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Today, FDA issued an emergency use authorization (EUA) for the second vaccine for the prevention of #COVID19 caused by SARS-CoV-2. The emergency use authorization allows the vaccine to be distributed in the U.S for use in individuals 18 years and older. fda.gov/news-events/pr
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“The FDA’s approval of this vaccine is a milestone as we continue to battle the #COVID19 pandemic.” – Acting FDA Commissioner
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The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.
Readers added context
To clear up confusion:
BIVALENT vaccines are authorized
MONOVALENT vaccines are not
Bivalent vaccines are designed to work against multiple variants whereas monovalent is designed for just one.
fda.gov/news-events/pr…
MONOVALENT vaccines are not
Bivalent vaccines are designed to work against multiple variants whereas monovalent is designed for just one.
fda.gov/news-events/pr…Today, FDA issued the first emergency use authorization (EUA) for a vaccine for the prevention of #COVID19 caused by SARS-CoV-2 in individuals 16 years of age and older. The emergency use authorization allows the vaccine to be distributed in the U.S. fda.gov/news-events/pr
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FDA’s “scientific & medical experts conducted an incredibly thorough & thoughtful evaluation of this vaccine … Although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.” – Director Dr. Peter Marks
Today, we authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of #COVID19 to include children 5 through 11 years of age. fda.gov/news-events/pr
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As of 4/12, 6.8m+ doses of the J&J vaccine have been administered in the U.S. CDC & FDA are reviewing data involving 6 reported U.S. cases of a rare & severe type of blood clot in individuals after receiving the vaccine. Right now, these adverse events appear to be extremely rare
Today, FDA expanded the EUA for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of #COVID19 to include adolescents 12-15 years of age. FDA amended the EUA issued on Dec. 11, 2020 for administration in individuals 16 years of age and older. fda.gov/news-events/pr
Today, we took action to expand the use of a booster dose for #COVID19 vaccines in eligible populations. We’re amending the EUAs for the vaccines to allow for the use of a single booster dose: ⬇️ ⬇️ fda.gov/news-events/pr
Some people are taking ivermectin, a drug often prescribed for animals, to try to prevent or treat #COVID19. FDA has not approved or authorized ivermectin for this use, and it can be dangerous for people. bit.ly/3kNRkvH
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Have you tried using an acronym but inexplicably have your letters touch each other?
Today, we amended the EUAs for the Moderna & Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose to be administered to those 18+ years old after completion of a primary vax series with any FDA-authorized/approved #COVID19 vaccine. fda.gov/news-events/pr
Today, we issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of hospitalized COVID-19 patients as part of the agency’s ongoing efforts to fight #COVID19. fda.gov/news-events/pr
Just a friendly reminder... this can really hurt you. Here's why you shouldn't use Ivermectin to treat or prevent #COVID19. fda.gov/consumers/cons
Today, we issued an emergency use authorization (EUA) for the first #COVID19 diagnostic test that allows for self-collection & testing at home and provides test results in 30 minutes or less. The test kit for home use is available by prescription only. bit.ly/2UAMLsv
Yep! We have to say it!
Don't eat #cicadas if you're allergic to seafood as these insects share a family relation to shrimp and lobsters. go.usa.gov/xHg69
Today, FDA amended the emergency use authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine to allow for the use of an additional dose in certain immunocompromised individuals. go.usa.gov/xFVdR
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Individuals who received #Moderna as their primary series 6+ months earlier are eligible for a booster if they are:
➡️ 65+ years old, or
➡️ 18-64 years old at high risk of severe COVID-19, or
➡️ 18-64 years old with frequent institutional or occupational exposure to SARS-CoV-2
Today, FDA issued an emergency use authorization (EUA) for the third vaccine for the prevention of #COVID19 caused by SARS-CoV-2. The EUA allows the vaccine to be distributed in the U.S for use in individuals 18 years and older. fda.gov/news-events/pr
Today we approved the first injectable treatment for use in at-risk adults and adolescents weighing at least 35 kilograms (77 pounds) for pre-exposure prevention to reduce the risk of sexually acquired HIV. fda.gov/news-events/pr
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Until that process is complete, we are recommending this pause. This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot.
