Medscape News Troy Brown, RN 6/23/16
The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) voted to recommend that live attenuated influenza vaccine (LAIV;FluMist Quadrivalent, MedImmune) should not be used in the United States for the 2016 to 2017 influenza season. LAIV is the only nasal spray influenza vaccine; the CDC recommends annual influenza vaccination for all persons aged 6 months and older and says people should use either the inactivated influenza vaccine (IIV) or recombinant influenza vaccine instead.
ACIP is a committee of immunization experts that advises the CDC; this is an interim recommendation for the 2016 to 2017 influenza season, as data may be different in future seasons.
Case in point, the ACIP endorsed the quadrivalent nasal spray over influenza shots for children aged 2 to 8 years in 2014.
The vote (13 yes, 1 no, 1 abstain for conflict of interest) follows a review of new data that show LAIV has been ineffective for the last three influenza seasons (2013-2014 through 2015-2016) in children aged 2 to 17 years. The new data show that IIV is more effective than LAIV against influenza A(H1N1)pdm09, and there is uncertainty about whether or not LAIV quadrivalent (LAIV4) is effective against influenza A(H3N2) and influenza B viruses.
Preliminary data from the US Influenza Effectiveness Network showed that during the 2015 to 2016 season, LAIV vaccine effectiveness against any influenza virus among children aged 2 through 17 years was only 3% (95% confidence interval, −49% to 37%) compared with 63% (95% confidence interval, 52% - 72%) for IIV. LAIV vaccine effectiveness was also "poor and/or lower than expected," during the 2014 to 2015 and 2013 to 2014 seasons, according to a CDC news release.
There are fewer data in adults, but tests in active military personnel showed poor vaccine effectiveness for LAIV3/4 against A(H1N1)pdm09.
Data about the effectiveness of LAIV before and soon after licensure suggest it was at least as effective as IIV. The US Food and Drug Administration approved quadrivalent LAIV in February 2012. An earlier trivalent version of LAIV was approved in June 2003 and was later replaced by the quadrivalent formulation.
Tom R. Frieden, MD, MPH, director of the CDC, addressed the committee before the meeting; he acknowledged that yesterday's decision was a challenging one, but urged the committee not to postpone it. "In public health, we are often faced with a situation of having to take action based on what we know today, because if there is one thing we always have to keep in mind, [it is that] a nondecision is also a decision," he said.
The committee discussed potential programmatic implications of taking the LAIV off the table. There are a total of 171 to 176 million projected influenza vaccine doses; LAIV accounts for 8% (14 million projected doses) of the total projected influenza vaccine supply. Providers may have difficulty purchasing other vaccines, and not all vaccine products are licensed for all age groups.
Some 5% of schoolchildren were vaccinated against influenza at school in recent seasons. Of those, 55% received LAIV.
The committee was asked to vote on whether to recommend that LAIV not be used at all, or whether it could be used in certain situations in which a person might not otherwise be vaccinated, such as when IIV is not available or when a patient or their parent refuses an injectable vaccine such as IIV.
"Dr Frieden had certainly seen this data before he came this morning. What he tried to focus on was the need to make decisions based on imperfect data, and that, as a science-driven group, you have to make a decision about whether we have actionable data," Nancy Messonnier, MD, director, National Center for Immunization and Respiratory Diseases, CDC, said. Dr Messonnier is an Ex Officio committee member.
"My understanding from the working group deliberations is that despite the fact that there are discrepancies in the data, the working group felt strongly that this data was actionable...where they fell out of consensus was whether that was an absolute, 'you should not use this vaccine,' which is what [the American Academy of Pediatrics] is saying, or whether or not — partly because of some of these programmatic issues, which [the American Academy of Family Physicians] is pointing out — there should be some space where, if clinicians didn't have another option, it was better to give this than nothing," Dr Messonnier explained.
"It's the younger adults and children who tend to get more severe disease with H1N1, which is also the group that the IIV is targeted for," said voting committee member Kelly Moore, MD, MPH, director, Tennessee Immunization Program, Tennessee Department of Health, and assistant clinical professor, Department of Health Policy, Vanderbilt University School of Medicine, Nashville, Tennessee. "I would not feel comfortable knowing ahead of time that [LAIV] wouldn't work against that or there is not evidence of effectiveness."
Dr Moore added, "The public looks to us to make recommendation about the best possible vaccine.... We can find other places, other providers for those children to get vaccines if there are individual spot shortages."
The CDC's director must review and approve the committee's recommendation before it becomes CDC policy.
Reasons for Ineffectiveness Unclear
A number of factors can affect how well the influenza vaccine works, and its effectiveness can vary a great deal from season to season. These factors include characteristics of the person receiving the vaccination, the similarity between viruses used in the vaccine and circulating viruses, and which vaccine is being used. LAIV vaccines, which contain live, weakened influenza viruses, can stimulate a stronger immune response than IIV vaccines, which contain inactivated virus.
Vaccines for Children Program
The committee voted (13 yes, 1 no, 1 abstain for conflict of interest) to remove LAIV from the Vaccines for Children (VFC) program. The IIV component of the program will not be changed.
The VFC program is a federally funded program that provides free vaccines to children who are unable to pay for them.
"For VCF vaccines, providers receive those; they don't purchase [or] pay for those. We provide contracts and make doses available to states for the VFC program...we will make vaccines available for children that are covered by the VFC program, and those are the vaccines that providers in the VFC program will get and will be able to administer," Jeanne Santoli, MD, MPH, deputy director, Immunization Services Division, National Center for Immunization and Respiratory Diseases, CDC, explained.
