UK PHE: Revisiting Influenza Antiviral Recommendations

Credit UK PHE

 

# 9283

 

Last spring the Cochrane group made headlines (again) for their less-than-sparkling review of the influenza antiviral drug oseltamivir (Tamiflu ®), which cast doubts on its efficacy and on the wisdom of governments around the world stockpiling the drug. (see Revisiting Tamiflu Efficacy (Again)).  

The Cochrane Summary is available at:

Neuraminidase inhibitors for preventing and treating influenza in healthy adults and children

Editorial Group: Cochrane Acute Respiratory Infections Group

Published Online: 10 APR 2014

These results were then picked up by tabloid (and other) media sources, tortured to within an inch of its life, and then splashed across the media as `proof’ that the governments of the world were nothing but shills for Big Pharma (see Ministers blew £650MILLION on useless anti-flu drugs.).

Much of this ire has been garnered through Roche’s long-standing resistance to releasing all of the testing data on their antiviral drug, and that has led to critical editorials in the BMJ, and frequent excoriation in the British press.

 

As a result, many people have come away with the erroneous impression that these drugs are worthless – or worse.   And that could dissuade some from seeking early medical treatment during this year’s flu season, costing lives in the process. 

While research purists may applaud their methods, the problem that I (and many others) have with this analysis is that the Cochrane group set the bar much too high as to what studies they would consider, excluding many observational studies. 

 

They also were looking at the effects of Tamiflu on healthy children and adults – those least likely to see benefits from taking antivirals.

 

Despite its critics, there are studies that show that Tamiflu can significantly reduce morbidity and mortality associated with influenza – particularly with severe infection, or those with comorbidities. Some we’ve looked at in the past include:

 

• In 2010 we saw an observational study that appeared in JAMA (see Study: Antivirals Saved Lives Of Pregnant Women) that strongly suggested that Tamiflu was life saving for some patients with pandemic flu.
• And again in 2010, in BMJ: Efficacy of Oseltamivir In Mild H1N1, we saw a study which suggested that the administration of oseltamivir may have significantly reduced the incidence of pneumonia among otherwise healthy pandemic H1N1 patients.
• In December of 2012, in Study: The Benefits Of Antiviral Therapy During the 2009 Pandemic we looked at a meta-analysis of 90 observational studies that appeared in the  Journal of Infectious Diseases that spanned nearly 35,000 patients, 85% of whom has laboratory confirmed H1N1.

Their main finding was antiviral therapy - principally oseltamivir - initiated within 48 hours of onset, reduced the likelihood of severe outcomes, namely admission to a critical care unit or death, by 49 to 65%.

• Last March in The Lancet: Effectiveness Of NAI Antivirals In Reducing Mortality In Hospitalized H1N1pdm09 Cases we looked at yet another observational study conducted by researchers at The University of Nottingham – that reviewed more than 29,000 hospitalized H1N1pdm cases across 38 countries between 2009 and 2011, and found that the administration of NAI antivirals was associated with a 19% reduction in mortality compared to receiving no NAI treatment at all.
• And last summer, in  CID Journal: Under Utilization Of Antivirals For At Risk Flu Patients, we saw a study showing that antiviral drugs are underused for at-risk patients, while antibiotics (which don’t work against viral infections) are overused.

 

While it is true that antivirals are of limited value for those who are healthy, and suffering from uncomplicated seasonal influenza, the preponderance of evidence shows significant benefits from the early administration in cases of severe infection, co-morbidities, or infection with novel influenza strains.

One of the most dramatic avian flu studies (see Study: Antiviral Therapy For H5N1) looked at the outcomes of H5N1 patients who either received, or did not receive, antiviral treatment. The research appears in the IDSA’s Journal of Infectious Diseases.

 

The bottom line is essentially out of 308 cases studied, the overall survival rate was a dismal 43.5%. But . . . of those who received at least one dose of Tamiflu . . .  60% survived . . .  as opposed to only 24% who received no antivirals.

 

Last April we saw the The CDC Responds To The Cochrane Tamiflu Study, where they provided their rationale for continuing to recommend its use. You can visit the CDC’s current advice on antiviral administration (which is unchanged) at this site:

 

Recommendations of the Advisory Committee on Immunization Practices (ACIP): Information for Health Care Professionals

The information on this page should be considered current for the 2014-2015 influenza season for clinical practice regarding the use of influenza antiviral medications. Also see the current summary of recommendations available at Influenza Antiviral Medications: Summary for Clinicians and a list of related references at Antiviral Guide References.

 

Today the UK’s Public Health England has released the following recommendations, which also restates their position on the use of antivirals: Influenza: treatment and prophylaxis using anti-viral agents  4 November 2014. 

In addition to their recommendations, you’ll also find a push-back against the Cochrane study.

Update following the 2014 Cochrane Review Public Health England (PHE) has produced a summary of the current guidance and evidence and a position statement on the use of antivirals for the treatment and prophylaxis of influenza. (2). The PHE summary and position statement has been published following the 2014 Cochrane Review on the efficacy of antivirals (3). The findings of the 2014 Cochrane review were not substantially different to the previous (2010 and 2012) reviews. Overall the 2014 review adds to the evidence base for the treatment of influenza in some settings, however the conclusions made are limited due to the variation in outcomes, patient groups, and settings studied.

The key messages from the summary are:

• there is evidence that antivirals can reduce the risk of death in patients hospitalised with influenza
• in the light of this evidence, it is important that doctors treating severely unwell patients continue to prescribe these drugs where appropriate
• PHE continues to support the early use of antivirals for patients with proven or suspected seasonal influenza who are in high risk groups, or who are considerably unwell (even if not in a high risk group)

This position is consistent with that taken by the World Health Organisation (WHO) and other national public health organisations such as the USA’s Centers for Disease Control and Prevention (CDC). Although there is no evidence to support any change to the recommended use of neuraminidase inhibitor, media reporting around the Cochrane Review 2014 publication suggested that antivirals are not effective for influenza. This may impact the prescribing of these important drugs. It is essential that physicians treating severely unwell patients in any setting are not deterred from prescribing what may be lifesaving drugs as a result of confusion over efficacy in this situation; this is especially true for patients hospitalised with proven or suspected influenza.