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Although we regulate milk, we can't recommend you try that. Perhaps enjoy a nice glass of 2% and return all those crates to the grocery store?
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FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria to amend the EUA, and that the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks, supporting the vaccine’s use.
Today, FDA amended the EUAs of the Pfizer-BioNTech and Moderna COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. fda.gov/news-events/pr
What you need to know. 🧵👇
Today, we authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age. fda.gov/news-events/pr
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FDA is requesting immediate removal of all Rx and over-the-counter ranitidine (Zantac) from the U.S. market. go.usa.gov/xvC7t
Today, the FDA issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for #COVID19. The Ellume COVID-19 Home Test is authorized for people 2 years old and up, including those not showing symptoms. fda.gov/news-events/pr
On #WorldHealthDay, we give thanks to the hardworking health care workers in the United States and across the globe 🌎 especially during this difficult time as we seek to mitigate and combat #COVID19. Show your support & help #SlowtheSpread whitehouse.gov/wp-content/upl
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Please join us via YouTube for an audio press conference at 10 a.m. EDT. We will keep the public updated as we learn more.
Vaccination is the best tool to turn the page on the #COVID19 pandemic.
Everyone over age 16 living in the U.S. is now eligible for the vaccine.
#WeCanDoThis
Find the latest available information and answers to frequently asked questions about #COVID19 on our website: fda.gov/emergency-prep
Today, FDA approved a second COVID-19 vaccine for the prevention of #COVID19 disease in individuals 18 years of age and older. fda.gov/news-events/pr
If you have recovered from #COVID19, confirmed by a positive test, you’re in a special position to help us fight the virus. Donate plasma now. Find a plasma donation center at coronavirus.gov.
🍕 and 🍫 anyone ?
This #NationalChocolateCoveredAnythingDay, everything is up for grabs!
Just be sure you know what ingredients are in your chocolate first. go.usa.gov/xeVA3
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RECALL ALERT: Tanimura & Antle is recalling packaged single head romaine lettuce with 10/15 or 10/16 pack dates due to possible E. coli contamination. Consumers shouldn’t eat affected product. We’re actively investigating & will provide more information. go.usa.gov/x7XKP
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Graphene oxide is NOT an ingredient in the vaccine. You're referring to a record produced by FDA under a court order. The Pfizer record was submitted to FDA & is 14 pages, “Structural and Biophysical Characterization of SARS-CoV-2 Spike Glycoprotein (P2 S) as a Vaccine Antigen.”
Today, we issued an emergency use authorization (EUA) for the fourth vaccine for the prevention of #COVID19 caused by SARS-CoV-2 in individuals 18 years of age and older. fda.gov/news-events/pr
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FDA is advising consumers not to purchase or use nitrite “poppers” which can result in serious adverse health effects, including death. These products are marketed as nail polish removers but are being ingested or inhaled for recreational use. go.usa.gov/x6pzZ
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Those who received #Pfizer-BioNTech as their primary series 6+ months earlier are eligible for a booster if they are:
➡️ 65+ years old, or
➡️ 18-64 years old at high risk of severe COVID-19, or
➡️ 18-64 years old with frequent institutional or occupational exposure to SARS-CoV-2
Today, FDA issued an EUA for the Quidel QuickVue At-Home #COVID19 Test, another antigen test where certain individuals can rapidly collect and test their sample at home, without needing to send a sample to a laboratory for analysis. fda.gov/news-events/pr
Today, we took action approving & authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants & to provide better protection against serious consequences of COVID. Here’s what you need to know: fda.gov/news-events/pr
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If you’ve fully recovered from #COVID19, you may be able to donate plasma to help others. You must have complete resolution of symptoms for at least 28 days OR have no symptoms for at least 14 days prior to donation & a negative COVID-19 lab test. go.usa.gov/xv5AY
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If you've recovered from COVID-19, you can help others by donating plasma.
More from @SteveFDA:
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Don’t be shocked! You can now #RechargeYourImmunity with an updated #COVID19 booster. fda.gov/update
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If you have fully recovered from #COVID19, you may be able to help patients currently fighting the infection by donating your plasma. Learn more: fda.gov/emergency-prep
If you have recovered from #COVID19, confirmed by a positive test, please donate plasma now. You can literally help save lives. There are thousands of locations across the country that have set up safe ways for you to donate. Find one at coronavirus.gov.
