Potency concerns for pandemic flu vaccine stockpiles; HHS planning update; more contracts awarded

For months, we've been discussing some of the many challenges and potential problems associated with the "pre-pandemic" avian flu vaccines currently being developed, tested, and stockpiled. More reason for concern came late last week, when this CIDRAP News story reported that a significant percentage of the stockpile has lost potency, resulting in a one-million-person decrease in the number of people who could potentially be protected by vaccine doses currently on hand (3 million, down from 4 million in an HHS document released in July). Here's an excerpt from the story, quoting an HHS spokesman:

"'All vaccines have shelf lives,' Hall told CIDRAP News. 'The early vaccine that was purchased, the first lots, have begun to lose their potency.'

He said the potency has begun to decrease for 'the majority' of doses in the stockpile, adding, 'That doesn't mean it goes from 100 percent to zero percent' or that the doses would be unusable."

On Friday, a day after the story above appeared, the same HHS spokesman seemed to walk back his earlier comments in this CIDRAP follow-up, explaining that only 20% of the current doses on hand are losing potency, not "a majority," as he previously said. Either way, it should come as a surprise to no one that these vaccines have a limited shelf life, an issue avoided by seasonal flu vaccines on account of their annual reformulations. Even with full potency, the vaccine doses in question are from "clade 1" virus samples from 2004. Since early this year, vaccine development has been based on a 2005 sample, working toward "clade 2" vaccines expected to be a closer fit to a possible pandemic strain.

All of this news came as a result of the release last week of the latest HHS Pandemic Planning Update. Not a lot of news in the 13-page report (and, thus, virtually no news coverage about its release), but it provides a good overview of the current status of U.S. planning and spending.

Finally, HHS announced today that another $200 million in contracts have been awarded to Sanofi Pasteur, Novartis, and GlaxoSmithKline for an additional 5.3 million doses of "clade 2" pre-pandemic vaccines, enough to vaccinate roughly 2.7 million people. (Here's the story from Reuters.) This would double the current stockpile (notwithstanding further decreases in potency of older vaccines), but still represent only a bit more than 1/4 of the goal of having enough vaccine stockpiled for 20 million Americans.

Penn research on HPV and vaccination willingness

We're generally more than a bit reluctant to post things based solely on press releases, but here's a very interesting item coming out of our own university about attitudes regarding HPV vaccination. The press release, "Likelihood of HPV Vaccination Affected by How Information Is Presented, Penn Study Reveals," describes a study presented last week at the American Association for Cancer Research's 5th Annual International Conference on Frontiers in Cancer Prevention Research.

A sample of 635 Americans was randomly assigned to read one of three different paragraphs explaining the purpose of HPV vaccination. Subjects were then asked about their willingness to receive the vaccine. The content of the paragraphs and corresponding results:

"One paragraph addressed how the vaccine protects against cervical cancer, another how the vaccine protects against cervical cancer and sexually transmitted infection and the third how the vaccine protects against cervical cancer, sexually transmitted infection and how it may or may not lead to increased sexual promiscuity among those vaccinated.... When women in the survey read that the vaccine protects only against cervical cancer, 63 percent indicated that they were very likely or somewhat likely to get the vaccine compared to 43 percent of women who read that the vaccine protects against cervical cancer and a sexually transmitted infection."

The survey was conducted by the Center for Excellence in Cancer Communication Research at Penn's Annenberg School for Communication. Without a published paper to consult, it's all but impossible at the moment to assess the strengths and weaknesses of the survey design and the overall value of these findings. (For example, the third paragraph about sexual promiscuity seems very peculiar, as does the absence of data regarding that portion of the survey.)

If confirmed, however, these would be very interesting insights regarding attitudes about sexually transmitted infections among potential recipients of HPV vaccines. We'll update you if and when the study appears in print.

Drive-through flu vaccination program tested in PA

From Saturday's Philadelphia Inquirer, here's a light-hearted story ("Start your engine, roll up your sleeve") about a drive-through flu vaccination program tested at a firehouse in Montgomery County, PA. According to the story, 238 vaccinations were administered in four hours. The county health director describes the test program as a success, pointing to its potential benefit in the event of an outbreak or pandemic. (In addition to being fairly quick, keeping vaccinees in their cars has the added benefit of limiting person-to-person contact at vaccination centers, a potentially serious problem during a pandemic.) The county plans to increase the number of drive-through clinics in 2007.

Merck launches Gardasil ad campaign

Merck today announced the launch of a national advertising campaign for Gardasil. Information on the campaign, dubbed "One Less" (as in 'one less life affected by cervical cancer'), appears in this press release. The TV ads are available for viewing on the Gardasil website.

As the press release notes, this campaign follows earlier (and continuing) HPV education efforts supported by Merck, "Tell Someone" and "Make the Connection". Back in May, we wrote about some of the questions being raised by the company's "Tell Someone" campaign here (our most widely visited post in our 8-month history), particularly the omission of any reference to the then-still-unlicensed Gardasil. (Mentioning the vaccine in an ad before it was licensed would have violated FDA guidelines, but the ads still raised eyebrows among some.)

