PKIDs’ Immunization News

Combination MMR-varicella vaccine is no longer favored over separate vaccines, and influenza vaccine is now recommended for all children aged 6 months to 18 years.

Two new recommendations were issued on February 27, 2008, following a meeting of the Advisory Committee on Immunization Practices (ACIP). The CDC will formally distribute and publish the recommendations in MMWR Morb Mortal Wkly Rep. Clinicians will want to know about both recommendations now because they might affect vaccine orders during the coming months.

Recommendation 1: The CDC no longer favors the combination vaccine ProQuad (containing measles, mumps, rubella [MMR], and varicella) over two separate injections for MMR and varicella. The Kaiser Permanente Vaccine Study Center presented data to the ACIP that revealed that ProQuad was associated with twice the risk for seizures within 10 days of vaccination (9 per 10,000 children), compared with separate MMR and varicella vaccines (4 per 10,000). The reason for the different seizure rates is unclear, and, according to Merck & Co., which manufacturers both the combined and separate-component vaccines, the difference disappeared in a comparison of rates at 30 days.

Comment: The ACIP’s statement about the combination vaccine does not require an immediate change in practice but simply replaces the CDC’s previously stated preference for the combination vaccine. I prefer to use separate MMR and varicella vaccines in children with personal or family histories of febrile seizures. The overall risk for seizure after administration of the separate vaccines is lower than that with the combined vaccine, and warnings already are included in the information materials we give to parents before vaccination.

Recommendation 2: The CDC expanded recommendations for influenza vaccine to all children aged 6 months to 18 years (except children with serious egg allergies). The previous recommendation was for children aged 6 to 59 months. Although the recommendation will be implemented no later than the 2009–2010 flu season, physicians are encouraged to begin vaccinating children according to the new recommendation during the next influenza season. Data were presented at the ACIP meeting that underscore the need for two doses of flu vaccine in children who receive the vaccine for the first time: Among children aged 6 to 23 months, fully vaccinated children had 75% vaccine efficacy in preventing influenza-related hospitalization, and children who received only one dose did not receive statistically significant protection.

Comment: The recommendation to expand influenza vaccine has been controversial for many years largely because of logistical concerns about implementation, but, in my opinion, it is a great idea. More-widespread vaccination will lead to fewer missed days in school and fewer doctor visits. Experts hope that widespread coverage will reduce transmission to both infants and older adults. Talking to families about the expanded recommendation at routine visits might be helpful, because, by increasing awareness now, implementation will be easier in the years to come.

— Peggy Sue Weintrub, MD
Published in Journal Watch Pediatrics and Adolescent Medicine March 12, 2008
Citation(s):
Stobbe M. Kids vaccine linked to fever, seizures. Associated Press. Feb 28 , 2008. (http://tinyurl.com/2qdr2h)
Centers for Disease Control and Prevention (CDC). CDC’s advisory committee recommends influenza vaccination for children 6 months through 18 years of age [press release correction]. Feb 27 , 2008. (http://tinyurl.com/2ojlto)

The revised label adds a warning about possible neuropsychiatric side effects.

The FDA and Roche Laboratories have revised the product label for Tamiflu (oseltamivir phosphate) to include a warning about possible neuropsychiatric events. The updated label is based on recommendations from the agency’s Pediatric Advisory Committee meeting in November 2007.

Postmarketing reports indicate that some patients with influenza who were receiving Tamiflu had delirium and abnormal behavior, leading to injury and even death. Most of the cases occurred in children and in Japan.
Although it’s not clear whether Tamiflu caused these events, the label cautions clinicians to monitor their patients for abnormal behavior when taking the drug. Adverse events should be reported through the FDA’s MedWatch site.

