April 9, 2014

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Summit Call Recap – March 20, 2014

Announcements

SUMMIT CALL RECAP – March 20, 2014

Reminders

Summit calls are scheduled every Thursday at 3 p.m. ET, unless cancelled. There will be a Summit call on Thursday, April 10 at 3 p.m. ET. Scheduled are updates on the current flu epidemiology, as well as on H7N9/H5N1/novel flu.
Please also visit the Summit’s new and revised website! Note that we now have home pages for each workgroup. In addition, a page for the new NVAC Standards for Adult Immunization Practices highlights supporting organizations and their action items.

Announcements – L.J Tan (IAC)

L.J opened the call by reminding partners about the 2014 National Adult and Influenza Immunization Summit (NAIIS), scheduled for May 13–15 in Atlanta, Georgia. Registration information is now available on the NAIIS website or directly through the registration link. Persons may contact L.J to obtain the password needed to complete registration. Partners also are asked to use the included link to reserve a room, as this will help the Summit meet its contractual obligation to the hotel.

The NAIIS website also contains information on submitting a nomination for the 2014 NAIIS Immunization Excellence Awards. In recognition of the broadened nature of the Summit, this year’s award categories have been revised significantly to include general adult immunizations. The five categories of recognition for the awards are:

Overall Flu Season Activities
Healthcare Personnel Campaign
“Immunization Neighborhood” Champion
Adult Immunization Champion
Corporate Campaign

Nominations will be accepted through 5 p.m. EDT on April 1, 2014. Summit partners are encouraged to nominate others or themselves for these awards.

Influenza Surveillance Update – Scott Epperson (CDC)

Scott reported that influenza activity has continued to decline over the last few weeks. There has been a continuing decrease in the number of positive specimens reported, but they have exhibited a slight shift in the relative proportions of the influenza types identified. Although the 2013–2014 season has overwhelmingly consisted of influenza 2009 H1N1, the past few weeks have shown an increase in influenza A H3N2 and influenza B. The weekly proportion of influenza A has been decreasing since February, with 68% of the positives being influenza A, and 63% of these as 2009 H1N1. Scott noted that this type of shift is not unusual when compared to previous seasons. There has been no change in the antigenic characterization of the identified viruses, with 99.9% of the H1N1 specimens found to be similar to the vaccine strain. Type B specimens continue to be split between two lineages, with 64% of the Yamagata lineage (found in both the trivalent and quadrivalent vaccines), and 36% of the Victoria strain (found only in the quadrivalent vaccine.)

Influenza-like illness (ILI) is still hovering around baseline levels, with 4 regions reporting being at or above the baseline. Activity is continuing to decline, and Scott anticipated that the Week 11 report likely will show all regions below baseline levels.

To date, 68 lab-confirmed pediatric influenza deaths have been reported. All cases in which influenza A subtyping was performed have been 2009 H1N1. Eight (15%) of children who were eligible for vaccination had a known vaccination history. Of these, 4 (50%) had an underlying high risk medical condition.

Scott reminded callers that the latest influenza information is always obtainable on CDC’s FluView website.

Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) Data Summary – Ros Hollingsworth (Pfizer)

Dr. Hollingsworth (Senior Director, Medical Lead for Prevnar 13 Adult at Pfizer) presented data from Pfizer’s Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) study. This study was established to examine the efficacy of 13-valent pneumococcal conjugate vaccine (PCV13) in the prevention of vaccine-serotype pneumococcal community-acquired pneumonia (CAP) and invasive pneumococcal disease (IPD). Historically, pneumococcal polysaccharide vaccines have been shown to be effective against IPD in adults. However, there has been controversy about the ability of this vaccine to prevent non-invasive illness, where the burden of diseases exists in adults.

The FDA granted Pfizer accelerated approval status for the approval of PCV13 for use in adults aged 50 years and older on the basis of a surrogate endpoint, functional antibody responses compared with those elicited by 23-valent pneumococcal polysaccharide vaccine. Under this regulation, Pfizer was required to conduct a confirmatory efficacy study, the CAPiTA study. With 85,000 participants, the study is thought to be the largest clinical trial in adults ever conducted. Screening and recruitment for these volunteers began in September 2008, and all vaccination ended by January 2010. Participants were given either PCV13 or a placebo, and the population was followed until a pre-defined number of vaccine-type pneumococcal pneumonia cases was reached in the third quarter of 2013.

