Tag Archives: vaccine

Can HPV Vaccination Be Simplified?

The human papillomavirus vaccine was recommended for routine use in 11-12 year old girls in 2007. But by 2010, the most recent year for which data are available, less than half had received one dose of the three-dose series and fewer than a third had received all three. The inconvenience of the need for three separate office visits along with the vaccine’s price – about $130 per Gardasil dose, as of July 2011 – have certainly contributed to the low uptake.

©BVDC/Fotolia.com

Now, some parts of the world – including Mexico, Switzerland, and parts of Canada have moved to either a two-dose schedule, or a so-called “extended dose” schedule, in which the third dose is delayed until 5 years after the second one. (In the current U.S. three-dose schedule, doses two and three are given at 2 and 6 months, respectively, after dose one.)

“There has been emerging interest in HPV vaccine schedules with fewer than three doses, for a variety of reasons. These schedules could facilitate implementation, they may be more convenient for providers, parents, and vaccinees, and of course they would be cost-saving,” said Dr. Lauri Markowitz, of the Centers for Disease Control and Prevention, at a recent meeting of the CDC’s Advisory Committee on Immunization Practices.

No data on the efficacy of fewer than three doses have been published by either Merck or GlaxoSmithKline from their pivotal trials of Gardasil and Cervarix, respectively. But some other data are available for both vaccines. A nonrandomized study in Costa Rica that included more than 1,100 women who had received just one or two doses of Cervarix suggested that two doses or maybe even just one – could be as protective as three doses against infection at 4 years.

And in an as-yet unpublished study done in Canada, immune responses against both HPV 16 and 18 at 3 years were similar between two doses of Gardasil given at age 9-13 years and three doses given at age 16-26 years. But, there are limited efficacy data and no long-term data, Dr. Markowitz said.

Electron micrograph of human papillomavirus (HPV) / Courtesy of the National Cancer Institute

In an e-mail, Deb Wambold of Merck Vaccines said that, while the company does support studies of alternative dosing schedules for HPV vaccination including two-dose regimens, so far those studies are “interesting preliminary explorations in select subpopulations of vaccinees,” and “It is important to note that there are no data on the clinical efficacy or durability of effectiveness with two doses of either of the HPV vaccines, as we have for the recommended three-dose vaccination regimen.”

Dr. Joseph A. Bocchini Jr., who chairs the ACIP HPV vaccine working group, concurred. In an interview at the ACIP meeting, he noted that the long-term efficacy of two doses is “worth looking at,” as is the varying of three-dose schedules. “But, at this point, there are too few data to apply this to recommendations in the United States.”

More data from ongoing trials will be available in the next few years, Dr. Markowitz said.

-Miriam E. Tucker (@MiriamETucker on Twitter)

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Quickening Pandemic Flu Vaccine Production

If a strain of avian H5N1 influenza that readily spread from person to person were to appear in the real world, the great fear is that it would produce a deadly pandemic to dwarf what happened in 1918.

The best defense against flu pandemics are vaccines, and the most recent experience with a global flu pandemic, in 2009, highlighted the gaps that existed in getting vaccine quickly made in large amounts. Three years ago, despite the U.S. government marshaling all its infectious disease-fighting muscle, the effort wound up delivering most of the vaccine too late to matter. The pandemic peaked in October 2009, while the vaccine supply didn’t hit its stride until sometime in December.

Novartis influenza-vaccine plant in Holly Springs, N.C./courtesy Novartis

In a report published today in Science as part of its H5N1 flu package, Dr. Rino Rappuoli, head of vaccines research for Novartis, spelled out seven steps that could hasten vaccine production for a newly appearing pandemic flu. The two most novel moves involve having vaccine manufacturers prepare in advance synthetic “vaccine seed” viruses and also adopting new ways to quantify viral antigens, a process that alone took about 2 months in 2009, he said. Adopting these two technological innovations could transform the vaccine-producing process “from a mid-20th century system … into a 21st century system of instantaneous electronic information exchange followed by immediate production.”

The modernized system would mean sequencing a newly isolated pandemic virus in the field and then — instead of shipping the virus — just sending gene sequences, followed by replicating the hemagglutinin gene at a remote site, putting the new gene into a waiting scaffold vaccine virus, and launching vaccine production.

