Vaccines: The Week in Review 24 November 2012

Editor’s Notes:

Email Summary: Vaccines: The Week in Review is available as a weekly email summary: please send your request to david.r.curry@centerforvaccineethicsandpolicy.org.

pdf version: A pdf of the current issues is available here: Vaccines_The Week in Review_24 November 2012

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WHO recommends seasonal influenza vaccination to pregnant women as the highest priority [WER]

WHO recommends seasonal influenza vaccination to pregnant women as the highest priority
“In an updated position paper, published in the Weekly Epidemiological Record today, WHO recommends that countries considering the initiation or expansion of seasonal influenza vaccination programmes give the highest priority to pregnant women. Additional risk groups to be considered for vaccination, in no particular order of priority, are: children aged 6-59 months; the elderly; individuals with specific chronic medical conditions; and healthcare workers.”

http://www.who.int/immunization/en/
The Weekly Epidemiological Record (WER) for 23 November 2012, vol. 87, 47 (pp. 461–476) includes: Vaccines against influenza – WHO position paper – November 2012
http://www.who.int/entity/wer/2012/wer8747.pdf

FDA approves Flucelvax – first licensed cell-culture influenza vaccine

   The FDA said it approved Flucelvax, described as the first seasonal influenza vaccine licensed in the United States produced using cultured animal cells, instead of fertilized chicken eggs. Flucelvax is approved to prevent seasonal influenza in people ages 18 years and older. The manufacturing process for Flucelvax is similar to the egg-based production method, but a significant difference is that the virus strains included in the vaccine are grown in animal cells of mammalian origin instead of in eggs. Cell culture technology has already been in use for several decades to produce other U.S. licensed vaccines. Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research, said, “Today’s approval represents the culmination of efforts to develop a seasonal influenza vaccine using cell culture as an alternative to the egg-based process.” Flucelvax is manufactured by Novartis Vaccines and Diagnostics GmbH, Marburg, Germany.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm328982.htm

EMA recommends marketing authorization for Bexsero (mening B – Novartis)

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the granting of a marketing authorisation for Bexsero, a new Novartis vaccine intended for the immunisation of individuals over two months of age against invasive meningococcal disease caused by Neisseria meningitidis group B. There is currently no authorised vaccine available in the European Union (EU) for bacterial meningitis caused by Neisseria meningitidis group B…In Europe, group B is the most prevalent meningococcal serogroup, with 3,406-4,819 cases reported annually between 2003 and 2007, according to a surveillance report published by the European Centre for Disease Prevention and Control….There are currently some geographical regions within the EU with higher incidence rates, mainly in Belgium, Ireland, Spain and the United Kingdom…The impact of invasive disease in different age groups as well as the variability of antigen epidemiology for group-B strains in different geographical areas should be considered when vaccinating. Vaccination with Bexsero should be in accordance with official recommendations applicable in the Member States. The CHMP’s opinion on Bexsero will now be sent to the European Commission for the granting of a marketing authorisation.

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/11/news_detail_001656.jsp&mid=WC0b01ac058004d5c1

GPEI: Polio this week – As of 20 Nov 2012

Update: Polio this week As of 20 Nov 2012
Global Polio Eradication Initiative
http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx

[Editor’s Extract]
– This week, immunization campaigns are being implemented in all three remaining endemic countries, Nigeria, Pakistan and Afghanistan. Focus continues to be on urgently boosting immunity levels in known high-risk areas.

Afghanistan
– Three new WPV cases were reported in the past week (one WPV1 from Kandahar and two WPV1s from Hilmand), bringing the total number of WPV cases for 2012 to 30. The WPV1 from Kandahar is the most recent case in the country and had onset of paralysis on 28 October.
– Supplementary immunization activities (SIAs) are taking place this week (19-21 November), with the next activity planned for 01-06 December.
– The current campaign is being conducted in border areas with Pakistan, and uses a combination of trivalent OPV and bivalent OPV (depending on the area, in response either to recent WPV1 cases in the area, or to detection of a circulating vaccine-derived poliovirus type 2 outbreak – cVDPV2 – across the border in Pakistan).
– The Technical Advisory Group (TAG) is meeting next week in Kabul, to review the impact of the national polio emergency action plan and discuss additional tactics to address on-going immunity gaps in known high-risk districts.

