Ladies and gentlemen,

17 September 2009

President Obama annou= nces US will donate 10% of its 2009 H1N1 pandemic flu vaccine (non-adjuvanted) <= span style=3D'mso-spacerun:yes'> to WHO for other nations, as WHO Di= rector Dr. Margaret Chan sees devastating impact of the pandemic virus in some cou= ntries

Today the White House posted a press release on their website stating that the US will donate 10% of its 2009 H1N1 pandemic flu vaccine, on a rolling basis as the vaccine becomes available, to the World Health Organization (WHO) for distribution to nations “that will not otherwise have direct access to the vaccine”. The US is joining at least eight (8) other nations in donating vaccine to the WHO. These nations (in alphabetical order) are: = Australia, Brazil, France, It= aly, New Zealand, Norway, Sw= itzerland, and the UK. Additional nations were invited to join these nine countries as vaccine bec= omes available more widely in the months ahead.

None of the four US pandemic vaccines licensed= by the Food and Drug Administration (FDA) on September 15 contain any vaccine adjuvant. Specifically, none of the US pand= emic vaccines containing any MF-59, squalene, or any other adjuvant. The = four vaccines licensed this week by the FDA are made by: Sanofi, MedImmune, CSL, and Novartis. (Some confusion may have arisen am= ong some health care workers and some members of the general population regardi= ng pandemic vaccine adjuvant because Novartis also has an MF-59 adjuvanted pandemic 2009 H1N1 vaccine about which= they reported a clinical study online September 10^th in the New Engla= nd Journal of Medicine). The FDA-licensed Novartis pandemic flu vaccine, howev= er, is a NON-adjuvanted vaccine.

President Obama’s announcement today is particular= ly timely. Two days ago (September 15), the Director-General of the World Heal= th Organization (WHO) Dr. Margaret Chan made the following poignant statement = on her view of the likely impact of the influenza pandemic in some developing nati= ons, during her address in Denmark to the Regional Committee for Europe:

“To date, we have been fortunate in the way the pandemic has evolved. The overwhelming majority of cases continue to experi= ence mild symptoms and recover fully within a week, even without any medical treatment.

But clinically, this is a virus of extremes. It does not seem to have a middle ground. At one extreme are the mild cases. At the other extreme is a small subset of patients who quickly develop very severe disease.

Though the numbers are small, the demands on health services are disproportionately high. Saving these lives depends on highly specialized intensive care, with highly specialized equipment and highly skilled staff. In countries that la= ck such capacities, these lives will be at great danger.

Of course, this is true for a multitude of other diseases and health problems. Weak capacities cost lives. But this pandemic, I believe, will make the same old point in an especially visible and tragic manner.

I believe that this pandemic will be a watershed event. It is taking place at= a time when differences, within and between countries, in income levels, in health status, and in levels of care, are greater than at any time in recent history. The pandemic will test the world on the issue of fairness in a substantial way.

The same virus that causes manageable disruption in affluent countries will alm= ost certainly have a devastating impact in countries with too few health facili= ties and staff, no regular supplies of essential medicines, little diagnostic and laboratory capacity, and vast populations with no access to safe water and sanitation. For these populations, advice such as wash your hands, call your doctor, or rush to the emergency ward will mean very little.

Let me give just one precise example. We know, from all outbreak sites, that pregnant women are at increased risk of severe or fatal infections. Increas= ed deaths of these women, because of the pandemic, will be tragic everywhere, = but most especially so in the developing world, as the numbers will be so much greater.”

Taken together, the above statement by Dr. Margaret Chan of the WHO and the announcement by President Obama will hopefully serve as a precedent not only for protection against pandemic influenza by vaccines now, but for enhanced international protection against other vaccine-preventable infectious disea= ses in the near-term future.

Daniel R. Lucey, MD, MPH=

EROne Institute, Department of Emergency Medicine

Washington Hospital Center=

Adjunct Professor, Department of Microbiology and Immunology

Georgetown University Medical Center, Washington<= /st1:place>, DC<= o:p>

Website for this posting: www.BePast.org (re= quires IE)