My name is Dr. Margaret Dayhoff-Brannigan and I am a senior fellow at the National Center for Health Research. Our research center scrutinizes scientific and medical data and provides objective health information to patients, providers and policy makers. We do not accept funding from pharmaceutical companies, and therefore I have no conflicts of interest.
Thank you for the opportunity to speak here today.
I completed my Ph.D. in Biochemistry and Molecular Biology at the Johns Hopkins School of Public Health. I bring a perspective as both a researcher and an advocate for public health here today.
An effective flu vaccine is critical for public health. Antiviral medications have very limited efficacy, so for many people the flu vaccine is the best line of defense to protect against infection. The CDC’s latest report calculated a 19% vaccine efficacy this year. That is simply not good enough. More importantly, this is not just one bad year. Four of the last 10 years the vaccine has been less than 40% effective.
When the flu vaccine does not work well, people think they should not bother to get it. This is bad for both for the pharmaceutical companies who have unused doses of vaccine, and for the general public that is less protected. It is important that we implement strategies to improve the efficacy of the influenza vaccine.
According to the briefing information, a new strain of influenza A(H3N2) was detected in March 2014, after last year’s vaccine production had already begun. Nothing was changed in response to these new data. We urge the FDA to consider changing the timeline for selecting strains for the vaccine to allow more time. We understand there are tight deadlines, but there should at least be a strategy for making a last minute change to one of the strains selected for inclusion, if it is found that there is a newer circulating strain within a certain time frame. In response to the 2009 H1N1 pandemic, vaccines were produced in an accelerated timeline, so we know that it is possible. While these strategies may cost more to implement, the increased cost is worth it if efficacy could be substantially improved. More effective vaccines will save lives, and will save money in reduced sick days taken, doctors visits, and hospitalizations.
Currently, there are few incentives for pharmaceutical companies to implement strategies to improve vaccine effectiveness. For example, military, health care and childcare workers will all be required to get the flu vaccine next season regardless of how ineffective the vaccines have been this season.
In addition, the FDA should look carefully at whether the live attenuated influenza vaccine (nasal spray) should still be approved, since for the second year in a row it has shown considerably lower efficacy than the standard flu shot. At the very least, the nasal spray labels should specify how ineffective they are compared to flu shots.
We urge the FDA to require new protocols to ensure that the best and most effective vaccine is produced each year.
Thank you for your time.