Posts Tagged "13-Valent Pneumococcal Conjugate Vaccine"

A study of hospital admission for severe acute respiratory infections (SARIs) in military personnel found that recent flu vaccination lowered the risk of severe disease, while occupational factors and comorbidities may increase SARI risk, according to findings yesterday in Vaccine.

An international team of researchers evaluated data on 11,086 hospitalizations due to pneumonia or influenza from 2000 through 2012 among US military personnel. Hospitalized people had a median age of 32 and were largely male (89.5%).

Chronic disease was also associated with developing SARI following hospitalization. Comorbidities with the highest risk of progression toward severe disease included chronic renal or liver disease; circulatory system disease, diabetes mellitus, obesity, cancer, and chronic obstructive pulmonary disease.

Under multivariate analysis, factors still significant for risk of severe disease included renal and liver disease, circulatory disease, and service in the Coast Guard or Air Force. Investigators cautioned, however, that risk associated with service branch may simply reflect differences in data reporting rather than physiologic risk.

Source: Center for Infectious Disease Research & Policy

More intensive management of high blood pressure, below a commonly recommended blood pressure target, significantly reduces rates of cardiovascular disease, and lowers risk of death in a group of adults 50 years and older with high blood pressure. This is according to the initial results of a landmark clinical trial sponsored by the National Institutes of Health called the Systolic Blood Pressure Intervention Trial (SPRINT). The intervention in this trial, which carefully adjusts the amount or type of blood pressure medication to achieve a target systolic pressure of 120 millimeters of mercury (mm Hg), reduced rates of cardiovascular events, such as heart attack and heart failure, as well as stroke, by almost a third and the risk of death by almost a quarter, as compared to the target systolic pressure of 140 mm Hg.

“This study provides potentially lifesaving information that will be useful to health care providers as they consider the best treatment options for some of their patients, particularly those over the age of 50,” said Gary H. Gibbons, M.D., director of the National Heart, Lung, and Blood Institute (NHLBI), the primary sponsor of SPRINT. “We are delighted to have achieved this important milestone in the study in advance of the expected closure date for the SPRINT trial and look forward to quickly communicating the results to help inform patient care and the future development of evidence-based clinical guidelines.”

High blood pressure, or hypertension, is a leading risk factor for heart disease, stroke, kidney failure, and other health problems. An estimated 1 in 3 people in the United States has high blood pressure.

The SPRINT study evaluates the benefits of maintaining a new target for systolic blood pressure, the top number in a blood pressure reading, among a group of patients 50 years and older at increased risk for heart disease or who have kidney disease. A systolic pressure of 120 mm Hg, maintained by this more intensive blood pressure intervention, could ultimately help save lives among adults age 50 and older who have a combination of high blood pressure and at least one additional risk factor for heart disease, the investigators say.

The SPRINT study, which began in the fall of 2009, includes more than 9,300 participants age 50 and older, recruited from about 100 medical centers and clinical practices throughout the United States and Puerto Rico. It is the largest study of its kind to date to examine how maintaining systolic blood pressure at a lower than currently recommended level will impact cardiovascular and kidney diseases. NIH stopped the blood pressure intervention earlier than originally planned in order to quickly disseminate the significant preliminary results.

The study population was diverse and included women, racial/ethnic minorities, and the elderly. The investigators point out that the SPRINT study did not include patients with diabetes, prior stroke, or polycystic kidney disease, as other research included those populations.

Source: NIH

At present, influenza activity is low in the United States but we expect activity to increase in the coming weeks as the U.S. typically experiences peak influenza activity between December and February. Based on our surveillance data we also expect an increase in norovirus in the very near future. In addition to vaccinations, it is also important to emphasize the early use of antivirals in the treatment of influenza. Antivirals are an important second line of defense, particularly for those at high-risk for complications from influenza. Two neuraminidase inhibitor antiviral medications are recommended for use in the United States—oseltamivir (Tamiflu®) and zanamivir (Relenza®). Current national surveillance data has not revealed significant resistance to oseltamivir and zanamivir to date.

