Vaccine Briefs

New UNAIDS Data Tracks Mature and Exploding Epidemics

In December 2002, UNAIDS released its yearly report on the global HIV epidemic. The State of the AIDS Epidemic 2002 (available at www.unaids.org) pairs a sobering global overview with close-up views of countries where the AIDS epidemic is expanding with horrifying speed. Overall, 42 million people are living with HIV in 2002, including 19.2 million women. Looking to emerging epidemics, the report cites China—where unchecked spread of HIV could lead to 10 million new infections by 2010—and India, where data from antenatal clinics from several states portends broader spread in the general population. The report also gives several alarming examples of the explosive epidemic in intravenous drug users (IDU). For example, in the Russian city of Togliatti, an initial survey found that 56% of IDUs were HIV-infected.

The report echoes the 2002 Barcelona Conference message that a comprehensive response to the epidemic could prevent millions of new infections, and that delaying implementation will “slash the potential gains.” It also confirms the enduring gap in access to anti-HIV drugs: fewer than 4% of HIV-positive people in low- and middle-income countries were able to access antiretroviral treatment at the end of 2001.

While UNAIDS statistics are the world’s most widely-cited AIDS figures, in-country data can yield divergent figures. The same week that UNAIDS released its report, the South Africa Human Sciences Research Council (HSRC) released the results of a 10,000 person study commissioned by the Nelson Mandela Children’s Fund. The study estimates a national prevalence rate of 15.2% in 15-49 year olds—the UNAIDS estimate for that age range is 20.1%—and notes an “unexpectedly” high prevalence of 5.6% among 2-14 year old children. In addition to perinatal infection and early sexual initiation, sexual abuse and use of nonsterile needles could explain this high rate, authors said.

Multi-Clade Trial Begins at US Vaccine Research Center

On 13 November 2002, the Vaccine Research Center (VRC) in Bethesda, Maryland, began Phase I studies of a “multi-clade” HIV-DNA vaccine developed in the lab of VRC director Gary Nabel. The vaccine contains env genes from HIV subtypes A, B and C (which together account for about 90% of all HIV infections worldwide), along with the gagpol and nef genes from subtype B. The trial, designated 03-I-0022, will enroll 50 volunteers, beginning with a 2 mg dosage group (including placebos); assuming no safety problems, the next group will receive 4 mg, and the last group, 8 mg—all given in three immunizations over 56 weeks. Work is also underway to produce a second vaccine with the same HIV genes in a vector made from adenovirus-5 (Ad-5). If the DNA and Ad-5 vaccines each yield good safety and immunogenicity data in Phase I studies, they will then be tested as a prime-boost combination.

AIDS Advocate Becomes Congressional Democratic Leader

In November 2002, Nancy Pelosi (San Francisco, CA) was chosen as Democratic leader in the US House of Representatives, where the Democrat Party is currently in the minority. Pelosi is a long-time AIDS advocate who in 1999 sponsored the first legislation (the ”Vaccines for the New Millennium Act”) to provide incentives to companies developing AIDS, TB and malaria vaccines. This legislation was never passed into law, but there may be renewed interest in similar proposals in 2003, building on momentum from initiatives to stimulate industry involvement in vaccines against bioterror agents.

Gates Grant to Fight AIDS in India

During a four-day trip to India in November, Microsoft CEO Bill Gates announced a US $100 million grant to combat HIV in the country’s vulnerable mobile populations, including truck drivers, migrant workers and commercial sex workers. The new initiative will be overseen by a board headed by the Indian minister for Health and Family Welfare and directed by Ashok Alexander, who most recently served as head of the Delhi office of the global consulting firm McKinsey & Company.

AIDS Funding Bill Dies as Congressional Session Ends

A landmark bill that authorized substantially increased funds for HIV/AIDS, tuberculosis and malaria was dropped from consideration when the 107th session of the US Congress ended in November 2002. According to Congressional procedure, the bill—the “US Leadership Against HIV/AIDS, TB and Malaria Act of 2002”—was dropped from consideration, since it had not been enacted at the session’s end. The House and Senate each passed separate versions of the bill, but work by staff to produce a reconciled version failed. The legislation called for US$5 billion in spending for global AIDS and substantial increases in US investment in microbicides research. No announcements have been made about whether similar legislation will be introduced when the 108th congressional session begins in January 2003. In a separate announcement, President George Bush put forward a presidential initiative that would grant US$500 million over three years to developing countries combating mother-to-child transmission.

New Head for the US FDA

Also in November, Mark McClellan was approved as the new Commissioner of the Food and Drug Administration (FDA), a post that has been vacant for two years. A health economist and professor at Stanford University, McClellan was generally supported by both political parties.

His appointment comes at a difficult time for the FDA. In October, the Bush Administration drew criticism for its appointment of W. David Hagar, a conservative Christian, as interim chair of the FDA panel on women’s health policy. That same month, more concerns arose when the administration suspended the “pediatric rule,” which allowed the FDA to require pediatric studies of products intended for widespread use in children. Recently, the institution has spoken publicly about its difficulties dealing with the volume of applications it receives.