Published in Journal Watch Pediatrics and Adolescent Medicine March 12, 2008
Originally published in Physician’s First Watch March 5, 2008

Boston Globe (03/13/08) Lee, Min — In an effort to prevent the spread of influenza, the Hong Kong government has closed all kindergartens and primary schools for two weeks. The students will start the Easter holiday early to help keep the disease from spreading. “We estimate this peak season of influenza will continue for a few weeks,” said Hong Kong’s Health Secretary, York Chow. Also this week, Chow asked Yuen Kwok-yung, who helped investigate Hong Kong’s outbreak of severe acute respiratory syndrome several years ago, to lead a panel looking into the deaths of three children in the past week. The most recent death, of a seven-year-old boy on Tuesday, increased concerns because five of his classmates were also hospitalized. His cause of death has not yet been determined; however, officials believe that some of the other students had the flu, and that school was closed earlier this week. In the past week, health experts have confirmed six flu outbreaks at schools, hospitals, and a nursing home in Hong Kong.

Boston Globe (03/07/08) Fox, Maggie

University of California at San Diego researchers have manipulated the structure of a protein that could be used in a vaccine for strep throat and rheumatic fever. The M1 protein was restructured by Partho Ghosh and fellow researchers to trigger an immune reaction. Ghosh said the manipulated structure is more effective and safer than the original version of M1, which had limitations for incorporation into a vaccine. Worldwide, Group A streptococcal infections take the lives of 400,000 people every year. While strep throat can be treated by antibiotics, untreated infections could result in rheumatic fever. Group A streptococcus can also lead to necrotizing fasciitis and bloodborne infections. The researchers findings are published in the journal Science.

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Seattle Times (03/11/08) Ostrom, Carol M. — Vaccine makers could have enough time to develop a targeted vaccine to considerably limit the spread of pandemic influenza in a big city as long as there is a fast response to provide antiviral drugs, close schools, and take other measures to reduce person-to-person contact. Researchers at Fred Hutchinson Cancer Research Center used the Chicago area as an example for their mathematical computer models on the best way to contain the flu. They found that such an intervention plan could reduce the number of people who would catch the flu within six months from about 4 million to 10,000 cases. “We can effectively reduce the number of cases and slow the pandemic,” says co-author Dr. M. Elizabeth Halloran, a professor of biostatistics at the University of Washington. The researchers have presented their findings to the White House and the Institute of Medicine, and their research also appears in the online early edition of the Proceedings of the National Academy of Sciences of the United States of America. Still, some critics say the report is unrealistic because it believes officials would be able to quickly identify a flu pandemic, people would be able to get antiviral drugs in a day, and that people would limit person-to-person contact.

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Researchers have shown that vaccinating mice with a modified form of a virus containing proteins from breast cancer cells can kill large breast cancer tumors and tumors that have spread to the lungs. The rodent model of cancer used in this study closely resembles a type of breast cancer seen in humans called HER2-positive. Although other cancer vaccines have shown activity in the treatment of very small tumors, their ability to influence large, established tumors, such as many HER2-positive breast cancers, has proven difficult. The study, led by researchers at the National Cancer Institute (NCI), part of the National Institutes of Health, appeared in the March 15, 2008, issue of “Cancer Research”.

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LONDON (Reuters) Mar 10 - GlaxoSmithKline Plc said on Monday its human papillomavirus (HPV) vaccine Cervarix provided significant protection for women against the four most common oncogenic HPV types for 6.4 years, the longest duration of protection reported to date.

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March 2008

Recent data from the influenza division of the CDC indicated that protection from both the influenza A H3N2 and B virus strain in the community may not be optimal.

“Ninety-three percent of the B strains we are seeing are in a different lineage than the vaccine strain and approximately 35% are type A (H3N2). It is important to remember that although a less-than-ideal virus match between the viruses in the vaccine and those in the circulating viruses can reduce vaccine effectiveness, we know from past influenza studies that the vaccine can still protect enough to make illness milder or prevent influenza-related complications,” Joe Bresee, MD, chief of the epidemiology and prevention branch at the CDC’s influenza division, said during a recent CDC news conference.
According to Bresee, although seasonal influenza activity had a slow start this year, it has increased in recent weeks.

