WHO: Drug Companies Must Prepare for Swine Flu Vaccine
By Lisa Schlein
06 May 2009
The World Health Organization said all pharmaceutical manufacturers must be ready to start producing vaccines to protect people against the Swine Influenza A-H1N1 virus as soon as they are given the go-ahead.
WHO said it will take four to six months for the first lot of swine flu vaccines to become available between the time the strain of the virus is identified and production begins.
So, WHO Director of the Initiative for Vaccine Research, Marie-Paule Kieny, said pharmaceutical companies should start getting ready now.
"What we have recommended for the timing at present, which was a technical recommendation for all manufacturers is to put everything in place to be able to start manufacturing vaccines," she said.
Dr. Kieny said it is still uncertain when pharmaceutical companies should go into full-scale manufacture of the vaccines. She said the situation is complicated by the fact that seasonal flu vaccines are still being manufactured and there are, as yet, no guidelines as to when this should stop.
The World Health Organization reports manufacturers currently have the capacity to make 900 million doses of seasonal flu vaccine per year. Scientists believe drug companies should be able to make between one and two billion doses of swine flu vaccine, should there be a pandemic.
This point has not yet been reached. WHO has issued a phase five international alert, which is one level below a full pandemic. WHO said there have now been more than 1,600 confirmed cases of the Influenza-A, H1N1, including 30 deaths.
But WHO said there is not yet any evidence the virus has spread to communities in a sustained way outside North America.
Dr. Kieny said the WHO Director-General and U.N. Secretary General will be meeting with the heads of all companies making influenza vaccines on May 19. She said the two leaders want to make sure drug companies provide equitable access for developing countries to this vaccine when it is available.
"We have in the meantime, we have already starting discussing with the individual manufacturers about potential procurement by the UN agencies…how and under which conditions they could allow the U.N. procuring agencies through WHO to be able to have vaccines as they come out of a production line. So, this is real time production for the benefit of developing countries," she added.
Dr. Kieny said there is still a lot unknown about the manufacture of a new influenza vaccine. For instance, she said no one yet knows whether one or two doses of the vaccine will be needed to provide immunity against the virus. Nor, she says, does anyone know whether the new vaccine will need to be modified should the virus mutate.
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