Drug Giant Uses Cells to Make H1N1 Vaccine
The Swiss drug giant Novartis AG says it has already produced an initial 10-liter batch of vaccine against the H1N1 pandemic influenza strain.
The vaccine is available for early testing -- and possibly some clinical trials -- "weeks ahead of expectations," the company said in a statement.
The announcement came the same day the World Health Organization declared that the outbreak of the novel H1N1 strain qualifies as a pandemic -- with sustained community transmission in at least two regions of the world.
Margaret Chan, M.D., the agency's director-general, noted that the global spread of the virus led to the declaration of the first flu pandemic in 41 years. But she added that -- based on evidence so far -- the pandemic is likely to be moderate. (See WHO Declares First Flu Pandemic in 41 Years)
Dr. Chan said that the agency has been in close contact with vaccine makers and believes that production of next fall's seasonal flu vaccine will be finished soon, leaving "full capacity" available for production of vaccine against the pandemic strain.
The speed of the Novartis vaccine development was made possible by the use of a cell-based manufacturing system, rather than the traditional method that uses chicken eggs to grow the vaccine, the company said.
A spokesman told MedPage Today that the company's vaccine production facility in Marburg, Germany could produce "millions of doses a week."
The company also plans to use its egg-based plants in England and Italy to make H1N1 vaccine.
The cell-based vaccine was based on the wild-type virus, not the seed strain distributed by the CDC in early May. But the company said it is close to making a vaccine based on the seed strain as well.
Based on the success of the wild-type vaccine production, the company said it expects to see "rapid manufacture and scale-up of a vaccine" based on the seed strain.
The company said it hopes to start clinical trials in July with a vaccine made from the seed strain and expects to have it licensed by the fall.
"Cell-based vaccine production has been predicted to abbreviate the time needed to produce new vaccines," said William Schaffner, M.D., of Vanderbilt University School of Medicine in Nashville, Tenn.
"Now it has been demonstrated quite dramatically that that is, indeed, the case," he said.
Aside from speed, Dr. Schaffner said, the cell-based method "eliminates the rare but vexing problem of egg allergy" that means some people can't take a flu vaccine.
It usually takes between three and six months to make a flu vaccine, "so this is very fast," commented Frank James, M.D., of the University of Washington in Seattle.
The use of the cell-based method is also significant because it avoids the difficulty that some flu strains -- notably the highly pathogenic avian H5N1 strain -- are deadly to chicken embryos, he added.
Novartis is suggesting that their vaccine will be used with their proprietary adjuvant MF59, which has been licensed in Europe for several years but is not approved in the U.S.
Dr. James said a vaccine against a novel strain of the flu would usually need two doses several weeks apart.
"With a potent adjuvant this might not be needed," he said, "and that would significantly decrease the time and complexity of the vaccination process."
One possible hurdle, Dr. Schaffner said, is the FDA's response to the use of MF59. "How will FDA handle an adjuvanted H1N1 vaccine? So far, no clear answer has appeared," he said.
The adjuvant could be quickly used in Europe and in resource-poor countries, according to Gregory Poland, M.D., of the Mayo Clinic in Rochester, Minn.
In the U.S., though, it will probably have to go through clinical trials, he said, "unless an emergency use authorization is granted."
Dr. Poland's concern was echoed by Donald Henderson, M.D., of the University of Pittsburgh Medical Center.
"The use of an adjuvant has much to recommend it," he said, "but the U.S., to date, has steadfastly refused to license any adjuvant other than aluminum hydroxide."
"I'm afraid that they will demand testing of a very large number of people over an extended period of time -- no matter what data have been produced in Europe," he said.
Dr. Henderson said the speed of production is less important than the successful commercial use of the cell-based technology.
Commenting on the speed with which the new vaccine was produced, Dr. Henderson chronicled the progression of the last pandemic.
He noted that the first specimen of the 1957 pandemic flu was received in the U.S. on May 13 and was confirmed as being a novel strain nine days later. Testing of a vaccine began in early July and 2.3 million doses for civilian use were shipped on Sept. 4 that year, he said.
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