An advisory panel to the US Food and Drug Administration (FDA) has given its support for approval of the first avian flu vaccine for humans.
The expert panel said that while the drug has not been tested on a wide scale, it is safe and sufficiently effective to act as a stop gap until a better one is available. New generations of the vaccine are already at the experimental stage.
The vaccine is manufactured by Sanofi-Aventis, and if the FDA approves it (they usually follow the advice of their expert panels), it will be the first US vaccine against the deadly H5N1 bird flu virus.
This measure reflects the concern of government agencies and advisors, although there have been no cases of the deadly H5N1 infections in birds and humans in the US, the virus is spreading in other parts of the world and experts think it is just a matter of time before it hits America.
Novartis and GSK are also developing vaccines against deadly H5N1, but they are not ready to seek approval yet.
According to one panelist, they hope that this support will give a positive signal to the other drug developers.
In the small trial of the Sanofi-Aventis vaccine, the FDA reported that 45 per cent of the 91 patients who received it had an appropriate immune response compared to 42 who received a placebo.
The expert panel, comprising 14 voting members, voted unanimously in favour of giving the Sanofi-Aventis vaccine approval, despite the limited results from the small trial. They admitted to being in the dark about how the vaccine would work on a large scale.
One panel member said this was not going to solve the bird flu problem but it was a step in the right direction.
Sanofi-Aventis and other drug makers have received government funding to help with vaccine development. The company said it is increasing production capacity in preparation for full scale manufacturing.
A representative from the US Health and Human Services Department (HHS) said the government plans to stockpile 20 million priority doses for critical workers, with another 600 million doses for the rest of the population. The plan is to vaccinate everyone within 6 months of the first signs of a pandemic.
The US government has announced that in the event of a pandemic there will not be enough vaccine to go round everyone in the early stages, which means they will have to decide who gets vaccinated first. A series of meetings is being held across America to poll public opinion about how the government should prioritize the early vaccination program.
According to the World Health Organization (WHO), the current level of global pandemic alert of deadly H5N1 is phase 3 “No or very limited human to human transmission”. There are six levels altogether, the highest alert level is “efficient and sustained human to human transmission”.
At the moment the only route for human infection is via close contact with contaminated poultry.
Globally, there have been 275 confirmed cases of humans infected with the deadly H5N1 since 2003, of which 167 of them have died.
The latest case is in the Lao People’s Democratic Republic, who reported on 27th February their first human infection by the H5N1 avian influenza virus.
Click here for One-stop access to US Government avian and pandemic flu information (HHS).
Written by: Catharine Paddock
Writer: Medical News Today