FDA

CVS Pharmacy tells us many stores here in Central Florida have already begun rolling out the vaccine.

With FDA approved over the counter options available, you can now get less expensive hearing aids from drug stores like Walgreens Here’s what you need to know if you’re considering over-the-counter hearing aids.

Justin Warmoth speaks with Susan Forbes on ‘The Weekly’

Vice President Kamala Harris is urging Americans to take action during “a critical point in our nation’s history” as thousands of people protested new limits to abortion rights in demonstrations across the country.

Missouri’s attorney general announced new restrictions Thursday on transgender care for adults in addition to minors in a move that is believed to be a first nationally and has advocacy groups threatening to sue.

There’s a new salvo in the fight to control Disney World.

Florida Gov. Ron DeSantis has advanced elements of his aggressive conservative agenda though the use of executive power, drawing on appointees, state boards and the state Constitution as he builds toward an expected presidential candidacy.

The U.S. Food and Drug Administration has approved selling overdose antidote naloxone over-the-counter, marking the first time an opioid treatment drug will be available without a prescription.

Missouri's Republican attorney general says his office will limit access to gender-affirming care for minors.

Two lots of Purely Soothing eye drops have been recalled “due to non-sterility,” that could lead to the risk of eye infections that could result in blindness, the FDA recently announced.

Few things define a culture quite like its food, and the United States is no different.

Amgen will acquire Horizon Therapeutics, a biopharmaceutical company that focuses on treatments for rare, autoimmune diseases, for about $26.4 billion.

Changes could be coming to the Federal Drug and Administration policy involving blood donations from men who have sex with men (MSM).

A new social media challenge is encouraging young people to cook their poultry in the basic ingredients in NyQuil and other over-the-counter cough products.

The U.S. Food and Drug Administration has posted another negative review of a closely watched drug for the deadly neurodegenerative disease ALS.

If you have some of King's Hawaiian products, they might need to be thrown out.

The U.S. Food and Drug Administration is investigating an outbreak of Hepatitis A possibly linked to organic strawberries.

Check your pantry and fridge, as more items are being recalled in connection to the JIF peanut butter recall.

What happened at the Abbott nutrition plant in Sturgis, Michigan?

A single lot of Great Value Buttermilk Pancake and Waffle Mix was recalled Saturday by Continental Mills due to a potential for foreign material contamination, according to the U.S. Food and Drug Administration.

The Food and Drug Administration recently announced it may be recommending a fourth COVID-19 vaccine shot as early as this fall.

The FDA is meeting later this month to consider allowing Pfizer's COVID-19 vaccine for kids as young as six months old.

After the Food and Drug Administration revised its authorization of the monoclonal antibody treatment Regeneron Monday, a Seminole County site has moved its appointments to another treatment option and will remain open Tuesday.

Dr. Anthony Fauci is encouraging people to continue to use at-home COVID-19 antigen tests after the U.S. Food and Drug Administration said Tuesday that the tests may be less sensitive at detecting the omicron variant.

We might not be able to claim that 2021 was *the* wildest year in recent history (2020 will likely get that credit for quite some time), but it might be a close second.

Several popular body sprays are being recalled due to concerns about a possible cancer-causing chemical.

The U.S. is opening COVID-19 vaccine boosters to all adults, and urging them for anyone 50 and older.

By the end of next week, millions of kids in the U.S. could be eligible to roll up their sleeves for a COVID-19 vaccine.

A panel of U.S. health advisers has endorsed booster shots for Moderna’s COVID-19 vaccine.

The U.S. Food and Drug Administration has added another hand sanitizer product to the should not use list.

The FDA will consider Pfizer’s vaccine for kids that age in just a couple of weeks.

Vaccination numbers appear to indicate that approval didn't change many of their minds.

Third-dose shots will be administered to immunocompromised individuals.

As the debate over COVID vaccine boosters continues, we could learn this week who is eligible to get the third shot.

Moderna submitted data to the U.S. Food and Drug Administration for a booster dose of its COVID-19 vaccine.

Hostess is recalling some of its hamburger and hot dog buns over concerns that could be contaminated with listeria and salmonella.

“I really strongly believe that it stopped my symptoms from progressing into anything,” Baum said.

The Food and Drug Administration is expected to make a major announcement Thursday when it comes to COVID-19 booster shots.

An untold number of Americans have managed to get COVID-19 booster shots even though the U.S. government hasn't approved them.

The U.S reached a major vaccine milestone.

Moderna's COVID-19 vaccine shows 93% efficacy up to six months after the second dose.

A roundup of some of the most popular but completely untrue stories and visuals of the week.

The agency is taking an all-hands-on-deck approach in order to complete the review of Pfizer's application, a spokesperson said Friday.

Despite the record-breaking number of hospitalizations happening in Central Florida right now, officials with most of the local hospital systems said they are not mandating staff to get vaccinated at this point.

The Food and Drug Administration said it is planning to add a warning to COVID-19 mRNA vaccines about the risk of heart inflammation and chest pain.

