WHO: Pandemic (H1N1) 2009 – update 93: 26 March 2010

The WHO continues to issue weekly “updates” and briefing notes on the H1N1 pandemic at: http://www.who.int/csr/disease/swineflu/en/index.html

Pandemic (H1N1) 2009 – update 93
Weekly update
26 March 2010

As of 21 March 2010, worldwide more than 213 countries and overseas territories or communities have reported laboratory confirmed cases of pandemic influenza H1N1 2009, including over 16,931 deaths.

WHO is actively monitoring the progress of the pandemic through frequent consultations with the WHO Regional Offices and member states and through monitoring of multiple sources of information.

Situation update:
The most active areas of pandemic influenza virus transmission currently are in parts of Southeast Asia, West Africa, and in the tropical zone of the Americas…

More at: http://www.who.int/csr/don/2010_03_26/en/index.html

GAVI: GSK, Pfizer commit pneumococcal vaccine under AMC

The GAVI Alliance announced that GlaxoSmithKline (GSK) and Pfizer became “the first two companies to make long-term commitments to supply new vaccines against pneumococcal disease” under the Advance Market Commitment (AMC) for pneumococcal disease. The AMC has been supported by the governments of Italy, the United Kingdom, Canada, Russia, Norway and the Bill & Melinda Gates Foundation. GAVI CEO Julian Lob-Levyt said, “Today’s landmark announcement promises to make new vaccines available affordably, where they are urgently needed, and faster than ever before. Through this AMC, and thanks to the political will demonstrated by donors and least developed nations and the participation of the pharmaceutical companies, prevention against the world’s biggest childhood killer is now within reach.” GAVI estimates that the introduction of suitable and affordable vaccines against the disease could save approximately 900,000 lives by 2015 and up to seven million lives by 2030.

Pfizer and GSK “have committed to supply 30 million doses each per year, for a 10 year period…(to be) made available at US$ 3.50 per dose to be paid by GAVI and the developing country governments that introduce the vaccines.” GAVI said that, for approximately 20% of the doses, companies will also receive an additional payment of US$3.50 for each dose they provide, which is paid with donor commitments (AMC funds). In total, this is a fraction of the current cost of pneumococcal vaccines in many industrialised countries, GAVI noted.


FDA, WHO, Global Advisory Committee Statements on porcine circovirus 1 (PCV1) in Rotarix

The FDA recommended that “healthcare practitioners temporarily suspend use of the Rotarix vaccine for rotavirus immunization in the United States while the agency learns more about components of an extraneous virus detected in the vaccine, noting that there is no evidence at this time that this finding poses a safety risk. Full text of the announcement follows:

“The agency recently became aware that an independent U.S. academic research team, using a novel technique, has found DNA from porcine circovirus 1 (PCV1) in Rotarix, which is manufactured by GlaxoSmithKline.  PCV1 is not known to cause illness in humans or other animals.  In addition, Rotarix has been studied extensively, before and after approval, and found to have an excellent safety record.

“Follow-up tests by GlaxoSmithKline and FDA scientists confirmed the academic team’s findings and confirmed that viral components have been present since the early stages of the vaccine’s development, including during clinical studies.  Preliminary testing by both the academic researchers and FDA scientists of another licensed vaccine against rotavirus infection, RotaTeq, has not detected components of PCV1.

“”We are making clinicians aware of information recently received by FDA about the Rotarix vaccine,” said Dr. Margaret A. Hamburg, Commissioner for Food and Drugs. “There is no evidence at this time that there is a safety concern.  FDA is recommending that clinicians temporarily suspend use of Rotarix until we can learn more about the situation.  We will keep the public and the clinical community updated on our findings…”

“…In many countries, rotavirus causes so much severe illness and death that the known benefits of continued use of Rotarix far outweigh any theoretical risk of harm from the vaccine,” said Dr. Thomas Frieden, Director of the Centers for Disease Control and Prevention.  “We anticipate that many countries will decide to continue vaccinating with Rotarix while more information becomes known.”

“FDA will continue to gather more information about the PCV1 components in Rotarix, including whether intact virus, as opposed to DNA fragments, is present.  The agency is assessing current vaccine testing methods.  In four to six weeks, FDA will convene an expert advisory committee and make additional recommendations on the use of rotavirus vaccines.

“FDA will provide updates to patients, providers, and the general public as more information becomes available.  The agency will also continue to communicate with the World Health Organization and counterpart regulatory agencies in other countries.


WHO: Rotavirus vaccination – WHO does not recommend any change to use of Rotarix vaccine 22 March 2010

Following announcements today by the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regarding use of the rotavirus vaccine, Rotarix, the World Health Organization (WHO) encourages all countries using the vaccine to carefully consider the significant benefits of continued use of the vaccine in any decisions about further use.