The volunteers, all of whom were located in the Netherlands, were identified by general practitioners and registered into the study if they were >65 years of age and did not meet any exclusion criteria, such as previous receipt of pneumococcal vaccine or current (at the time of vaccination) immunosuppression. The individuals also had to be living in the community, rather than residing in a nursing home/long-term care facility.

The primary objective of the study was to demonstrate the efficacy of PCV13 in the prevention of a first episode of vaccine-serotype (VT) pneumococcal CAP. Secondary objectives included the prevention of a first episode of (1) VT non-bacteremic/non-invasive (NB/NI) pneumococcal CAP or (2) VT IPD, with or without pneumonia. In addition, adverse event information was solicited from the subset of 2,000 patients included in the immunogenicity portion of the study, but serious adverse events and deaths were included from all study participants.

VT-CAP cases were identified when study subjects presented with a clinical suspicion of CAP at the ER in 58 sentinel hospitals in the Netherlands. They received a diagnostic work-up including a chest x-ray, blood culture, and urine sample. Dr. Hollingsworth reported a high rate of success in obtaining the requested information, with blood cultures obtained from approximately 80% of patients. Urine samples were tested according to standard care practice using BinaxNOW®, as well as the Serotype-Specific Urinary Antigen Detection (SSUAD) Assay developed by Pfizer specifically for the CAPiTA study. X-rays were read by an independent adjudication committee. A definition of CAP was based on protocol defined clinical criteria AND X-ray findings consistent with pneumonia.

The SSUAD Assay for the detection of PCV13-type capsular polysaccharide enabled accurate testing of urine for the presence of any PCV13 serotype with 97% sensitivity and 100% specificity. The CAPiTA study marked the first time that a test was able to reliably and simultaneously detect the 13 serotypes found in the vaccine. Development of the assay greatly reduced the amount of time that otherwise would have been needed to complete the study. The SSUAD Assay also is now being used in other epidemiological studies about CAP, including several in the US.

The study population was equally divided between persons receiving PCV13 or a placebo. The mean age of both male and female participants was approximately 72 years. At least 42% of participants reported at least one co-morbidity, which is comparable to the 37% of the U.S. population with at least one risk factor for pneumococcal infection. Approximately 12% of participants were current smokers.

Persons met the primary endpoint of confirmed VT pneumococcal CAP if they exhibited >2 specified clinical findings consistent with CAP and a chest x-ray and a culture of VT S. pneumoniae from blood, pleural fluid, or other sterile site and/or positive VT SSUAD. The definition for the secondary endpoint of confirmed NB/NI VT pneumococcal CAP required identification of the vaccine types from blood culture and negative results from pleural fluid or other sterile site. In order to confirm non-invasive disease, the secondary endpoint of VT-IPD was much more specific, requiring identification of VT S. pneumoniae from blood, pleural fluid, or other sterile site.

As noted in Pfizer’s February 24 press release, the study achieved its primary clinical objective and both secondary clinical objectives. The vaccine efficacy (VE) against a first episode of confirmed VT pneumococcal CAP was 45.58%. Similarly, the VE against a confirmed case of NB/NI VT pneumococcal CAP was 45%. The secondary objective of prevention of a first episode of VT-IPD indicated a VE of 75%. All of these results were highly statistically significant.

An almost 4 year follow-up indicated the effect of the vaccine did not wane, with VE for VT-CAP remaining at over 45%. While not quite reaching the level of statistical significance, the efficacy data for individual serotypes was quite encouraging for all 3 study endpoints.

Even though they were not powered for statistical significance, numerous exploratory endpoints will continue to be examined. Safety data for local reactions or systemic events within 7 days after vaccination within the immunogenicity subset of participants did not indicate anything unexpected and were consistent with previous studies of PCV13 in adults. None of the serious adverse events or deaths which occurred in this elderly study population were considered to be vaccine-related.

