August 6, 2009

Swine Flu Vaccines On Fast-Track Are Safe

The World Health Organization stated on Thursday that the procedures being implemented to speed approvals of the new vaccines for the swine flu do not reduce safety.

According to the WHO, vaccines have to be readily accessible and available in large amounts to have the greatest impact.

"The public needs to be reassured that 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," it said.

The WHO previously said the current outbreak of H1N1, which was declared a pandemic on June 11, is the fastest escalating pandemic ever and could ultimately affect 2 billion people across the globe.

Concerns had been voiced about H1N1 vaccine safety, said a WHO statement.

However, the United Nations agency claims that vaccines were too late in arriving during the 1957 and 1968 flu pandemics, therefore not being very useful. Also, flu vaccines had not yet been developed in the 1918 "Spanish flu" pandemic which amounted in the deaths of around 50 millions people.

The WHO said it had been joining with government regulators and vaccine makers in 2007 in an effort to find a way to hasten the approval of a new vaccine should a new strain of the infamous virus emerge.

The process could be faster in some cases since the vaccine was not actually new, but rather based on the same technology being used for seasonal flu vaccines, the agency said.

But when the vaccine is administered on a broad scale during a pandemic, the WHO says safety issues could come up whether they showed up in safety trials or not.

"For these reasons, WHO advises all countries administering pandemic vaccines to conduct intensive monitoring for safety and efficacy, and many countries have plans in place for doing so," it said.

The WHO's top vaccines expert, Dr Marie-Paule Kieny, is expected to give an update on H1N1 vaccines at a briefing at 8:30 a.m. EDT.

Top flu vaccine makers include Sanofi-Aventis, Novartis, Baxter, GlaxoSmithKline and Solvay.

Company officials announced on Tuesday that Novartis has begun human testing of H1N1 swine flu vaccine candidates while Sanofi-Aventis, the world leader in flu shots, will begin within days.


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