Download the full 22 page PDF file

WHO Video: Updated Recommendations For PPEs For Current Ebola Outbreak

 

# 9270

 

Dr. Edward Kelley, Director, Service Delivery and Safety, at the World Health Organization held a 40 minute press conference in Geneva today to preview some upcoming changes to the WHO’s recommendations for HCWs Personal Protective Equipment (PPEs) when dealing with Ebola.

With well over 500 healthcare workers already infected (albeit, not all while working with patients), finding practical ways to protect those working (often in resource limited places) with Ebola patients becomes a major priority.

 

While stressing that PPEs are only part of a layered IPC (Infection Protection Control) system, Dr. Kelley cited several areas of PPE safety. The new guidance (which should be posted later today on the WHO website) also stresses training in the donning and doffing of PPEs.

 

1. Protection of the mucosa of the eyes, nose and mouth – with an emphasis on masks that do not lie flat against the face, which tend to get moist and deteriorate in high heat environments.
2. Hand Hygiene including strongly recommending double gloving.
3. New guidance on the use of gowns and coveralls
4. Guidance on footwear
5. Guidance on head covers

 

Many of these recommendations are clarifications, or incremental changes, but some are clearly more stringent – such as the recommendation for double gloving (nitrile),  the need for masks that are structured to lie away from the face, and recommendations (where appropriate) to provide cover for the head and neck.

 

I’ll update this blog post with the links to the new guidance documents when they become available.

Note: The PDF File is now online, click the image below:

 

You can watch the press conference by clicking this link, or the image below:

 

KSA MOH Updates Health Protection Advice For Umrah & Hajj

 

 

# 7477

 

Last month the Kingdom of Saudi Arabia announced an abrupt Limit to Umrah & Hajj Visitors this year, citing construction as the Grand Mosque as the primary reason behind a 20% cutback in Visas.

 

Many observers believed the recent surge in MERS-CoV cases were the real reason behind this decision - but until today - we’ve not seen any official acknowledgment of that from the MOH.  

 

Today the MOH published (in Arabic) updated requirements and advice for Hajj and Umrah visitors this year (h/t Ironorehopper on FluTrackers).

 

The most notable change is they are now publically citing MERS-CoV as the reason why the elderly, those with chronic illnesses, immune dysfunctions, as well as pregnant women and children ought not to make a pilgrimage this year.

 

Here is a machine translation of today’s statement (bolding mine).

 

Hajj and Umrah requirements for the year 1434 AH

September 04, 1434  (July 12th, 2013)

Ministry of Health issued health requirements that must be met in coming for Umrah and Hajj 1434 H as part of precautionary measures for disease virus Koruna new (MERS-COV) and so out of the keenness of the Government of the Custodian of the Two Holy Mosques in maintaining the health of everyone and provide an atmosphere healthy and safe, God willing, for the pilgrims and pilgrims to perform This all rites smoothly and health and contentment.

 

I have included these requirements issued by the ministry's recommendation to postpone the performance of Umrah and Hajj this year for the elderly and people with chronic diseases as patients heart, kidney, respiratory and diabetes, as well as patients with immune deficiency congenital and acquired, in addition to ill tumors, as well as pregnant women and children.

 

It also included requirements set of tips and guidance health awareness for citizens, residents and pilgrims of them; pollutants to wash your hands thoroughly with soap and water or disinfectant other allocated to it, especially after coughing and sneezing, as well as the use of tissue when coughing or sneezing and dispose of the waste basket, in addition to not touch eyes, nose and mouth by hand, and the reduction of direct contact with the injured and non-participation tools personal, as well as the wearing of masks in crowded locations, and maintaining personal hygiene as a whole.

 

These requirements also included on the next to get a valid certificate of vaccination against meningitis before the advent of the Kingdom of not less than 10 days and not more than 3 years, as well as get a certificate of vaccination against polio-affected countries, according to specific requirements.

 

Also included stipulations importance of vaccination against seasonal flu vaccine, especially for people with chronic diseases such as heart, kidney, diabetes and respiratory and neurology as well as diseases of HIV congenital and acquired, and metabolic diseases, as well as pregnant women and children less than 5 years and those with obesity.

 

 

The advice to wear a facemask is not exactly new, as ARIs (Acute Respiratory Infections) have been common health complaints during the Hajj and Umrah, and calls for wearing masks have been made often over the years.

 

Last year, in The Hajj: communicable and non-communicable health hazards and current guidance for pilgrims masks were recommended to reduce the spread of TB and other respiratory illnesses, and similar calls have been made in the past, including in 2009 during the H1N1 pandemic.

 

The wearing masks is mentioned repeatedly on the KSA MOH web page on Health Tips to Be Followed During Hajj.  A couple of examples include:

 

• Face-masks are recommended at crowded and congested places, especially during circumambulation of the Ka'ba (Tawaf), stoning (Rajm), and walking between Safa and Marwa (Sa'i). They should be changed regularly (every six hours), or when dirty, in accordance with the guidelines provided by the manufacturer, along with washing hands with water and soap when taking them off.
• Using face-masks, especially in overcrowded places, and changing them every now and then (in accordance with the manufacturer's instructions) helps protect you from the infectious diseases transmitted through coughing or sneezing.

 

Compliance with this advice is apparently difficult, as Islam teaches that women may not `cover their face’ while in Ihram (a sacred state which a Muslim must enter in order to perform the Hajj or Umrah).

During the 2009 Pandemic the Grand Mufti of Saudi Arabia permitted the use of masks while performing the Umrah, stating that it was not the same as `covering the face’, but stated `that it should not be used unless needed.’

 

In the November 2009 edition of the EID Journal, a report entitled Hajj Pilgrims’ Knowledge about Acute Respiratory Infections

 

Saudi health authorities recommend use of surgical face masks (5); however, data conflict about the protective effect of such masks during the pilgrimage (5,6). Use of face masks varies according to the origin of Hajj pilgrims; in 1 study, only 15% of pilgrims from the Middle East, 17% from Europe and the United States, and 45% from Southeast Asia used a mask (4). Promotion and distribution of free masks increased their use from 34% to 81% in another cohort of Saudi pilgrims (6).

