Geneva, Switzerland (Apr. 27)—A meeting of the World Health Organization (WHO, www.who.int) and the Committee for Medicinal Products for Human Use’s (London, www.emea.eu.int) approval of Novartis’s (Basel, Switzerland, www.novartis.com) new cell culture-derived influenza vaccine offered new hope that sufficient numbers of vaccines could be produced in case of a pandemic.
Increasing vaccine production capacity has been a concern for WHO since it was determined during a two-day meeting in February 2007 that the industry lacked “the manufacturing capacity to meet potential pandemic influenza vaccine demand” (see “WHO Stresses Lack of Capacity for Pandemic Flu Vaccine.”
At a meeting at WHO headquarters on April 25, representatives from countries that have experienced human H5N1 infections, donor countries, and vaccine manufacturers agreed to develop a mechanism to ensure developing countries have access to influenza vaccines in case of a pandemic. Attendees also discussed the possibility of creating a stockpile of H5N1 vaccine and concluded that it “may be feasible” as vaccine manufacturers increase capacity over the next three to five years to meet growing demand.
WHO plans to set up expert groups to explore the best way to create, maintain, fund, and use a stockpile of avian influenza vaccine. However, Marie-Paule Kieny, the director of the WHO initiative for vaccine research, admitted that presently “most countries with resource constraints do not have the means to access influenza vaccines.” To address this issue, WHO is supporting an effort to build production facilities in developing and industrialized countries. This effort has received financial support from the Japanese Government and from the United States Department of Health and Human Services (HHS, Washington, DC, www.hhs.gov). Projects to establish influenza vaccine manufacturing facilities are in the final stages of approval in two Latin American and four Asian countries.
The International Federation of Pharmaceutical Manufacturers & Associations (Geneva, Switzerland, 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://en.sanofi-aventis.com ) already has transferred vaccine technology to the Brazilian government. The government passed the technology on to the Butant„ Institute (Sao Paulo, Brazil, www.butantan.gov.br), which has already 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.