Good news for GSK bird flu vaccine development

We'd be remiss not to at least mention the headlines generated regarding GSK's avian flu vaccine. In short, they announced that their candidate vaccine provided significant levels of antibody protection in more research subjects at a much lower dose than another vaccine in development (namely, the Sanofi vaccine which we wrote about here back in March.)

Here's a sampling of the coverage: New York Times, Washington Post, Philadelphia Inquirer, and Associated Press.

This may prove to be excellent news for pandemic preparedness efforts, but as many of the quotes in the stories above illustrate, it's wise to be cautious for now while estimating the significance of the announcement. Part of the reason for this is that the GSK data has not yet been published in the medical literature -- we're all relying on press releases (such as this one) and media briefings at the moment.

More generally, there are a number of issues arising from any 'pre-pandemic' vaccine (i.e., one developed before the virus mutates into a form that spreads easily from human-to-human.). We've written about many of these in the past in response to prior developments, but the editors at Effect Measure explain in this post a number of the unanswered questions specifically relating to the GSK announcement. They consistently do an excellent job covering all aspects of avian flu (not just vaccines) and public health in general, and this post is no exception.

Los Angeles school district planning to offer Gardasil to students

A very interesting story in Monday's Los Angeles Times -- "Schools to Offer STD Vaccine" -- explains that the Los Angeles Unified School District will make Gardasil available to students in its schools in as little as six months, administering vaccines provided by the federal Vaccines for Children program. Here are three noteworthy excerpts from the story:

"Karen Maiorca, who retired two weeks ago as L.A. Unified's director of nursing services, said the vaccine would be offered each year at dozens of clinics that the district operates. The district's 600 school nurses will be responsible for spreading the word. And though the Vaccines for Children program is designed for uninsured and underinsured children, she said, no student will be turned away."

While turning no student away is an admirable policy, it would seem that such a practice would run afoul of the eligibility requirements of the VFC program. Likewise, Gardasil's manufacturer, Merck, must not be thrilled to learn that students with adequate insurance to cover the cost of vaccine could receive doses sold to the government at significantly reduced rates as part of the VFC program.

"[Peter] Kerndt, [director of the county health department's sexually transmitted disease program], said he will soon recommend to county supervisors that all female adolescents in Los Angeles County receive the vaccine unless their parents opt out."

Only a recommendation at this point, Kerndt's 'opt out' comment seems to suggest creating a presumed consent policy for HPV vaccination, rather than requiring active parental consent to vaccinate. Again, this would presumably be an effective strategy to deliver the vaccine to as many girls as possible, but it would seem that the county would likely face legal opposition to such a policy, the resolution of which is unclear.

"County and L.A. Unified officials said they have not received opposition to the idea of providing the vaccine to students. But they have not yet publicized its availability and a number of groups said they were not aware of the school district's plans.

'Wow, that really is different,' said Linda Klepacki, a spokeswoman for Focus on the Family in Colorado Springs, Colo., who originally believed that the vaccine would be available only through private physicians and government welfare agencies."

The use of schools as a vaccine distribution mechanism is not particularly common in the U.S. today, but in a recent paper in Lancet Infectious Diseases (which we wrote about here), school vaccination programs were suggested as a way to increase Gardasil's uptake among African-American populations disproportionately impacted by HPV infection and cervical cancer mortality.

Gates gives $287 million for HIV vaccine research

News about the Gates Foundation making an enormous contribution to global health has become nearly a weekly occurrence lately. Today's headline is the announcement of 16 grants totaling $287 million to continue work toward a possible HIV vaccine. Here's the New York Times story, the AP story, and the press release from Gates with an accompanying background document offering details on the recipients and their projects.

The amount of funding is impressive in isolation but is even more staggering when compared to the total dollars directed to HIV vaccine work in years past. In 2004, for example, U.S. research totaled $582 million, with an additional $120 million worldwide. Yesterday's announcement marks a significant investment in the work and another strong show of support for it from Gates.