Treatment works best when started within the first 48 hours of illness and can shorten the duration of symptoms and reduce the risk of severe complications and death. Treatment with antiviral medications is recommended for patients with influenza who are hospitalized; have severe, complicated or progressive illness; or are at higher risk for influenza complications. Antiviral treatment may also be considered in other populations, if treatment can be initiated within 48 hours of illness onset. Use of antivirals for the prevention of influenza should be considered for institutional outbreaks (such as in nursing homes or other closed populations) or for those who have contraindications to influenza vaccination. Other preventive health practices that may help decrease the spread of influenza and other common winter illnesses (such as norovirus), include staying home from work and school when ill, staying away from people who are sick, increasing hand washing, and using cough etiquette and respiratory hygiene practices.

Source: CDC

“The Center has plenty of Quadrivalent Influenza vaccine available.”

Despite the recent Advisory below, it is still important to get vaccinated against Influenza this year. We offer the Quadrivalent Influenza vaccine which protects against 4 Influenza viruses including partial protection against the H3N2 virus.

Influenza activity is currently low in the United States as a whole, but is increasing in some parts of the country. This season, influenza A (H3N2) viruses have been reported most frequently and have been detected in almost all states.

During past seasons when influenza A (H3N2) viruses have predominated, higher overall and age-specific hospitalization rates and more mortality have been observed, especially among older people, very young children, and persons with certain chronic medical conditions compared with seasons during which influenza A (H1N1) or influenza B viruses have predominated.

Influenza viral characterization data indicates that 48% of the influenza A (H3N2) viruses collected and analyzed in the United States from October 1 through November 22, 2014 were antigenically “like” the 2014–2015 influenza A (H3N2) vaccine component, but that 52% were antigenically different (drifted) from the H3N2 vaccine virus. In past seasons during which predominant circulating influenza viruses have been antigenically drifted, decreased vaccine effectiveness has been observed. However, vaccination has been found to provide some protection against drifted viruses. Though reduced, this cross-protection might reduce the likelihood of severe outcomes such as hospitalization and death. In addition, vaccination will offer protection against circulating influenza strains that have not undergone significant antigenic drift from the vaccine viruses (such as influenza A (H1N1) and B viruses).

Because of the detection of these drifted influenza A (H3N2) viruses, this CDC Health Advisory is being issued to re-emphasize the importance of the use of neuraminidase inhibitor antiviral medications when indicated for treatment and prevention of influenza, as an adjunct to vaccination.

The two prescription antiviral medications recommended for treatment or prevention of influenza are oseltamivir (Tamiflu) and zanamivir (Relenza). Evidence from past influenza seasons and the 2009 H1N1 pandemic has shown that treatment with neuraminidase inhibitors has clinical and public health benefit in reducing severe outcomes of influenza and, when indicated, should be initiated as soon as possible after illness onset. Clinical trials and observational data show that early antiviral treatment can:

• shorten the duration of fever and illness symptoms;
• reduce the risk of complications from influenza (e.g., otitis media in young children and pneumonia requiring antibiotics in adults); and
• reduce the risk of death among hospitalized patients.

Source: CDC

The sixth annual World Pneumonia Day was observed this week to raise awareness about pneumonia’s toll and to promote interventions to protect against, treat, and prevent the disease globally. The United States has made great strides in protecting children from the serious, and sometimes deadly, effects of pneumonia through recent vaccination efforts. Tennessee, for example, is experiencing historically low rates of pneumonia hospitalizations in children aged <2 years since pneumococcal conjugate vaccines were introduced in 2000. Data suggest that this progress also is being seen across the country. In spite of this success, however, pneumonia still kills approximately 50,000 people in the United States each year, 85% of whom are adults aged ≥65 years. In response, this year CDC recommended pneumococcal conjugate vaccine for adults aged ≥65 years.

Globally, pneumonia kills nearly 1 million children aged <5 years each year. In addition to bacterial pathogens, many viruses such as respiratory syncytial virus, influenza, and measles also are major causes of pneumonia globally. Many deaths and illnesses from pneumonia can be prevented with the use of 1) pneumococcal, Haemophilus influenzae type b (Hib), influenza, and measles vaccines; 2) appropriate antimicrobial therapy; and 3) supportive health care, among other strategies.

