Tuesday, August 18, 2009

Sinovac: Chinese Vaccine `Protects’ With 1 Dose

 

 

# 3637

 

 

Over night from Bloomberg news we get what appears to be the first (albeit, scant) information regarding clinical trials being conducted on the new H1N1 vaccine.   This trial data comes out of China, and based on Sinovac’s novel H1N1 vaccine.

 

As you are probably aware, the assumption has been that it will take 2 shots to confer immunity to most people. 

 

If, as suggested by Sinovac’s overnight announcement, reasonable immunity can be created with just one shot, it would greatly expand our capacity to vaccinate large numbers of the public.  

 

It is, however, probably a bit soon to be popping the Champagne corks.

 

Sinovac offered no data with their announcement, and so we have no idea about the dose, whether it was adjuvanted or unadjuvanted, the level of antibody response it elicited, or the age groups of those that showed this response.


In other words, all we have is a broad statement by company, and no data to back it up.  Yet.

 

This semi-encouraging report from Bloomberg.

 

 

China-Made Swine Flu Vaccine Protects After One Shot (Update1)

 

By Simeon Bennett

Aug. 18 (Bloomberg) -- Swine flu vaccine made in China by Sinovac Biotech Co. is safe and protects people against the pandemic virus after a single shot, according to its developer.

 

Studies showed the inoculation met “international criteria for vaccines” and caused no severe adverse reactions in any of the 1,614 volunteers who received it, Sinovac said in an e- mailed statement today. It didn’t give details about the efficacy of differing doses or vaccination methods used.

 

The results are the first reported anywhere in the world on a vaccine to fight the new H1N1 strain that’s sparked the first influenza pandemic in 41 years, said Beijing-based Sinovac, which was created in 2001 to make immunizations for hepatitis. The company is compiling data on the flu shot as soon as possible before seeking regulatory approval for it in China.

 

“The reported results of the Sinovac trial of H1N1 vaccine hinting at good efficacy after a single inoculation are encouraging,” said Lorena Brown, professor of microbiology and immunology at the University of Melbourne. “These will be of particular interest when the data are analyzed in terms of age- group, vaccine dose, vaccine form and the requirement for adjuvant, all of which can effect the practicality of vaccine manufacture and use.”

 

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