U.S. Food And Drug Administration Coronavirus (COVID-19) Update: FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals

U.S. Food And Drug Administration Coronavirus (COVID-19) Update: FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals | site |



Information contained in U.S. Food and Drug Administration (FDA) press release dated: May 5, 2022

Today, the U.S. Food and Drug Administration has limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.

Key Points:

• After conducting an updated analysis, evaluation and investigation of reported cases, the FDA has determined that the risk of thrombosis with thrombocytopenia syndrome (TTS), a syndrome of rare and potentially life-threatening blood clots in combination with low

...

U.S. Food and Drug Administration Approves First Oral Blood Thinning Medication for Children | site |




(Information contained in U.S. Food and Drug Administration [FDA] press release dated: June 21, 2021) Today, the U.S. Food and Drug Administration approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism (a condition where blood clots form in the veins) directly after they have been treated with a blood thinner given by injection for at least five days. The FDA also approved Pradaxa oral pellets to prevent recurrent clots among patients 3 months to less than 12 years old who completed treatment for their first venous thromboembolism. In addition, Pradaxa was approved in capsule form to treat blood clots in patients eight years and older with venous thromboembolism directly after they have been treated with a blood thinner given by injection for at least five days, and to preve...

Federal Trade Commission Returns Nearly $60 Million to Those Suffering from Opioid Addiction Who Were Allegedly Overcharged in Suboxone Film Scheme| site |



FTC says funds for these payments come from the FTC’s settlements with Reckitt Benckiser Group and Indivior, Inc. who took advantage of their unique market position to scare consumers away from generic Suboxone tablets


(Information contained in Federal Trade Commission [FTC] press release dated: May 10, 2021)

The Federal Trade Commission is sending 51,875 payments totaling more than $59 million to consumers who were victims of an allegedly deceptive scheme by Reckitt Benckiser Group and Indivior, Inc. to thwart lower-priced generic competition with the branded drug Suboxone. The average payment

Courtesy: Federal Trade Commission

amount is $1,139. The payments will be mailed...

U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab | site |



FDA says "Alternative monoclonal antibody therapies authorized to treat patients with COVID-19 remain available"


(Information contained in U.S. Food and Drug Administration [FDA] press release dated: April 16, 2021)

Today, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. Based on its ongoing analysis of emerging scientific data, specifically the sustained increase of SARS-CoV-2 viral variants that are resistant to bamlanivimab alone resulting in the increased risk for treatment failure, the FDA has determined that the known and potential...

Coronavirus (COVID-19) Update: U.S. Food and Drug Administration Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine | site |



Update Provides Alternative Temperature for Transportation and Temporary Storage for Frozen Vials Before Dilution


(Information contained in U.S. Food and Drug Administration [FDA] press release dated: February 25, 2021) Today, the U.S. Food and Drug Administration announced that it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks. This reflects an alternative to the preferred storage of the undiluted vials in an ultra-low temperature freezer between -80ºC to -60ºC (-112ºF to -76ºF). The change is being reflected in updates to the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers)....

Biden Administration purchases additional Doses of COVID-19 Vaccines from Pfizer and Moderna | site |


(Information contained in U.S. Department of Health and Human Services [HHS] press release dated: February 11, 2021) The U.S. Department of Health and Human Services and Department of Defense (DOD) have purchased an additional 100 million doses of COVID-19 vaccines from both Pfizer Inc. and Moderna Inc. to help meet demand for COVID-19 vaccines in the United States. The orders placed today bring the vaccine purchased by the U.S. government from these two companies to a total of 600 million doses, enough to vaccinate 300 million people. Each company is delivering 300 million doses in regular increments through the end of July 2021. Each company will leverage U.S.-based manufacturing capacity to fill, finish and ship vials as the bulk material is produced.” “As the President directed, we are expanding our supply of COVID vaccines to protect people...

U.S. Food and Drug Administration Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines | site |



(Information contained in U.S. Food and Drug Administration [FDA] press release: January 4, 2021)

January 04, 2021

Statement From:

Commissioner of Food and Drugs - Food and Drug Administration
Stephen M. Hahn M.D.

Director - Center for Biologics Evaluation and Research (CBER)
Peter Marks M.D., PhD. Two different mRNA vaccines have now shown remarkable effectiveness of about 95% in preventing COVID-19 infection in adults. As the first round of vaccine recipients become eligible to receive their second dose, we want to remind the public about the importance of receiving COVID-19 vaccines according to how they’ve been authorized by the FDA in order to safely receive the level of protection observed in the large randomized trials supporting their effectiveness. We have been ...

National Institutes of Health says Peer-reviewed Report on Moderna COVID-19 Vaccine Publishes | site |



NIH says "Data from Phase 3 clinical trial confirm vaccine is effective".


(Information contained in National Institutes of Health [NIH] press release dated: December 30, 2020)

The investigational vaccine known as mRNA-1273 was 94.1% efficacious in preventing symptomatic coronavirus disease 2019 (COVID-19), according to preliminary results from a Phase 3 clinical trial reported in the New England Journal of Medicine. The vaccine also demonstrated efficacy in preventing severe COVID-19. Investigators identified no safety concerns and no evidence of vaccine-associated enhanced respiratory disease (VAERD). The vaccine was co-developed by Moderna, Inc., a biotechnology company based in Cambridge, Massachusetts, and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. ...

Transcript: Centers for Disease Control and Prevention Update on COVID-19 - - December 30, 2020 | site |




(Information contained in Centers for Disease Control and Prevention [CDC] press release: December 30, 2020)

Please Note: This transcript is not edited and may contain errors.

OPERATOR: WELCOME AND THANK YOU FOR STANDING BY. ALL LINES HAVE BEEN PLACED IN A LISTEN ONLY MODE FOR TODAY’S PREPARATION. THE CALL IS BEING RECORDED. IF YOU HAVE ANY OBJECTIONS, YOU MAY DISCONNECT AT THIS TIME. I WILL NOW INTRODUCE YOUR CONFERENCE HOST, MR. BENJAMIN HAYNES. YOU MAY BEGIN.

HAYNES: THANK YOU EVERYONE WHO HAS JOINS US TO DISCUSS TWO, NEW VARIANTS OF THE VIRUS THAT CAUSES COVID-19 AS WELL AS COVID-19 VACCINES. WE ARE JOINED BY DR. HENRY WALKE, THE INCIDENT MANAGER FOR CDC’S COVID-19 RESPONSE AND DR. NANCY MESSONNIER, DIRECTOR CDC’S NATIONAL CENTER FOR IMMUNIZATION AND RESPIRATORY DISEASES, AND THE SENIOR FEDERAL...

U.S. Food and Drug Administration Approves First Generic of Drug Used to Treat Severe Hypoglycemia | site |


Agency Supports Development of Complex Generic Drugs to Improve Competition and Access to More Affordable Medicines


(Information contained in U.S. Food and Drug Administration [FDA] press release: December 28, 2020) Today, the U.S. Food and Drug Administration approved the first generic of glucagon for injection USP, 1 mg/vial packaged in an emergency kit, for the treatment of severe hypoglycemia (very low blood sugar), which may occur in patients with diabetes mellitus. The drug is also indicated as a diagnostic aid in the radiologic examination of the stomach, duodenum (the first part of the small intestine beyond the stomach), small bowel and colon when diminished intestinal motility (reduced ability to move) would be advantageous. “Glucagon for injection has been approved for use in the U.S. for more than 20 years, but unti...