The International Federation of Pharmaceutical Manufacturers & Associations (Geneva, Switzerland,
http://www.ifpma.org/) is collaborating with WHO to help developing countries gain access to pandemic influenza vaccines through technology transfer,
and Sanofi-Aventis (Paris, France, http://
http://en.sanofi-aventis.com/ ) already has transferred vaccine technology to the Brazilian government. The government passed the technology on to the
Butantã Institute (Sao Paulo, Brazil,
http://www.butantan.gov.br/), which has begun producing vaccines. In addition, WHO is working with UNICEF to help developing countries find financing
to access products manufactured by multinational vaccine producers.
Influenza vaccine production could be made easier if cell culture-derived vaccines become more prevalent. Novartis's "Optaflu"
influenza vaccine recently was recommended for approval by the Committee for Medicinal Products for Human Use. Optaflu could
be the first influenza vaccine to reach the market that uses a mammalian cell line rather than chicken eggs for antigen production.
According to Dr. Jorg Reinhardt, chief executive officer of Novartis Vaccines and Diagnostics, cell culture-derived vaccines
can be scaled up quickly and easily in the event of a pandemic. Virus cultivation also could be more robust because most circulating
viral strains are unable to replicate in chicken eggs.
FDA Licenses Sanofi-Pasteur's H5N1 Vaccine
Lyon, France (Apr. 17)—Sanofi-Pasteur (http://
http://en.sanofi-aventis.com/), the vaccine division of the Sanofi-Aventis Group, announced that the US Food and Drug Administration (Rockville, MD,
http://www.fda.gov/) has licensed its H5N1 vaccine, making it the first avian-influenza vaccine for humans in the US. The vaccine will be part
of the government's vaccine-stockpile program to prepare for a potential pandemic.
Licensure was based on a clinical trial conducted by the National Institute of Allergy and Infectious Diseases completed in
Although no human cases of H5N1 infection have been reported in the US, nearly 300 people worldwide have been infected with
the virus since 2003, and more than half have died.
Ensuring sufficient manufacturing capacity to provide an adequate number of doses remains a challenge, however, as worldwide
agencies develop strategies for timely development, manufacture, and distribution.
"We are working closely with other government agencies, global partners, and the vaccine industry to facilitate development,
licensure, and availability of needed supplies of safe and effective vaccines to protect against the pandemic threat," said
Jesse Goodman, MD, MPH, director of FDA's Center for Biologics Research and Evaluation, in an FDA release.