Communities around the world face a range of respiratory disease threats, including reemerging or newly identified pathogens. In late summer, infection with the uncommon enterovirus EV-D68 led to the hospitalization of hundreds of children in multiple states. In and around the Arabian Peninsula, a recently recognized coronavirus (Middle East respiratory syndrome coronavirus) has been fatal in about one third of reported cases. Vaccines are not available to provide protection against these or many of the other pathogens that commonly cause pneumonia, including respiratory syncytial virus, human metapneumovirus, and Mycoplasma pneumoniae, highlighting the importance of research into vaccine development as well as effective treatment and diagnostics for viral and bacterial pneumonia. Additional information regarding World Pneumonia Day is available at https://worldpneumoniaday.org.

Source: CDC
The Presidential Healthcare Center offers Prevnar-13 as a special order vaccination.

On August 13, 2014, the Advisory Committee on Immunization Practices (ACIP) recommended routine use of 13-valent pneumococcal conjugate vaccine (PCV13 [Prevnar 13, Wyeth Pharmaceuticals, Inc., a subsidiary of Pfizer Inc.]) among adults aged ≥65 years. PCV13 should be administered in series with the 23-valent pneumococcal polysaccharide vaccine (PPSV23 [Pneumovax23, Merck & Co., Inc.]), the vaccine currently recommended for adults aged ≥65 years. PCV13 was approved by the Food and Drug Administration (FDA) in late 2011 for use among adults aged ≥50 years. In June 2014, the results of a randomized placebo-controlled trial evaluating efficacy of PCV13 for preventing community-acquired pneumonia among approximately 85,000 adults aged ≥65 years with no prior pneumococcal vaccination history (CAPiTA trial) became available and were presented to ACIP. The evidence supporting PCV13 vaccination of adults was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework and determined to be type 2 (moderate level of evidence); the recommendation was categorized as a Category A recommendation. This report outlines the new recommendations for PCV13 use, provides guidance for use of PCV13 and PPSV23 among adults aged ≥65 years, and summarizes the evidence considered by ACIP to make this recommendation.

Streptococcus pneumoniae (pneumococcus) remains a leading infectious cause of serious illness, including bacteremia, meningitis, and pneumonia, among older adults in the United States. Use of a 7-valent pneumococcal conjugate vaccine (PCV7) since 2000 and PCV13 since 2010 among children in the United States has reduced pneumococcal infections directly and indirectly among children, and indirectly among adults. By 2013, the incidence of invasive pneumococcal disease (IPD) caused by serotypes unique to PCV13 among adults aged ≥65 years had declined by approximately 50% compared with 2010, when PCV13 replaced PCV7 in the pediatric immunization schedule. However, in 2013 an estimated 13,500 cases of IPD occurred among adults aged ≥65 years. Approximately, 20%–25% of IPD cases and 10% of community-acquired pneumonia cases in adults aged ≥65 years are caused by PCV13 serotypes and are potentially preventable with the use of PCV13 in this population.

On December 30, 2011, PCV13 was approved for use among adults aged ≥50 years to prevent pneumonia and invasive disease caused by S. pneumoniae serotypes contained in the vaccine. The new use for Prevnar 13 was approved under FDA’s accelerated approval pathway, which allows for earlier approval of products that provide meaningful therapeutic benefit over existing treatments for serious and life-threatening illnesses. FDA defined “meaningful therapeutic benefit over existing treatments” as protection of adults aged ≥50 years from nonbacteremic pneumococcal pneumonia or nonbacteremic pneumococcal pneumonia combined with protection from IPD. On June 20, 2012, ACIP recommended routine use of PCV13 for adults aged ≥19 years with immunocompromising conditions, functional or anatomic asplenia, cerebrospinal fluid leak, or cochlear implants. The ACIP decision to recommend PCV13 use among adults aged ≥65 years was deferred until data became available on 1) the impact of PCV13 use in children on disease in adults (i.e., indirect effects) and 2) the efficacy of PCV13 against noninvasive pneumococcal pneumonia among adults. In accordance with accelerated approval requirements, a randomized placebo-controlled trial (CAPiTA trial) was conducted in the Netherlands among approximately 85,000 adults aged ≥65 years during 2008–2013 to verify and describe further the clinical benefit of PCV13 in the prevention of pneumococcal pneumonia. The results of the CAPiTA trial demonstrated 45.6% (95% confidence interval [CI] = 21.8%–62.5%) efficacy of PCV13 against vaccine-type pneumococcal pneumonia, 45.0% (CI = 14.2%–65.3%) efficacy against vaccine-type nonbacteremic pneumococcal pneumonia, and 75.0% (CI = 41.4%–90.8%) efficacy against vaccine-type IPD among adults aged ≥65 years.

