other method of diluting the vaccine should be used.
3. When fractional dose YF vaccine is used, preference should be given to the administration of the vaccine according to standard route, i.e. SC or IM. The minimal dose administered should preferentially contain 3000 IU/dose, but no less than 1000 IU/dose and the minimum volume of the inoculum should be not less than 0.1 ml.
4. The dose fractioning (e.g. 1/2 or 1/5th) should be done considering the potency of the vaccine batch, the shortage of supply and availability of suitable injection devices.
5. In the absence of data on the use of fractional dose YF vaccination in young children, children aged less than 2 years should preferentially be offered a full dose of vaccine (i.e. at least 3000 IU) during emergency campaigns.
6. Different expansion scenarios for YF vaccine fractional dose administration should be considered in view of the potential risk of further spread of the disease, and shortage of vaccine supply. Actual potencies of available vaccines need to be considered to meet the necessary potency levels:
a. 1/2 dose of Bio-Manguinhos vaccine administered SC.
b. Should the shortage of vaccine limit the use of a 1/2 dose, use of a 1/5th dose of Bio-Manguinhos vaccine administered SC could be considered.
c. If the shortage limits fractional dose supplies, all WHO prequalified vaccines could be administered as 1/2 or 1/5th fractional dose SC, depending on potency of the batch. In this context, use of Stamaril ® (Sanofi) via ID administration (0.1.ml) is, while off-label, also acceptable, depending on the preferences of the country. As a general rule, fractional doses should not be less than the minimal dose range (see recommendation 3).
7. Reconstituted YF vaccine is heat labile and must be kept at 2–8 °C at all times and discarded after 6 hours in accordance with WHO’s open vial policy.
8. Multidose vials containing more than 10 full doses should not be used for fractional dose administration in order to avoid increased risk of contamination due to multiple punctures of the septum.
9. Every effort should be made to monitor safety and YF vaccine AEFIs.
10. Vaccination with fractional doses should be recorded using personalized registries for the purpose of safety and effectiveness monitoring. Such information may prove useful in assessing eventual re-vaccination needs with full doses, for which currently there is no recommendation.
11. All other precautions and recommendations for YF vaccination remain valid as detailed in the WHO yellow fever vaccine position paper (2013)…
vaccines and global health :: ethics and policy 