If you have fully recovered from #COVID19, you may be able to help patients currently fighting the infection by donating your plasma. Learn more: fda.gov/emergency-prep
Today, we amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster dose, to be administered at least 6 months after completion of the vaccine’s primary series in certain populations. fda.gov/news-events/pr
Today, we authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals. fda.gov/news-events/pr
Today, we gave the first FDA approval for a #COVID19 treatment. The drug was approved for adults and children ages 12 and older for the treatment of #COVID19 requiring hospitalization. fda.gov/news-events/pr
People who have fully recovered from #COVID19 for at least two weeks are encouraged to consider donating plasma, which may help save the lives of other patients. fda.gov/emergency-prep #DonatePlasma #DonateCOVIDPlasma
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Today, we amended the authorizations of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize updated formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination. fda.gov/news-events/pr
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Amid the epidemic levels of youth e-cigarette use and the popularity of certain products among young people, FDA today finalized an enforcement policy on unauthorized flavored cartridge-based e-cigarettes most used by youth. go.usa.gov/xpeDv
Over the years, FDA has worked with several celebrities to help spread the word about protecting public health. In the early 1970s, Dick Van Dyke starred in this short film promoting nutrition food labels. Do you remember this, ? #FDAHistory
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“After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna vaccines.” – Acting Commissioner
This #NationalDoctorsDay we want to express our immense gratitude to everyone working in the healthcare arena. You are superheroes.
Today, FDA approved a naloxone hydrochloride nasal spray for over-the-counter, nonprescription, use – the first naloxone product approved for use without a prescription. fda.gov/news-events/pr
FDA has authorized the first #COVID19 diagnostic test with a home collection option. go.usa.gov/xvNFZ
FDA issued an EUA for Paxlovid for the treatment of mild-to-moderate #COVID19 in adults & pediatric patients (age 12 & older weighing at least 40 kg) w/ positive results of direct SARS-CoV-2 testing, and at high risk for progression to severe #COVID19. fda.gov/news-events/pr
New Nutrition Facts label finalized for packaged foods, feat. added sugars, updated servings go.usa.gov/cJk7J
Today, we limited the authorized use of the Janssen #COVID19 Vaccine to those 18+ for whom other auth/approved vaccines are not accessible or clinically appropriate, & to those who elect Janssen because they would otherwise not receive a COVID vaccine. go.usa.gov/xudMH
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Graphene oxide is included in a sentence on page 7 to describe, in part, the lab procedure pertaining to the study of the structural characterization of the SARS-CoV-2 spike protein using a specific type of microscope. Graphene oxide is a material to aid in the protein imaging.
Today, we issued an emergency use authorization (EUA) for two monoclonal antibodies to be administered together for the treatment of mild to moderate #COVID19 in high-risk adults and pediatric patients age 12 and older. fda.gov/news-events/pr
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FDA is advising consumers not to use Similac, Alimentum, or EleCare powdered infant formulas if:
• the first two digits of the code are 22 through 37 and
• the code on the container contains K8, SH, or Z2, and
• the expiration date is 4-1-2022 (APR 2022) or later.
FDA alerts consumers of nationwide voluntary recall of EpiPen and EpiPen Jr. go.usa.gov/xXNsU
Today, we approved the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of type 1 diabetes. fda.gov/news-events/pr
Today, we amended the emergency use authorizations (EUAs) of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children down to 6 months of age. fda.gov/news-events/pr
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FDA Commissioner and Director Dr. Peter Marks issue a statement on yesterday’s Vaccines and Related Biological Products Advisory Committee Meeting. go.usa.gov/xAcjW
When grocery shopping, buying just 1 to 2 weeks’ worth of groceries at a time can help to prevent unnecessary demand & temporary food shortages during the #COVID19 pandemic. Find more tips on how to safely grocery shop from FDA’s website. fda.gov/food/food-safe
FDA approves the first treatment directed at the underlying biology of Alzheimer’s disease, which is expected to reduce the clinical decline of patients with this disease: fda.gov/news-events/pr
