The chance of having this occur is very low. The safety analysis set included 437 participants in the bivalent vaccine (Original and Omicron BA.1) booster dose group and 377 participants in the Moderna COVID-19 Vaccine booster dose group. Partner with us to explore the possibility of Moderna's optimized mRNA for the benefit of global health. (See Full EUA Prescribing Information), Adverse reactions reported in clinical trials following administration of bivalent vaccine (Original and Omicron BA.1) in individuals 18 years of age and older include pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, axillary swelling/tenderness, nausea/vomiting, erythema at the injection site, swelling at the injection site, and fever. To access the most recent Fact Sheets, please scan the QR code provided below. Subsequent EUA amendments and authorizations have followed. Lot Numbers - Centers for Disease Control and Prevention In these analyses, 97.3% of study participants had at least 28 days of follow-up after Dose 2. Cambridge, MA 02139 Participants were monitored for unsolicited adverse events for up to 28 days following each dose and follow-up is ongoing. Participants who were immunocompromised and those with a known history of SARS-CoV-2 infection were excluded from the study. Step 1: Go to Moderna's Lot Number Lookup Site To find the expiration date for any vial of Moderna COVID-19 Vaccine visit this link Moderna How To Look Up Vial Expiration Date on the Carton. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle and body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea. We will evaluate your request and send the registration approval . For more information on EUA, see the What is an Emergency Use Authorization (EUA)? section at the end of this Fact Sheet. ARE OTHER CHOICES AVAILABLE FOR PREVENTING COVID-19 BESIDES MODERNA COVID-19 VACCINE OR Moderna COVID-19 Vaccine, Bivalent? Find your COVID-19 Vaccine CPT Codes - AMA In Study 5, the neutralizing antibody titers (50% inhibitory dose [ID50]) against a pseudovirus expressing the original SARS-CoV-2 Spike protein (D614G) and a pseudovirus expressing the Omicron BA.1 Spike protein were evaluated. As of the data cutoff date of February 21, 2022, the median duration of blinded follow-up for safety for participants 6 months through 23 months was 68 days after Dose 2. EUA-authorized for ages 5 yrs to < 12 yrs. CVX and MVX codes are identified for vaccines that have received emergency authorization from the World Health Organization (WHO), US Food and Drug Administration (FDA) or both. BIVALENT Moderna COVID-19 Vaccine BIVALENT Moderna COVID-19 Vaccine BIVALENT Moderna COVID-19 Vaccine BIVALENT Moderna COVID-19 Vaccine - Ages: 6 months through 5 years STORAGE LABEL Store vaccine between -50C and -15C . Participants with a known history of SARS-CoV-2 infection within 2 weeks of study vaccination were excluded from the study. WHERE CAN I REPORT CASES OF SUSPECTED FRAUD? Participants were monitored for unsolicited adverse events for up to 28 days following the booster dose. The VAERS toll-free number is 1-800-822-7967 or report . In addition, the FDA decision is based on the totality of the scientific evidence available showing that the product may be effective to prevent COVID-19 during the COVID-19 pandemic and that the known and potential benefits of the product outweigh the known and potential risks of the product. June 22, 2022, 8:54 AM PDT By Berkeley Lovelace Jr. An updated version of Moderna's Covid-19 booster shot appears to work against the fast-spreading omicron subvariants BA.4 and BA.5, the company. Note: Codes will become effective only upon EUA issuance or BLA licensure of COVID-19 vaccine(s) by the Food and Drug Administration (FDA). As of May 8, 2021, serious adverse events were reported by 0.2% (n=6) of participants who received Moderna COVID-19 Vaccine and 0.2% (n=2) of participants who received placebo. The vaccination provider enrolled in the federal COVID-19 Vaccination Program is responsible for the MANDATORY reporting of the listed events following administration of the Moderna COVID-19 Vaccine, Bivalent to the Vaccine Adverse Event Reporting System (VAERS). a two-dose primary series to individuals 6 months through 5 years of age; and. Overall, the 171 participants who received a booster dose had a median follow-up time of 5.7 months after the booster dose to the cut-off date (August 16, 2021). The safety of Moderna COVID-19 Vaccine was evaluated in an ongoing Phase 3 randomized, placebo-controlled, observer-blind clinical trial conducted in the United States involving 30,346 participants 18 years of age and older who received at least one