PATH: MenAfriVac (meningococcal meningitis) receives WHO prequalification

PATH said that MenAfriVac, a vaccine developed through the Meningitis Vaccine Project (MVP) to protect against life-threatening meningococcal meningitis, received prequalification from the World Health Organization. The action clears the way for phased introduction of the vaccine in Africa later this year, PATH said.  Dr. Christopher J. Elias, president and CEO of PATH, commented, “Prequalification is a major milestone for MenAfriVac and MVP. This partnership between PATH and WHO is a stellar example of our mission and strategy at work. Through nine years of collaboration with a range of partners, WHO and PATH have been able to bring this vaccine from idea to reality, and we’re poised now to deliver it to the people who need it most.” PATH described meningococcal meningitis as a bacterial infection of the fluid surrounding the brain and spinal cord which is highly contagious and kills about one in ten people who get it. Even with treatment, as many as a quarter of survivors suffer permanent damage—most commonly hearing loss, mental retardation, or epilepsy. The infection causes repeated epidemics during the annual dry season in sub-Saharan Africa—a region known as “the meningitis belt.”

Dr. F. Marc LaForce, director of the Meningitis Vaccine Project, said, “At 40 cents a dose, it is a moral imperative to introduce the vaccine in meningitis belt countries, most of which are among the poorest countries in the world. It is everybody’s wish that the global health community and funding agencies will come forward to help introduce the first affordable conjugate vaccine that offers the hope to end 100 years of group A meningitis epidemics in Africa.” MenAfriVac is produced by the Serum Institute of India Ltd. (SIIL), which received marketing authorization for export and use of MenAfriVac in Africa earlier this year.

http://www.path.org/news/an100623-menafrivac.php

WHO: Pandemic (H1N1) 2009 – update 106: 25 June 2010

The WHO continues to issue weekly updates and occasional briefing notes on the H1N1 pandemic at http://www.who.int/csr/disease/swineflu/en/index.html
Pandemic (H1N1) 2009 – update 106
Weekly update
25 June 2010 — As of 20 June, worldwide more than 214 countries and overseas territories or communities have reported laboratory confirmed cases of pandemic influenza H1N1 2009, including over 18209 deaths.

Situation update:
Worldwide, overall pandemic and seasonal influenza activity remains low. Active transmission of pandemic influenza virus persists in parts of the tropics, particularly in the Caribbean, West Africa, and South and Southeast Asia. Pandemic and seasonal influenza viruses have been detected only sporadically during the early part of winter in the temperate regions of the southern hemisphere. Global circulation of seasonal influenza virus type B viruses has declined substantially and persists at low levels in parts of East Asia, Central Africa, and Central America. During the past month, seasonal influenza H3N2 viruses have been detected at low levels across parts of East Africa and South America. More at: http://www.who.int/csr/don/2010_06_25/en/index.html

IFPMA: statement on H1N1 pandemic response

The IFPMA released a statement on the overall response to the 2009-10 H1N1 influenza pandemic. IFPMA noted that “from the perspective of the vaccine manufacturers, several elements of the response were particularly effective:
– High level of preparedness. For many years prior to the H1N1 outbreak, public health authorities, regulatory agencies and vaccine producers worked together on pandemic preparedness. These efforts intensified following the spread of H5N1 ‘avian’ influenza. The resulting level of preparedness allowed authorities to respond robustly to the H1N1 pandemic, in a manner that was not previously possible.
– Global co-operation and flexibility. The rapid development and testing of H1N1 vaccines presented many technical challenges, particularly in the initial stages. WHO network and industry scientists worked together, to share technical information and resolve urgent key issues, such as improving vaccine virus production yields and vaccine standardization. Industry interaction with the WHO regarding the H1N1 pandemic was focused on the development of H1N1 pandemic vaccines and on improving vaccine availability, and did not extend to pandemic alert status decision-making.
– Robust vaccine monitoring. By implementing existing surveillance plans and sharing data publicly, authorities were able to confirm rapidly the safety of H1N1 vaccines.
IFPMA also noted that “improvements to several areas of the pandemic response could strengthen future preparedness.
– Technical improvements. Production yields from initial H1N1 vaccine viruses were 1/3 to 1/2 of those achieved with seasonal strains. Therefore, processes to rapidly evaluate multiple candidate vaccine strains and to select those with the best growth potential could improve yields and increase vaccine supply. Similarly, processes to speed up reagent production and broadening the range of techniques available for vaccine standardization would accelerate vaccine availability.
– Establishing advance supply agreements. Large numbers of countries initiated negotiations for vaccine supply after the emergence of H1N1 influenza. Establishing advance supply agreements beforehand could avoid the need for complex discussions under intense time pressure during a pandemic.
– Enhancing regulatory processes. International co-operation, mutual recognition of existing regulatory approvals and reduction of bureaucracy could all accelerate vaccine availability, while maintaining robust safety standards.
– Strengthening public communications. Throughout the pandemic, vaccination rates have remained low even in target risk groups (for instance, coverage among healthcare workers reached just 37.1% in the USA by mid-January 2010(1) while a study of healthcare workers in Greece showed an acceptance rate of only 17% for pandemic vaccination(2)). In some instances, views propagated by social media may have eroded public confidence in the safety of H1N1 vaccines. Authorities need to recognize the importance of new communication channels to motivate the public to seek vaccination. It is important to emphasize the public health value and safety of vaccination, as well as the comprehensive system that is in place to evaluate and monitor vaccine safety.
1) US Centers for Disease Control and Prevention. MMWR April 2, 2010;59(12):357-362. (http://www.cdc.gov/mmwr/pdf/wk/mm5912.pdf).
2) Rachiotis G, Mouchtouri VA, Kremastinou J, Gourgoulianis K, Hadjichristodoulou C. Low acceptance of vaccination against the 2009 pandemic influenza A(H1N1) among healthcare workers in Greece. Euro Surveill. 2010;15(6): pii=19486. Available online: (http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=19486)

