Dr. Stephen M. Hahn Profile picture
Sep 30, 2018 22 tweets 15 min read Twitter logo Read on Twitter
It’s the start of flu season – time to protect yourself and your family by getting vaccinated! In today’s #FDA #SUNDAYTWEETORIAL I’m going to talk about #FDA’s role in ensuring the safety, effectiveness, and availability of the 2019 influenza vaccines. #VaccinesWork #FightFlu
I know there are questions about the effectiveness and benefits of the flu vaccine given the severity of last year’s flu season, so I want to update you on what we’ve learned, the effectiveness of this year’s vaccine and why vaccination is important go.usa.gov/xPWhS.
We've made important modifications to this year's #Flu vaccine to improve its effectiveness; changing two of the strains (for the H3N2 and Influenza B components) to better reflect the influenza strains that we believe are most likely to circulate this winter. More on this later.
First, some basics. Influenza, or the #Flu, is a contagious respiratory disease caused by different types of influenza viruses. Symptoms can include fever, headache, cough, sore throat, congestion and body aches. Complications of flu can be severe go.usa.gov/xPZqa.
The @CDC estimates that the #Flu has caused between 9.2 million and 35.6 million illnesses; between 140,000 & 710,000 hospitalizations; and between 12,000 and 56,000 deaths annually since 2010. It now appears the numbers were even higher last flu season go.usa.gov/xPZaU.
Children under five; adults over the age of 65, pregnant women, and people with certain health conditions are at higher risk of serious complications from the #Flu go.usa.gov/xPZqj.
Seasonal #Flu viruses are detected year-round but are most common during the fall and winter. Activity often begins to increase in October and peaks between December and February, although activity can last as late as May.
One of the most effective and safest ways to protect yourself and your family is to get the #Flu vaccine every year. FDA and @CDC recommend that most individuals 6 months of age and older get the flu vaccine to protect against influenza disease and its complications.
How do #Flu vaccines prevent the disease? They expose the body’s immune system to versions of multiple flu strains that are anticipated to be circulating that season, so that the immune system is able to recognize and respond should the virus appear.
#FDA works year-round to ensure that the vaccines are safe, effective & manufactured to high quality standards. This includes evaluating & potentially adjusting the composition of the vaccine every year so that it matches the influenza virus strains expected to be in circulation
Flu vaccines are designed to target the 3 or 4 of the flu viruses most likely to circulate during the season: 2 influenza A types (H1N1 and H3N2) and 1 (trivalent formulation) or 2 (quadrivalent formulation) types of influenza B. go.usa.gov/xPZYn go.usa.gov/xPZYU
FDA, WHO & @CDC review data on strains circulating worldwide to ID those likely to cause the most illness during flu season. Work is done months in advance to give time to make the vaccine. An FDA advisory committee chose this year’s strains in March 2018 go.usa.gov/xPZ4g.
We’ve improved our scientific methods and changed some strains for this year’s vaccine. The #FDA has increased confidence, based on the pattern of influenza circulating now in the Southern hemisphere, that this year’s flu vaccine should offer Americans good protection.
#FDA produces materials in our labs that are critical for making flu vaccines. We provide seed viruses used to make vaccine strains & reagents that are used to test vaccines for potency & identity. This ensures they are potent and includes the FDA recommended influenza strains.
Throughout their manufacturing, the vaccines undergo quality control testing, including sterility testing. Manufacturers submit the test results and sample vials from each lot to FDA for lot release. Once #FDA OK’s the lots, they're distributed nationwide go.usa.gov/xPZYk
We collaborate with our federal partners year-round to develop new ways to collect and track vaccine effectiveness and better understand if different manufacturing processes have an impact on effectiveness, so that we can identify ways to improve the #Flu vaccine in the future.
Most #Flu vaccines are made using chicken eggs. In recent years, #FDA has approved influenza vaccines that utilize other manufacturing methods - including cell culture and recombinant DNA technology - that offer certain advantages over the egg based system go.usa.gov/xPZcf
During the 2017-2018 flu season, a preliminary analysis of @CMSGov data indicated that cell-based vaccines appeared to be somewhat more effective in preventing #flu than egg-based vaccines. More data are needed to better understand these findings go.usa.gov/xPZYp.
#FDA is working to facilitate development of more effective cell lines that can be better scaled through advanced manufacturing technologies, and ways to increase vaccine yield in recombinant vaccine manufacturing.
These manufacturing advances hold great promise – potentially, supply could more easily be ramped up on short notice to adapt to changes in #flu strains since influenza viruses can mutate not only between seasons, but during the course of a single season go.usa.gov/xPDAS.
Could a #flu vaccine that lasts many years be on the horizon? Universal vaccines have the potential to prevent disease caused by any flu virus. However, much more research and development work needs to be done to make this a reality bit.ly/2NNIe4Z.
What can you do now to prevent the #flu? Be sure to wash your hands with soap and water, cover your nose and mouth when you cough or sneeze, stay home when you’re sick and be sure to get your flu vaccine, like I did last week with the @Surgeon_General! It’s widely available now.

