FDA Approves First Oral Treatment For COVID-19 In Adults
May 26, 2023 – Today, the U.S. Food and Drug Administration approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is the fourth drug—and first oral antiviral pill—approved by the FDA to treat COVID-19 in adults....
USFDA Authorizes Bivalent COVID-19 Vaccines For Children Down To 6 Months of Age
FDA NEWS RELEASE — December 8, 2022 Today, the U.S. Food and Drug Administration 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. “More children now have the opportunity to update their protection against COVID-19 with a bivalent COVID-19 vaccine, and we encourage parents and caregivers of those eligible to...
Coronavirus (COVID-19) Update: FDA Approves First COVID-19 Treatment For Young Children
Today, the U.S. Food and Drug Administration expanded the approval to Gilead Sciences Inc. of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive results of direct SARS-CoV-2 viral testing, who are: Hospitalized, orNot hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19,...
USFDA Authorizes Second Booster Dose Of Pfizer, Moderna COVID-19 Vaccines For Ages 50 And Up And Immunocompromised Individuals
Today (March 28, 2022), the U.S. Food and Drug Administration authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals. The FDA previously authorized a single booster dose for certain immunocompromised individuals following completion of a three-dose primary vaccination series. This makes a second booster dose of both vaccines available...
FDA Approves Second COVID-19 Vaccine
News Release – Monday, Jan. 31, 2022 Moderna To Be Marketed as Spikevax COVID-19 Vaccine For Ages 18+ Today (Jan. 31, 2022), the U.S. Food and Drug Administration approved a second COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine; the approved vaccine will be marketed as Spikevax for the prevention of COVID-19 in individuals 18 years of age and older. Key points Spikevax meets the FDA’s rigorous...
COVID Transmission Rates Across The US, Texas, Hopkins County Continue To Be High
COVID transmission rates across the Country, state and county continue to be high this week, increasing 2.7 percent across the United States over the past 7 days compared to the previous 7, according to the Centers for Disease Control. A total of 627,752 active cases were reported in Texas, including 483 Hopkins County residents who actively had COVID-19 at 1:40 p.m. Tuesday, Jan. 11, 2022, according to Texas Department of State...
FDA Acts To Expand Use Of Pfizer COVID-19 Vaccine
FDA Jan. 3, 2022 News Release Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to: Expand the use of a single booster dose to include use in individuals 12 through 15 years of age.Shorten the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 Vaccine and a booster dose to at least five months.Allow for a third primary...
FDA Expands Eligibility For COVID-19 Vaccine Booster For All Individuals 18 Or Older
FDA News Release – November 19, 2021 Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines, authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. The Centers for Disease Control and Prevention’s (CDC)...
FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine For Emergency Use In Children 5 Through 11 Years of Age
Friday, Oct. 29, 2021 USFDA New Release Today, the U.S. Food and Drug Administration authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5 through 11 years of age. The authorization was based on the FDA’s thorough and transparent evaluation of the data that included input from independent advisory committee experts who overwhelmingly voted in favor of making the...
FDA Takes Additional Actions On Use Of A Booster Dose For COVID-19 Vaccines
US FDA News Release The U.S. Food and Drug Administration Wednesday, Oct. 20, took action to expand the use of a booster dose for COVID-19 vaccines in eligible populations. The agency is amending the emergency use authorizations (EUA) for COVID-19 vaccines to allow for the use of a single booster dose as follows: The use of a single booster dose of the Moderna COVID-19 Vaccine that may be administered at least 6 months after...