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…FDA official said, "We'd like for you to vote on this in the context of this product being used in a pandemic."
…On a 14-0 vote, the committee agreed that the immunogenicity data support licensure for the vaccine.
A fairly short discussion preceded the committee's vote on whether the safety data supported licensure of the vaccine. The panel voted 14-0 in favor.
Q-Pan is …based on a 2005 strain of H5N1 from Indonesia, but a GSK official said that once the vaccine is licensed, the strain used in the vaccine can be changed.
Glaxo contracted with the federal government in 2007 to make a prototype vaccine to protect against potential infection with the bird flu. It contains only 3.75 micrograms of the inactivated H5N1 antigen, or protein, compared with 90 micrograms in an already licensed vaccine made by French drugmaker Sanofi.
With such a tiny amount of needed antigen, Friedland said Glaxo could easily make "far more doses" of the vaccine than it otherwise could.
…"It's the adjuvant that makes the difference," he said.
The U.S. contract with Glaxo called for the company to develop an antigen-sparing vaccine, which would allow more doses to be made with a given amount of antigen.
Classical vaccine manufacturing techniques are beset by limitations such as difficulties ramping up production volume, contamination of vaccines by a range of antigenic impurities, and even difficulties accurately targeting diseases, such as influenza, whose composition changes from year to year. Synthetic vaccines hold the promise of creating new, highly targeted vaccines from crafted peptide sequences, which could be much more effective than classical vaccines without the side effects.
Synthetic vaccine production is straightforward to ramp up, since it involves standardized peptide manufacturing techniques already in use across multiple industries, with accompanying economies of scale. By contrast, nearly all vaccines sold today are manufactured using early-20th century technologies, such as using live chicken eggs as incubators for tiny batches of highly impure doses. [ed. Which is why they need adjuvants.]
I thought there were only like five confirmed cases of the H5N1 last year.
Local authorities worry that it took just one month to spread from north to central Vietnam, but international experts do not predict a worse scenario than in previous years
…“There is a new strain of the H5N1 virus that is spreading fast with a high capacity to kill humans,” Diep Kinh Tan, deputy minister of Agriculture and Rural Development, said at a recent meeting of the National Committee for Avian Influenza Disease Control and Prevention.
I am willing to take a deep look at the proposed legislation regarding this before it goes for a vote. Probably thousands of pages long with hidden agendas such as forced vaccines if in the future it is "needed" for the general population.
I would like to see for myself the wording on how they plan to use it.
The American Medical Association (AMA) recently published a paper proposing the introduction of a new law to force you and your children into experimental vaccine trials against your wishes. Your only way out of this directive would be to sign a 'opt out form.'
…"Compulsory involvement in vaccine studies is …not as outlandish as it might seem on first consideration."
…if this does go through which I am positive the $$$ has already changed hands and been spent, when is the projected timeframe of the infection hitting the population? How much time do we have?
GlaxoSmithKline (GSK) is bolstering its pandemic H5N1 vaccine presence in the US after being awarded a contract (in 2007) to provide 22.5 million doses of bulk antigen to the US stockpile while launching clinical trials for its adjuvanted H5N1 vaccine.
[NOTE: started with 7 US states, 2 Canadian provinces - expanded to larger multi-centre trial in late 2007]