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% FDA Watch: J&J Vaccine Okay Expected, COVID Spread Not Tied to Food, Multistate Listeria Outbreak Traced to Cheese Everyday Health MenuNewslettersSearch FDA
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FDA Watch J& J Vaccine Approved for Emergency Use COVID Spread Not Tied to Food Multistate Listeria Outbreak Traced to CheeseThe latest news on U.S. Food and Drug Administration updates, recalls, approvals, and more. By Don RaufFebruary 27, 2021Everyday Health ArchiveFact-CheckedThe FDA released an analysis showing that the Johnson & Johnson vaccine meets efficacy and safety standards.Cezary Kowalski SOPA Images via ZUMA WireThe FDA greenlights Johnson & Johnson's COVID-19 vaccine for emergency use. The U.S.
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Food and Drug Administration (FDA) issued an emergency use authorization (EUA) on Saturday for Johnson & Johnson’s single-dose COVID-19 vaccine in people 18 and older. “The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” said Acting FDA Commissioner Janet Woodcock, MD, in an FDA news release
The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) had voted unanimously on Friday to recommend the authorization.
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The FDA released an analysis on February 24 showing that the product meets efficacy and safety standards and requirements based on already published research. COVID-19 does not spread through food or packaging.
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Acting U.S. Department of Agriculture (USDA) Secretary Kevin Shea and Acting FDA Commissioner Janet Woodcock, MD, put out an FDA statement on February 18 stressing that there is no credible evidence of food or food packaging being linked with the transmission of the coronavirus.
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The report cites a statement from the International Commission on Microbiological Specifications for Foods (ICMSF) saying, “Despite the billions of meals and food packages handled since the beginning of the COVID-19 pandemic, to date there has not been any evidence that food, food packaging, or food handling is a source or important transmission route for SARS-CoV-2 resulting in COVID-19.”
The FDA has warned of pulse oximeter limitations. The FDA issued a statement on February 19 cautioning that, although pulse oximeters can be useful for estimating blood oxygen levels, the devices have limitations and a risk of inaccuracy under certain circumstances. FDA experts underscored that the devices may be less accurate in people with dark skin pigmentation.
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The agency urged consumers who are monitoring their condition at home to “pay attention to all signs and symptoms of their condition and communicate any concerns to their healthcare provider.”
A combo of monoclonal antibodies prevents hospitalizations for COVID-19. On February 9, the FDA gave its okay for the use of monoclonal antibodies bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients.
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A clinical trial found that a single intravenous infusion of the drug combo significantly reduced COVID-related hospitalization and death during 29 days of follow-up compared with placebo. The FDA stresses that the drug cocktail is not approved for more severe cases of the illness.
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In the fall of 2020, the FDA had already granted emergency use authorization for bamlanivimab alone as treatment for mild-to-moderate COVID-19 in adult and pediatric patients. Monoclonal antibodies are laboratory-made proteins that mimic those produced by the immune system to fight off invaders like viruses.
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The FDA says that a potential difference between bamlanivimab alone and bamlanivimab and etesevimab together is in the risk for emergent resistant variants. Emergent variants were less frequently detected in patients who received bamlanivimab and etesevimab together compared with patients who received bamlanivimab alone.
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The FDA narrowed the use of convalescent plasma for COVID-19. Earlier in the pandemic, doctors thought that infusing COVID-19 patients with the antibody-rich blood from people who have survived an infection could offer a possible remedy for the disease.
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However, evidence has been mounting that the therapy may not be as effective as originally thought. In January, an international trial testing convalescent blood plasma on COVID-19 patients with moderate and severe illness stopped enrollment because it found no benefit in severely ill patients. Based on this and other new research, the FDA revised its emergency use authorization for convalescent plasma this month to limit the authorization to use with hospitalized patients early in the disease course.
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As The Wall Street Journal reported February 17, Mount Sinai Health System in New York City will no longer use convalescent blood-plasma to treat hospitalized COVID-19 patients, citing emerging clinical trials data that didn’t show a benefit for patients who received the therapy. Food Recalls and Warnings
Hispanic-style fresh and soft cheeses have been recalled after possibly sickening seven with listeria.
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The FDA, along with the Centers for Disease Control and Prevention (CDC) and state and local partners, is investigating a multistate outbreak of Listeria monocytogenes infections potentially linked to Hispanic-style fresh and soft cheeses. So far, seven hospitalizations have been recorded in Connecticut, Maryland, New York, and Virginia.
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As a result, El Abuelito Cheese is recalling all its queso fresco products with sell-by dates through March 28, according to a February 22 announcement. Products include El Abuelito, Rio Grande, and Rio Lindo brand queso frescos. The FDA also issued a warning in Spanish on February 24.
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The FDA issued a warning for homemade infant formulas. The FDA is advising against making and feeding homemade infant formula to infants.
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Parents or caregivers of any infant who consumed a homemade formula should contact a healthcare provider and report symptoms to local health departments. Homemade infant formula recipes have not been evaluated by the FDA and may lack vital nutrients.
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The FDA has received reports of hospitalized infants fed homemade formulas suffering from hypocalcemia. Basil may cause intestinal infection. As of February 8, Shenandoah Growers is pulling about 3,240 units of its organic basil from store shelves because there’s a chance it contains the Cyclospora parasite, which can cause an intestinal infection called Cyclosporiasis.
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Products were distributed between February 3 and 4 in Illinois, Indiana, Iowa, Michigan, Minnesota, Mississippi, Missouri, Ohio, Tennessee, and Wisconsin. Undeclared soy has been found in salmon. On February 8, Ocean Beauty Seafood recalled 8,450 packages of Publix brand Parmesan-Crusted Wild Alaskan Salmon Fillets because they may contain soy but the packaging did not indicate it.