"[Providers] don't bill for those; they bill for the administration fee, and that will happen as normal, but this is limiting what the formulary will be for the vaccines in the VFC program this year," Dr Santoli added.
Shared from: Medscape Pulmonary Medicine>Viewpoints
Non-pharmacological Treatments for COPD
Mulhall P, Criner G
Respirology. 2016 Apr 21. [Epub ahead of print]
Despite excellent bronchodilators for chronic obstructive pulmonary disease (COPD), and their continued development in regard to both potency and delivery, a substantial proportion of the COPD population remains impaired and continues to experience deterioration in their overall wellbeing. However, there are nonpharmacologic treatments that can provide relief for many patients.
The most important of these is smoking cessation. For continuing cigarette smokers, no pharmacologic therapy will provide more relief than quitting smoking. The use of a pharmacologic agent to assist patients in discontinuing smoking, such as one of the current nicotine replacement therapies (NRTs), should be reinforced by counseling and follow-up. The most effective NRT is likely the electronic cigarette, of which there are now several varieties. Studies have shown that the use of an NRT can double the quit rate of cigarette smoking. Besides NRTs, there are three approved medications that may further facilitate smoking cessation. These are bupropion (Zyban®), varenicline (Chantix®), and cytisine (Tabex™). Comprehensive care management programs (CCMPs) can also facilitate smoking cessation and should be more widely used. Most medical centers are able to provide access to a CCMP.
Telemedicine allows patients with COPD to connect electronically with a specialized care consultant. Telemedicine can be used to collect information from the patient and track his or her progress on a daily basis, if necessary. It has been used to alert the medical team to the early onset of acute exacerbation of COPD, thus avoiding emergency department visits and hospital admissions. However, more evidence is needed as some studies state that "telemonitoring for COPD is not yet proven and further work is required."
Pulmonary rehabilitation aims to counteract the loss of skeletal muscle that is common in COPD and to improve exercise tolerance and exertional dyspnea. Pulmonary rehabilitation consists of a variety of interventions including exercise training, nutritional supplementation, and psychosocial support, which is usually under the supervision of physiatrists in a special clinic. According to the current review, no improvements in survival or lung function have been reported thus far; however, there have been improvements in health-related quality of life, dyspnea, and exercise tolerance. There has also been a tendency for any accumulated improvements to deteriorate with time unless the above modalities are continued.
Long-term oxygen therapy is also an option for some patients with COPD. Short-term oxygen administration during exercise in patients with any degree of hypoxemia has long been known to improve dyspnea and increase exercise tolerance. However, short-term oxygen administration does not appear to improve survival. For patients who are chronically hypoxemic (resting PaO2<55 mm Hg at rest), long-term oxygen therapy (18 or more hours of oxygen every day) not only improves exercise performance but improves survival substantially.
In the treatment of acute exacerbations of COPD, bilevel noninvasive positive pressure ventilation(NIV) has been effective. Gas exchange and respiratory mechanics are improved, resulting in decreases in intubation rates, shortening hospitalizations, and improving mortality. However, its long-term role in managing chronic hypoxemia due to COPD has not been demonstrated. A meta-analysis of several studies in which nocturnal NIV was given to subjects with hypercapnic COPD for 3 months was unable to demonstrate that lung function, gas exchange, or sleep efficiency were significantly improved.
Patients with severe emphysema typically have bullae, usually worst in the upper zones of the lung. These occupy space within the thorax but do not provide much gas exchange. In fact, they are likely to impair the function of less diseased lungs by occupying dead space within the thorax and contributing to air trapping and ventilation/perfusion mismatching. The aim of surgical lung volume reduction is to remove nonfunctional lung and thus improve lung physiology and symptoms. In the large study of its kind, the NET Trial, the only patients to receive benefit were those with predominantly upper lobe disease and low prior exercise tolerance. Other subjects tended to have higher mortality. The procedure is rarely performed today, but there are attempts to achieve a similar outcome, a reduction in dead-space lung, by less invasive methods. These employ the placement of one-way valves in the lung airways that allow gas to leave bullae but not inspiratory flow. The valves, usually more than one, are placed bronchoscopically. In general, some improvement in lung function, less dyspnea, and improvements in exercise capacity have been obtained. But there has usually been an increase in adverse effects, including acute exacerbations of COPD and pneumothorax, sometimes requiring removal of the valve(s). Other experimental lung procedures with the same aim have attempted to collapse the most emphysematous lung regions by closing the airways to those regions by other means, but development of these modalities is incomplete.
Lung transplantation has been an option for patients with severe COPD since 2000, with 50% survival being in the region of 5 years and steadily improving. It should be considered only in patients with end-stage COPD, only when all other therapies have been tried and failed to provide relief, and should only be performed in those few centers where transplant surgery is routinely performed. Primary graft failure, chronic rejection, and infection are common problems. However, there can be successes where lung function and quality of life can markedly improve, and outcomes are improving with time.
ViewpointCOPD is now the third leading cause of death in the western world and remains a condition where much advancement in therapy is needed. Smoking cessation remains a major goal, although great strides have been taken. Unfortunately, pulmonary rehabilitation has turned out to be less effective than rehabilitation for other systemic disorders. Its place in the routine management of COPD is today unclear.
To the above modalities of nonpharmacologic treatments for COPD, one can add the development in electronic communications between the patient and the pulmonary team. With modern and developing telemetry, real-time information can be exchanged between patients, the pulmonary care team, and others involved in patient care.