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COVID-19 Update: FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose in Younger Age Groups

The FDA amended the emergency use authorizations of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize their use as a single booster dose in younger age groups.

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SILVER SPRING, Md. /PRNewswire/ — The U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize their use as a single booster dose in younger age groups. The Moderna COVID-19 Vaccine, Bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to six years of age. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to five years of age.

These bivalent COVID-19 vaccines include an mRNA component of the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component in common between the omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the omicron variant. The mRNA in these vaccines is a specific piece of genetic material that instructs cells in the body to make the distinctive “spike” protein of the original virus strain and the omicron variant lineages BA.4 and BA.5. The spike proteins of BA.4 and BA.5 are identical.

“Since children have gone back to school in person and people are resuming pre-pandemic behaviors and activities, there is the potential for increased risk of exposure to the virus that causes COVID-19. Vaccination remains the most effective measure to prevent the severe consequences of COVID-19, including hospitalization and death,” said Peter Marks, M.D., Ph.D. “While it has largely been the case that COVID-19 tends to be less severe in children than adults, as the various waves of COVID-19 have occurred, more children have gotten sick with the disease and have been hospitalized. Children may also experience long-term effects, even following initially mild disease. We encourage parents to consider primary vaccination for children and follow-up with an updated booster dose when eligible.”

With today’s authorization, the monovalent Pfizer-BioNTech COVID-19 Vaccine is no longer authorized as a booster dose for individuals five through 11 years of age. Both the Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine continue to be authorized for primary series administration in individuals six months of age and older.

For each of the bivalent COVID-19 vaccines authorized today, the FDA relied on immune response and safety data that it had previously evaluated from a clinical study in adults of a booster dose of a bivalent COVID-19 vaccine that contained a component of the original strain of SARS-CoV-2 and a component of omicron lineage BA.1. The FDA considers such data as relevant and supportive of vaccines containing a component of the omicron variant BA.4 and BA.5 lineages. In addition, the FDA has evaluated and considered immune response and safety data from clinical studies of the monovalent mRNA COVID-19 vaccines, including as a booster dose in pediatric age groups. These data and real-world experience with the monovalent mRNA COVID-19 vaccines, which have been administered to millions of people, including young children, support the EUA of the bivalent COVID-19 vaccines in younger age groups.

What You Need to Know: Authorization of Moderna COVID-19 Vaccine, Bivalent

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  • The data supporting FDA’s authorization of a single booster dose of the Moderna COVID-19 Vaccine, Bivalent for both the 6 years through 11 years age group and 12 through 17 years age group is based on the FDA’s previous analysis of immune response and safety data from a clinical study in adults 18 years of age and older who received a booster dose of Moderna’s investigational bivalent COVID-19 vaccine that contained a component of the original strain of SARS-CoV-2 and a component of Omicron lineage BA.1.
  • For the 12 through 17 years age group, the authorization is also based on the effectiveness of a single booster dose of the monovalent Moderna COVID-19 Vaccine in this age group. The FDA’s analysis included a comparison of the immune response among approximately 250 clinical trial participants in this age group who received a single booster dose of Moderna COVID-19 Vaccine at least five months after completion of a two-dose primary series of the vaccine to the immune responses among approximately 300 clinical trial participants 18 through 25 years of age who had received a two-dose primary series of Moderna COVID-19 Vaccine in a previous study which determined the vaccine to be effective in preventing COVID-19. The immune response to the booster dose of Moderna COVID-19 Vaccine in the 12 through 17 years age group was comparable to the immune response to the two-dose primary series in the adult participants.
  • For the 6 years through 11 years age group, the authorization is also based on the effectiveness of a single booster dose of the monovalent Moderna COVID-19 Vaccine in this age group. The FDA’s analysis included a comparison of the immune response among approximately 100 clinical trial participants 6 years through 11 years of age who received a single booster dose of Moderna COVID-19 Vaccine at least six months after completion of a two-dose primary series of the vaccine to the immune responses among approximately 300 clinical trial participants 18 through 25 years of age who had received a two-dose primary series of Moderna COVID-19 Vaccine in a previous study which determined the vaccine to be effective in preventing COVID-19. The immune response to the booster dose of Moderna COVID-19 Vaccine in the 6 years through 11 years age group was comparable to the immune response to the two-dose primary series in the adult participants.
  • The safety of a single booster dose of monovalent Moderna COVID-19 Vaccine was evaluated in approximately 1,300 participants 12 through 17 years of age who received a booster dose of monovalent Moderna COVID-19 Vaccine at least five months after the second dose of the primary series, and approximately 1,300 participants 6 years through 11 years of age who received a booster dose of monovalent Moderna COVID-19 Vaccine at least six months after the second dose of the primary series. The most commonly reported side effects after a booster dose of the monovalent Moderna COVID-19 Vaccine in the clinical trial participants for both age groups were pain, redness and swelling at the injection site, tiredness, headache, muscle pain, chills, joint pain, underarm swollen lymph nodes in the same arm as the injection, nausea/vomiting and fever.
  • Individuals who receive the bivalent vaccine may experience similar side effects reported by individuals who received the monovalent Moderna COVID-19 Vaccine.

