Today's Top Stories
Xconomy has an interesting Q&A with Andrin Oswald, Novartis' chief of vaccines and diagnostics. Oswald explains that the vaccines division swelled by 1,000 people over the summer as the pharma giant added to its manufacturing staff to meet the sudden spike in flu vaccine demand.
Asked to describe the most "exciting new technology" in vaccine development, Oswald answered:
"I think it's the combination of reverse vaccinology, where we try to identify the right antigens by understanding the genome of the bacteria, and structural vaccinology, where with modern three-dimensional technologies we are able to actually visualize the antigen-based on which we can almost
design the right antigen that you would use in a vaccine to create the intended immune response."
Novartis' other big vaccine initiative is a big new cell-based manufacturing center in North Carolina, which HHS is helping to fund in exchange for priority access when needed. HHS had to face a storm of criticism for the recent shortfall in the initial supply of swine flu vaccine. That heat
would have turned blistering in the event the pandemic turned out to be more deadly than it did. In a future pandemic, HHS's $486 million investment in North Carolina could look like a real bargain.
- here's the Q&A from Xconomy
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The swine flu pandemic is likely to have a long-term impact on the U.S. government's strategy for dealing with outbreaks. HHS Secretary Kathleen Sebelius is vowing to make sure that the next pandemic will be fought with vaccines that can be produced in vast quantities far faster than we've
seen this year. And more of it will be produced in the U.S.
"We were fighting the 2009 H1N1 flu with vaccine technology from the 1950s," Sebelius says. "We could race to begin vaccine production, but there was nothing we could do if vaccine grew slowly in eggs. We could make deals with foreign vaccine producers ahead of time, but we still wouldn't
have as much control over the vaccine as if they were based in the U.S. If we wanted to avoid these problems in the future, we needed to make some long-term investments in developing countermeasures that were just as safe and effective, but could be produced faster and more reliably."
With H1N1 vaccine supplies flowing into the U.S., there were widespread signs that the initial shortfall has eased considerably. Some 69 million doses of the vaccine have been made available in the U.S., and regions around the country have started to ease restrictions on who gets a shot.
There is also significant evidence that the new flu vaccine is safe. So far, 10 million Europeans have been jabbed with GlaxoSmithKline's Pandemrix, Novartis's Focetria or Baxter's Celvapan, and there have been no serious incidents reported. Adverse reactions have typically been limited to
headache, nausea and fever, which is common for flu vaccines. But new clinical data indicates that infants injected with Pandemrix suffered from a relatively high rate of fever after the second dose. Investigators are staying focused on that trend.
- here's the report from the Washington Post on Sebelius
- check out ABC News' story on the safety
issue
- here's a Fox News report on vaccine supplies
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Novavax reported a pair of key milestones this week in its quest to introduce a new vaccine technology to the world.
Researchers reported that the developer's closely-watched trial of a new swine flu vaccine successfully cleared the first of two phases, with no systemic side effects seen among the 1,000 healthy people recruited for the study in Mexico. And the company launched a mid-stage trial of its seasonal
influenza vaccine among people 60 or older--a target group that gets little protection from currently approved vaccines. Novavax says positive results from a mid-stage trial would set the stage for a Phase III in 2010.
In the swine flu trial, patients received either two doses of 5 micrograms, 15 mcg or 45 mcg of its vaccine or a placebo, with no sign of serious side effects after 14 days. Researchers in Mexico say the trial, which is being conducted with Avimex Labs, will now proceed to the second phase,
with 3,000 people getting a 15 mcg vaccination. Shares of the Rockville, MD-based vaccine developer jumped eight percent on the news.
Novavax has one of the hottest stocks in biotech, with investors keen to cash in on the work it's doing. Instead of using a live virus strain, Novavax produces its vaccine using virus-like particles created in
the lab.
- read the Reuters story on the swine flu trial
- here's the piece from the Washington Business
Journal on the seasonal flu study
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Researchers have now had a chance to track the experiences of a large group of girls in New Mexico who had been injected with the Cervarix HPV vaccine more than six years ago. And they say that the vaccine continues to protect them from cervical cancer with no indication yet that a booster shot
is needed.
Their study in The Lancet reports that all of the girls who had been inoculated were 100 percent protected against strains 16 and 18 of the human papilloma virus, which are the most common types that trigger cervical cancer. Eight percent of the girls who had been vaccinated with
Cervarix reported health problems compared to 10 percent of the group which had been given a placebo. But none of the problems were caused by the vaccine.
"Although further assessment is necessary to confirm long-term effects, in view of the data from our study, we expect protection to continue for many more years," said Dr. Cosette Wheeler of the University of New Mexico. She conducted the study with colleagues from GlaxoSmithKline, which
makes Cervarix.
- read the story in The Lancet
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December 15th at 2 p.m. EST. Dr. Royce Morrison, director of clinical strategy for Charles River Clinical Services,
and Dr. Barbara Tardiff, corporate vice president of data sciences at Parexel, will be joining Tufts' Ken Getz and expert developer Neil Bodick.