The FDA and EMA statements follow the recent report to the vaccine manufacturer that DNA sequences originating from porcine circovirus 1 (PCV1) had been detected in two batches of the vaccine during a study undertaken in the United States of America (USA).

WHO concurs with the views of the FDA and EMA that the findings do not present a threat to public health. Moreover, rotaviruses are the most common cause of severe diarrhoeal disease in young children throughout the world, with an estimated 527 000 deaths among children under five years old, most of whom live in low-income countries. Therefore, WHO does not recommend any change to use of the vaccine. The vaccine is prequalified by WHO, and the prequalification status remains unchanged.

WHO will continue to work closely with the FDA , EMA and other regulatory agencies to evaluate further information that the manufacturer will be providing as a matter of urgency.


Statement of the Global Advisory Committee on Vaccine Safety on Rotarix

On 25 March 2010, WHO’s Global Advisory Committee on Vaccine Safety (GACVS) met by teleconference to review new data on Rotarix, an oral vaccine for prevention of rotavirus gastroenteritis. Academic investigators recently reported to the vaccine manufacturer, GlaxoSmithKline, that the vaccine contains DNA from porcine circovirus type 1 (PCV1). PCV1 is not known to cause disease in animals or humans. Further analysis of the master cell bank and master viral seed used for vaccine production have demonstrated the presence of PCV1 DNA, which in retrospect has been in the vaccine throughout its clinical development, including the prelicensure clinical trials. There are studies underway both by the manufacturer and others that will provide additional information to help more fully assess this new finding.

The safety of Rotarix is supported by both large clinical trials prelicensure and an extensive (>60 million doses) postlicensure safety experience. GACVS reviewed the safety data from both clinical trials and spontaneous reports, both of which supported the continued safety of Rotarix. Rotavirus gastroenteritis is the most common cause of severe diarrheal disease in young children throughout the world, with an estimated 527 000 deaths annually among children under five years old. Given the extensive clinical data supporting the safety of Rotarix and the benefits of rotavirus vaccination for children, GACVS considers that the benefits of vaccination far outweigh any currently known risk associated with use of Rotarix. GACVS will continue to review data as it becomes available and will update this statement as we learn more.


Partnership: PATH and International Enteric Vaccine Consortium (EntVac)

PATH and the International Enteric Vaccine Consortium (EntVac) announced a new partnership for early-stage research into a vaccine concept against enterotoxigenic E. coli (ETEC), described as one of the leading bacterial causes of diarrheal disease. PATH will fund EntVac, a consortium of universities anchored by the University of Maryland School of Medicine, to pursue preclinical proof of concept of a stable toxin (ST) toxoid vaccine. PATH said such a vaccine “offers the prospect of broad protection against ETEC, but requires additional research and evaluation.” PATH will provide funding of US$1.1 million over 2.5 years for the research effort. ETEC is responsible for up to 840 million infections and approximately 400,000 deaths worldwide each year, mostly in children in developing countries. The research will be conducted at the University of Maryland School of Medicine’s Center for Vaccine Development, the University of Bergen, the University of South Dakota, and Tulane University. The Research Council of Norway is also funding the EntVac consortium for this research project.


CSIS releases Smart Global Health Policy report

The Center for Strategic and International Studies (CSIS) Commission on Smart Global Health Policy launched its final report – A Healthier, Safer and More Prosperous World – “promoting a long-term, strategic US approach to global health.” The report advises U.S. policymakers in five major issue areas which “chart a course for US global health investment through 2025”:

– Maintaining commitments to HIV/AIDS, tuberculosis, and malaria

– Narrowing health gaps for women and children

– Strengthening prevention and preparedness capabilities

– Improving coordination and increasing capacity between implementers and policymakers

– Making smart investments in multilateral institutions.

Dr. Christopher Elias, president and CEO of PATH and a member of the CSIS commission, said, “The report from the CSIS Commission on Smart Global Health Policy highlights how crucial research and innovation for new global health products are to overall US global health efforts. It also illustrates how innovative financing mechanisms play vital roles in spurring the development of new vaccines, drugs, and other tools that save lives worldwide. US policymakers should implement these recommendations to maximize the country’s efforts to improve health around the world.”

The report and additional information available at: http://smartglobalhealth.org/content/report


MMWR Weekly for March 26, 2010

The MMWR Weekly for March 26, 2010 / Vol. 59 / No. 11 includes:
2009 Pandemic Influenza A (H1N1) in Pregnant Women Requiring Intensive Care — New York City, 2009

To characterize the severity of 2009 H1N1 virus infection in pregnant women, the New York City Department of Health and Mental Hygiene conducted surveillance for cases in pregnant women requiring intensive care. The findings indicated that, during 2009, 16 pregnant women and one who was postpartum were admitted to intensive-care units. Two women died. Of the 17 women, 12 had no risk factors for severe influenza complications other than pregnancy, and only one woman received antiviral treatment within 2 days of symptom onset.