 

National Health Service for England does not advise the use of masks, considering compliance with this advice unlikely because many Muslims believe that covering the face during the Hajj is prohibited and because masks need to be of high quality and changed at least every 6 hours to remain effective (7).

 

Recent studies demonstrated that surgical and N95 masks were equally effective in preventing spread of PCR-detectable influenza virus when used by infected patients. These masks also were potentially effective at preventing respiratory virus acquisition by household contacts of infected persons when worn by healthy persons. However, effectiveness depended largely on adherence to mask use (8,9).

 

And finally, I should point out that the World Health Organization has not (at this time) issued any advice for religious pilgrims to Saudi Arabia to wear masks (see WHO: MERS, Masks, And The Media).

WHO: Updated MERS-CoV Surveillance Recommendations

Photo Credit WHO

 

#7434

 

Late this week the World Health Organization released revised MERS-CoV Surveillance recommendations that emphasize the need for taking lower respiratory specimens for diagnostic testing, and extend the supposed incubation period of the virus up to 2 weeks.

 

These changes come about as a result of studies (see The NEJM Saudi MERS-CoV Cluster Report & The Lancet: Virological Analysis Of A MERS-CoV Patient) recently published on cases in Saudi Arabia and France.

 

This document reiterates the WHO’s request that all `probable and confirmed cases be reported within 24 hours of classification, through the Regional Contact Point for International Health Regulations at the appropriate WHO Regional Office’.

 

First a link and some excerpts from the document, then a link to last night’s CIDRAP overview of MERS-News.

 

 

Interim surveillance recommendations for human infection with Middle East respiratory syndrome coronavirus

As of 27 June 2013

Update

WHO is updating its guidance for surveillance for Middle East respiratory syndrome coronavirus (MERS-
CoV) that were first published in late 2012. WHO will continue to update these recommendations as
new information becomes available.

 

This document summarizes WHO recommendations, and is not a comprehensive summary of current
case reports, which are found on WHO’s novel coronavirus page
(http://www.who.int/csr/disease/coronavirus_infections/en/).

It is important to note that these WHO recommendations need to be implemented in different countries with varying resources and
epidemiological patterns.

 

Two key changes in this 27 June 2013 update 

• Stronger recommendations for lower respiratory specimens, rather than nasopharyngeal swabs, to be used to diagnose MERS-CoV infection.
• A longer period of observation for contacts of cases; this is based on accumulating information about the incubation period.

<SNIP>

 

Recommendations for specimen collection
It is strongly advised that lower respiratory specimens such as sputum, endotracheal aspirate, or
bronchoalveolar lavage should be used when possible until more information is available. If patients do not have signs or symptoms of lower respiratory tract infection and lower tract specimens are not possible or clinically indicated, both nasopharyngeal and oropharyngeal specimens should be collected.

 

The two can be combined in a single collection container and tested together. If initial testing of a nasopharyngeal swab is negative in a patient who is strongly suspected to have MERS-CoV infection, patients should be retested using a lower respiratory specimen or a repeat nasopharyngeal specimen with additional oropharyngeal specimen if lower respiratory specimens are not possible. For patients in whom adequate lower respiratory samples are not possible, investigators may also want to consider other types of auxiliary testing such as nasopharyngeal wash and paired acute and convalescent sera.

 

Virus has also been demonstrated in other body fluids such as blood, urine, and stool but the usefulness of those body fluids in diagnosing MERS-CoV infection is uncertain.

(Continue . . . )

 

 

For more on this, and a round up of additional MERS-CoV news, I’d invite you to visit CIDRAP NEWS and read Robert Roos & Lisa Schnirring’s report from last night.

 

WHO revises MERS-CoV surveillance advice

Filed Under:

MERS-CoV

Robert Roos and Lisa Schnirring | Staff Writers | CIDRAP News

 

The World Health Organization (WHO) yesterday updated its surveillance recommendations for MERS-CoV (Middle East respiratory syndrome coronavirus) to make them consistent with recent findings about diagnostic samples and the disease's potentially long incubation period.

(Continue . . . )

 

WHO: Revised NCoV Surveillance Recommendations

 

Credit WHO

 

# 7012

 

Last week we learned that the index case in the UK family cluster of novel coronavirus infection – returned from the Middle East last month – was co-infected with influenza A (see Eurosurveillance: H2H Transmission of NCoV In UK Family Cluster), and that two family members were co-infected with Type 2 parainfluenza virus.

 

His positive influenza A test led to a week’s delay in diagnosing the patient’s underlying NCoV infection. 

 

As you might expect – with only 15 confirmed infections worldwide – there is still much unknown about this emerging virus, and the World Health Organization  must continually update and adjust their surveillance recommendations as new data is received.

 

Yesterday, WHO released updated interim guidance on surveillance, parts of which are excerpted below:

Interim surveillance recommendations for human infection with novel coronavirus

As of 18 March 2013

Update

This document provides updated surveillance guidance for novel coronavirus (nCoV). WHO will continue to update these recommendations as more information becomes available.

Current numbers and descriptions of reported cases are found on the main WHO novel coronavirus page.

The primary changes included in this revision are:

• Addition of a recommendation to test individuals with unusually severe respiratory disease even in the presence of another aetiology if the other agent does not fully explain the patient’s illness.
• Specific revised recommendations for countries where the novel coronavirus has been detected.
• Recommendations for investigations and studies to be carried out where cases are detected, which may help describe critical clinical and epidemiological features of the virus.

Background

A number of unanswered questions remain, including the virus reservoir, the means by which seemingly sporadic infections are being acquired, the mode of transmission between infected persons, the clinical spectrum of infection and the incubation period.

In 2013 a third cluster of cases now provides clear evidence of limited, non-sustained human-to-human transmission {HPA LINK }. The mode of transmission has not been determined. One of the cases in the cluster originally tested positive for influenza A and was not initially thought to have infection with nCoV.

