CIDRAP- ACIP recommends against inhaled flu vaccine for next season

[Shiloh]

Source: http://www.cidrap.umn.edu/news-pers...mends-against-inhaled-flu-vaccine-next-season


ACIP recommends against inhaled flu vaccine for next season
Filed Under:
Influenza Vaccines
Lisa Schnirring | News Editor | CIDRAP News
| Jun 22, 2016 In an emotional vote today sure to shake-up flu immunization plans for the upcoming flu season, federal vaccine advisors recommended against using the nasal spray vaccine, made by AstraZeneca's MedImmune and sold as FluMist, because of problems with vaccine effectiveness over the past three flu seasons.
The vote marks a dramatic turnaround for a version of the vaccine for which health officials have had high hopes. In 2014, the Advisory Committee on Immunization Practices (ACIP), a group of outside experts that helps guide Centers for Disease Control and Prevention (CDC) vaccine policy, made a preferential recommendation for nasal spray version, also called the live attenuated influenza vaccine (LAIV), because it seemed to provide better protection.
ACIP reversed itself, however, in 2015 because of disappointing performance against the 2009 H1N1 virus. As with other vaccines, LAIV also didn't work well during the 2014-15 season against a drifted H3N2 strain.
[h=3]Clear scientific evidence[/h] Though the measure passed overwhelmingly with 13 for, 1 abstention, and 1 against, many ACIP members had reservations about their votes. During today's meeting, several experts raised concerns about how the vote would affect the upcoming season's immunization programs and the challenges explaining the new recommendation to the public.
After the vote, ACIP chair Nancy Bennett, MD, said, "This is a very sad day for the influenza world." Bennett is professor of medicine and public health sciences at the University of Rochester School of Medicine and Dentistry.
Members were swayed, though, by scientific findings showing low effectiveness over the past three seasons and opted not to adopt wording that would have allowed for use of LAIV if the injectable version wasn't available. They also thought that public health messaging, while still difficult, would be simpler with the more definitive recommendation.
Before the vote, Carol Baker, MD, former ACIP chair who was at today's meeting representing the Infectious Disease Society of America, said. "One thing I've learned about flu is it changes all the time. The science makes this actionable. I don't think it's a choice." Baker is a pediatrics professor and virologist at Baylor College of Medicine in Houston.
The vote against LAIV has the support of the American Academy of Pediatrics and the Pediatric Infectious Diseases Society.
During meeting presentations, experts said producers expect to make 171 million to 176 million doses of flu vaccine for the upcoming flu season, of which about 14 million doses (8%) are LAIV. Many providers have already ordered vaccine, leaving some scrambling to replace the inhaled doses they ordered, and the lack of inhaled vaccine will likely affect school-based flu vaccine programs, which reach 5% of schoolkids. LAIV accounts for about 55% of vaccine used in school-based programs.
[h=3]Actions on meningococcal, cholera vaccines[/h] Earlier today ACIP approved a routine meningococcal vaccine recommendation for people infected with HIV and recommended cholera vaccine for US travelers who will be visiting cholera outbreak countries.
Ian Branam, a public affairs specialist with the CDC's National Center for Immunization and Respiratory Diseases, said ACIP's recommendation applies to those infected with HIV who are age 2 months or older.
Invasive meningococcal disease has a high fatality rate in people living with HIV, and today's ACIP action pertains to the meningococcal conjugate vaccine (MenACWY).
The group's recommendation for the cholera vaccine comes on the heels of the Food and Drug Administration's Jun 10 approval of the Vaxchora, the first cholera vaccine available to US travelers.
Vaxchora, produced by PaxVax, is approved for adults 64 and younger who plan to travel to cholera-affected areas. It is given as a single dose and targets Vibrio cholerae serogroup O1. Brittany Behm, MPH, public affairs specialist with the CDC's Division of Foodborne, Waterborne, and Environmental Diseases, said the decision to receive the vaccine is between the clinician and the traveler, based on travel plans and risk factors. She added that no countries currently require cholera vaccine as a condition for entry.
ACIP members meet tomorrow for a second of 2 days. No votes are planned, but the group will discuss respiratory syncytial virus in older adults; safety of maternal tetanus, diphtheria, acellular pertussis (Tdap) vaccine; lab containment of poliovirus type 2; and human papillomavirus (HPV) vaccines. ACIP meeting webcasts are available on the CDC's Web site.
See also:
Feb 26, 2015, CIDRAP news story "ACIP drops preference for nasal-spray flu vaccine in kids"
Jun 22-23 ACIP meeting agenda
ACIP meeting webcast

