Expediting vaccine for influenza A(H1N1) will not jeopardize safety – UN agency

The rush to produce a vaccine to fight the spread of the influenza A(H1N1) virus will not jeopardize the safety or effectiveness of any new drug, the United Nations health agency said today in a bid to reassure the public after concerns were raised in the media.

According to the World Health Organization (WHO), the “regulatory procedures in place for the licensing of pandemic vaccines, including procedures for expediting regulatory approval, are rigorous and do not compromise safety or quality controls.”

To have the greatest impact, vaccines need to be available quickly and in large quantities as they are among the most effective medical interventions for reducing illness and deaths during a pandemic, WHO said in a news release.

In preparation for a flu outbreak in 2007, WHO examined ways to fast-track the approval of pandemic vaccines with the help of health officials, regulatory authorities and vaccine manufacturers.

The agency sought to shorten the time between the emergence of a pandemic virus and the availability of safe and effective vaccines, while maintaining regulatory control and setting out in detail precautions to guarantee the quality, safety, and effectiveness of the drugs.

WHO noted that in some cases, vaccines are not regarded by regulatory authorities as entirely new, as they build on existing technology used to produce inoculations for seasonal influenza, procedures for testing and regulatory control, and safety data.

It stressed that flu vaccines have been used for more than 60 years and have an established record of safety in all age groups, and although some serious adverse effects have been reported. WHO said they are rare and expected during a pandemic when a vaccine is administered on a massive scale.

“Time constraints mean that clinical data at the time when pandemic vaccines are first administered will inevitably be limited,” said WHO. “Further testing of safety and effectiveness will need to take place after administration of the vaccine has begun.”

WHO calculates that completing the steps involved in developing a new vaccine from start – obtaining a virus sample – to finish, when the first supplies of the approved vaccine available for use, takes around five to six months.