The data for the monovalent Moderna COVID-19 Vaccine are relevant to the Moderna COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process.

What You Need to Know: Authorization of Pfizer-BioNTech COVID-19 Vaccine, Bivalent

  • The data supporting the authorization of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 5 through 11 years of age is based in part on the FDA’s previous analysis of immune response and safety data from a clinical study in adults greater than 55 years of age who received a booster dose of a Pfizer-BioNTech’s investigational bivalent COVID-19 vaccine that contained a component of the original strain of SARS-CoV-2 and a component of Omicron lineage BA.1. In addition, the authorization is based on the FDA’s previous analysis of safety and effectiveness data of a booster dose of monovalent Pfizer-BioNTech COVID-19 Vaccine in children 5 through 11 years of age.
  • Individuals who receive Pfizer-BioNTech COVID-19 Vaccine, Bivalent may experience similar side effects reported by individuals who received the monovalent Pfizer-BioNTech COVID-19 Vaccine.

The fact sheets for both of the bivalent COVID-19 vaccines for recipients and caregivers and for healthcare providers include information about potential side effects, as well as the risks of myocarditis and pericarditis.

The amendments to the EUAs were issued to Moderna TX Inc. and Pfizer Inc.

Additional Resources:

Consumer InquiriesEmail or 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration

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FDA CDC News

Food Safety Tips for Game Day

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/PRNewswire/ — Super Bowl Sunday is coming up and you may be planning a party with friends and family. These parties often involve finger foods, communal dishes, and treats that are left out for long periods of time—which can lead to foodborne illness (also known as food poisoning).  Don’t let foodborne illness ruin the fun. Check out these tips from the U.S. Food and Drug Administration and learn how you can keep your food safe.

Food Safety Tips for Game Day

CLEAN

  • Wash your hands with warm water and soap for at least 20 seconds before and after handling food and after using the bathroom, changing diapers, and handling pets.
  • Wash your cutting boards, dishes, utensils, and counter tops with hot soapy water after preparing each food item.
  • Rinse fresh fruits and vegetables under running tap water, including those with skins and rinds that are not eaten. Scrub firm produce with a clean produce brush.

SEPERATE

  • Separate raw meat, poultry, seafood, and eggs from other foods in your shopping cart, grocery bags, and refrigerator.
  • Use one cutting board for fresh produce and a separate one for raw meat, poultry, and seafood.
  • Never place cooked food on a plate that previously held raw meat, poultry, seafood, or eggs unless the plate has been washed in hot, soapy water.
  • Don’t reuse marinades used on raw foods unless you bring them to a boil first.
  • If baking, make sure that no raw flour is on surfaces that contact other foods.

COOK

  • Use a food thermometer to ensure the safety of meat, poultry, seafood, and egg products. These foods must be cooked to a safe minimum internal temperature to destroy any harmful bacteria.
  • When cooking in a microwave oven, cover food, stir, and rotate for even cooking. If there is no turntable, rotate the dish by hand once or twice during cooking. Always allow standing time, which completes the cooking, before checking the internal temperature with a food thermometer.

CHILL

  • Refrigerate or freeze meat, poultry, eggs, seafood, and other perishables within 2 hours of cooking or purchasing. Refrigerate within 1 hour if the temperature outside is above 90° F.
  • Divide large amounts of leftovers into shallow containers for quicker cooling in the refrigerator.

SERVE

  • Keep cold foods chilled to 40 °F or below and hot foods heated to 140 °F or above.
  • If you’re planning a buffet and aren’t sure how quickly the food will be eaten, keep serving portions small. Prepare a number of small platters and dishes ahead of time and replace the serving dishes with the fresh ones throughout the party.
  • Don’t add new food to an already filled serving dish. Instead, replace nearly empty serving dishes with freshly filled ones.
  • Watch the clock with leftovers. Whether you’re sending “doggie bags” home with guests or are saving them for yourself, leftovers should be refrigerated as soon as guests arrive home and/or within 2 hours!