It is anticipated these study results will be submitted for publication in a peer-reviewed journal shortly. Data will also continue to be submitted to international congresses.

In response to questions, Dr. Hollingsworth noted that the study group was designed to include only persons age >65 years in order to catch the peak of pneumococcal cases occurring in that age group. If younger participants had been included, it would have extended the time needed to accrue study cases. It is felt this data will be easily interpretable to lower age groups.

Pfizer does not plan to follow the study cohort for additional years in order to look at the duration of immunity.

The current standard of care in the Netherlands calls for the use of polysaccharide vaccine for high risk persons only; there are no age-based recommendations. Over 70% of the population is vaccinated against influenza, and study participants were allowed to obtain influenza vaccine during the trial. Pfizer will be unable to assess for a potential compounding effect of influenza vaccine with PCV13 because influenza vaccine status was available only at the time of receipt of PCV13/placebo (when about 1/3 of participants received the vaccines concurrently) or if the individual appeared at the hospital. Approximately 30% of hospital patients (i.e., of the efficacy episodes) reported receiving influenza vaccine within the last year, which was similar to the levels found at the beginning of the trial.

VE against a first episode of all-cause CAP (5.08%) was examined as an exploratory objective, but this did not reach statistical significance.

L.J expressed great appreciation to Dr. Hollingsworth for providing Summit callers with this “hot off the press” information.

CDC/Influenza Division Weekly Influenza Surveillance Report and CDC Key Points

The CDC weekly influenza surveillance report for week 13 (ending March 29, 2014) and region specific data are now available. Of all deaths reported through the 122 Cities Mortality Reporting System, 6.5% were due to P&I. This percentage was below the epidemic threshold of 7.3% for week 13.

Three influenza-associated pediatric deaths were reported to CDC during week 13. Two deaths were associated with influenza A viruses for which no subtyping was performed and occurred during weeks 9 and 12 (weeks ending March 1 and March 22, 2014). One death was associated with an influenza B virus and occurred during week 13 (week ending March 29, 2014).

A total of 82 influenza-associated pediatric deaths have been reported during the 2013-2014 season from Chicago [1], New York City [2] and 29 states (AR [4]; AZ [1]; CA [8]; FL [4]; GA [1]; IA [1]; IL [1]; KS [2]; KY [1]; LA [5]; MA [2]; MD [1]; ME [1]; MI [2]; MS [1]; NC [5]; NE [1]; NJ [1]; NV [1]; OK [2]; OR [1]; PA [3]; SC [2]; TN [4]; TX [17]; UT [2]; VA [1]; WI [2]; and WV [2]).

Nationwide during week 13, 1.6% of patient visits reported through the U.S. Outpatient Influenza-like Illness Surveillance Network (ILINet) were due to influenza-like illness (ILI). This percentage is below the national baseline of 2.0%. ILI is defined as fever (temperature of 100°F [37.8°C] or greater, and cough and/or sore throat. On a regional level, the percentage of outpatient visits for ILI ranged from 0.6% to 3.7% during week 13. Two of 10 regions reported a proportion of outpatient visits for ILI at or above their region-specific baseline level. An Influenza Summary Update of the influenza activity reported by state and territorial epidemiologists, which indicates geographic spread of influenza viruses but does not measure the intensity of influenza activity, is available.

During week 13, New York City experienced high ILI activity. Two states (New Jersey and Texas) experienced moderate ILI activity. Three states (Connecticut, Delaware, and New York) experienced low ILI activity. Forty-five states (Alabama, Alaska, Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming) experienced minimal ILI activity. Data were insufficient to calculate an ILI activity level for the District of Columbia.

Archives of previous FluViews and CDC’s seasonal influenza key points for April 4, 2014 are available.

