Share this page!

U.S. FDA Profile picture
Twitter logo
23 Aug, 4 tweets, 2 min read
Today, FDA approved the first COVID-19 vaccine for the prevention of #COVID19 disease in individuals 16 years of age and older. fda.gov/news-events/pr…
The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the #COVID19 pandemic.” – Acting FDA Commissioner @DrWoodcockFDA
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.” – @FDACBER Director Dr. Peter Marks

• • •

Missing some Tweet in this thread? You can try to force a refresh
　

Keep Current with U.S. FDA

U.S. FDA Profile picture

Stay in touch and get notified when new unrolls are available from this author!

Read all threads

This Thread may be Removed Anytime!

PDF

Twitter may remove this content at anytime! Save it as PDF for later use!

Try unrolling a thread yourself!

how to unroll video
  1. Follow @ThreadReaderApp to mention us!

  2. From a Twitter thread mention us with a keyword "unroll"
@threadreaderapp unroll

Practice here first or read more on our help page!

More from @US_FDA

U.S. FDA Profile picture
20 Aug
Here’s an update on some of the actions we’ve taken this week in our ongoing response to the #COVID19 pandemic. fda.gov/news-events/pr… Image
We issued a warning letter jointly with the Federal Trade Commission to Mahita, LLC dba PushMyCart for selling unapproved products with unproven COVID-19 claims. fda.gov/inspections-co…
On August 13, the FDA held a stakeholder call in recognition of National Immunization Awareness Month to discuss vaccines for younger children and adolescents in preparation for the school year.
Read 4 tweets
U.S. FDA Profile picture
11 Jun
FDA announcing today that it is authorizing for use, under the emergency use authorization (EUA) for the Janssen #COVID19 vaccine, two batches of vaccine drug substance manufactured at the Emergent BioSolutions facility in Baltimore. fda.gov/news-events/pr…
While the FDA is not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, the agency continues to work through issues there with Janssen and Emergent BioSolutions management.
The FDA’s decision to include these two batches of vaccine drug substance in the EUA for the Janssen COVID-19 vaccine means that Janssen vaccine made with this drug substance can be used in the U.S. or exported to other countries.
Read 6 tweets
U.S. FDA Profile picture
8 Jun
Here is today's update on some of the actions we’ve taken recently in our ongoing response to the #COVID19 pandemic. fda.gov/news-events/pr… Image
We contributed to a series of policy recommendations to address the vulnerabilities in U.S. pharmaceutical supply chains during emergencies like #COVID19. These recommendations were part of a report that was published by @WhiteHouse today. fda.gov/about-fda/repo…
We issued joint warning letters with @FTC to Beauty & Spa Concepts, DBA Beenefits and to Everything Health LLC for selling unapproved products with unproven #COVID19 claims. fda.gov/inspections-co…
Read 6 tweets
U.S. FDA Profile picture
18 May
Here is today's update on some of the actions we’ve taken in our ongoing response to the #COVID19 pandemic. fda.gov/news-events/pr…
We provided info about the status of the monoclonal antibody investigational drug, leronlimab, for the treatment of #COVID19. The data from CytoDyn, Inc.’s recent clinical trials do not support the clinical benefit of leronlimab for COVID-19 treatment.
We updated the Johnson & Johnson #COVID19 vaccine fact sheet for recipients and caregivers to be available in multiple languages. fda.gov/emergency-prep…
Read 4 tweets
U.S. FDA Profile picture
10 May
The FDA’s Center for Biologics Evaluation and Research @FDACBER will convene a virtual meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 10, 2021, via webcast. fda.gov/news-events/pr…
During the meeting the agency will provide a status update on our approach to emergency use authorization (EUA) for #COVID19 vaccines intended for use in individuals 12 through 17 years of age.
The committee will also discuss the data needed to support an EUA and a biologics license application (BLA) for a #COVID19 vaccine intended for use in children less than 12 years of age. The committee will not discuss any specific products.
Read 4 tweets
U.S. FDA Profile picture
13 Apr
Today FDA and @CDCgov issued a statement regarding the Johnson & Johnson #COVID19 vaccine. We are recommending a pause in the use of this vaccine out of an abundance of caution.
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
Treatment of this specific type of blood clot is different from the treatment that might typically be administered.
Read 7 tweets

Did Thread Reader help you today?

Support us! We are indie developers!

This site is made by just two indie developers on a laptop doing marketing, support and development! Read more about the story.

Become a Premium Member ($3/month or $30/year) and get exclusive features!

Become Premium

Too expensive? Make a small donation by buying us coffee ($5) or help with server cost ($10)

Donate via Paypal Become our Patreon

Thank you for your support!

Follow Us on Twitter!

Like this author's thread?

Get emails when @US_FDA has new unrolls!

Check out other threads from @US_FDA!

Read all threads by @US_FDA

:(