dose of Moderna COVID-19 Vaccine (100 mcg mRNA; n=15,184) or placebo (n=15,162) (Study 1, NCT04470427). Spikevax is also available as two adapted vaccines . This EUA for Moderna COVID-19 Vaccine, Bivalent will end when the Secretary of HHS determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed. Patent(s): www.modernatx.com/patents Table 1 and Table 2 present the frequency and severity of reported solicited local and systemic adverse reactions within 7 days following a second booster dose with bivalent vaccine (Original and Omicron BA.1) booster dose compared to Moderna COVID-19 Vaccine in participants 18 to <65 years of age and 65 years of age. I verify that Im in the U.S. and agree to receive communication from the AMA or third parties on behalf of AMA. Of the 171 participants who received a booster dose of Moderna COVID-19 Vaccine, there were no serious adverse events reported from the booster dose through 28 days after the booster dose. A product authorized for emergency use has not undergone the same type of review by FDA as an FDA approved product. PDF Moderna COVID-19 Vaccine - Centers for Disease Control and Prevention Study 3 (NCT04649151) is a Phase 2/3 clinical trial with multiple parts. Authorized by WHO 5/19/2022 Counted toward immunity in US, CONVIDECIA (CanSino Biologics) COVID-19 Vaccine, SARS-COV-2 COVID-19 Protein Subunit Non-US Vaccine Product (Anhui Zhifei Longcom Biopharmaceutical + Institute of Microbiology, Chinese Academy of Sciences), COVID-19 PS Non-US Vaccine (Anhui Zhifei Longcom Biopharmaceutical + Institute of Microbiology, Chinese Academy of Sciences, SARS-COV-2 COVID-19 Protein Subunit Non-US Vaccine Product (Jiangsu Province Centers for Disease Control and Prevention), COVID-19 PS Non-US Vaccine (Jiangsu Province Centers for Disease Control and Prevention), SARS-COV-2 COVID-19 Protein Subunit Non-US Vaccine Product (EpiVacCorona), COVID-19 PS Non-US Vaccine (EpiVacCorona), SARS-COV-2 COVID-19 Inactivated Virus Non-US Vaccine Product (BIBP, Sinopharm), COVID-19 IV Non-US Vaccine (BIBP, Sinopharm), Pandemic Non-US Vaccine. Moderna Events that persisted for more than 7 days were followed until resolution. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of adverse events (including other neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Moderna COVID-19 Vaccine. As of May 16, 2022, among the 1,364 participants who had received a booster dose, unsolicited adverse events that occurred within 28 days following vaccination were reported by 14.2% of participants (n=194). Available for Android and iOS devices. For the Moderna COVID-19 Vaccine, the observed risk is highest in males 18 through 24 years of age. Anaphylaxis and other severe allergic reactions, myocarditis, pericarditis, syncope, and urticaria have been reported following administration of Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine, Bivalent outside of clinical trials. In these analyses, 99.3% of study participants had at least 28 days of follow-up. For any further questions contact Moderna. Title: Moderna COVID-19 Vaccine Bivalent Concurrence Letter on Extended Shelf-life Expiry Dates 11042022 Created Date: 11/21/2022 3:30:08 PM The effectiveness of a booster dose of Moderna COVID-19 Vaccine, Bivalent is based on effectiveness of primary and booster vaccination with Moderna COVID-19 Vaccine and immunogenicity of a second booster dose with the bivalent vaccine (Original and Omicron BA.1). Advise recipient or caregiver that more information about IISs can be found at: https://www.cdc.gov/vaccines/programs/iis/about.html. Each 0.2 mL booster dose of Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), supplied in a multiple-dose vial with a dark pink cap and a label with a yellow box, contains 5 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Wuhan-Hu-1 strain (Original) and 5 mcg mRNA encoding the pre-fusion stabilized S-protein of the SARS-CoV-2 Omicron variant lineages BA.4 and BA.5 (Omicron BA.4/BA.5). For the authorized uses, although limited scientific information is available, based on the totality of the scientific evidence available to date, it is reasonable to believe that Moderna COVID-19 Vaccine, Bivalent may be effective for the prevention of COVID-19 in individuals as specified in the Full EUA Prescribing Information. Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine, Bivalent are not FDA-approved for use in individuals 6 months through 5 years of age. Non-US Tradename for same formulation (Comirnaty Bivalent) counted toward immunity in US, Pfizer-BioNTech COVID-19 Bivalent, Original + BA.4/BA.5 (Non-US Tradename COMIRNATY Bivalent), SARS-COV-2 (COVID-19) vaccine, mRNA, spike protein, LNP, bivalent booster, preservative free, 50 mcg/0.5 mL or 25 mcg/0.25 mL dose, COVID-19, mRNA, LNP-S, bivalent booster, PF, 50 mcg/0.5 mL or 25mcg/0.25 mL dose, EUA authorized Moderna bivalent booster original strain + omicron BA.4/BA.5 2 dose levels: ages 6 yrs thru 11 yrs 0.25mL dose; 12 years and older 0.5mL dose. The difference in seroresponse rates (Study 4 participants minus Study 1 participants) in this post-hoc analysis was -4.7% (95% CI -14.0, -0.9). CDC twenty four seven. In Study 1, the median age of the population was 52 years (range 18-95); 22,826 (75.2%) participants were 18 to 64 years of age and 7,520 (24.8%) participants were 65 years of age and older. Of the study participants in the Per-Protocol Set, 18.5% were at increased risk of severe COVID-19 due to at least one pre-existing medical condition (chronic lung disease, significant cardiac disease, severe obesity, diabetes, liver disease, or HIV infection) regardless of age. Serious adverse events and medically attended adverse events will be recorded for the entire study duration. Its safety and effectiveness in younger people has not yet been established. Safety data for Moderna COVID-19 Vaccine from the blinded portion of Study 4 included data in 6,388 participants 6 months through 5 years of age who received at least one dose of Moderna COVID-19 Vaccine (25 mcg mRNA; n=4,792) or placebo (n=1,596). 1. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html). Get 1 updated COVID-19 vaccine Everyone 6 years and older should get 1 updated Pfizer-BioNTech or Moderna COVID-19 vaccine, regardless of whether they've received any original COVID-19 vaccines. Tell the vaccination provider about all of your childs medical conditions, including if your child: WHO SHOULD NOT GET MODERNA COVID-19 VACCINE OR Moderna COVID-19 Vaccine, Bivalent? At this time, there are no plans to distribute product with these NDCs., SARS-COV-2 (COVID-19) vaccine, mRNA, spike protein, LNP, preservative free, 100 mcg or 50 mcg dose, COVID-19, mRNA, LNP-S, PF, 100 mcg or 50 mcg dose, EUA 12/18/2020, 2-dose vaccine. Hypersensitivity events in the vaccine group included injection site rash and injection site urticaria, which are likely related to vaccination. Serious adverse events and medically attended adverse events will be recorded for the entire study duration. IIS COVID-19 Vaccine Related Code | CDC Among participants assessed for immunogenicity, the median age of the population was 62 years (range 20-96). Pfizer and Moderna are two-dose vaccines, while J&J is one dose. Overall, 51.9%% were male, 48.1% were female, 15.6% were Hispanic or Latino, 65.7% were White, 11.0% were African American, 7.8% were Asian, 0.5% were American Indian or Alaska Native, <0.1% were Native Hawaiian or Pacific Islander, 1.9% were other races, and 11.8% were Multiracial. Study 1 and 4 participants included in the analysis population had no serologic or virologic evidence of SARS-CoV-2 infection prior to the first primary series dose and prior to the booster dose, respectively. Centers for Disease Control and Prevention. Local and systemic adverse reactions and use of antipyretic medication were solicited in an electronic diary for 7 days following the injection (i.e., day of vaccination and the next 6 days) among participants receiving Moderna COVID-19 Vaccine (10 mcg mRNA). The NDCs related to the Carton of 10 7.5mL vials (80777-100-98/80777-100-15) will not be manufactured. As of August 18, 2022, with a median follow-up duration after the booster dose of 99 days, there were no serious adverse events reported following the booster dose. In addition, you can report side effects to ModernaTX, Inc. at 1-866-MODERNA (1-866-663-3762). Administer Moderna COVID-19 Vaccine, Bivalent intramuscularly. The CDC's Covid-19 vaccination card, annotated | CNN The frequency and severity of reported solicited local and systemic adverse reactions within 7 days of a booster vaccination among participants 17 months through 36 months are presented in Table 3, and among participants 37 months through 5 years are presented in Table 4. The COVID-19 vaccine-related codes are provided in anticipation of potential vaccine availability under an EUA. This Fact Sheet for Recipients and Caregivers comprises the Fact Sheet for the authorized Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine, Bivalent for use in individuals 6 months through 5 years of age. We comply with the HONcode standard for trustworthy health information. To find the expiration for any Moderna COVID-19 Vaccine, locate the lot number printed on the carton and vial. Press Submit. 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