Regardless, the "One Less" campaign is unabashedly promoting Gardasil, as is entirely appropriate for Merck to do. From all appearances, if this isn't the first major national ad campaign for a vaccine, it will certainly be the largest by far, likely to supplement ads in medical journals (the traditional domain of vaccine advertisements) with those on television and other popular media. Yet another sign that the world of vaccines has entered a new, very different, and very promising phase in its history.

Speaking of Merck, there's a notable story in today's Times of Trenton from Dow Jones Newswires -- "Merck stakes its future on demand for vaccines." In yet another story explaining the growing importance of vaccine sales to pharmaceutical companies, there are some interesting facts about Gardasil's production facilities and plans. For example...

"In a plant that Merck expanded a few years ago while Gardasil was still being tested in clinical trials, three shifts of employees now work around the clock producing the vaccine. So far, at least 750,000 doses have been shipped since Gardasil's June launch, contributing to sales of more than $80 million so far."

Short-lived plan for flu vaccine at Houston polling places dropped

The Houston Chronicle has been on top of the mild controversy in Houston this week surrounding the "Vote and Vax" program that would have administered free flu vaccinations at polling places on election day. Here's the lead from yesterday's Chronicle...

"Voting is good. Flu shots are good. But mix them together in the middle of a hard-fought election season and politics takes over.

Mayor Bill White ordered a halt Wednesday to the city health department's privately funded drive to offer flu vaccinations at early voting sites in predominantly Hispanic and black neighborhoods, amid conservative criticism that the effort would boost Democratic turnout."

Regardless of the motivation for the ill-fated program, the good news, as this story in today's Chronicle reports, is that the 1,600 free vaccine doses have been donated to clinics and churches in low-income areas.

This AP story courtesy of the New York Times explains that the "Vote and Vax" program is part of a $320,000 grant from the Robert Wood Johnson Foundation for similar initiatives in 25 American cities.

HPV: favorable data for male vaccination; VFC action; CDC shift in research focus

A paper published in the November issue of the journal Pediatrics includes new data from Merck on some of their ongoing trials of Gardasil in different populations. It's a highly technical paper with an equally complex title: "Comparison of the Immunogenicity and Reactogenicity of a Prophylactic Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) L1 Virus-Like Particle Vaccine in Male and Female Adolescents and Young Adult Women." (free abstract; subscription required for full-text).

To summarize, the paper reports the results of trials examining whether the vaccine's response in 10-15 year olds mirrors what's been shown in older females (16-23 year-olds). The short answer is that it does generate a comparable ('noninferior,' in scientific jargon) immune response in younger populations. Good news. The most interesting finding from the perspective of potential ethical issues is the comparison of data between 10-15 year old boys versus girls. Boys had a nearly identical response to the vaccine as their female counterparts did as well as a virtually identical safety profile between genders. As the paper's authors (all of whom are employees or consultants of Merck, critics might note, despite that being an obvious result of a Merck trial) note:

"Our findings in boys lend support for implementation of gender-neutral immunization using this vaccine for the purpose of preventing the widespread morbidity and mortality from anogenital cancer, as well as dysplastic cervical and external genital lesions, in the general population."

Speaking of Gardasil, news earlier this week that the vaccine has officially been added to the federal government's Vaccines for Children program, ensuring its availability to uninsured children age 18 or under. Here's a brief story from UPI.

One final related item: a story from Wednesday's Washington Post, "CDC Shifts Vaccine-Data Focus," reports on the decision to refocus intensive data-collection activities on immunization in 22 major cities on teenagers rather than young children. The move is a result of multiple new vaccines recommended for adolescents, including vaccines against HPV, meningococcus, and tetanus/diphtheria/pertussis (Tdap).

Follow-up on Minnesota pandemic vaccine report

Following up on Sunday's post about a Minnesota group's report on pandemic flu allocation strategies, the folks at CIDRAP published a story on the same topic earlier this week featuring some perspectives on it from us, for those who are interested.

Even more bad news for VaxGen anthrax vaccine development

Back in March, we wrote about the Washington Post's reporting on setback for VaxGen in their development of a next generation anthrax vaccine as part of a $1 billion contract through Project Bioshield. (The New York Times chimed in back in October, as we noted then as well.)

Today, this story, also from the Washington Post:

"The Food and Drug Administration has postponed advanced testing of a proposed anthrax vaccine that was supposed to be stockpiled this year because of concerns it could lose its potency too fast to be useful, the company developing the drug announced today.

The announcement by VaxGen Inc. was yet another setback to the U.S. government's $1 billion effort to develop a new anthrax vaccine. It followed predictions on Capitol Hill two-and-a-half years ago that a small company like VaxGen wouldn't be able to meet the government's aggressive schedule for stockpiling 25 million doses of the new vaccine by this month."

As this VaxGen press release explains...

"The FDA's Center for Biologics Evaluation and Research (CBER) said the hold notice was issued because data submitted to date by the company are insufficient to determine that the product is stable enough to resume clinical testing. In the notification, the agency expressed concerns that the vaccine's potency could decline during the immunization phase of the trial, potentially resulting in an uninterpretable outcome."