Posted: 05/02/07

Tough flu, tougher vaccine
FDA approves vaccine for human-to-human bird flu

Larry Frisoli | contributing writer
lfrisoli@smcvt.edu

The first FDA approved vaccine designed to protect people from the H5N1 type bird flu has been purchased by the federal government. Research and testing from the University of Rochester Medical Center lead to the discovery of the vaccine which, in high doses, “can reduce immune responses in healthy adults,” according to the official press release from the Natural Institute for Allergy and Infectious Disease (NIAID).

A URMC press release states that the vaccine will soon begin to be stockpiled for distribution in case of an epidemic. The World Health Organization (WHO) has taken steps to expand the “domestic manufacturing capacity” of the vaccine by making way for $15 million in grants to be given to six countries, according to a statement made by Mike Leavitt, the Secretary of Health and Human Services of the FDA. Leavitt says the primary objective of the grant money is to have these six countries, “be able to make seasonal influenza vaccine domestically under the standards of good manufacturing practices, to protect their populations,” according to this April 24 press release.

H5N1: Avian Bird Flu

H5N1 is a virus that causes what is known as the Avian Bird Flu, a disease which has killed nearly half of the 300 humans it has infected around the world, according to the Web site of the Natural Institute for Allergy and Infectious Disease.

The new FDA approved vaccine was created from testing an inactivated strain of H5N1 virus ensnared in 2004. Since the vaccine received a stamp of approval from the FDA, the WHO and NIAID have sprung off the starting line beginning the race to stockpile the vaccine.

One critically dangerous aspect of the H5N1 virus is that an infection from the virus cannot be diagnosed by symptoms alone and lab results can take several weeks, according to the official Web site for the Center for Disease Control (CDC). Instead of being transmitted through saliva, blood, or other bodily fluids, the virus can make its way into an individual's system through the air via small particle aerosols. In past years, footage of people in affected areas wearing filtration masks have been associated with the Avian Bird Flu, although the CDC does not recommend masks for routine use.

If the H5N1 type flu was to mutate into an airborne zoonoses (a disease that is capable of being transmitted from animal to human, then human to human) there is a potential for a global pandemic. The WHO, NIAID, and associated doctors have been aware of this possible next step for the deadly H5N1 virus. A sudden mutation turning the H5N1 virus into a zoonoses could be both lethal and fast spreading.

"The threat of an influenza pandemic is, at present, one of the most significant public health issues our nation and world faces. The approval of this vaccine is an important step forward in our protection against a pandemic," says Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs in an April 19 FDA press release.

The cost

Sophomore Kelly McQuade led a University Research and Global Health workshop during the Global Health Conference hosted by the Edmundite Center for Peace and Justice on Thursday, April 28.

During The Pharmaceutical Companies & Global Health session of Thursday’s conference, a panel of speakers discussed a few world-wide concerns regarding patented drugs and generic drugs. (Larry Frisoli, photo)

McQuade, a poltical science major, says that many developing countries are not financially able to protect their populations with vaccines. One possible route to bring viral protection to the impoverished populations of this world would be for the researchers of new vaccines to, “make a stipulation with whatever company they sold [the vaccine] to so people in developing countries can have access to it with free or reduced cost,” McQuade says.

Senator Patrick Leahy is currently pushing congress to oblige major research universities to require similar stipulations in their products, McQuade says.

At least two of the lectures and discussions of the Global Health Conference gave mention to the obstacle of money which prevents a percentage of the world population from receiving medication for diseases, specifically HIV/AIDS.

During The Pharmaceutical Companies & Global Health session of Thursday’s conference, a panel of speakers discussed a few world-wide concerns regarding patented drugs and generic drugs, at times focusing on the patent monopolies of multi-national drug companies.

A topic covered by both Bill Haddad, a former CEO of a generic drug company, and Jamie Love, the director of CP Tech, was the gap between production cost and shelf price of HIV/AIDS pharmaceuticals. Although both of these professionals have unique points of view on the subject, Love showed no objection to Haddad when he said, “They can’t sell at their production price…[lucrative] business is motivation for the innovator.”

What’s next?

While there is no crystal ball that gives a definite future for the H5N1 virus, there are plenty of possibilities. Organizations like the GHO, NIAID and CDC are concerned with preparation for the worse case scenario.

The company that holds the license to the H5N1 Influenza Virus Vaccine, Sanofi Pasteur Inc., does not intend to produce the vaccine for commercial distribution, according to an April 17 letter from the Sanofi Pasteur Office of Vaccines Research and Review. Sanofi Pasteur is the world’s largest company dedicated exclusively to vaccines, and stated in an April 18 press release that the company plans to work on, “vaccine formulations [which] generate immune responses against other strains of the H5N1 virus.”

The April 19 FDA official Press Release states, “With the support of FDA, the U.S. National Institutes of Health and other government agencies, sanofi pasteur and other manufacturers are working to develop a next generation of influenza vaccines for enhanced immune responses at lower doses, using technologies intended to boost the immune response. Meanwhile, the approval and availability of this vaccine will enhance national readiness and the nation's ability to protect those at increased risk of exposure.”

Anna Michael, a senior double major in music and biology, explains the tedious process of finding a vaccine. Obtaining the virus, culturing it, sequencing and testing antibiotics are just four early steps in the process, and when the pressure is on to find a vaccine, there may be risks involved.

“The FDA is being pressured, because of the bird flu, to allow licensed drugs that may not be safe.”

With some chemicals there are unforeseen consequences, Michael says. As the key cop on the scene, the FDA claims to stand as a reliable overseer for safety in drugs, according to the FDA’s mission statement.

Michael says the drugs that the FDA clears for circulation are almost always safe. The organization’s key role is to act as a watchdog to make sure people and animals aren’t ingesting dangerous chemicals.

“Once it’s out on the market, it’s pretty much on to stay unless new research on it says it's really bad.” Michael says.