If these two changes had been in place in 2009, “the vaccine would have been available in large quantities before the peak of viral infection,” Dr. Rappuoli said in his paper.

More importantly, speaking at a June 20 press conference Dr. Anthony Fauci said that the National Institutes of Health, as well as the Centers for Disease Control and Prevention and the Food and Drug Administration, had already begun to move on this, adopting “the fundamental principles of bringing influenza vaccinology into the 21st century.” Steps already taken along the lines of what Dr. Rappuoli suggested carry the potential for “a significant change right now” in the time needed to get out a pandemic vaccine, Dr. Fauci said.

He particularly cited NIH studies underway using an immunoadjuvant to expand the coverage potential of stockpiled H5N1 vaccine, a step that would “markedly accelerate availability.

“We are right now in a much better position [to distribute pandemic vaccine quickly] than we were in 2009 when we had vaccine available only after the peak of the H1N1 pandemic,” Dr. Fauci said.

—Mitchel Zoler (on Twitter @mitchelzoler)

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Have You Had Your Pertussis Vaccine?

As the North Pacific Pediatric Society’s annual meeting got underway recently, organizers invited Dr. Maxine Hayes of the Washington State Department of Health to the podium to deliver a special – and urgent – message.

Dr. Maxine Hayes (Sherry Boschert/IMNG Medical Media)

Her plea to pediatricians: Make sure that you, all of your staff, and your patients have been immunized against pertussis. Not only was the Society meeting during National Infant Immunization Week, but Washington State had just recorded its 1,000th case of pertussis in 2012, with 61% of cases in school-age children, she reported.

“It’s the worst we’ve seen in six decades,” Dr. Hayes said. “If infections continue at this rate, we’ll have more than 3,000 cases by the end of the year.”

Washington State had 1,008 reported cases of pertussis by April 21, 2012 – nearly 10 times more than the 110 cases reported during the same period in 2011, according to the U.S. Centers for Disease Control and Prevention. There are more pertussis cases in the state already for 2012 than there were in all of 2011 (965 cases) or all of 2010 (608 cases).

The Washington epidemic follows on the heals of a 2010 outbreak of 9,143 cases in California – the most in 63 years – that killed at least 10 infants.

My colleagues at IMNG Medical Media have been following the story, with multiple reports. The California epidemic probably was due to the waning immunity of the tetanus-diphtheria-acellular pertussis (Tdap) vaccine. Tdap vaccine is recommended for all health care workers.

And it’s not just for kids, health care workers, and medical office staff. If you’re a physician who treats adults, you should know that older adults need the Tdap vaccine too. Even pregnant women should be vaccinated.

When Dr. Michael E. Pichichero randomly asked 10 pediatricians if they’d had the Tdap vaccine, 8 of them said no, with some pretty weak excuses, if you ask me.

“I know that there are people in this room who have not had their Tdaps,” Dr. Hayes said with an accusing smile. “I also know that in busy practices, you have people in and out every day that have not had their Tdap. I’m calling on you to really get on it.” Make sure that your emergency rooms have Tdap in stock, too, she added.

“And if you’re not in Washington, don’t be smug about this, because you could be next,” Dr. Hayes said. Her public health colleagues in Oregon State are taking this so seriously that they’re planning to open pertussis booster clinics, she noted.

–Sherry Boschert (@sherryboschert on Twitter)

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Approved or not Approved? That is a Good Question.

In a move last month that apparently took at least two device manufacturers completely by surprise, one center of the Food and Drug Administration recommended against an intended use of their products, despite the products’ approval and licensure by another FDA center.

PharmaJet's Stratis is used to vaccinate a Cambodian child against measles. Photo courtesy of Heather Potters.

Recent jet injector models, including Bioject’s ZetaJet and Biojector 2000 and PharmaJet’s Stratis, were approved and licensed by the FDA’s Center for Devices and Radiological Health (CDRH) as needle-free alternatives for injecting vaccines and injectable medications. Both companies had been marketing their devices for influenza immunization in the current flu season.

On October 26th, the FDA’s Center for Biologics Evaluation and Research (CBER) issued a notice  advising healthcare professionals that inactivated influenza vaccines should be administered only with a sterile needle and syringe. The reason: “Safety and effectiveness information that would support labeling inactivated influenza vaccines for delivery by jet injector have not been submitted to FDA.” However, CBER said, individuals who have already received a flu vaccine with a jet injector do not need to be revaccinated.