One laboratory-confirmed case and one probable case have presented with relatively mild illness with an uneventful recovery; however, most patients have had severe pneumonia. To date, there have been 15 laboratory-confirmed cases of nCoV infection, of which nine have died.

Complications of their clinical course have included severe pneumonia and acute respiratory distress syndrome requiring mechanical ventilation, multi-organ failure, renal failure requiring dialysis, consumptive coagulopathy and pericarditis. At least two cases had a history of recent travel, which occurred five to ten days before onset of illness.

Currently the virus has been found in a limited number of countries, mainly in the WHO Eastern Mediterranean Region.1 However, given the non-specific clinical presentation of the infection the presence of the virus in other areas cannot be ruled out in the absence of laboratory testing.

Objectives of surveillance

The primary objectives of the enhancements described in this document are to:

1 See: http://www.emro.who.int/landing-pages/countries/countries.html

1. Detect early, sustained human-to-human transmission.
2. Determine the geographic risk area for infection with the virus.

Additional clinical and epidemiological investigations (see table below) are needed to:

1. Determine key clinical characteristics of the infection, such as incubation period, the spectrum and natural history of the disease.
2. Determine key epidemiological characteristics of the virus, such as exposures that result in infection, risk factors, reservoir of the virus, secondary attack rates, and modes of transmission.

The following persons should be evaluated epidemiologically and tested for novel coronavirus:

1. A person with an acute respiratory infection, which may include history of fever and cough and indications of pulmonary parenchymal disease (e.g. pneumonia or the acute respiratory distress syndrome [ARDS]), based on clinical or radiological evidence of consolidation, who requires admission to hospital.
   AND any of the following:

• The disease occurs as part of a cluster that occurs within a 10-day period , without regard to place of residence or history of travel, unless another aetiology has been identified.
• The disease occurs in a health care worker who has been working in an environment where patients with severe acute respiratory infections are being cared for, particularly patients requiring intensive care, without regard to place of residence or history of travel, unless another aetiology has been identified.
• Develops an unexpectedly severe clinical course despite appropriate treatment, without regard to place of residence or history of travel, even if another aetiology has been identified, if that alternate aetiology does not fully explain the presentation or clinical course of the patient.

    2. A person with an acute respiratory illness of any degree of severity who, within 10 days  before onset of illness, had close contact with a confirmed or probable case of novel coronavirus infection, while the case was ill.

   3. For countries where the novel coronavirus has already been detected, the minimum standard for surveillance should be testing of patients with severe respiratory disease requiring mechanical ventilation. The minimum standard should include all those in three categories listed above—patients with unexplained pneumonia or ARDS occurring in clusters; health care workers requiring admission for respiratory disease and patients with unusual presentation or clinical course. However, countries where the novel coronavirus has already been detected are also strongly encouraged to consider adding testing for nCoV to current testing algorithms as part of routine sentinel respiratory disease surveillance and, if local capacity can support it, some testing of patients with milder, unexplained, community-acquired pneumonia requiring admission to hospital.

   4.  WHO does not advise special screening at points of entry with regard to this event nor does it recommend that any travel or trade restrictions be applied.

 

Reporting

Health care providers should report all cases meeting the confirmed or probable case definition immediately, to national authorities, through established reporting channels

 

(Continue . . . )

 

ACP Calls For Health Care Worker Immunizations

 

Photo Credit – CDC PHIL

# 5854

 

Today the American College of Physicians (ACP) – the second largest physician group in the United States – issued a statement supporting the immunization of all health care workers against influenza, along with a variety of other vaccine-preventable communicable diseases (including diphtheria; hepatitis B; measles, mumps, and rubella; pertussis (whooping cough); and varicella.

 

Their policy recommendations fall short of calling for across-the-board `mandatory’ vaccinations, as they do allow for exemptions due to medical reasons or religious objections to immunization.

 

You may recall that last October the  CMAJ (Canadian Medical Association Journal) endorsed requiring HCWs (Health Care Workers) to get a seasonal flu shot (see CMAJ On Mandatory Flu Shot For HCWs).

 

While strongly advocating influenza vaccination for HCPs, the CDC has stopped short of mandating them. I blogged on this back in June of 2010 (see CDC: Proposed Influenza Infection Control Guidance).

 

Many professional medical organizations have taken a stronger stance, adopting policies calling for mandatory vaccination of health care workers (HCWs).  A few earlier blogs on this include:

 

APIC Calls For Mandatory Flu Vaccination For HCWs

AAP: Recommends Mandatory Flu Vaccinations For HCWs

SHEA: Mandatory Vaccination Of Health Care Workers

IDSA Urges Mandatory Flu Vaccinations For Healthcare Workers

 

This latest call for flu vaccination comes as the first state-mandated flu vaccine requirement for HCWs – see Rhode Island Adopts New Flu Vaccination Requirements For HCPs - is being contested by a healthcare worker’s union in court. 

 

This from AMEDNEWS.COM.

 

First state flu shot mandate at center of legal battle

A union is suing Rhode Island over a regulation requiring all health workers to receive influenza vaccine or wear masks while they’re working.

By Alicia Gallegos, amednews staff. Posted Jan. 14, 2013.

The Rhode Island Dept. of Health is asking a federal judge to throw out a lawsuit challenging its recently issued mandate that health care employees receive the influenza vaccine.

(Continue . . . )

 

While many infection control experts see mandatory immunization a necessary and long overdue step in patient and co-worker protection, this is a hugely divisive issue, with many HCWs believing that it is an infringement of their rights to decide what will be injected into their bodies.

 

I’ve covered HCW’s objections to forced flu shots in the past, including:

 

HCWs: Refusing To Bare Arms

HCWs: Developing a Different Kind Of Resistance

 

Despite recent studies showing that flu shots provide only about 60% protection against influenza, many hospitals see this as both a liability and an economic issue, on top of their concerns over patient welfare.