http://www.ifpma.org/News/NewsReleaseDetail.aspx?nID=13803

PhRMA: statement regarding clinical trials conducted abroad

The PhRMA (Pharmaceutical Research and Manufacturers of America) issued a statement regarding clinical trials conducted abroad:

“America’s biopharmaceutical research companies are proud to be among the nation’s primary economic engines. Pharmaceutical research companies lead the world in the search for new life-saving and life-enhancing medications and, in 2009 alone, invested an estimated $65.3 billion to discover and develop new medicines.

“While the number of experimental medicines in clinical testing today – more than 2,900 medicines for nearly 4,600 different indications – represents an all-time high, America’s biopharmaceutical research companies develop drugs for a worldwide market and conduct clinical trials inside and outside the U.S.

“It’s important to remember that the Food and Drug Administration (FDA) has jurisdiction over clinical trials conducted in foreign countries for drugs approved in the U.S. or being studied for approval in the U.S. The same strict regulatory standards apply to foreign trials as trials conducted domestically. Sponsors are typically in communication with the FDA throughout clinical trials – no matter where they are conducted.

“Clinical trials occur globally because we have global companies that make medicines for use around the world. Our member companies make every effort to combat diseases that are common in the developed, as well as the developing world. That can, ultimately, deliver life-saving and life-enhancing medications to patients around the world more quickly.

“Is it ethical to conduct such studies outside of the U.S.? In a word: Yes. Consistent with PhRMA’s Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results, our member companies are committed to adhering to Good Clinical Practice guidelines around the world.

“In fact, PhRMA has conducted educational seminars and symposiums – at times, in conjunction with the FDA – in other countries to educate potential clinical trial principal investigators about Good Clinical Practices, ethics oversight by outside review boards, and the need to maintain the highest standards for data quality.

“Regardless of the location, however, companies seeking U.S. approval must maintain the FDA’s high standards for conducting the trial. For instance, any related trials conducted outside the U.S. must comply with FDA requirements covering Good Clinical Practices, in addition to meeting the requirements mandated in these important emerging markets.

“Clinical research is a critical element in the development of revolutionary medicines that help patients live longer, healthier lives. Through carefully controlled clinical studies, researchers thoroughly assess the safety and efficacy of new drug candidates.

“America’s pharmaceutical research and biotechnology companies have a long-standing commitment to help ensure physicians and other healthcare providers receive meaningful information from these clinical trials.

“The PhRMA Clinical Trial Principles, created in 2002 and strengthened last year, have been an invaluable guide to member companies and underscore our commitment to the safety of clinical trial participants and communication of important medical findings from clinical trials.”

http://www.phrma.org/news/news/phrma_statement_foreign_clinical_trials

MMWR: Malaria Surveillance — United States 2008

The MMWR for June 25, 2010 / Vol. 59 / No. SS–7 includes: Malaria Surveillance — United States, 2008
Abstract
The majority of malaria infections in the United States occur among persons who have traveled to areas with ongoing malaria transmission. CDC received reports of 1,298 cases of malaria with an onset of symptoms in 2008 among patients in the United States, a decrease of 13.8% from the 1,505 cases reported for 2007 (p<0.001). The first documented case of simian malaria, Plasmodium knowlesi, was reported in a U.S. traveler. The highest estimated relative case rates of malaria among travelers occurred among those returning from countries in West Africa. In the majority of reported cases, U.S. civilians who acquired malaria abroad had not adhered to a chemoprophylaxis regimen that was appropriate for the country in which they acquired the infection. Any person who has been to a malarious area and who subsequently develops a fever or influenza-like symptoms should seek medical care immediately and report their travel history to the clinician; investigation should always include blood-film tests for malaria with results available immediately. Malaria infections can be fatal if not diagnosed and treated promptly.

http://www.cdc.gov/mmwr/preview/mmwrhtml/ss5907a1.htm?s_cid=ss5907a1_w