Smallpox: Vaccinia exposures linked to vaccinees; new vaccine updates

Somewhat unexpectedly, May has been a very busy month for news about smallpox and the vaccinia vaccine used against it. Here are the headlines:

• MMWR reported a vaccinia infection in the genital region of a woman reporting sexual contact with a U.S. military member who had received been vaccinated against smallpox. Here's the MMWR report, a related story from CIDRAP News, and the Reuters item. The woman's case was minor and resolved with minimal treatment.

• A similar story, albeit a much more severe event, was reported last week, also via MMWR and picked up by CIDRAP News and Reuters. A two-year old child developed a severe case of eczema vaccinatum from his father, a soldier vaccinated against smallpox prior to service in Iraq. After a 48-day hospitalization, the child is expected to suffer no long-term effects from his illness. It is the first case of the rare, potentially fatal condition in the U.S. since 1998.

• A new smallpox vaccine developed by Acambis received a positive vote from a key FDA advisory committee, all but assuring licensure in the near future. Here's the story from Forbes and the Chicago Tribune. The Tribune story acknowledges the very serious side-effects associated with this new vaccine, likely limiting its use to emergency scenarios only.

• The website of Congressional Quarterly reports that HHS is nearing a contract a Danish company called Bavarian Nordic for 20 million doses of a new smallpox vaccine. The vaccine is hoped to have a more favorable side-effect profile than the current vaccine or the Acambis product noted above.
  

• Finally, this MSNBC story notes that the WHO delayed a decision on the fate of the (known) stockpiles of smallpox -- the actual virus, not the vaccine -- held by the U.S. and Russia. The story reports that both countries are reluctant to destroy their stockpiles, citing their potential value if the virus is found elsewhere. Unclear from the story is the WHO or U.N. authority to enforce their decisions, whenever they may be made.
  

Legal fears block vaccine research for pregnant women, newborns

That's the topic of this story in Friday's Baltimore Sun -- "Pregnant Pause." It examines the potential for a vaccine against Group B Streptococcus -- which affects thousands of newborns annually -- and the (seemingly justifiable) reluctance of the pharmaceutical industry to pursue a vaccine against it.

Why? Among other reasons, the story points to the regulatory difficulties of testing new product in pregnant women and newborns and the extreme legal vulnerability the companies would face if allegations of safety concerns come to light (real or alleged) even after a potential vaccine was licensed.

The story goes on to outline how legal worries influence physician attitudes regarding pertussis and influenza vaccination for pregnant women, contrary to the recommendations of the scientific and medical communities. It's a very interesting story for those thinking about how science, law, and policy interact.

Update on HIV Vaccine Research Strategies

Despite the many challenges facing the development of a safe and effective HIV vaccine (many of which we've discussed previously), we continue to be interested observers in the status of HIV vaccine research, cognizant of the incredible benefits a vaccine would bring.

The latest New England Journal of Medicine includes a review article by NIAID Director Dr. Anthony Fauci and researcher Dr. Margaret Johnston titled "An HIV Vaccine -- Evolving Concepts."

It's a science-laden paper, but its conclusion reflects the increasingly modest hopes for a potential first-generation HIV vaccine. Johnston and Fauci describe a different type of vaccine, one that would alter the common understanding of the protection vaccines provide and create additional implementation concerns along with the potential for tremendous benefits...

" A vaccine that conforms to the classic paradigm of viral vaccines remains the goal of efforts to develop an HIV vaccine. Such a vaccine would induce immune responses that prevented the establishment of HIV infection by clearing virus before latent viral reservoirs were produced. This goal may not be realized with first-generation vaccines. The development of an HIV vaccine may diverge from the classic paradigm for viral vaccines. There is optimism that even a less-than-perfect vaccine could benefit both individual recipients and the at-risk community. By blunting the initial burst of viremia and reducing virus levels, such a vaccine could prolong the disease-free period and also reduce transmission. If licensed, such a vaccine will have to be delivered as part of a comprehensive, multifaceted, prevention program."

More Benefits of Gardasil?

With GSK's HPV vaccine -- Cervarix -- about to enter the final stages of FDA review prior to its all but certain licensure in the coming months, the marketing battle between GSK and Merck is about to begin in earnest.

One precursor of what's to come has been the occasional announcements and published papers noting protection against additional HPV strains beyond those specifically included in the vaccine. We've linked to many of those items previously.

Another sign is this headline: "Gardasil Guards Against Vaginal, Vulval Cancers: Researchers found cervical cancer vaccine reduced risk of lesions by 49%". The story is based on a paper in the latest issue of The Lancet by Joura and colleagues (abstract available here with free registration).