 

Which is why – despite protests from some employees – an increasing number of hospitals and medical offices are making flu vaccination mandatory over the past few years. A couple of recent examples include:

 

Mandatory Flu Shots For Children's Medical Center Employees

Hospital's 'Cocoon Strategy' Aimed At Protecting Young Patients

 

Local health system mandates flu vaccine for upcoming season

 

 

 

Here is the ACP link, and some excerpts, from today’s press release:

 

American College of Physicians calls for immunizations for all health care providers

40,000 to 50,000 adults die from vaccine-preventable diseases each year in the U.S.

PHILADELPHIA, January 14, 2013 -- The American College of Physicians (ACP) has approved a policy recommendation that all health care providers (HCPs) be immunized against influenza; diphtheria; hepatitis B; measles, mumps, and rubella; pertussis (whooping cough); and varicella (chickenpox) according to the Advisory Committee on Immunization Practices (ACIP) Adult Immunization Schedule. ACP’s policy exempts HCPs for medical reasons or a religious objection to immunization.

 

“These transmissible infectious diseases represent a threat to health care providers and the patients we serve, who are often highly vulnerable to infection,” said David L. Bronson, MD, FACP, president, ACP. “Proper immunization safely and effectively prevents a significant number of infections, hospitalizations, and deaths among patients as well as preventing workplace disruption and medical errors by absent workers due to illness.”

 

With a severe flu season underway, ACP urges all adults to get a flu shot if they haven’t already and to talk with their internist about other immunizations they might need. Only 39 percent of adults received the flu vaccine during the 2011-12 season. People who cannot get a flu shot or other immunizations for medical reasons should talk to their internist about other ways of protecting themselves.

 

ACP is committed to improving public health through encouraging appropriate immunization of adults. In August 2012, ACP was awarded an initial $175,000 of a total $525,000 grant for 2012-13 from the Centers for Disease Control and Prevention (CDC) to create a three-year, evidence-based program to increase adult immunization rates in five states. In addition, the American Board of Internal Medicine (ABIM) approved practice improvement credit for the Medical Home Builder adult immunization module for recertifying physicians.

 

(Continue . . . )

Popular among HCWs or not  – short of an overturn in the courts – the requirement for annual flu vaccinations in HCPs continues to gain traction across the country, and around the world.

 

WHO: Northern Hemisphere 2012-2013 Flu Vaccine Composition

 

Photo Credit PHIL

# 6167

 

 

After consultations this week with public health officials, researchers, and pharmaceutical companies the World Health Organization has released their recommendation for the antigen composition of this fall’s trivalent flu vaccine.

 

 

Recommended composition of influenza virus vaccines for use in the 2012-2013 northern hemisphere influenza season

It is recommended that vaccines for use in the 2012-2013 influenza season (northern hemisphere winter) contain the following:

• an A/California/7/2009 (H1N1)pdm09-like virus;
• an A/Victoria/361/2011 (H3N2)-like virus;
• a B/Wisconsin/1/2010-like virus.

For more information

Recommended composition of influenza virus vaccines for use in the 2012-2013 influenza season - full report
pdf, 521kb

 

Due to the continual antigenic drift of flu viruses, flu vaccine formulations are frequently adjusted. After 3 years with essentially no changes in the flu vaccine, this new formulation makes changes to both the H3N2 and B virus strains.

 

The H1N1 component remains essentially unchanged, with the A/California/7/2009 (H1N1)pdm09-like  still recommended.

 

• The old A/Perth/16/2009 (H3N2)-like virus now gives way to the A/Victoria/361/2011 (H3N2)-like virus.
• And the Victoria lineage B/Brisbane/60/2008-like virus will be replaced by a Yamagata strain; the B/Wisconsin/1/2010-like virus. 

 

While the World Health Organization makes vaccine recommendations twice each year (Recommendations  are made in September for the Southern Hemisphere), national and regional public health organizations are responsible for deciding what formulation to use locally.

ACIP Broadens Adult Immunization Recommendations

 

Photo Credit PHIL

# 6113

 

 

ACIP, the CDC's Advisory Committee on Immunization Practices, has published their revised recommendations for adult immunizations today in the February 1st edition of the Annals of Internal Medicine.

 

Among the changes, ACIP now recommends routine HPV vaccination for males aged 11 to 12 years, and has broadened their recommendations for administering the Hepatitis B vaccine.

 

The entire recommendation can be read at:

 

Recommended Adult Immunization Schedule: United States, 2012*

1. Advisory Committee on Immunization Practices†

 

But for the short version, we have this press release from the American College of Physicians.

 

2012 adult immunization schedule broadens recommendations for HPV and hepatitis B vaccinations

Annals of Internal Medicine early release article for Feb. 1, 2012

Philadelphia, February 1, 2012 – The CDC's Advisory Committee on Immunization Practices (ACIP) now recommends routine HPV vaccination for males aged 11 to 12 years and catch-up vaccination for males aged 13 to 21. These are just two of the changes to the 2012 Recommended Adult Immunization Schedule being published February 1 in Annals of Internal Medicine (www.annals.org), the flagship journal of the American College of Physicians (ACP).

 

In addition to the changes in the HPV vaccine, the ACIP now recommends vaccination against Hepatitis B for adults younger than age 60 who have diabetes, as soon as possible after diabetes is diagnosed. Hepatitis B vaccinations should also be given to adults with diabetes aged 60 years or older based on a patient's need for assisted blood glucose monitoring, likelihood of acquiring hepatitis B, and likelihood of immune response to vaccination.

 

The ACIP is comprised of the ACP and 16 other medical societies representing various medical practice areas. Each year, the ACIP reviews the CDC's Recommended Adult Immunization Schedule to ensure the schedule reflects current clinical recommendations for licensed vaccines. The recommendations are intended to guide physicians and other clinicians about the appropriate vaccines for their adult patients. In October 2010, the ACIP adopted an evidence-based process that considers quality of evidence, benefits and harms, values and preferences of affected populations, and economic impact. Voting to expand routine HPV vaccination to males and hepatitis B vaccinations to young adult diabetics was the first exercise of this approach.