Learn more at:
http://www.fda.gov/Food/FoodborneIllnessContaminants/BuyStoreServeSafeFood/ucm328131.htm

SOURCE U.S. Food and Drug Administration

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FDA CDC News

FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward

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Statement From:Janet Woodcock, M.D.
Principal Deputy Commissioner – Office of the Commissioner

January 26, 2023

Given the growing cannabidiol (CBD) products market, the U.S. Food and Drug Administration convened a high-level internal working group to explore potential regulatory pathways for CBD products. Today we are announcing that after careful review, the FDA has concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks. The agency is prepared to work with Congress on this matter. Today, we are also denying three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.  

The use of CBD raises various safety concerns, especially with long-term use. Studies have shown the potential for harm to the liver, interactions with certain medications and possible harm to the male reproductive system. CBD exposure is also concerning when it comes to certain vulnerable populations such as children and those who are pregnant. 

A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products. Some risk management tools could include clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children. In addition, a new pathway could provide access and oversight for certain CBD-containing products for animals.

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The FDA’s existing foods and dietary supplement authorities provide only limited tools for managing many of the risks associated with CBD products. Under the law, any substance, including CBD, must meet specific safety standards to be lawfully marketed as a dietary supplement or food additive. 

The working group, which I chair, has closely examined studies related to the CBD-based drug Epidiolex, published scientific literatureinformation submitted to a public docket, as well as studies both conducted and commissioned by the agency. Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives. For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods. 

CBD also poses risks to animals, and people could be unknowingly exposed to CBD through meat, milk and eggs from animals fed CBD. Because it is not apparent how CBD products could meet the safety standard for substances in animal food, we also do not intend to pursue rulemaking allowing the use of CBD in animal food. A new regulatory pathway could provide access and oversight for certain CBD-containing products for animals.

The FDA will continue to take action against CBD and other cannabis-derived products to protect the public, in coordination with state regulatory partners, when appropriate. We will remain diligent in monitoring the marketplace, identifying products that pose risks and acting within our authorities. The FDA looks forward to working with Congress to develop a cross-agency strategy for the regulation of these products to protect the public’s health and safety.

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FDA CDC News

Nationwide Artificial Tears Lubricant Eye Drops Recall Due to Possible Contamination

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Global Pharma Healthcare is voluntarily recalling all lots within expiry of their Artificial Tears Lubricant Eye Dropsdistributed by /EzriCare, LLC- and Delsam Pharma, to the consumer level, due to possible contamination. The Centers for Disease Control and Prevention (CDC) alerted FDA to an investigation of a multi-state cluster of Verona Integron-mediated Metallo-β-lactamase (VIM)- and Guiana-Extended Spectrum-β-Lactamase (GES)- producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) infections possibly associated with the use of the artificial tears manufactured by Global Pharma Healthcare. To date, there are 55 reports of adverse events including eye infections, permanent loss of vision, and a death with a bloodstream infection.

Risk Statement: Use of contaminated artificial tears can result in the risk of eye infections that could result in blindness.

Artificial Tears (carboxymethylcellulose sodium) Lubricant Eye Drops, 10 mg in 1 mL, ½ fl oz (15 ml) bottle are used as a protectant against further irritation or to relieve dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun. The product is packaged in a bottle with a safety seal and are placed in a carton box Ezricare NDC 79503-0101-15, UPC 3 79503 10115 7; Delsam Pharma’s NDC 72570-121-15, UPC -72570-0121-15. It can be identified by the photos below. The product was distributed Nationwide in the USA over the Internet.

Global Pharma Healthcare is notifying the distributors of this product, Aru Pharma Inc. and Delsam Pharma and is requesting that wholesalers, retailers and customers who have the recalled product should stop use.

Consumers with questions regarding this recall can contact the distributors: Aru Pharma/Ezricare, LLC – by phone: 1-518-738-7602 or by e-mail: [email protected] from Monday to Friday, 11am to 4pm EST; or DELSAM Pharma LLC by phone: 1-866-826-1309 or by e-mail: [email protected] from Monday to Friday from 11am to 4pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these over-the-counter drug products.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

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  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

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