The Gates Foundation has been an active supporter of HIV vaccine research for several years, playing central roles in the creation and launch of the Global HIV Vaccine Enterprise (which we previously wrote about here). In fact, it's often difficult to determine where the Gates Foundation ends and the Enterprise begins, and vice versa. The grants announced yesterday fund projects linked to the Scientific Strategic Plan of the Global Vaccine Enterprise, awarded to very prominent vaccine researchers including Barton Haynes of Duke and David Ho of Rockefeller University, among others.

Novartis to build first U.S. cell-culture flu vaccine plant

Using $220 million awarded in May by HHS as part of the government's pandemic flu plan, Novartis announced plans yesterday to build the first U.S. manufacturing plant for cell-culture derived flu vaccines. The plant, to be built in Holly Springs, NC, has a total bill of $600 million, according to this Novartis press release. Here is a news report on the announcement from Reuters and a lengthier story from the U. of Minnesota's CIDRAP.

Once complete, the plant will be able to produce 50 million doses of seasonal flu vaccine annually and as many as 150 million doses of a possible pandemic flu vaccine. It marks another step away from reliance on an egg-based flu vaccine production method, with its many shortcomings. We'll still be using eggs for many years to come, however. Novartis estimates the plant won't be fully functional until 2012.

Two cautionary views on Gardasil

With essentially the same points being made repeatedly in editorial and op-ed pages across the country, we suspect that we'll be linking to far fewer opinion pieces regarding Gardasil in the weeks ahead. (Exceptions will certainly be made for essays such as Alice Dreger's that offer a unique perspective.)

Since nearly every commentary we've seen has offered unabashed praise for HPV vaccines, it seems fair to call attention to two commentaries published in the last few days offering a slightly more cautionary take while still supporting the vaccine generally (it would be hard not to).

The first was written by Peter Sprigg of the Family Research Council and published in Saturday's Washington Post. Titled, "Pro-family, pro-vaccine--but keep it voluntary," the op-ed begins by citing the positive reception the vaccine has received from the FRC and other conservative organizations. However, Sprigg then outlines two concerns: the first notes the importance of accurate communication about what level of protection the vaccine does and does not provide. His point that claims of Gardasil's "100 percent effectiveness," while accurate in their intended context, can create confusion when used less precisely is on target. (Data suggest the vaccine is 100% effective against the 70% of cervical cancer-causing HPV strains it targets.) Sprigg's second concern touches about the FRC's oft-stated opposition to mandating HPV vaccination as a condition of school entry, a decision the group (and others) believe should be left to families.

A second essay with a very similar thesis appeared in today's New York Times, titled "A new vaccine for girls, but should it be compulsory?" by Roni Rabin. Rabin advocates continued vigilance regarding pap smears (as nearly everyone does), but questions the ACIP universal recommendation for HPV vaccination due to the continued decrease in cervical cancer incidence in the past 50 years. In her essay, she suggests the funds that will pay for the vaccine could be better spent on 'preventive health care' (a category that, for Rabin, apparently doesn't include vaccination). She also wonders aloud about as-yet-unknown potential safety concerns and the limited size of the clinical trial cohort of younger girls.

Newark Star-Ledger chronicles HIV vaccine efforts

It's been several months since we pointed to a story updating the quest for an HIV vaccine. This lengthy feature in today's Newark Star-Ledger is worth reading. Titled "AIDS at 25: For scientists in search of a vaccine, the elusive and ever-deadly HIV virus is a mystery that may never be solved," the story opens with a similar pessimism:

"After 25 years and countless billions of research dollars, some of the nation's top scientists say a vaccine that provides absolute immunity against the virus that causes AIDS -- the best hope of curbing the worst epidemic of our time -- may never happen.

Despite breakthroughs in treatments for people already infected with HIV, researchers have hit one obstacle after another in efforts to develop a vaccine, long considered the holy grail of AIDS research. The science, they say, is just too hard."

The story includes extensive quotes from several prominent HIV vaccine researchers, particularly Ron Desrosiers (Harvard and elsewhere) and Emilio Emini (currently at Wyeth, previously at IAVI and Merck). There's a surprising level of scientific detail for a newspaper piece, outlining many of the obstacles impeding the development of a safe and effective vaccine.