 

Changes were also made to when mothers should receive the tetanus, diphtheria, and acellular pertussis (Tdap) booster that is designed to protect infants from pertusiss. According to the 2012 schedule, women should receive the vaccine during pregnancy, preferably after 20 weeks of gestation. Protective maternal antibodies will pass to the fetus.

 

Adult patients should continue to be vaccinated against influenza. Egg allergy is no longer a contraindication, but patients with an egg allergy should get the inactivated flu shot because that is what has been studied.

 

A footnote was added to the schedule directing readers to links for the full ACIP vaccine recommendations. Specific vaccine recommendations for travelers also were added. In another new addition, the schedule now includes a table summarizing precautions and contraindications for vaccines.

###

The full 2012 Recommended Adult Immunization Schedule can be viewed at www.annals.org.

WHO: Southern Hemisphere 2012 Flu Vaccine Composition

 

 

#5876

 

 

Twice each year influenza experts gather to discuss recent developments in human and animal influenza viruses around the world, and to decide on the composition of the next influenza season’s flu vaccine.

 

Due to the time it takes to manufacture a vaccine, decisions on which strains to include must be made six months in advance. 

 

The composition of the northern hemisphere’s vaccine is decided upon in February of each year, and decisions on the southern hemisphere’ vaccine are made in September.

 

Accordingly, last week representatives from divisions of the World Health Organization’s  GISRS (Global Influenza Surveillance and Response System), along with members of OFFLU (the OIE/FAO Network on Animal Influenza), and other experts gathered in Chavannes-de-Bogis, Switzerland.

 

The agenda for this meeting (WHO Consultation on the Composition of Influenza Vaccine for the Southern Hemisphere 2012) states the following objectives:

 

1.  Analyse the antigenic and genetic characteristics of influenza viruses circulating and infecting humans, taking into consideration of available epidemiological and clinical information from individual countries and regions;

 
2.  Make recommendations on the composition of the influenza vaccines for use in the southern hemisphere 2012;

3.  Review the antigenic and genetic characteristics of recent A(H5N1) viruses that the WHO Collaborating Centres of the WHO GISRS received and the need to develop new A(H5N1) candidate vaccine viruses for pandemic preparedness purposes; 

4.  Review the antigenic and genetic characteristics of other subtype influenza viruses, if any, infecting humans recently, and the need to develop new candidate vaccine viruses for pandemic preparedness purposes. 

 

Below are some excerpts from their 15-page report: Recommended composition of influenza virus vaccines for use in the 2012 influenza season - full report

 

 

Zoonotic influenza infections caused by avian A(H5N1), avian A(H9N2) and swine A(H3N2) viruses

From 16 February 2011 to 19 September 2011, 45 confirmed human cases of A(H5N1), 24 of which were fatal, were reported by Bangladesh, Cambodia, Egypt and Indonesia, countries in which highly pathogenic avian influenza A(H5N1) is present in poultry. Since December 2003, a total of 564 cases with 330 deaths have been confirmed in 15 countries. To date there has been no evidence of sustained human-to-human transmission.

One human case of influenza A(H9N2) was detected in Bangladesh and four human infections caused by swine A(H3N2) viruses were detected in the United States of America during the same period. 

 

Under the heading: Antigenic and genetic characteristics of recent isolates, the group found that despite growing diversity among variants of the 2009 H1N1 pandemic virus, the vast majority remain antigenically similar to the original virus.

 

 

Influenza A(H1N1) viruses

Between February and August 2011, all influenza A(H1N1) viruses detected worldwide were A(H1N1)pdm09; no former seasonal A(H1N1) viruses were detected. Haemagglutination inhibition (HI) tests using post-infection ferret antisera indicated that A(H1N1)pdm09 viruses remained antigenically homogeneous and closely related to the vaccine virus A/California/7/2009.

 

The same could be said for the H3N2 virus, where the majority of samples remain antigenically similar to the A/Perth/16/2009 virus which has been part of the flu vaccine for the past couple of years.

 

Influenza A(H3N2) viruses

 

The majority of A(H3N2) viruses collected  from February to August 2011 were antigenically closely related to the vaccine virus A/Perth/16/2009. Antigenic characteristics were assessed with panels of post-infection ferret antisera in HI and virus neutralization assays. The HA genes of recent viruses fell into two phylogenetic clades represented by A/Perth/16/2009 and A/Victoria/208/2009, with the  vast  majority falling within the A/Victoria/208/2009 clade.

 

Influenza B is always a bit of a wildcard, since there are two main strains in circulation, and only one is currently included in the vaccine. In recent years the Victoria strain has been dominant, but the Yamagata lineage waits in the wings and continues to circulate in northern China.

 

Influenza B viruses

Influenza B viruses  of both the B/Victoria/2/87 and the B/Yamagata/16/88 lineages  co-circulated, with B/Victoria/2/87 lineage viruses continuing to predominate globally. However,in  northern  China, B/Yamagata/16/88 lineage viruses predominated from  February  to  May 2011 before influenza activity declined. 

 

 

The bottom line: The bulk of the influenza viruses currently circulating, while they continue to evolve, remain antigenically similar to to those that have been including in the flu vaccine since 2010.

 

When a strain is said to be `antigenically similar’  to the vaccine strain, it is expected (but not assured) that the vaccine remains reasonably effective. 

 

While research and refinements in candidate vaccines continue, next year’s vaccine recommendations for the southern hemisphere remains essentially the same for the third year in a row. 

 

The report concludes:

 

It is expected that  A(H1N1)pdm09, A(H3N2) and B viruses will co-circulate in the 2012 southern hemisphere season.

 

It is recommended that the following viruses be used for influenza vaccines in the 2012 influenza season (southern hemisphere):

– an A/California/7/2009 (H1N1)pdm09-like virus;
– an A/Perth/16/2009 (H3N2)-like virus;
– a B/Brisbane/60/2008-like virus. 

 

 

Flu viruses are constantly changing, mutating, and evolving making any forecast a bit of a gamble. As we saw with the 2009 H1N1 swine flu, a novel virus can emerge and change the viral landscape practically overnight.