Nigeria
– Four new WPV cases were reported in the past week (one WPV1 each from Jigawa, Kaduna, Kano and Katsina), bringing the total number of WPV cases for 2012 to 104. The WPV1 from Kaduna is the most recent case in the country and had onset of paralysis on 30 October.

Horn of Africa
– Efforts are continuing to stop an ongoing cVDPV2 outbreak in Kenya and parts of Somalia (in a Somali refugee camp in Dadaab, Kenya, and Kismayo, south-central Somalia).
– Immunizations of older age groups have taken place in Dadaab. In Somalia, campaigns have been conducted in border areas with Kenya and Ethiopia, and in some areas of central Somalia (access allowing).

WHO: Global Alert and Response (GAR) – Disease Outbreak News [to 24 Nov 2012]

WHO:  Global Alert and Response (GAR) – Disease Outbreak News

– Announcement: WHO to change the way it reports H5N1 cases
Henceforward, WHO will publish information on human cases with H5N1 avian influenza infection on a monthly basis on the Influenza webpage:
Influenza at human-animal interface – Monthly Risk Assessment Summary
Cases of human infection with H5N1 will only be reported on Disease Outbreak News for events that are unusual or associated with potential increased risks.
Member States will be continued to require to report information on every sporadic case of H5N1 human infection or novel influenza virus infection to WHO as per Article 6 of the International Health Regulations (2005).

Most recent news items
– Ebola in Uganda  23 November 2012
– Novel coronavirus infection – update  23 November 2012
– Marburg haemorrhagic fever in Uganda – update  23 November 2012
– Yellow fever in Sudan – update  22 November 2012
http://www.who.int/csr/don/en/index.html

Time for global action on fake and substandard drugs

British Medical Journal
24 November 2012 (Vol 345, Issue 7884)
http://www.bmj.com/content/345/7884

Time for global action on fake and substandard drugs
BMJ 2012;345:e7917 (Published 21 November 2012)

Excerpt
“In an article this week a self defined “diverse group of authors from the health professions, health charities, legal and medical academia, and former or current government officials in health” present us with a troubling paradox: the world currently has tighter laws to tackle fake tobacco products than it does to tackle fake drugs (doi:10.1136/bmj.e7381). At the moment, as they explain, there are laws that promote an open global medicines trade but no binding international health law on drug safety. The result is that fake and substandard drugs continue to harm and kill people around the world, affecting both proprietary and generic drugs, and haunting rich countries as well as poor. As Andrew Jack explains (doi:10.1136/bmj.e7836), the rapid growth of unregulated internet sales of drugs has raised the stakes even further. In the accompanying podcast, Amir Attiran emphasises the absurd situation by which trading fake medicines is currently legal under international law, and Sania Nishtar highlights worryingly weak pharmacovigilance systems in Pakistan (www.bmj.com/multimedia).

Why the lack of progress on this globally damaging health problem? There’s no simple answer to what is clearly a complex problem, but the authors suggest that the main barriers have been the lack of an internationally agreed terminology and a focus in law on commercial interests rather than public health…”

Faking it
BMJ 2012;345:e7836 (Published 20 November 2012)
Analysis
Podcast

How to achieve international action on falsified and substandard medicines
BMJ 2012;345:e7381 (Published 13 November 2012)
Analysis
Podcast
Feature
Press release

Commentary: Substandard medicines are the priority for neglected tropical diseases
BMJ 2012;345:e7518 (Published 14 November 2012)
Analysis