A baby foods company is recalling one lot of rice cereal for babies due to high arsenic levels.

The FDA required the safety trial, which also investigated other potential risks, including blood clots in the lungs and death. AdIn the release, the FDA said:“Tofacitinib was first approved in 2012 to treat adults with rheumatoid arthritis (RA) who did not respond well to the medicine methotrexate. In 2017, we approved tofacitinib to treat patients with a second condition that causes joint pain and swelling, psoriatic arthritis (PsA), who did not respond well to methotrexate or other similar medicines. In 2018, we approved the medicine to treat ulcerative colitis, which is a chronic, inflammatory disease affecting the colon. Tofacitinib works by decreasing the activity of the immune system; an overactive immune system contributes to RA, PsA, and ulcerative colitis.

ORLANDO, Fla. – While the vaccine has given us hope, the coronavirus continues to surge across the United States. Cases and hospitalizations are spiking, and the country just had its deadliest week on record. As more people get the Pfizer or Moderna vaccine, other companies -- including Johnson and Johnson -- are hoping their versions will get FDA authorization soon. Dr. Kenneth Alexander with Nemours Hospital joined anchor Justin Warmoth on “The Weekly on ClickOrlando.com” to discuss the pandemic, vaccine distribution and what we know about a new variant of the virus.

Registered nurse Cynthia Banada holds a vial of the Moderna COVID-19 vaccine at Miami Jewish Health, a senior healthcare facility, Monday, Dec. 28, 2020, in Miami. (AP Photo/Lynne Sladky)The FDA is meeting this week to consider giving half-doses of Moderna’s COVID-19 vaccine to people ages 18 to 55. [TRENDING: How to get vaccine in Florida | New attractions coming to Central Florida theme parks]The effort to roll out the vaccine has been slower than expected. The Trump administration had the original goal of vaccinating 20 million Americans by the end of 2020. So far, four million Americans have received their first of the two COVID-19 shots required.

ORLANDO, Fla. – For the first time, Orlando Health clinicians and non-clinicians at risk received the COVID-19 vaccine, while AdventHealth continued vaccinating frontline health workers on Friday. In Volusia County, leaders are preparing for large-scale vaccination clinics once a vaccine is ready for mass distribution. “This may be in large venues such as the Daytona International Speedway,” Dr. Peter Springer, Volusia County Operational Medical Director, said. “The COVID-19 vaccine is crucial to preventing further spread from the virus but we need to take an effective fact-based approach to stop the spread.”For Gomez, that means continuing precautions this holiday season. “Keep in mind the virus is still out there and when you get a chance, get your vaccine.”

After the United States Food and Drug Administration and the Centers for Disease Control and Prevention approved a new COVID-19 vaccine for emergency use, the first shipments will arrive at AdventHealth Orlando on Tuesday, according to Florida Gov. | Pilot killed in Fla. gyroscope crash]“(Tuesday), Jackson Memorial in Miami will receive its shipment, as well as AdventHealth in Orlando,” DeSantis said. U.S. Secretary of Health and Human Services Alex Azar said he expects about 20 million doses to go out across the U.S. this month. Seminole County leaders told News 6 they’re prepping now to possibly receive about 8,000 to 10,000 doses during a second shipment. However, AdventHealth leaders told us there should be more data before children receive it.

Relieved,” said critical case nurse Sandra Lindsay after getting a shot in the arm at Long Island Jewish Medical Center in New York. But we also recognize that this end is in sight,” said Dr. Chris Dale of Swedish Health Services in Seattle. Plus, the shots can cause temporary fever, fatigue and aches as they rev up people’s immune systems, forcing hospitals to stagger employee vaccinations. A wary public will be watching closely to see whether health workers embrace vaccination. While effective against COVID-19 illness, it’s not yet clear if vaccination will stop the symptomless spread that accounts for half of all cases.

“I feel like healing is coming.”With a countdown of “3-2-1,” workers at Ohio State University's Wexner Medical Center gave initial injections to applause. High-risk health care workers were first in line. It just represents a moral failing,” said Jennifer Nuzzo, a public health researcher at Johns Hopkins. And later this week, the FDA will decide whether to greenlight the world’s second rigorously studied COVID-19 vaccine, made by Moderna Inc. “We’re also in the middle of a surge, and it’s the holidays, and our health care workers have been working at an extraordinary pace,” said Sue Mashni, chief pharmacy officer at Mount Sinai Health System in New York City.

OSCEOLA COUNTY, Fla. – As the Federal Drug Administration edges closer to approving a COVID-19 vaccine, Osceola County leaders are ironing out the final details in its mass distribution plans. Osceola County’s Emergency Management Director, Bill Litton, said Heritage Park will actually serve as their primary site for mass vaccine distribution, once it’s available for the general population. In talking about the Heritage Park testing site, Litton said it provides a lot of area that would allow them to potentially have up to six lanes of vaccine administration. As storing the vaccine seems to be less of a hassle than initially though, Litton tells says for planned mobile sites and drive-up vaccination sites, county leaders are looking at having refrigerators on location. He also added they can recharge the vaccine shipments with dry ice every five days, for up to a maximum of 15 days.