Two randomized, multicenter, immunogenicity studies conducted in the United States and Europe among older adults showed that PCV13 induced an immune response as good as or better than that induced by PPSV23. Functional antibody responses were measured 1 month after vaccination using an opsonophagocytic activity (OPA) assay. In adults aged 60–64 years with no prior pneumococcal vaccination, PCV13 elicited OPA geometric mean antibody titers (GMTs) to the 12 serotypes common to both vaccines that were comparable with, or higher than, responses elicited by PPSV23. In adults aged ≥70 years who previously had been immunized with a single dose of PPSV23 ≥5 years before enrollment, PCV13 elicited OPA responses that were comparable with those elicited by PPSV23 for two serotypes and higher for 10 serotypes.

Immunogenicity studies evaluating responses to PCV7 and PPSV23 administered in series showed a better immune response when PCV7 was administered first. An evaluation of immune response after a second pneumococcal vaccination administered 1 year after the initial study doses showed that subjects who received PPSV23 as the initial study dose had lower OPA antibody responses after subsequent administration of PCV13 than those who had received PCV13 as the initial dose followed by a dose of PPSV23, regardless of the level of the initial OPA response to PPSV23. Studies evaluating the immune response after a sequence of PCV7 or PCV13 followed by PPSV23 with intervals of 2, 6, and 12 months or 3–4 years demonstrated that after the PPSV23 dose, antibody levels were higher than the pre-PCV baseline, and a noninferior response was observed when compared with post-PCV antibody levels. None of the studies were designed to evaluate the optimal interval between vaccine doses.

Safety of PCV13 was evaluated in approximately 6,000 PPSV23-naïve and PPSV23-experienced adults aged ≥50 years. Overall incidence of serious adverse events reported within 1 month of an initial study dose of PCV13 or PPSV23 did not differ between the two vaccines and ranged from 0.2% to 1.7%. From 1 to 6 months after an initial study dose, the overall incidence of serious adverse events ranged from 1.2% to 5.8% among persons vaccinated with PCV13 and 2.4% to 5.5% among persons vaccinated with PPSV23. Rates of reported serious adverse events in the treatment groups were similar among studies that enrolled PPSV23-naïve subjects and studies that enrolled PPSV23-experienced subjects. Common adverse reactions reported with PCV13 were pain, redness, and swelling at the injection site; limitation of movement of the arm in which the injection was given; fatigue; headache; chills; decreased appetite; generalized muscle pain; and joint pain. Similar reactions were observed in adults who received PPSV23.

Indirect effects from PCV13 use among children, if similar to those observed after PCV7 introduction, might further reduce the remaining burden of adult pneumococcal disease caused by PCV13-types. A preliminary analysis using a probabilistic model following a single cohort of persons aged 65 years demonstrated that adding a dose of PCV13 to the current PPSV23 recommendations for adults aged ≥65 years, compared with current PPSV23 recommendations, would lead to additional health benefits. This strategy would prevent an estimated 230 cases of IPD and approximately 12,000 cases of community-acquired pneumonia over the lifetime of a single cohort of persons aged 65 years, assuming current indirect effects from the child immunization program and current PPSV23 vaccination coverage among adults aged ≥65 years (approximately 60%). In a setting of fully realized indirect effects assuming the same vaccination coverage, the expected benefits of PCV13 use among this cohort will likely decline to an estimated 160 cases of IPD and 4,500 cases of community-acquired pneumonia averted among persons aged ≥65 years.