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The product is labeled “Best Before/Use By Date 021122.”
Beware almonds in yogurt-covered cranberries. Hickory Harvest Foods announced February 9 that its Vanilla Flavored Yogurt Covered Cranberries may contain undeclared almonds. The product displays a best sell date of May 28, 2021.
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A shrimp allergy alert has been issued on Thai peanut and curry sauces. Delicae Gourmet is recalling Thai Peanut Sauce, Panang Curry Sauce, and Spicy Red Curry Sauce, because it contains undeclared shrimp allergen, as of February 8.
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The product is sold in Springfield, Missouri; Crystal Lake, Illinois; Palisade, Colorado; Colorado Springs, Colorado; Long Lake, New York; Long Grove, Illinois; Sheridan, Wyoming; Venice, Florida; Pittsburgh, Pennsylvania; and Nassawadox, Virginia. Wheat and nut allergens have been detected in salad kits. Dole put out a warning February 10 that its Sunflower Crunch Chopped Salad Kit may contain wheat and tree nut allergens.
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The batch under recall displays a best use date of February 11, 2021. Undeclared anchovies have been found in cauliflower bites.
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A recall has been placed on Kowalski’s brand Buffalo Cauliflower Bites with Kowalski’s Steakhouse Blue Dressing because the product might contain undeclared anchovies. The bites, distributed to seven metro Kowalski’s stores located in Minnesota, carry expiration dates running through February 10, 2021.
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There's more anchovy trouble. On February 15, word went out that Brite Harbor Caesar Dressing & Dip could contain undeclared anchovies.
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The potential allergen affects one lot labeled “03 071321” that was sold in Washington, Oregon, Idaho, and Utah. Pecans may be hidden in the chocolate pretzels.
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Chocolate-covered pretzels from Giant Eagle sold in three Market District locations in Pennsylvania and Ohio may contain undeclared pecans, as announced February 19. The recalled pretzels have “sell by” dates through April 4, 2021.
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Organic drinks may contain undeclared almonds and cashews. On February 22, a recall was issued for the Urban Remedy beverages Almond Maca and Cacao Mocha sold in California and packaged with use-by dates of March 11, 2021.
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The drinks may contain undeclared almonds and cashews. Smoked fish has been taken back. Aaron’s Gourmet produced smoked fish products without the proper licensure and regulatory oversight.
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The company withdrew its items distributed to Growers Outlet and Berry Good PDX in Portland, Oregon, according to a February 18 announcement. Drug and Supplement Recalls
Ten companies have been warned to stop selling supplements that claim to treat depression.
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Ten companies were issued warning letters on February 19 to stop illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent depression and other mental health disorders. The companies are Enlifta, Lifted Naturals, Mountain Peak Nutritionals, SANA Group, Wholesome Wellness, Dr. Garber’s Natural Solutions, ProHealth, Blossom Nature, FDC Nutrition, and Silver Star Brands.
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The FDA said, “in general, consumers should be cautious of products marketed and sold online with unproven claims to prevent, treat, mitigate, or cure diseases.”
A blood clot preventive medication recalled. Apotex’s enoxaparin sodium injection is prescribed to prevent deep vein thrombosis (DVT), which is a blood clot in a deep vein, usually in the legs.
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The company issued a recall on February 2 for two batches of its product (batch numbers CS008 and CT003) due to a mislabeling of syringe barrel measurement markings. A nasal spray may contain contaminated yeast.
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Contaminated yeast has been detected in a lot of Manukaguard Allercleanse nasal spray, as of February 10. The company is stopping the sale of a lot with the expiration date of October 2023.
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Male energy pills have been removed from sale. FDA laboratory analysis has found that Adam’s Secret Extra Strength 1500 and Adam’s Secret Extra Strength 3000 capsules contain undeclared sildenafil or tadalafil.
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Because consumers with underlying medical issues may experience health risks, the company has recalled the product as of February 16. Treatment and Device Approvals
A sleep apnea device has been given the green light. For those with mild obstructive sleep apnea, the health agency approved a new prescription-only device intended to reduce snoring, on February 5.
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The eXciteOSA device is unique in that the user wears it during the day and receives electrical muscle stimulation through a mouthpiece that sits around the tongue. The impulses are designed to improve tongue muscle function, which in time can help prevent the tongue from collapsing backwards and obstructing the airway during sleep.
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A new gene therapy offers later stage option for lymphoma. On February 5, the FDA confirmed the use of a new cell-based gene therapy to treat adult patients with certain types of large B-cell lymphoma. Called Breyanzi (lisocabtagene maraleucel), the T-cell treatment is intended who have not responded to, or who have relapsed after, at least two other types of systemic treatment.
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The customized therapy collects a patient’s T-cells and then genetically modifies them to include a new gene that facilitates targeting and killing of the lymphoma cells. The modified cells are infused back into the patient. Therapy may protect bone marrow cells from chemotherapy damage.
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On February 12, Cosela (trilaciclib) was given the green light as the first therapy in its class to reduce the frequency of chemotherapy-induced bone marrow suppression in adults who receive certain types of chemotherapy for extensive-stage small cell lung cancer. The medication gives patients a treatment option that can reduce the occurrence of a common, harmful side effect of chemotherapy, which can damage normal tissues as it kills cancer cells. An ankle joint implant for rare bone disease has been okayed. As of February 17, the Patient Specific Talus Spacer can be made available as a humanitarian use device to benefit patients with Avascular Necrosis ("AVN") of the ankle joint.
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The implant offers a joint-sparing alternative to other surgical interventions to treat this serious and progressive condition, which may lead to the death of bone tissue stemming from a lack of blood supply to the area. NEWSLETTERS
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