Currently, only the measles-mumps-rubella vaccine is approved and specifically labeled for administration by jet injector.

So what’s the concern with influenza vaccine? “A jet injector subjects the vaccine to a different pressure than it would receive during administration by sterile needle and syringe and as a result the effectiveness and the safety profile of the injected vaccine may be altered,” according to the CBER document.

Evidently this information had not been previously communicated to the manufacturers. “We were provided no notice by FDA of any concerns about Jet Injectors or FDA’s statement. To our knowledge, no other needle-free injection manufacturer received notice or an opportunity to discuss this matter with FDA,” PharmaJet said in a statement.

Bioject’s President and CEO Ralph Makar was similarly taken aback by the FDA notice. “The FDA communication on the use of jet injectors with influenza vaccines was surprising given that Bioject’s Needle-Free Injection Devices…are both FDA 510(k) cleared with indications for use that describe their use in delivery of subcutaneous or intramuscular injections of vaccines and other injectable drugs,” he said in a statement.

In a public comment at the October meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, PharmaJet Inc’s chairman Heather Potters said, “Last year we scaled up to provide several hundred thousand syringes, and this season we were expecting to sell several million. Now, our domestic sales have virtually stopped, except for [investigational trials].”

The companies are expected to meet with the FDA in early January to work this out. According to Mr. Makar, “We are looking into the matter to better understand the situation and the FDA’s concerns. A number of Bioject’s Needle-Free Injection devices have been on the market for many years and we are committed to resolving this matter with the FDA in a timely manner.”

-Miriam E. Tucker (@MiriamETucker on Twitter)

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Fear Factor: Sending the Right Messages on Vaccine Safety

Parents don’t need another reason to worry about vaccinating their children. That was the general view during a discussion of febrile seizures at the June meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

 

ACIP’s general recommendations working group has a subgroup dedicated to febrile seizures. One job of this subgroup is to review data on what is known about the incidence of febrile seizures associated with various childhood vaccines alone or in combination. The bottom line: the working group decided to recommend that ACIP NOT make a recommendation about vaccination and febrile seizures.

courtesy of flickr user hartland martin (creative commons)

Several presentations included data showing that febrile seizures are neither unusual nor significantly associated with vaccinations. Dr. Andrew Kroger of the CDC acknowledged that data are limited, especially data on the risk/benefit ratios of simultaneous vaccinations and febrile seizures.

“How much risk of influenza and invasive pneumococcal disease are we willing to take with delayed vaccination, in order to prevent the occurrence of febrile seizures?” Dr. Kroger asked.

Ultimately, the working group decided that, for now at least, the issue was “best addressed through messaging,” rather than voting. A majority of the working group recommended that providers should simply inform parents of the increased risk of febrile seizures with concomitant vaccinations but not recommend any delay of vaccination because of it.

This option seemed to go over well during the discussion period.   

“The worst thing we could do is send a message that delaying vaccinations is preferable to preventing febrile seizures,” Dr. Michael Brady, representing the American Academy of Pediatrics, said during the discussion period. 

courtesy of flickr user Jimee, Jackie, Tom & Asha (creative commons)

Dr. Doug Campos-Outcalt, representing the American Academy of Family Physicians, agreed. “It’s important to consider febrile seizure numbers in the context of the disease,” he said.

ACIP member Dr. Janet Englund noted that “for ACIP to mandate discussion of febrile seizures during a visit would be harmful to the [vaccination] process.”

In fact, some data suggest that vaccination has a protective effect on febrile seizures, and such data could be useful when collected over the long term, said Dr. Jeff Duchin, chair of the general recommendations working group.

Hmm. Something else to encourage childhood vaccination. That sounds like a good message.

–Heidi Splete (on twitter @hsplete)

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Oh Boy, Another Vaccine Conundrum

Should the human papillomavirus (HPV) vaccine Gardasil be recommended for routine use in boys aged 11-12 years, as it is now for girls? Or should the vaccine’s use in boys remain an option but not a routine recommendation? Alternatively, should it be routinely recommended for males who have sex with other males, a group that is at increased risk for anal infection and cancer due to HPV?