More Information from CDC

Current Seasonal Influenza Vaccine Distribution: CDC published on its website recent distribution numbers for all influenza vaccines. As of February 28, 2014, 134.5 million doses have been distributed.
National Influenza Vaccination Disparities Partnership (NIVDP) Influential News newsletter available in Spanish! The latest edition of the Influential News newsletter has been released in Spanish. Additionally, new sell sheets for disparate populations have been added to the National Influenza Vaccine Disparities (NIVDP) home page.
New Sell Sheets on Influenza: CDC has added a new sell sheet – Flu Vaccination Resources for the General Public – to their Free Resources website.

Don’t forget to register for the 2014 Summit Face-to-Face Meeting Information!

Registration is available through the NAIIS website. As the meeting is invitation only, please contact L.J Tan if you need the password.

Also, please register for your hotel room in the Hyatt Regency rooming block through the link on the Summit website. Thanks!

ANNOUNCEMENTS

Don’t forget to check out DHHS’ influenza website!

Reminder! There are many good resources directed at populations such as businesses, schools, and communities on the DHHS flu.gov website!

“Dear Colleague” letter urges strong provider recommendation for HPV vaccination

HPV vaccine is cancer prevention. However, HPV vaccine is underutilized in our country, despite the overwhelming evidence of its safety and effectiveness. While vaccination rates continue to improve for other vaccines, HPV vaccination rates have not. Missed opportunities data suggest that providers are not giving strong recommendations for HPV vaccine. The healthcare provider recommendation is the single best predictor of vaccination. Recent studies show that a patient who receives a provider recommendation is 4-5 times more likely to receive the HPV vaccine.

Members of the immunization neighborhood have an important role to play in improving HPV vaccination rates. What providers say, and how they say it, matters. Consistency in delivered messages is also important. A half-hearted recommendation to a patient may not only result in the patient leaving a practice unvaccinated, but may lead the patient to believe that HPV vaccine is not as important as the other vaccines. Whether you actually administer the vaccine or refer the patient to a provider who will administer the vaccine, you have an influence on patients’ beliefs.

As the first step in improving HPV immunization coverage rates, a “Dear Colleague” letter has been developed and released focusing on the importance of a strong provider recommendation. This letter provides key facts about HPV vaccine safety and effectiveness, with the hope that they will lead providers to recommend HPV vaccination – firmly and strongly – to their patients. It is clear that in order for adolescents and adults to be properly protected against HPV infection, the effort of the entire immunization neighborhood will be required. The letter and press release are available online.

Invitation to attend the Fifth ESWI Influenza Conference; Travel grants available

The European Scientific Working group on Influenza (ESWI) invites partners of the U.S. National Adult and Influenza Immunization Summit to join other scientists and public health officials at the Fifth ESWI Influenza Conference in Riga, Latvia, on 14 –17 September 2014. The aim of the conference is to discuss the most recent advances in influenza research, control, prevention and treatment, while a tailor-made program for public health officials will cover the entire spectrum of influenza policy making. This program represents the 2014 European edition of their Flu Summit, which is modeled from the successes of our own Summit.

Registration is now open. To encourage the participation of outstanding students and young, promising researchers, ESWI will provide some 50 travel and accommodation grants through the ESWI Young Scientist Fund. Application for these grants opened on February 1, 2014. Please feel free to forward this information to anyone you think may be interested in applying for a Young Scientists travel and accommodation grant.

FDA is Working Closely with Manufacturers of Meningitis B

Meningitis has been in the news recently because of outbreaks of a specific strain (called “serogroup B” or “MenB”) on college campuses.

To address this critical public health need, FDA worked closely with CDC, in order for CDC to make an unapproved MenB vaccine available as quickly as possible to the universities where CDC determined outbreaks had occurred. This was accomplished under FDA’s expanded access program for investigational (or unapproved) products. The program allows the use of unapproved drugs or vaccines to treat or prevent serious or immediately life-threatening conditions when other options are not available. Additional information is available on the FDA Voice blogsite.

Summit Website Offers Wonderful Resources on Influenza Vaccination!

Remember to visit the Summit website for the latest on influenza immunization resources and to find archived copies of the Summit Buzz.

Reminder: Please email L.J or LaDora if you have any updates on activities to provide to the Summit.