A first-person perspective on the potential impact of HPV vaccination

We've linked to a number of newspaper editorials on HPV vaccines over the past few months, nearly all in support of their broad availability. While those pieces were almost exclusively written in the traditional editorial page third person, this excellent op-ed in the Chicago Tribune earlier this month offers a powerful first-person look at the potential benefits of HPV vaccination.

Written by Alice Dreger, an Associate Professor of Medical Humanities and Bioethics at Northwestern University, the essay is titled "A shot that could save thousands of lives in the U.S." Despite the generic headline handed down by editors at the Tribune, Dreger's piece recounts her own experiences being infected with HPV strains known to cause cervical cancer and the impact of this on herself and her relationships, particularly with her husband. From this perspective, she offers a unique take on the ongoing discussions regarding which groups to vaccinate and potential opposition to its use in teenage girls.

Published earlier this month, the essay led to several letters to the editor that were printed Saturday, applauding Dreger for sharing her story and offering similar first-person experiences of HPV infection and its consequences.

How to make global bird flu vaccination efforts feasible

That's the focus of a paper in the current issue of the ominously-named journal Biosecurity and Bioterrorism. It's titled "Removing barriers to global pandemic influenza vaccination" (available free) and authored by Gigi Kwik Gronvall and Luciana Borio of the University of Pittsburgh. The paper begins this way:

"In an influenza pandemic, most of the world will not get vaccine. Vaccination would be the best way to prevent infection and save lives, but there simply won’t be enough. The United States, France, Australia, Canada, Japan, and other wealthy countries have contracted with manufacturers to produce pandemic vaccine for their citizens, but their demand will quickly exceed the global production capacity. The manufacturing capacity for seasonal influenza vaccine is only about 300 million doses per year globally, and the capacity for pandemic influenza vaccine will be even less."

How can this situation be improved? The authors focus on harmonizing the varying regulatory structures and requirements employed by the U.S., E.U., and Japan, among other suggestions.

Follow-up on ACIP Gardasil recommendation

Following up on last Thursday's post on the ACIP recommendation of Gardasil, here's a sampling of reaction in newspapers around the country:

• Both the Detroit Free Press and Press of Atlantic City ran 'local reaction' stories about the ACIP recommendation, surveying views from parents and physicians in their communities. Though some reservations are expressed -- both those unique to HPV as well as those common across all vaccines (i.e., safety) -- the vast majority of opinions in the story are positive.

• Two editorials specifically address the ACIP recommendation -- "A cancer vaccine triumph" (Chicago Tribune) and "Cancer prevention: Protect our girls" (Seattle Post-Intelligencer). Both pieces praise the recommendation (as the headlines would suggest), while postponing discussion of possible state mandates. The Tribune editorial ends this way:

  "But please, let's remember, this is a cancer vaccine. It's not a surrogate for the abstinence debate. Everyone is best served if this public discussion is about the safety, efficacy and cost-effectiveness of the new vaccine--and that's all."

Finally, the CDC website on HPV has been updated to reflect the Gardasil licensure and ACIP recommendation.

"Science Times" on nicotine vaccine in development

Yesterday's "Science Times" section of the New York Times featured a noteworthy story on research underway to develop what's being dubbed a 'vaccine against smoking.' The story, "Scientists testing vaccines to help smokers quit," looks at a nicotine vaccine (NicVAX) being developed by Nabi Biopharmaceuticals. It's the latest example of how the definition of 'vaccine' is being expanded to include a host of new directions and new targets for preventive medical interventions.

The Times story and the information available on Nabi's website (including this FAQ) explain how the vaccine is thought to work. Here's the one-paragraph summary: The vaccine will produce antibodies specific to nicotine molecules -- nicotine being the primary contributor to the pleasurable and addictive nature of smoking. In order to have these effects, nicotine must reach the brain. It is thought that the antibodies generated by the vaccine will bind to nicotine molecules inhaled by smokers. This antibody/nicotine complex will be too large to enter the brain, so that nicotine would be unable to have its usual effects. As a result, those attempting to quit smoking would be able to do so more easily, as they'd lack the typical response from smoking that makes it difficult to quit.

As with most stories previewing 'the next big thing', the availability of NicVAX is years away, and much research is needed between now and then. But it's an intriguing product and an interesting strategy, one sure to be applied to the gamut of other addictive substances if successful.