Last Thursday, Moderna officially filed for emergency use authorization (EUA) for its COVID-19 vaccine for use in kids between 6 months and under 6 years. The request is for the approval of two doses of 25 micrograms of the mRNA vaccine. Moderna’s clinical data showed the vaccine was 51% effective for the younger cohort of […]
Tag: FDA Food and Drug Administration
FDA Reviewers Not Impressed by new ALS Drug
Health Day News reports that despite months of intense lobbying by patient advocates, federal health officials on Monday posted a largely negative review of an experimental drug for the devastating illness known as amyotrophic lateral sclerosis (ALS). In an analysis of Amylyx Pharmaceuticals’ drug, known for now only as AMX3005, regulators from the U.S. Food […]
Moderna announces results of Covid-19 Vaccine trials for Children 6 and under, will Seek FDA Authorization
Moderna has announced interim results of its Covid-19 vaccine for children younger than 6.. As CNN reports, the company said two 25-microgram doses of its Covid-19 vaccine for children ages 6 months through 5 years old provided a similar immune response to two 100-microgram doses for adults ages 18 to 25, indicating that the benefit […]
COVID-19 cases will likely increase soon with BA.2 and other Variants, though not necessarily Hospitalizations
Over the next few weeks, the U.S. should expect an increase in COVID-19 cases from the Omicron BA.2 variant, also known as the “Stealth Variant,” Dr. Anthony Fauci said in an interview with ABC News, but it may not lead to as severe a surge in hospitalizations or deaths. “I would not be surprised if in […]
Biden announces initiative to give Americans Free Antiviral Treatment after Positive Covid Test
President Biden announced during his State of the Union address on Tuesday that individuals who test positive for COVID-19 at a pharmacy will soon be able to get free antiviral treatments immediately after. The President stated, “We’ve ordered more pills than anyone in the world has. Pfizer is working overtime to get us a million […]
FDA Officially Approves First Condom for protection against STI’s during Anal Sex
On February 23, the United States Food and Drug Administration (FDA) authorized ONE condoms to be used for protection against STIs during anal sex, marking the first time that the FDA granted condom approval specifically for “anal pentration.” The condoms, marketed as ONE male condom and manufactured by Global Protection Corp., had a failure rate […]
Moderna wins full approval for its Covid-19 vaccine, as Novavax seeks authorization for its version
As STAT News reports, ever-evolving landscape of Covid-19 vaccines shifted again on Monday, with Moderna winning full approval for its jab from the Food and Drug Administration, and Novavax submitting a long-awaited application to the agency for an emergency use authorization for its vaccine. The approval of Moderna’s vaccine, Spikevax, makes it the country’s second […]
January is Cervical Cancer Awareness Month – What it is, and What You can do about it!
January is Cervical Cancer Awareness Month. Cervical Cancer was once a leading cause of cancer death for women in the United States. Today, screening and prevention have greatly reduced the impact of this form of cancer. Still, nearly 14,500 women in the United States received a diagnosis of cervical cancer and more than 4,200 died from […]
FDA warns of fake COVID test kits
The omicron variant has increased the need and demand for at-home testing. But those tests are harder to come by now, and with that demand comes a strong FDA warning to be on the lookout for fakes. As the highly transmissible omicron variant causes cases of COVID to surge and the demand for testing increases, […]
After the FDA approval, CDC signs off on Pfizer Covid vaccine boosters for kids 12 – 15
NBC News reports that the Centers for Disease Control and Prevention (CDC) advisory panel on Wednesday voted to recommend Pfizer-BioNTech Covid-19 booster shot for kids ages 12 to 15, a critical step in distributing additional shots to adolescents this week. The panel, called the Advisory Committee on Immunization Practices, voted 13-1 in favor of giving […]