 

[sharon sanders]

From: "Media@cdc.gov (CDC)" <sohco@CDC.GOV>
To: MMWR-MEDIA@LISTSERV.CDC.GOV
Subject: CDC Media Statement: ACIP votes down use of LAIV for 2016-2017 flu season
Date: Jun 22, 2016 7:18 PM


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[TD] Media Statement

For Immediate Release
Wednesday, June 22, 2016

Contact: CDC Media Relations
404-639-3286

ACIP votes down use of LAIV for 2016-2017 flu season

CDC?s Advisory Committee on Immunization Practices (ACIP) today voted that live attenuated influenza vaccine (LAIV), also known as the ?nasal spray? flu vaccine, should not be used during the 2016-2017 flu season. ACIP continues to recommend annual flu vaccination, with either the inactivated influenza vaccine (IIV) or recombinant influenza vaccine (RIV), for everyone 6 months and older.

ACIP is a panel of immunization experts that advises the Centers for Disease Control and Prevention (CDC). This ACIP vote is based on data showing poor or relatively lower effectiveness of LAIV from 2013 through 2016.

In late May, preliminary data on the effectiveness of LAIV among children 2 years through 17 years during 2015-2016 season became available from the U.S. Influenza Vaccine Effectiveness Network. That data showed the estimate for LAIV VE among study participants in that age group against any flu virus was 3 percent (with a 95 percent Confidence Interval (CI) of -49 percent to 37 percent). This 3 percent estimate means no protective benefit could be measured. In comparison, IIV (flu shots) had a VE estimate of 63 percent (with a 95 percent CI of 52 percent to 72 percent) against any flu virus among children 2 years through 17 years. Other (non-CDC) studies support the conclusion that LAIV worked less well than IIV this season. The data from 2015-2016 follows two previous seasons ( 2013-2014 and 2014-2015 )showing poor and/or lower than expected vaccine effectiveness (VE) for LAIV.

How well the flu vaccine works (or its ability to prevent flu illness) can range widely from season to season and can be affected by a number of factors, including characteristics of the person being vaccinated, the similarity between vaccine viruses and circulating viruses, and even which vaccine is used. LAIV contains live, weakened influenza viruses. Vaccines containing live viruses can cause a stronger immune response than vaccines with inactivated virus. LAIV VE data before and soon after licensure suggested it was either comparable to, or better than, IIV. The reason for the recent poor performance of LAIV is not known.

Vaccine manufacturers had projected that as many as 171 million to 176 million doses of flu vaccine, in all forms, would be available for the United States during the 2016-2017 season. The makers of LAIV had projected a supply of as many as 14 million doses of LAIV/nasal spray flu vaccine, or about 8 percent of the total projected supply. LAIV is sold as FluMist Quadrivalent and it is produced by MedImmune, a subsidiary of AstraZeneca. LAIV was initially licensed in 2003 as a trivalent (three-component) vaccine. LAIV is currently the only non-injection-based flu vaccine available on the market.

Today?s ACIP vote could have implications for vaccine providers who have already placed vaccine orders. The ACIP recommendation may particularly affect pediatricians and other vaccine providers for children since data from recent seasons suggests nasal spray flu vaccine accounts for about one-third of all flu vaccines given to children. CDC will be working with manufacturers throughout the summer to ensure there is enough vaccine supply to meet the demand.

CDC conducts vaccine effectiveness (VE) studies each season to estimate flu vaccine effectiveness. Today?s ACIP vote highlights the importance of measuring and evaluating the effectiveness of public health interventions, which can have significant implications for public health policy. The change in the ACIP recommendation is an example of using new available data to ensure public health actions are most beneficial. Influenza is a serious disease that causes millions of illnesses, hundreds of thousands of hospitalizations, and thousands or tens of thousands of deaths each year. While the protection offered by flu vaccines can vary, the flu shot?s overall VE estimate of 49 percent suggests that millions of people were protected against flu last season.

Today?s ACIP recommendation must be reviewed and approved by CDC?s director before it becomes CDC policy. The final annual recommendations on the prevention and control of influenza with vaccines will be published in a CDC Morbidity and Mortality Weekly Report (MMWR), Recommendations and Reports in late summer or early fall.

CDC has recommended an annual influenza vaccination for everyone ages 6 months and older since February 24, 2010. CDC and ACIP briefly had a preferential recommendation for nasal spray vaccine for young children (during 2014-2015); however, during the 2015-2016 season, influenza vaccination was recommended without any preference for one vaccine type or formulation over another.
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