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More from @SteveFDA

Sep 9, 2018
Compounded drugs serve an important medical need for patients who can’t use an FDA-approved medication. In today’s #FDA #SUNDAYTWEETORIAL, I’m going to talk about what FDA is doing to preserve access to appropriately compounded drugs while protecting patients from serious risks.
In drug compounding, ingredients are combined, mixed or altered to create a sterile or non-sterile medication tailored to a patient - such as those with an allergy who need a drug without a certain dye or a child who can’t swallow a tablet and needs medicine in a liquid form.
But compounded drugs, which aren’t FDA-approved, may pose serious risks if not produced properly, potentially resulting in contamination or medications that do not possess the strength, quality or purity they are supposed to have bit.ly/2G7IpjB
Read 23 tweets
Sep 2, 2018
As kids are heading back to school, for this #FDA #SUNDAYTWEETORIAL I’m going to talk about MEASLES and the vital importance of vaccination. You may’ve seen recent news stories reporting cases of measles in parts of the US and EU. Most cases have occurred in unvaccinated people
In 2018 there have been 124 individual cases of measles in 22 states and D.C. Measles can spread when it reaches a community where there are groups of unvaccinated people. And travelers with measles continue to bring the disease into the United States go.usa.gov/xUzwa
Measles is caused by the rubeola virus and is highly contagious. It is normally passed through direct contact or through the air. The virus infects the respiratory tract, then spreads throughout the body, causing a skin rash, fever, cough and runny nose.
Read 19 tweets
Aug 19, 2018
Consumers want and expect safe, wholesome and affordable food. They deserve nothing less. In today’s #FDA #SUNDAYTWEETORIAL I’m talking about what steps the FDA, the states and produce farmers are taking - in collaboration - to ensure the safety of fresh fruits and vegetables.
We hear too often about food safety concerns involving fresh fruit and vegetables -most recently the outbreak of E. coli O157:H7 infections associated with romaine lettuce from the Yuma growing region, the largest such outbreak in the U.S. in more than 10 years.
From 1998-2008 there were 455 produce-associated food outbreaks, with more than 16,000 people becoming ill, more than twice the number of produce-associated illnesses from 1973-1997. This is a significant public health burden that should be largely preventable.
Read 25 tweets
Jul 30, 2018
THREAD ON NEW ENFORCEMENT ACTION: We’re taking action against manufacturers marketing “vaginal rejuvenation” devices to women by deceptively claiming the procedures treat conditions and symptoms related to menopause, urinary incontinence, & sexual function fda.gov/NewsEvents/New…
These products have serious risks and don’t have adequate evidence to support their use for these purposes. We’re deeply concerned women are being harmed by these procedures
In some cases, the devices are marketed to women who’ve completed treatment for breast cancer and experience symptoms caused by early menopause. Deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious.
Read 7 tweets
Jul 29, 2018
For this weekend's #FDA #SUNDAYTWEETORIAL I’m going to talk about what FDA is doing to modernize clinical trials to reduce the cost of drug development, potentially lower drug costs and bring more safe, effective therapies to patients.
FDA’s mission is to both promote and protect public health. For medical products, this means ensuring that they are safe and effective for their intended use. Clinical trials are the primary vehicle for generating the evidence FDA needs to ensure that.
The traditional drug development paradigm calls for 3 clinical trial phases: A small phase 1 tests safety and dosing, phase 2 tests short-term side effects and effectiveness over a range of doses; and the large phase 3 assesses whether the product’s benefits outweigh its risks.
Read 22 tweets
Jul 15, 2018
The topic of this week’s #FDA #SUNDAYTWEETORIAL is #drugshortages. FDA does everything possible within our authority to help address shortages. While we’ve made progress to mitigate shortages; we must do even more to understand and address the root causes of persistent shortages
Manufacturing & quality issues are some of the proximate causes of drug shortages. Availability of raw materials; unexpected increases in demand, i.e. due to illness outbreaks or changes in clinical practice; or unavailability of other drugs in a class also can lead to a shortage
We’ve seen # of new drug shortages steadily decline due to work by FDA, industry and others. In 2017, we worked w/ manufacturers to prevent 145 shortages. There were still 35 new shortages last year, but this compared to peak of 251 new shortages in ‘11 bit.ly/2JiNGpf
Read 17 tweets

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