FLU VACCINE MAY HIT FAST TRACK

Local researchers show online data transfer could lead to safer response in days rather than months

Flu pandemic vaccine manufacturing could begin in days, not months, potentially saving a great numbers of lives in case of a severe outbreak, according to a study published Wednesday in Science Translational Medicine.

Starting with digitized viral genomes, researchers led by San Diego geneticist J. Craig Venter along with Rino Rappuoli of Novartis, reproduced, or “rescued” flu viruses in just four days and four hours. Traditional methods take about four months.

“To date, we have not encountered any influenza virus strain that cannot be rescued synthetically,” the paper stated. Moreover, the synthesized viruses grown in cell cultures make better vaccines than those made by the traditional method of growing them in chicken eggs, it stated.

The process allows immediate transfer of viral information to manufacturing centers by the Internet, eliminating the time and potential hazard of shipping specimens for culture.

The project was a public-private collaboration also involving Novartis’ Philip R. Dormitzer and the Department of Health and Human Services. It also included San Diego researchers from the J. Craig Venter Institute and Synthetic Genomics, which Venter founded. Its goal was to speed up response to new flu strains, especially from potentially deadly pandemics, by using modern biotechnology and the Internet.

The 2009 H1N1 influenza pandemic demonstrated the need for faster and better vaccine production, Venter said.

“With H1N1, the vaccine didn’t become available until two months after the pandemic peaked,” Venter said. “And if H1N1 was going to be as bad as people predicted, there would have been a humongous number of deaths as a result of not having that vaccine.”

The process of developing and distributing the H1N1 vaccine took about nine months, Venter said. “If it’s a really egregious pandemic, I think we can get it down to six weeks.”

In addition to making viruses from Internet-transmitted information, the collaboration also seeks to create a digital bank of flu virus strains. If a new outbreak matches one of the strains already stored, vaccine manufacturing can begin nearly immediately, Venter said.

Moving away from using eggs to grow viruses is the other part of the story, Venter said. Novartis has recently received approval to make flu vaccines in animal cell cultures at a plant in North Carolina, using what are called Madin-Darby canine kidney, or MDCK, cells. This method is faster than growing in eggs and also is more suited to making vaccines that work in people, Venter said.

The best results will come from marrying the digital technology for making the virus with the new manufacturing technique.

“We’re going to put one of our synthetic facilities at the North Carolina plant, so all that has to be done with the new emerging flu strains of the future, is that the digital information is sent there, and the synthesis people will immediately make it, and it will go right into the production facility there,” Venter said. “Right now we’re making it in San Diego and shipping it by Federal Express, so we’ll eliminate a couple of days there.”

The work was funded by the Biomedical Advanced Research and Development Authority, in addition to the Novartis Foundation and National Institute for Allergy and Infectious Diseases.

Venter said the technology might work for other infectious diseases besides the flu.

“In theory, it could apply to anything where there’s rapid changes in the genome,” Venter said. “A lot of diseases that vaccines haven’t worked with are in that category.”

You will notice that I did not claim that you are lying about having GB. I explained as unemotionally as possible about GB; often people take my unemotional presentation as criticism, which it is not. I firmly believe that emotions should not be allowed to color information. My comment about the kooks was not aimed at you.

GB is an autoimmune disease which most often happens after certain infections. About 1 per 100,000 children under 18 develop GB per year, unrelated to vaccines. Less than 1 case per 1,000,000 vaccinated is thought to occur.

The most likely cause of this autoimmune disease (GB) is that a protein in the pathogen looks like a human nervous system protein. When your body responds to the pathogen by making antibodies, some of those antibodies then recognize these nervous system proteins as invaders. Cells containing those proteins are destroyed by the immune system. I think that how much influenza proteins resemble human nervous system proteins is dependent on the type of influenza. There are many types of influenza; new influenza viruses appear frequently.

When you receive a vaccine, you get a small dose of influenza proteins. When you get influenza, you get a large dose of those proteins. I think that a person who is unlucky enough to develop GB after a vaccination would almost certainly develop GB if they were to get sick with the same virus that is in the vaccine.

Perfectly healthy children die from influenza. They can die because influenza induces a “cytokine storm”, which is when the immune system goes into overdrive. Or they can die because influenza weakens the immune system, causing them to be susceptible to bacterial infections. Or the influenza can just kill them without those complications. People over 65 are also highly likely to die of influenza. Healthy adults below age 65 are less likely to die of influenza.

A vaccine contains a selection of proteins from the pathogen. It cannot make you sick. It teaches your body how to respond if you encounter that pathogen. There is no antigen in the vaccine that isn’t in the pathogen. However, in many cases, the pathogen can kill.

Did you go to www.clinicaltrials.gov and read a few of the clinical trials being conducted on influenza vaccines right now? You can also go to www.pubmed.org and look for published studies on vaccine trials. Vaccines are extensively tested in thousands of patients. I don’t know where you get the idea that they aren’t tested.

Vaccines are made out of dead pathogens. In the unlikely event a vaccine interacted with some drug, then the live pathogen would certainly interact with that drug. And since live pathogens can do so much damage, up to permanent damage and death, I’d rather have a small dose of dead pathogen in a vaccine.

Vaccines are probably the most important medical advance in human history. Vaccines are responsible for the fact that the life span is now close to 80 years. We eradicated the killer smallpox with vaccines, and are on track for eradicating polio within a few years. Vaccines already have made the world safer for us.

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