Global Community To Boost Developing-Nation Access to Vaccines

Six countries receive grants to begin influenza vaccine production

Developing nations are getting help from the World Health Organization (WHO) and the global community to improve their access to vaccines that protect against influenza and possibly against a future flu pandemic.

On April 24, WHO announced that six developing countries - Brazil, India, Indonesia, Mexico, Thailand and Vietnam - each will receive grants of about $2.5 million to establish in-country manufacturing capacity for flu vaccines. Japan provided $8 million of this money and the United States provided $10 million.

WHO says it plans to use the rest of the funds - about $3 million - to help the countries implement their vaccine-production processes.

"Once this production capacity is in place," said Michael Leavitt, secretary of the U.S. Department of Health and Human Services in an April 24 statement, "these countries will be able to make seasonal influenza vaccine domestically ... to protect their populations."

If an influenza pandemic emerges, Leavitt added, the countries "will have the infrastructure in place to convert their production lines to manufacturing pandemic vaccine."

During an April 25 meeting in Geneva convened by WHO Director-General Margaret Chan, WHO officials and representatives of donor and developing nations, vaccine manufacturers and industry associations discussed mechanisms for acquiring and stockpiling doses of pre-pandemic vaccine.

"I believe that developing countries are right to ask us to address the issue of more equitable access now," Chan said. "At the moment, the threat is still in the future, unpredictable in timing and severity. This is the best time to invest in an insurance policy."

The meeting followed up on earlier meetings, most recently March 27 in Jakarta, Indonesia, and discussions at the 59th World Health Assembly in 2006.

Indonesia Health Minister Siti Fadilah Supari has focused global attention over the past few months on the fact that developing countries supply H5N1 samples to WHO collaborating centers for analysis and eventual vaccine production but cannot afford the vaccines. (See related article.)

Vaccine Production

Welcoming attendees to Geneva, Chan acknowledged that the inequitable distribution of vaccines is due to many factors, including unequal levels of resources and the problem of finite manufacturing capacity.

"For a trivalent pandemic vaccine [containing three different strains of vaccine], annual manufacturing capacity is about 500 million doses," Chan said. "For a monovalent vaccine [containing one strain], this figure increases to 1.5 billion doses. This is still not enough for a world of well over 6 billion people."

It will take the countries that receive grants three years to five years to begin producing vaccine. Until then, the countries will need support to access vaccines to protect their populations.

"It is imperative that the global community works collectively to ensure more equitable access to a vaccine and other health measures in the event of an influenza pandemic," said Dr. David Heymann, WHO assistant director-general for communicable diseases. "We all have a responsibility to protect global public health security."

The grants help implement the Global Pandemic Influenza Action Plan, which seeks to close a production gap of several billion doses of influenza vaccine.

Human H5N1 Vaccine

In the United States, the U.S. Food and Drug Administration (FDA) has approved the first human vaccine developed to protect against the highly pathogenic H5N1 avian flu virus.

The vaccine could be used if the H5N1 virus develops the ability to spread easily from person to person, which could cause a rapid spread of the disease worldwide, according to an April 17 FDA statement. If a flu pandemic emerges, the vaccine could offer early limited protection in the months before a vaccine tailored to the pandemic strain could be developed and produced.

"We are working closely with other government agencies, global partners and the vaccine industry," said Dr. Jesse Goodman, director of FDA's Center for Biologics Evaluation and Research, "to facilitate the development, licensure and availability of needed supplies of safe and effective vaccines to protect against the pandemic threat."

The vaccine comes from a human strain of the virus and is intended to immunize people age 18 through 64 who could be at increased risk of exposure to the H5N1 virus in the vaccine. The vaccine is administered by two intramuscular injections, given about 30 days apart.

The manufacturer, Sanofi Pasteur, will not sell the vaccine commercially. The U.S. government is buying the vaccine for its national stockpile for future distribution by public health officials. The vaccine will be manufactured at Sanofi Pasteur's facility in Pennsylvania.

"In the United States," Leavitt said in an April 24 statement, "we have been making significant investments in vaccine research and development and in expanding influenza vaccine production surge capacity. ... These investments will likely benefit not only citizens of the United States, but also citizens of the world."

For more information on U.S. and international efforts to combat avian influenza, see Bird Flu (Avian Influenza).

Source: U.S. Department of State

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