February ACIP Minutes Available

The minutes of the February meeting of the CDC's Advisory Committee on Immunization Practices are now available here. The 96-page report includes discussions of the report this spring of a possible link between RotaTeq and intussusception, an overview of the thimerosal/safety debate, an update on pandemic flu vaccine development, and presentations from Merck and GSK on their HPV vaccines.

As always, very interesting reading for those seeking unfiltered coverage (comparatively speaking) of the latest in federal vaccine policy.

Supply shortage expected for ProQuad vaccine

Following up on this post from March regarding possible shortages of varicella-containing vaccines, this announcement in MMWR last week alerted readers that Merck's ProQuad (a measles, mumps, rubella, and varicella combination vaccine) would be unavailable beginning in July through at least the end of 2007.

With varicella vaccine limited in supply, Merck is prioritizing production of its stand-alone chickenpox vaccine for children and its new shingles vaccine for adults -- both of which are varicella vaccines -- ahead of ProQuad. With its MMR vaccine still available, no children should go unprotected as a result of this temporary shortage, but an additional injection will be needed to provide full protection against the four infections, as this AP story on the announcement explains.

While this news is more of an inconvenience than a serious concern for physicians or patients, it does illustrate the vulnerability of a system in which a vaccine is produced by a single manufacturer, as is the case for many in the United States.

HPV Roundup -- CQ Report, Texas Aftermath, N.H. Success, and More

Another look at recent news and perspectives on Gardasil and HPV vaccine policy appearing in print or online...

• The latest issue of CQ Researcher -- the issue-focused publication affiliated with Congressional Quarterly -- looks exclusively at HPV vaccines and the debate over mandates. The 24-page report is well researched, extensively cited, and offers an incredible range of information as to the scientific, political, public health, and economic considerations in play. It might be the single best source for non-scientists looking to understand 'what all the fuss is about.' Sadly, access requires a subscription to www.cqresearcher.com, but it's likely that readers with university affiliations can access it through their libraries.

• This story in the New Scientist -- US Conservatives Block Cancer Vaccine for Girls -- updates the US state mandate landscape, particularly this month's Texas law effectively overriding Gov. Rick Perry's executive order in February. (More on the Texas legislation can be found here and here. Also, here is the text of Gov. Perry's remarks upon the bill's passage with veto-proof majorities.)

• A major contrast to the Texas saga is what's been happening with Gardasil in New Hampshire, as described in this story from the New York Times: "In New Hampshire, Soft Sell Eases Vaccine Fears." Instead of mandates, the state's practice of voluntary, free vaccination has led to a surge in demand for Gardasil, the story explains.

• We're just about exhausted with op-eds on HPV mandates. At this point, all one hears are the same arguments (for or against) over and over. Here's one that does attempt to say something new, courtesy of The Hastings Center's "Bioethics Forum": In "Choosing Paternalism?", Karen Maschke explores lessons from the U.S. Gardasil experience thus far that might be useful when considering the vaccine's implementation in the developing world.

• Earlier this month, this story in the Washington Post -- "Who Gets Stuck? Doctors, Patients Want Insurers to Pay More for Vaccines" -- looks at some of the reimbursement issues being raised by physicians, particularly the (small) amounts provided for vaccine-related costs beyond the price of the dose itself.

HPV mandates and more in JAMA and NEJM

There is a lot of discussion on HPV vaccination and mandates in recent issues of the New England Journal of Medicine and the Journal of the American Medical Association.

In the May 2 JAMA, Lawrence Gostin -- a professor of health law at Georgetown -- and Catherine DeAngelis -- the editor of JAMA -- wrote an editorial titled "Mandatory HPV Vaccination: Public Health vs Private Wealth." Gostin and DeAngelis reject mandates for HPV at this time, referring to any use of state mandates as "a last resort." Specifically, they point to questions regarding cost/payment, long-term safety, injury compensation, and the fact that HPV is not "a highly infectious airborne disease" to support their argument against mandates.

The latest NEJM includes seven pieces on HPV vaccines, including two commentaries, two reports, two editorials, and a letter. All are available for free here. Of note is the commentary by Alta Charo -- professor of law and bioethics at the University of Wisconsin -- titled "Politics, Parents, and Prophylaxis -- Mandating HPV Vaccination in the United States." Charo argues in favor of state mandates, pointing to the easy-to-secure exemptions available in every state in which a mandate has been explored. With essentially any parent objecting the vaccine having the ability to receive such an exemption, the overall merits of a state mandate greatly outweigh the slight inconvenience the exemption process imposes on parents seeking it, she suggests.

Also of interest is "Introducting HPV Vaccine in Developing Countries -- Key Challenges and Issues" by Agosti and Goldie. The authors point to availability, access, and cost concerns related to the international implementation of HPV vaccination programs.