 

But despite the variability  and unpredictability of influenza, the track record for selecting influenza A strains for the flu shot has actually been pretty good over the years.

 

We won’t know how well this decision will turn out in the southern hemisphere for another 6 to 12 months, but for those of us north of the equator, this is a pretty good indication that confidence in the makeup of this fall’s flu vaccine remains high.

 

A good enough reason to go ahead and get the shot this year, before flu season arrives.

WHO: Northern Hemisphere 2011-2012 Flu Vaccine Composition

 

 

# 5321

 

 

After consultations this week with public health officials, researchers, and pharmaceutical companies the World Health Organization has released their recommendation for the antigen composition of this fall’s trivalent flu vaccine.

 

 

Recommended composition of influenza virus vaccines for use in the 2011-2012 northern hemisphere influenza season

It is recommended that vaccines for use in the 2011-2012 influenza season (northern hemisphere) contain the following:

• an A/California/7/2009 (H1N1)-like virus;
• an A/Perth/16/2009 (H3N2)-like virus;
• a B/Brisbane/60/2008-like virus.

 

If this list looks familiar, it’s because this is the same mixture the WHO recommended for last fall’s flu shot, and the one to be used over the coming months in the southern hemisphere.

 

The WHO also posted a full report with their rationale for each strain selection which you can access at:

 

Recommended composition of influenza virus vaccines for use in the 2011-2012 influenza season - full report.

 

 

The short version is: while minor variations have been observed in both the 2009 H1N1 and the seasonal H3N2 viruses over the past year, HI (Hemagglutination inhibition) testing of isolates suggest that the vast majority remain antigenically indistinguishable from the recommended strains.

 

Lisa Schnirring, writing for CIDRAP, has a nice summation of today’s report, along with information about new H5N1 vaccine candidates.

 

WHO sticks with current strains for next flu vaccine

Lisa Schnirring Staff Writer

Feb 17, 2011 (CIDRAP News) – Signaling that the current flu strains are likely to persist over the next several months, the World Health Organization (WHO) today recommended sticking with the current trio of vaccine strains for the Northern Hemisphere's next influenza season.

(Continue . . .)

ACCV Teleconference Today

 

 

# 4767

 

 

With the fall flu vaccination campaign slated to begin less than 2 months from now, the ACCV (Advisory Commission on Childhood Vaccines) will hold a teleconference this afternoon to review the CDC's draft statements for the upcoming flu season.

 

Interested parties may listen in, or make a public comment at the end of the meeting. 

 

This notice appears on the right hand news column of the HRSA Vaccine Compensation Website.

 

 

Interim Influenza Vaccine Information Statements Special Meeting

Thursday July 29, 1 to 2 pm ET

The Advisory Commission on Childhood Vaccines will review the CDC's draft statements slated for distribution during the 2010-2011 flu season. The conference call meeting is open to the public. Persons who wish to make oral statements may announce their intent at the time of the public comment period.

To join, phone 1-888-606-5950.
Leader’s Name: Dr. Geoffrey Evans
Password: ACCV

Meeting Agenda (PDF - 10 KB)

Federal Register (PDF - 57 KB)

Inactivated Influenza Vaccine: What You Need to Know 2010 – 2011 (PDF - 33 KB)

Live, Intranasal Influenza Vaccine: What You Need to Know 2010 – 2011 (PDF - 36 KB)

VICP Authorizing Legislation (PDF - 497 KB) (January 13, 2010)

Review of Adverse Effects of Vaccines Committee Membership Comment on provisional appointments by April 9

ACIP Adjusts Pediatric Flu Vaccine Recommendations

 

 

# 4674

 

 

Yesterday ACIP  (the CDC’s Advisory Committee on Immunization Practices) made a small adjustment to this fall’s seasonal flu vaccine recommendations for children under the age of 10.

 

In a non-unanimous decision (10-5), the panel voted that children who didn’t receive at least one dose of the H1N1 pandemic vaccine last year should receive two doses of the trivalent seasonal vaccine this year.

 

Those that already received the monovalent H1N1 vaccine would only need one shot. 

 

Lisa Schnirring of CIDRAP has the details, along with some information on studies being conducted by the CDC  on CSL’s trivalent vaccine which produced an unusually high number of side effects (mostly fever) in Australian children under the age of five.

 

CDC advisors tweak seasonal flu vaccine advice for young kids

Lisa Schnirring Staff Writer

Jun 24, 2010 (CIDRAP News) – Aiming to close some of the gaps in protection against the pandemic H1N1 virus expected to circulate this fall, a federal vaccine advisory group today recommended that children aged 6 months to 9 years who haven't received at least one dose of monovalent pandemic vaccine receive two doses of the upcoming season's trivalent vaccine.

 

The Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) made the recommendation at its meeting today after seeing the most recent immunogenicity data for the pandemic vaccine. Though it was 62% protective among all age-groups after one dose, rates were lower in younger children. Some CDC experts said this supports the recommendation for a 2-dose, prime-boost pandemic immunization strategy for children 6 months to 9 years old.

(Continue . . .)

ACIP Provisional Influenza Vaccine Recommendations

 

 

# 4400

 

Before you skip past what sounds like it will be a boring and routine report . . . read on. 

 

There’s some news to be had here.

 

Aside from recommending nearly universal flu vaccinations (just about everyone over the age of 6 mos.), ACIP (Advisory Committee on Immunization Practices) has announced the availability of a high dose flu vaccine for the 2010-11 season for those over the age of 65.

 

One of the concerns about the flu vaccine has been the less robust immune response in those (traditionally) most at risk from influenza – the elderly.

 

While a healthy adult under the age of 65 may see a 70%-90% level of protection from a well-matched flu vaccine, those over the age of 65 often see far less.   

A few choice blogs on this topic include:

 

Another Study: Flu Vaccines Do Not Reduce Mortality Rates In The Elderly

 

Study: Flu Vaccines And The Elderly

 

Flu Shots For The Elderly May Have Limited Benefits

 

Roughly 18 months ago we learned (see Vaccines: Sometimes You Just Need A Bigger Hammer) of a study conducted by Sanofi-Pasteur where several thousand people over the age of 65 were given a flu vaccine with 4 times the antigen of a standard shot.  