Policy decisions regarding vaccine use are often complex and nuanced, even for vaccines that aren’t already as controversial as Gardasil. The issue of vaccinating males is causing headaches for the panel tasked with making the decision, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention.

Pat Ramsey photo via Flickr Creative Commons

Of the two HPV vaccines on the U.S. market, only Gardasil is licensed for use in males. It contains four strains of HPV, two (16 and 18) that are associated with cervical and other types of anogenital and oral cancers, and two (6 and 11) that are associated with genital warts. In December 2010, the Food and Drug Administration added the indication of prevention of anal cancer due to HPV vaccine strains in both males and females.

In 2009, ACIP said that Gardasil could be given to males aged 9 through 26 years, but didn’t make a routine recommendation. Some are now in favor of doing so, arguing that the vaccine protects males against both genital warts and anal cancer, it reduces HPV transmission to females by preventing infection in their male sex partners, and it’s simply more equitable and convenient for physicians to offer the vaccine to both male and female patients.

The main argument against the move is the vaccine’s cost, approximately $360 for the full three-dose series. A CDC-commissioned cost-effectiveness analysis posed a conundrum: Use of Gardasil in males is more cost-effective the less it is used in females, and vice versa. At current female coverage levels – just 27% for all three doses among 13- to 17-year-olds in 2009 ¬ use of the vaccine in males makes the cost-effectiveness cut-off in some models, depending on assumptions. But of course, public health officials are hoping that coverage among females will increase.

Restricting Gardasil’s use to males who have sex with males would dramatically increase the vaccine’s cost-effectiveness, as anal cancer in that group is actually more common than is cervical cancer among all women. While the vaccine’s use could certainly be promoted among older male teens and young adults who are already “out,” screening for sexual orientation among 11- to 12-year-old boys is unlikely to be a viable option.

A vote on this is likely to come later this year, but it won’t be an easy one, ACIP working group chair Dr. Janet A. Englund told me at the panel’s meeting last week in Atlanta. “The concern about cost and cost-effectiveness is a very important consideration for the committee.”

-Miriam E. Tucker (@MiriamETucker on Twitter)

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A Pox on Both Your Houses: Should the United States Destroy Its Stockpile of Smallpox Virus?

 The situation: A potential standoff between Russia and the U.S., both of whom have stashed smallpox virus to develop emergency countermeasures in the event of biological warfare.

courtesy of flickr user hukuzatuna

In advance of the World Health Assembly this May, a commentary in a journal called Biosecurity and Bioterrorism (published online ahead of print on January 10, 2011) calls on the United States to get rid of most or all of its stock of smallpox virus.

The author, Jonathan B. Tucker, Ph.D., is a “professor of science and technology for peace and security” at Darmstadt University of Technology in Germany. That’s a title you don’t hear very often.

But Dr. Tucker writes that many public health experts and scientists, especially those in developing countries, would like to destroy any virus stashes, citing the overexaggerated risk of biological warfare and the existence of antiviral drugs that are in development but could be used in a public health emergency under an Emergency Use Authorization (EUA).

Failing an agreement between the U.S. and Russia to clean house and get rid of their smallpox viruses, Dr. Tucker offers some suggestions for compromise, including an agreement by the U.S. and Russia to share their smallpox research with World Health Organization (WHO) member countries and develop a stash of antiviral drugs to be controlled by the WHO for distribution to victims of a smallpox outbreak anywhere in the world. Both countries would then increase their contribution of smallpox vaccines to this WHO reserve.

What do you think? Should we keep some smallpox virus in reserve, or get rid of it?

–Heidi Splete (on twitter @hsplete)

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H1N1 Flu Virus Goes “Post-Pandemic”

The pandemic caused by the 2009 H1N1 influenza virus is now post-pandemic, according to a statement issued today by WHO Director-General Dr. Margaret Chan.

