US regulators stole a march on their European counterparts on Tuesday by approving four pandemic flu vaccines, clearing the way for an immunisation programme to begin across the country next month.
The Food and Drug Administration said it had authorised the use of products made by CSL, Sanofi-Aventis, Novartis and MedImmune, using the traditional techniques for seasonal flu but adapted to help protect against the current H1N1 swine flu virus.
However, it has yet to make a decision on a newer range of more sophisticated vaccines that would allow global supplies to stretch further and help protect a far larger number of people.
The European Medicines Agency has already approved in principle pandemic vaccines based on “mock-up” dossiers submitted for similar products developed to protect against the H5N1 bird flu virus, but is still considering safety data from final trials in the vaccines adapted for the current flu strain.
Margaret Hamburg, the FDA’s commissioner, said in a statement: “Today’s approval is good news for our nation’s response to the 2009 H1N1 influenza virus. This vaccine will help protect individuals from serious illness and death from influenza.”
But the FDA has yet to rule on the safety and efficacy of other flu vaccines containing “adjuvants” – chemicals designed to stimulate the human immune response – including variants made by Sanofi-Aventis and Novartis, as well as rivals such as GlaxoSmithKline.
Adjuvants would help lift global production capacity for flu vaccines, although recent studies have already raised hope that a single dose of vaccine may be sufficient to provide protection rather than two as previously thought.
The US regulator has not approved any new adjuvanted vaccine for 80 years, although this month FDA officials played down long-standing concerns over the safety of the adjuvant AS04 contained in Cervarix, GSK’s vaccine against the HPV virus that causes cervical cancer.
The US government has bought 48m doses of the Sanofi-Aventis vaccine alone, but the company said clinical trials for its adjuvanted vaccine that had been planned in the US prior to approval had yet to begin.
The Food and Drug Administration said it had authorised the use of products made by CSL, Sanofi-Aventis, Novartis and MedImmune, using the traditional techniques for seasonal flu but adapted to help protect against the current H1N1 swine flu virus.
However, it has yet to make a decision on a newer range of more sophisticated vaccines that would allow global supplies to stretch further and help protect a far larger number of people.
The European Medicines Agency has already approved in principle pandemic vaccines based on “mock-up” dossiers submitted for similar products developed to protect against the H5N1 bird flu virus, but is still considering safety data from final trials in the vaccines adapted for the current flu strain.
Margaret Hamburg, the FDA’s commissioner, said in a statement: “Today’s approval is good news for our nation’s response to the 2009 H1N1 influenza virus. This vaccine will help protect individuals from serious illness and death from influenza.”
But the FDA has yet to rule on the safety and efficacy of other flu vaccines containing “adjuvants” – chemicals designed to stimulate the human immune response – including variants made by Sanofi-Aventis and Novartis, as well as rivals such as GlaxoSmithKline.
Adjuvants would help lift global production capacity for flu vaccines, although recent studies have already raised hope that a single dose of vaccine may be sufficient to provide protection rather than two as previously thought.
The US regulator has not approved any new adjuvanted vaccine for 80 years, although this month FDA officials played down long-standing concerns over the safety of the adjuvant AS04 contained in Cervarix, GSK’s vaccine against the HPV virus that causes cervical cancer.
The US government has bought 48m doses of the Sanofi-Aventis vaccine alone, but the company said clinical trials for its adjuvanted vaccine that had been planned in the US prior to approval had yet to begin.
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