CDC will assess the implementation and impact of the recommendation for PCV13 use among adults aged ≥65 years, including coverage with PCV13 and PPSV23, and impact of PCV13 on vaccine-type IPD burden and community-acquired pneumonia. Monitoring disease trends among adults who do not receive PCV13 might help quantify indirect effects and the long-term utility of routine PCV13 use among adults. ACIP will be updated routinely on changes in the burden of IPD and community-acquired pneumonia among adults during the next 3 years to determine the need for revisions to the adult PCV13 recommendations.

A single dose of PPSV23 is recommended for routine use in the United States among adults aged ≥65 years. Effectiveness of PPSV23 in preventing IPD in adults has been demonstrated, but the data on the effectiveness of this vaccine in preventing noninvasive pneumococcal pneumonia among adults aged ≥65 years have been inconsistent. PPSV23 contains 12 serotypes in common with PCV13 and 11 additional serotypes. In 2013, 38% of IPD among adults aged ≥65 years was caused by serotypes unique to PPSV23. Given the high proportion of IPD caused by serotypes unique to PPSV23, broader protection is expected to be provided through use of both PCV13 and PPSV23 in series. ACIP considered multiple factors when determining the optimal interval between a dose of PCV13 and PPSV23, including immune response, safety, the risk window for protection against disease caused by serotypes unique to PPSV23, as well as timing for the next visit to the vaccination provider.

Both PCV13 and PPSV23 should be administered routinely in series to all adults aged ≥65 years.

Pneumococcal vaccine-naïve persons. Adults aged ≥65 years who have not previously received pneumococcal vaccine or whose previous vaccination history is unknown should receive a dose of PCV13 first, followed by a dose of PPSV23. The dose of PPSV23 should be given 6–12 months after a dose of PCV13. If PPSV23 cannot be given during this time window, the dose of PPSV23 should be given during the next visit. The two vaccines should not be coadministered, and the minimum acceptable interval between PCV13 and PPSV23 is 8 weeks.

Previous vaccination with PPSV23. Adults aged ≥65 years who have previously received ≥1 doses of PPSV23 also should receive a dose of PCV13 if they have not yet received it. A dose of PCV13 should be given ≥1 year after receipt of the most recent PPSV23 dose. For those for whom an additional dose of PPSV23 is indicated, this subsequent PPSV23 dose should be given 6–12 months after PCV13 and ≥5 years after the most recent dose of PPSV23.

Potential Time-Limited Utility of Routine PCV13 Use Among Adults ≥65 Years. The recommendations for routine PCV13 use among adults aged ≥65 years will be reevaluated in 2018 and revised as needed.

ACIP recommendations for routine use of PCV13 in adults aged ≥19 years with immunocompromising conditions, functional or anatomic asplenia, cerebrospinal fluid leak, or cochlear implants remain unchanged.

Concomitant administration of PCV13 and trivalent inactivated influenza vaccine (TIV) has been demonstrated to be immunogenic and safe. PCV13 can be coadministered with TIV in an adult immunization program. However, a randomized double-blind trial found slightly lower pneumococcal serotype–specific geometric mean concentrations and lower proportion achieving at least a fourfold rise in hemagglutination inhibition assay titer for one of three influenza subtypes (influenza A[H3N2]) with PCV13 plus TIV compared with PCV13 alone or TIV alone among adults aged ≥65 years. Currently, no data are available on coadministration with other vaccines (e.g., tetanus, diphtheria, and acellular pertussis vaccine or zoster vaccine) among adults.

Before administering PCV13, vaccination providers should consult the package insert for precautions, warnings, and contraindications. Vaccination with PCV13 is contraindicated in persons known to have a severe allergic reaction (e.g., anaphylaxis) to any component of PCV13 or PCV7 or to any diphtheria toxoid–containing vaccine.

Source: CDC