We should consider ourselves lucky that the 2009 H1N1 virus remained relatively mild, despite its hostile takeover of other circulating flu viruses last fall. Now, according to data from the WHO, many countries where seasonal flu is occuring are reporting a mix of viruses. So, it sounds like the 2009 H1N1 is settling down to play happily in the mix with other circulating flu viruses, learning how to take turns with the likes of H1N3 and influenza B, which join 2009 H1N1 in the 2010-2011 seasonal flu vaccine. But hold on to your hand sanitizer—“Pandemics, like the viruses that cause them, are unpredictable,” Dr. Chan said in her statement. And she’s right: Think back to every horror movie you have ever seen, or any book where it seems like the villain must be dead.

courtesy of flickr user sdecoret (creative commons)

“No one could have survived that fall/ explosion /fire/gunshot wound/ decapitation/banishment to a parallel universe.”

Not until it’s time for the sequel.

The 2009 H1N1 pandemic was, in many ways, a trial run for how the government and the medical community can work together to provide information—and health care—to the public in an emergency. There is room for improvement, especially as social media evolves, but the regular media updates and availability of information online was at least a starting point for communicating this type of news effectively. And even though there has been some controversy over whether governments ordered too much of the H1N1 vaccine, one could argue that it is better to have too much than not enough. Imagine the panic if the H1N1 virus had been deadlier, and there was a vaccine shortage.That’s another potential positive side effect of the 2009 H1N1 pandemic—a revisiting of the vaccine-making process. Maybe we can look forward to quicker, more efficient vaccine production. Maybe not right away, but perhaps in time for H1N1 II: The Swine Flu Strikes Back. Coming Soon to a Germy Person Near You.

“Continued vigilance is extremely important,” Dr. Chan said in her statement. To that end, the WHO offers recommendations for the post-pandemic period on its website, and the CDC continues to provide the latest flu information.
—Heidi Splete (On Twitter @HSplete)
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Why Pregnant Women Skip Flu Shots

Even though the Centers for Disease Control and Prevention identified pregnant women as one of the five initial target groups to receive the 2009 monovalent H1N1 influenza vaccine, many pregnant women report not knowing about the importance of vaccination.

Image via Flickr user USACE Europe District by Creative Commons License.

The finding comes from a cross-sectional study of 813 postpartum women at the University of Colorado Hospital conducted between November 2009 and May 2010. Barbra M. Fisher, a maternal-fetal medicine fellow at the University of Colorado, Denver, reported that 64% of women received the seasonal influenza vaccine during the study period and 54% received the novel H1N1 influenza vaccine.

Women who chose not to receive either vaccine cited the following reasons for opting out: not knowledgeable about the importance of vaccination (25%), concern for effects on fetal health (18%), concern for effects on maternal health (9%) and not knowing where to obtain vaccination (9%). In addition, 6% said that the vaccine was not available to them.

The findings, Dr. Fisher said, suggest that future vaccination campaigns “should focus on education of vaccine safety, enhance provider-patient education and communication –– targeting specific portions of the population –– and early availability of appropriate vaccines.”

— Doug Brunk (on Twitter @dougbrunk)
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Allergen of the Year for 2010 Announced

from the American Contact Dermatitis Society annual meeting, Miami Beach

Drum roll please … the American Contact Dermatitis Society has named the antibiotic neomycin as Allergen of the Year for 2010.

Courtesy flickr user project 365 under common license

“It’s a very common allergen and raises a number of issues when someone patch tests positive to it. We thought it is something the general public and dermatologists should be aware of,” said Dr. Donald Belsito, a dermatologist in private practice in Shawnee, Kans., when making the announcement.

A positive patch test can take 7 days or more to develop, so have patients return or counsel them on what to look for, Dr. Belsito said.

He noted that there are a couple things to keep in mind when making the diagnosis of neomycin allergy.

First, many vaccines contain neomycin as a preservative. The risk to benefit considerations need to include the likely worst-case scenario–an eczematous rash–if a sensitive patient receives a vaccine containing neomycin. Contrast that with the likely worst-case scenario–contraction of a potentially lethal disease–if the sensitive patient avoids vaccination. Discuss. And don’t forget to bring the patient’s primary care doctor into the conversation, Dr. Belsito counseled.

Second, neomycin-sensitive patients can have cross reactivities to other aminoglycocides. Think kanamycin, tobramycin and others, said Dr. Belsito, who had no relevant financial disclosures.

Neomycin is more of a household name than last year’s Allergen of the Year, mixed dialkyl thioureas. My colleague Bruce Jancin described last year’s winner and patients’ reactions to it in a blog post one year ago.

—Damian McNamara (@MedReporter on Twitter)
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