 

Instead of 15ug of antigen per strain, these shots contained 60ug.

 

Those who received the stronger shot developed a significantly stronger immune response than those who received the standard dose.

 

The FDA approved the use of Sanofi’s High Dose Fluzone last December.

 

 

FDA PRESS RELEASE

For Immediate Release: Dec. 23, 2009

FDA Approves A High Dose Seasonal Influenza Vaccine Specifically Intended for People Ages 65 and Older

Accelerated approval process used in vaccine approval

The U.S. Food and Drug Administration today approved Fluzone High-Dose, an inactivated influenza virus vaccine for people ages 65 years and older to prevent disease caused by influenza virus subtypes A and B.

People in this age group are at highest risk for seasonal influenza complications, which may result in hospitalization and death. Annual vaccination remains the best protection from influenza, particularly for people 65 and older.

(Continue . . . )

 

ACIP has not expressed a preference for the new High Dose Fluzone for those over 65, so eligible recipients should discuss that option with their personal physician.

 

It will likely take a year or more before scientists can assess the impact of this higher dose flu vaccine. 

 

Here then are the Provisional recommendations for the upcoming flu season, released yesterday. 

 

 

ACIP Provisional Recommendations for the Use of Influenza Vaccines

Date of ACIP vote: February 24, 2010 Date of posting of provisional recommendations: March 2, 2010

Tentative date of publication of recommendations in CDC Morbidity and Mortality Weekly Report: June 2010

On February 24, 2010, the ACIP voted on updated recommendations for use of trivalent seasonal influenza vaccine for the 2010-2011 influenza season.

Provisional recommendations for the prevention and control of seasonal influenza (2010-2011 influenza season):

Vaccination recommendations for adults were expanded to include all adults beginning in the 2010-11 influenza season.

Therefore, all people age 6 months and older are now recommended to receive annual influenza vaccination.

Background information on influenza vaccines

•The 2010–2011 trivalent vaccines will contain A/California/7/2009 (H1N1)-like, A/Perth/16/2009 (H3N2)-like, and B/Brisbane/60/2008-like antigens. Compared to the 2009-10 Northern Hemisphere influenza vaccine, the influenza A(H1N1) and A(H3N2) strains are changed. The A/California/7/2009 (H1N1)-like strain is the same strain that was included in the pandemic influenza A(H1N1) 2009 monovalent vaccines.

•A higher dose formulation of an inactivated seasonal influenza vaccine (Fluzone High-Dose, manufactured by sanofi pasteur, licensed by FDA on December 23, 2009) for use in people age 65 years and older will be available in the 2010-11 influenza season.∗ Fluzone High-Dose contains four times the amount of influenza antigen compared to other inactivated seasonal influenza vaccines. Fluzone High-Dose vaccine in one study of people age 65 years and older produced higher antibody levels, but slightly higher frequency of local reactions. Studies are underway to assess the relative effectiveness of Fluzone High-Dose compared to standard dose inactivated influenza vaccine, but results from those studies will not be available before the 2010-11 influenza season. The ACIP has not expressed a preference for Fluzone High-Dose or any other licensed inactivated influenza vaccine for use in people age 65 and older.

•An additional inactivated vaccine (Agriflu, manufactured by Novartis, licensed by FDA on November 27, 2009) will be available in the 2010-11 influenza season.† Agriflu is licensed for use in people age 18 years and older.

•Age indications for two inactivated influenza vaccines have changed. Afluria, manufactured by CSL Vaccines, is now licensed for use in people age 6 months and older. Fluarix, manufactured by GSK Biologicals, is now licensed for use in people age 3 years and older.

∗ Fluzone High-Dose has been licensed by FDA, but will not be available until the 2010-11 influenza season.
† Agriflu has been licensed by FDA, but will not be available until the 2010-11 influenza season.

ACIP Recommends Near `Universal’ Flu Vaccinations

 

 

# 4384

 

 

ACIP, the Advisory Committee on Immunization Practices, yesterday came forth with a long anticipated recommendation that just about all Americans over the age of 6 months should receive a yearly flu vaccination.

 

 

Maggie Fox, science and health editor for Reuters, brings us the details in her story.

 

UPDATE 1-Everyone in US should get flu vaccine - experts

Thu Feb 25, 2010 1:44am GMT

(Updates with vote on flu vaccine)

* 97 million H1N1 vaccines administered in U.S.

* Deaths could exceed normal seasonal flu year

* Obese and children at highest risk

By Maggie Fox, Health and Science Editor

WASHINGTON, Feb 24 (Reuters) - Everyone in the United States over the age of six months should get seasonal influenza vaccines every year, federal vaccine advisers said on Wednesday.

 

The Advisory Committee on Immunization Practices made the long-awaited vote to recommend virtually universal flu vaccination -- something public health experts have long recommended.

 

"The new recommendation seeks to remove barriers to influenza immunization and signals the importance of preventing influenza across the entire population," the U.S. Centers for Disease Control and Prevention said in a statement.

 

Earlier, experts told the committee that people who were morbidly obese and school-aged children were much more likely to become seriously ill or to die from H1N1 swine flu, as opposed to seasonal flu, which mostly kills the frail elderly.

(Continue . . .)

 

 

Two additional points are  brought out in this article.

 

First, Maggie reports that H3N2 is on the rise in China, accounting now for about 6% of their influenza cases.  This suggests that reports of seasonal flu’s demise may yet be premature.

 

Second is that the pandemic death toll in the United States – now estimated at near 17,000 – may be revised upward over the coming months and may exceed the 36,000 deaths we `expect’ from an average flu season.

 

(36K deaths is the CDC’s yearly estimate of flu deaths.  Not a count)

 

While many have been quick to latch onto early numbers and jump to conclusions regarding the impact and severity of this pandemic, the simple truth is that it will take months – likely years – before we can analyze most of the data.

 

Until then, pronouncements regarding this pandemic need to be viewed as preliminary at best.