The race to create a reliable and safe COVID-19 vaccine continued Friday after one company asked for emergency use of it’s vaccine. Below is information provided by the Florida Department of Health for Friday, Nov. 20. CasesThe Florida Department of Health reported 9,085 new cases on Friday, bringing the state’s overall total to 923,418 cases since March. DeathsThe Florida Department of Health on Friday reported 80 people have recently died from COVID-19. The Florida Department of Health reported 226 recent hospitalizations.

In September, the district reported about 13 new coronavirus cases weekly, mostly involving teachers and staff, when it first opened early childhood education classes. ___ST. PETERSBURG, Fla. — Five Florida mayors are expressing concern about the rising number of coronavirus cases in the state, and are urging Gov. But the state’s rolling seven-day average for new coronavirus cases was more than nine times higher Wednesday than it was than when her first order took effect. Officials began instituting local shutdowns in neighborhoods where coronavirus cases were rapidly rising. There were 5,102 cases reported in Minnesota on Wednesday, along with 67 deaths.

FDA gives emergency OK to Eli Lilly antibody treatment for COVID-19Published: November 10, 2020, 9:40 amU.S. health officials have allowed emergency use of the first antibody drug to help the immune system fight COVID-19, an experimental approach against the virus that has killed more than 238,000 Americans.o

A TikTok challenge has led to an FDA investigation. Thursday the federal agency announced it is looking into reports of teens participating in the so-called “Benadryl challenge.”The over-the-counter medication is used to treat allergies. According to the FDA, teens have reportedly ended up in emergency rooms with serious injuries and some may have died. The FDA warns that taking too much Benadryl can lead to severe health problems even death. It says it contacted TikTok and is urging the app to remove videos of the challenge from its platform.

With a global pandemic underway, companies have gotten creative to meet the demand for hand sanitizer but the Food and Drug Administration warns some of that creativity may be dangerous to consumers. The FDA issued a warning this week about alcohol-based hand sanitizers being packaged in containers that may look like food or drink items. Recently, the FDA learned of a person who purchased a bottle they thought contained drinking water but it was hand sanitizer. Ingesting hand sanitizer can be toxic and the FDA is reporting an increasing number of cases where people suffer serious symptoms or even death from drinking the germ killer. I am increasingly concerned about hand sanitizer being packaged to appear to be consumable products, such as baby food or beverages.

Tainted peaches could be the cause of a salmonella outbreak in nine states. More than 60 people were sickened from the bad fruit. The bagged peaches were reportedly sold under the Wawona brand name at Aldi stores in 16 states starting in June. The grocery store chain has recalled the peaches in the states affected. The FDA is urging anyone who bought the peaches to throw them out.

The U.S. Food and Drug Administration has given the OK for the world’s first fully transparent surgical mask. They're made by ClearMask, an American medical supply company. Traditional surgical masks block mouths, which can sometimes impede effective communication. The company says ClearMask helps improve visual communication while still offering a high level of protection. ClearMask says their masks are especially helpful for people with hearing impairments and during conversations between people who don't speak the same language.

The Food and Drug Administration is warning labs and healthcare providers that a common COVID-19 test is providing false positive results. The BD Max System COVID-19 diagnostic test from Becton Dickinson is showing an error rate of 3% false positives. The nasal swab based test was given an emergency authorization from the FDA on April 8. [CORONAVIRUS BRIEFING: Daily ClickOrlando.com newsletter delivered to your inbox]The FDA is recommending patients confirm their results with an alternative authorized test. To keep up with the latest news on the pandemic, subscribe to News 6s coronavirus newsletter and go to ClickOrlando.com/coronavirus.

How long do experts forecast for a COVID-19 vaccine to be created? Moderna, one of the U.S. companies working on a vaccine, said it could have a vaccine ready for a phase one clinical trial in people within three months. Phase I vaccine trials - This is the first attempt to try out the vaccine in a small group of adults -- usually 20 to 80 subjects. Phase II vaccine trials - The vaccine is tested on a larger group of individuals to assess the safety of the vaccine and method of delivery. Phase III vaccine trials - If the vaccine passed the first two phases, it’s then tested on tens of thousands of people to make sure there are few adverse side effects and the vaccine is effective.

The FDA announced a voluntary recall of a sinus nasal spray from CVS due to possible microbiological contamination. The product recalled is CVS Health 12 Hour Sinus Relief Nasal Mist. The FDA said the following in a press release:Repetitive use of a nasal spray containing a gram-negative pathogen can potentially lead to colonization and subsequent infection which can be life-threatening in certain patient populations, such as those with cystic fibrosis or immuno-compromised. The affected CVS Health 12 Hour Sinus Relief Nasal Mist lot is lot number 173089J, EXP 09/19. The product can be identified by a white nasal spray bottle and an orange label with Sinus Relief stated in white with CVS Health on top left.