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.
Measles has the potential to be life-threatening. According to #CDC, as many as 1 out of every 20 children with measles gets pneumonia, & for every 1,000 children who get measles, 1 or 2 will die from it. go.usa.gov/xUzwC
Immunization is one of the most effective public health measures for combating vaccine-preventable diseases such as measles. The MMR vaccine prevents measles, mumps & rubella. It is 97% effective against measles with 2 doses, starting at 12 months. bit.ly/2Pjbj4k
Vaccines take advantage of how the body’s immune system works. When the germ enters the body, the immune system generates a response to fight the infection. The immune system has memory and can come to your defense if the same germ tries to infect the body again.
Vaccines mimic germs. They are made from weakened versions of viruses/bacteria that cause disease. While they trigger the same immune response to convey future immunity, they don’t make you sick.
FDA plays a vital role in ensuring the safety and effectiveness of vaccines used in the U.S. Our scientific experts evaluate medical information and manufacturing data before approving vaccines to make sure their benefits outweigh the risks. go.usa.gov/xPqk8
Like many medical products, MMR vaccine has known potential side effects, but they are generally mild and short-lived, such as rash and fever.
#FDA and numerous public health agencies around the world evaluate the safety of vaccines extensively on an ongoing basis. Vaccines currently administered to children in the United States have been found to be safe both by agencies in the US and overseas.
Some people have concerns that autism may be linked to MMR or other vaccines that children receive. That has been refuted. There is no credible scientific evidence to support any link between vaccines and autism or other developmental disorders. go.usa.gov/xUzwY
This unfounded claim began many years ago with a short publication reporting a link between MMR vaccine and autism, which was later debunked and retracted by the journal. Among other things, the journal found that the lead author of the study was guilty of professional misconduct
Further, in January 2011, the British Medical Journal (BMJ) published a series of articles that conclude that the data in the original publication were misrepresented or altered. bit.ly/2wsg6JI
Vaccinating against measles not only protects your child, it protects children who can’t be vaccinated, including children with compromised immune systems due to illness, such as kids with cancer who receive chemotherapy.
In 2016, 91.1% of children aged 19-35 months had received the MMR vaccine, according to the CDC. But pockets of unvaccinated people can exist in states with high vaccination coverage, underscoring considerable measles susceptibility at some local levels.
For information about MMR or other childhood vaccines, visit FDA’s website and talk to your pediatrician. #VaccinesWorkgo.usa.gov/xUzwg
The MMR vaccine is one of the most extensively studied medical products. It's safety profile is firmly established over many years in some of the largest vaccine studies ever undertaken. Parents should have confidence #FDA understands the risks and benefits associated with MMR
To address lingering doubts, the U.S. invested enormous sums in studies to evaluate any link between MMR and autism or other developmental disorders. Parents should have full confidence. This is one of the most extensively studied questions of our time. There is no association.
I wish everyone a happy, healthy school year. #FDA will continue to work hard to ensure the safety & quality of vaccines we use to protect our children. I have young kids too. Nothing is more important. This is one of my highest obligations. The MMR vaccine is critical. Be safe.
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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.
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
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.
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.
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.
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