U.S. FDA Profile picture
11 Jun, 6 tweets, 2 min read
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.
Additionally, the FDA has extended the expiration dating for the refrigerated Janssen COVID-19 Vaccine after reviewing information submitted by Janssen and determining that the vaccine can be stored at 2-8°C for 4.5 months instead of 3 months. fda.gov/media/150064/d…
Dr. Peter Marks, @FDACBER Director: “These actions followed an extensive review of records, including the production history of the facility and the testing performed to evaluate the quality of the product.”
With the action to extend the shelf life for refrigerated Janssen vaccine, jurisdictions that have doses on hand now have more time to administer the vaccine, Dr. Marks said.

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More from @US_FDA

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
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
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
2 Mar
In our ongoing response to the #COVID19 pandemic, we’ve taken several actions. Here’s our update: fda.gov/news-events/pr… Image
We’ve updated our FDA COVID-19 Response At-A-Glance Summary, which provides a quick look at facts, figures and highlights on the FDA's response efforts. fda.gov/media/137005/d…
The FDA issued an Emergency Use Authorization (EUA) to Quidel for its QuickVue At-Home #COVID19 Test for at-home use with a prescription.
Read 7 tweets
27 Feb
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… Image
“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for #COVID19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States.” – Acting FDA Commissioner @DrWoodcockFDA
The FDA has determined that the #COVID19 vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence it may be effective in preventing #COVID19.
Read 5 tweets

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