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NEW YORK (Reuters Health) Feb 28 - In a study of UK children born between 2000 and 2002, roughly 89% had been immunized with measles, mumps, rubella (MMR) vaccine by 3 years of age, but this is not enough to ensure adequate disease control, a new report indicates.

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Background: In 2006, a new rotavirus vaccine (RotaTeq) was licensed in the US and recommended for routine immunization of all US infants. Because a previously licensed vaccine (Rotashield) was withdrawn from the US for safety concerns, identifying barriers to uptake of RotaTeq will help develop strategies to broaden vaccine coverage.

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NEW YORK (Reuters Health) Mar 03 - Intranasal live attenuated influenza vaccine (LAIV) can be safely given to young children concurrently with MMR and varicella vaccines without compromising immunogenicity, according to a report in the March issue of Pediatrics.

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Seattle Times (March 5, 2008) - “How far would you go to help wipe out one of the world’s worst scourges? Seattle-area residents will soon be able to go all the way: allowing themselves to be bitten by malaria-infected mosquitoes to aid in the quest for new vaccines and drugs. Seattle Biomedical Research Institute (SBRI) is announcing plans today for a facility where volunteers will be exposed to the deadliest form of the disease, which kills at least a million people a year… But scientists are quick to point out that participating in the clinical trials won’t be a life-threatening experience… While many volunteers will actually contract malaria, the cloned strain used in the experimentscan be quickly cured, and does not cause a recurring form of the disease… The world’s richest philanthropy has devoted more than $1 billion to a multipronged attack on malaria, including $350 million for one of its top priorities: development of a vaccine… The bulk of the vaccine money goes to the PATH Malaria Vaccine Initiative (MVI), a program that aims to accelerate studies on vaccine candidates… SBRI scientists are working on a vaccine that uses genetic engineering to render malaria parasites harmless. They also will analyze blood from the human volunteers to learn more about the body’s immune response to the disease.”

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Associated Press (March 12, 2008) - “As doctors struggle to eradicate polio worldwide, one of their biggest problems is persuading parents to vaccinate their children. In Belgium, authorities are resorting to an extreme measure: prison sentences. Two sets of parents in Belgium were recently handed five month prison terms for failing to vaccinate their children against polio. Each parent was also fined 4,100 euros ($8,000)… The parents can still avoid prison — their sentences were delayed to give them a chance to vaccinate their children. But if that deadline also passes without their children receiving the injections, the parents could be put behind bars… The polio vaccine is the only one required by Belgian law. Exceptions are granted only if parents can prove their children might have a bad physical reaction to the vaccine… Aside from Belgium, only France makes polio vaccinations mandatory by law. In the United States, children must be vaccinated against many diseases including polio, but most states allow children to opt out if their parents have religious or ‘philosophical’ objections… Ethicists argue that people who refuse vaccinations are taking advantage of everyone else who has been vaccinated.”

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Washington Post (March 15, 2008) - “A Northern Virginia toddler caught measles on a family trip to India, and health officials are trying to find people in this area who might have been exposed to her. Health officials said the girl’s case is the first reported in Virginia since 2001. Measles can be serious, but a vaccine has almost eliminated the illness in this country, authorities said. They said 37 cases were reported in the United States in 2004, compared with hundreds of thousands a year before the vaccine. Fairfax County officials were told March 7 of the 15-month-old’s case and have identified 600 people possibly exposed, said Mike Andrews, a county health department spokesman. No new cases have been found, and the girl, no longer contagious, is doing well, he said. Measles symptoms include fever of more than 101 degrees, cough, runny nose, conjunctivitis and a persistent rash that proceeds down the body. Authorities said the incubation period is from seven to 18 days, usually 14. Those who have had measles, were born before 1957 or have been vaccinated are considered to be immune.”

