U.S. FDA Profile picture
20 Oct, 5 tweets, 2 min read
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…
We’re also authorizing the use of each of the available vaccines as a heterologous (or “mix-and-match”) booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine.
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
Individuals who received #Janssen (J&J) as their primary vaccine are eligible for a booster if they are:
➡️ 18+ years old, and
➡️ at least two months out from their primary dose
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

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More from @US_FDA

19 Oct
In our ongoing response to the #COVID19 pandemic, here’s an update on some of the actions we’ve taken. fda.gov/news-events/pr…
On Oct. 12, we approved an abbreviated new drug application for propofol injectable emulsion, single patient-use vials. accessdata.fda.gov/scripts/cder/o…
We updated the Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kits recall classification notice & letter to health care providers to clarify that the potential for false positive results is due to the software associated with the kits. fda.gov/medical-device…
Read 4 tweets
23 Aug
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
Read 4 tweets
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
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
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
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

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