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Metro (UK) (March 11, 2008) - “Cases of whooping cough have nearly tripled since 2003, while instances of TB and cholera have also soared, figures suggested yesterday. There were 1,071 cases of whooping cough in England last year, up 177 per cent compared with the 386 in 2003, data from the Department of Health showed. Cholera has also jumped 52 per cent, from 25 cases to 38 and cases of TB rose by 17 per cent, reaching 7,862 in 2006 from 6,741 five years ago. Since the 1990s, the number of people catching it has fallen dramatically. In 1991, more than 4,000 contracted the disease but since the rise of a vaccine given to babies, cases have fallen. The jab, given to two-, three- and four-month-olds, also protects against diptheria, tetanus, polio and a meningitis-causing infection. More than 90 per cent of infants have the jab, so the rise in cases is a worry. Illnesses we thought were being wiped out are on the increase again, said shadow health secretary Andrew Lansley.He added the government must take urgent action to halt the rise in cases of diseases such as whooping cough.”

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Kansas City Star (March 12, 2008) - “Grown-ups think of vaccinations as a matter for childhood. Many get their annual flu shot and figure that’s that. Infectious disease specialists wish it weren’t so. A recent report from the national Centers for Disease Control and Prevention confirmed that Americans tend to put adult vaccinations on the way-back burner, if they’re familiar with them at all… Think of vaccines for adults as prevention tools, said Gina Mootrey, associate director of adult immunization at the CDC, along the lines of mammography, colonoscopy and diabetes screening. ‘Prevention is better than treatment,’ she said. And another reason: ‘There’s the perspective that adults get vaccinated to protect those they love,’ Mootrey said, ‘particularly infants who don’t have full immunity and the elderly.’”

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Reuters (February 2, 2008) - “French authorities have opened a formal investigation into two managers from drugs groups GlaxoSmithKline and Sanofi Pasteur over a vaccination campaign in the 1990s, a judicial source said late on Thursday. Judge Marie-Odile Bertella-Geffroy also opened an investigation for manslaughter against Sanofi Pasteur MSD, a joint venture between Sanofi Aventis and Merck the same source said. The investigations follow allegations that the companies failed to fully disclose side effects from an anti-hepatitis B drug used in a vaccination campaign between 1994 and 1998…Some 30 plaintiffs have launched a civil action in the case, including the families of five people who died after vaccination.”

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BBC News (February 22, 2008) - “The number of measles cases in England and Wales jumped more than 30% last year to the highest level since records began in 1995. The Health Protection Agency (HPA) recorded 971 cases during the year - up from 740 in 2006…MMR immunisation rates dipped following research which raised the possibility that the jab may be linked to an increased risk of autism. However, the research has since been debunked, and a string of studies have concluded that the triple vaccine - which protects against rubella and mumps as well as measles - is perfectly safe.”
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New York Times (February 24, 2008) - “How cool are those Gardasil Girls?…But someone’s missing from this grrlpower tableau. Ah, that would be Gardasil Boy. Gardasil Girl’s cancer-related virus? Sexually transmitted. She almost certainly got it from him…By 2009, the vaccine could be approved for boys as well. Although Gardasil also protects against genital warts, which are not life-threatening, the primary reason to extend approval to boys would be to slow the rates of cervical cancer. Public health folks charmlessly call this ‘herd immunity’…A few reports show that American parents generally favor the Big Idea that Gardasil be made available to both boys and girls. But few surveys discern whether parents would consider the vaccine specifically for their own sons.”

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Newsday (February 24, 2008) - “There is only one message Richard Kanowitz wants to convey to the world at large: Influenza is deadly and is never to be confused with seasonal sniffles or a bout with the common cold. Kanowitz, who lives in Manhattan and grew up in Oceanside, learned about the power of the flu four years ago when it killed his daughter Amanda, who was 4 years old…He believes his daughter would be alive had she been vaccinated…She emphasizes that flu shots for children and pregnant women do not contain thimerosal, a preservative that anti-vaccination groups have said is linked to autism. The flu vaccine is the only one recommended for pregnant women.”

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