novavax covid vaccine fda approval date

The Novavax COVID-19 vaccine is a protein subunit vaccine. Sign up for free newsletters and get more CNBC delivered to your inbox. The CDCs Advisory Committee on Immunization Practices is scheduled to meet on July 19. Novavax produces the virus spike outside the human body. The vaccine also uses an adjuvant, an extract purified from the bark of a tree in South America, to induce a broader immune response. Novavax Inc.s long-awaited Covid-19 vaccine is moving toward U.S. authorization after the company said it resolved On Monday, Stanley Erck, the CEO of U.S. vaccine maker Novavax, said he In general, CDC recommends that people receive the age-appropriate vaccine product and dosage based on their age on the day of vaccination (Table 1). Vaccine doses should be administered by the intramuscular route. Novavax or Johnson & Johnsons Janssen COVID-19 vaccines were not affected by the changes The benefit of vaccination outweighs the risks for most people. Anti-spike protein antibody testing cannot be used to determine SARS-CoV-2 infection status in a vaccinated person because a positive test result can be induced by either COVID-19 vaccination or SARS-CoV-2 infection. On January 31, 2022, FDA approved the Moderna COVID-19 Vaccine, now known as Spikevax, for the prevention of COVID-19. Studies have shown that increased time between infection and vaccination might result in an improved immune response to vaccination. Note: Some COVID-19 monovalent vaccine products are expired or expiring soon. How will it change your life? If authorized by the FDA, Novavax's shot will be the first new Covid vaccine to hit the market in more than a year. Novavax on Friday filed final data with the Food and Drug Administration for its COVID-19 vaccine, clearing the way for a potential emergency approval next year.The move was the last step for the M A growing body of evidence on the safety and effectiveness of COVID-19 vaccination indicates that the benefits of vaccination outweigh any potential risks of COVID-19 vaccination during pregnancy. This subunit approach isn't new. The FDA has selected three possible dates June 8, 21 and 22 to discuss Moderna and Pfizer's shots for children under age 5 who are not yet eligible for vaccination. Counseling should include the need to seek care if symptoms of myocarditis or pericarditisdevelop after vaccination, particularly in the week after vaccination. People with known current SARS-CoV-2 infection should defer any COVID-19 vaccination at least until recovery from the acute illness (if symptoms were present) and criteriato discontinue isolation have been met. WebPlease read CDC guidance on interchanging COVID-19 vaccines for more information. Novavax applied to the FDA for authorization in January of this year. The vaccine uses synthetic coronavirus proteins to teach the bodys immune system to recognize bits of the virus. CDC recommends that people ages 6 months and older receive at least 1 bivalent mRNA COVID-19 vaccine. It requires two shots. Vaccines for human papillomavirus and hepatitis B have used similar methods. There are limited data on the safety of COVID-19 vaccines in people who have had MIS-C or MIS-A (MIS C/A). FDA advisers greenlight Novavax COVID-19 vaccine Agency urged to authorize fourth U.S. vaccine despite some concern about rare heart inflammation as a side effect 7 Jun 2022 7:15 PM By Meredith Wadman A man receives a Novavax injection in Seattle in February 2021 as part of the companys North American clinical trial. For more information on the assessment and potential management of anaphylaxis, see Preparing for the Potential Management of Anaphylaxis after COVID-19 Vaccination. MIS-A, a similar condition in adults, is even rarer and less well characterized. Summary of recent changes (last updated April 22, 2023): People with an allergy-related contraindication to one type of COVID-19 vaccine have a precaution to the, Centers for Disease Control and Prevention. Certain Americans at high risk of becoming seriously ill from COVID-19 will be able to get an extra bivalent vaccine booster this spring, the FDA says. Information on how to submit a report to VAERS is available at https://vaers.hhs.govor by calling 1-800-822-7967. For best practices for administering multiple injections, see ACIPs general best practicesandEpidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book). Based on the overall data to date, the risk for myocarditis and pericarditis after an mRNA COVID-19 booster dose in adolescents and young adults appears generally similar to or lower than the risk after a second mRNA COVID-19 vaccine primary series dose. For young children, multiple doses will continue to be recommended and vary by age, vaccine and which vaccines were previously received, the CDC said. Administration of antihistamines before COVID-19 vaccination to prevent allergic reactions is not generally recommended. The Novavax COVID-19 vaccine is a protein subunit vaccine. Another COVID-19 booster shot may be coming. Syncope (fainting) might occur in association with any injectable vaccine, especially in adolescents. Doses administered up to 4 days before the minimum interval, known as the 4-day grace period, are considered valid. The FDA is not bound to follow the committee's recommendations, though it usually does. WebThe Novavax COVID-19 Vaccine CANNOT be stored in the freezer. CDPH remains concerned that Californians who have not received recommended doses now or in the future will suffer unnecessarily from severe COVID-19 or long COVID.. Until additional safety data are available, experts advise that these people should: Considerations for subsequent COVID-19 vaccination might include: Safety monitoring is ongoing to further assess the known and potential risks for myocarditis and pericarditis after COVID-19 vaccination in all age groups. Development of myocarditis or pericarditis after a dose of any COVID-19 vaccine is a precaution to a subsequent dose of any COVID-19 vaccine, and subsequent doses should generally be avoided. EVUSHELD was previously recommended for pre-exposure prophylaxis to supplement vaccine protection; however, SARS-CoV-2 variants currently circulating in the United States are resistant to EVUSHELD. Research The agency also said that most immunocompromised people may receive an additional booster dose at least two months following their first updated booster dose. The FDAs signoff isnt the last step: The decision will now to go the Centers for Disease Control and Prevention and its advisory committee to issue their own recommendation on how the shots should be used. The company's initial application for U.S. authorization of the shot was delayed by almost a year on development and production problems, making it a late entrant in the country's market for COVID vaccines. Adverse events that occur in a recipient following COVID-19 vaccination should be reported to VAERS. For Immediate Release: Wednesday, April 19, 2023 Contact: Media Relations (404) 639-3286 Following FDA regulatory action, CDC has taken steps to simplify COVID-19 vaccine recommendations and allow more flexibility for people at higher risk who want the option of added protection from additional COVID-19 vaccine doses. Overall, symptoms were more frequent in people ages 1264 years compared to people ages 65 years and older and more frequent after dose 2 than dose 1 of the primary series. They were designed with BA.4 and BA.5 in mind, as those sibling subvariants rose to prominence last spring and summer. For patients who receive B-cell-depleting therapies on a continuing basis, COVID-19 vaccines should be administered approximately 4 weeks before the next scheduled therapy. The vaccine, already approved in Europe, is based on a technology that has been used for decades to combat diseases including hepatitis B and influenza. Pfizer and Moderna are both studying shots that target the omicron variant as well as the original strain that emerged in Wuhan, China in 2019. Some health officials have also expressed concern with the relatively low uptake among seniors. Clinical trial results, published in The New England Journal of Medicine in December, found two doses of Novavaxs vaccine were about 90% effective. The Food and Drug Administration on Wednesday authorized Novavaxs protein-based Covid vaccine for adults, providing Americans with an alternative to the mRNA-based shots from Pfizer-BioNTech and Moderna. People with a known or potential SARS-CoV-2 exposure may receive vaccine if they do not have symptoms consistent with SARS-CoV-2 infection; however, people should follow CDCs post-exposure guidance. The monovalent Novavax booster dose is administered, Active treatment for solid tumor and hematologic malignancies, Hematologic malignancies associated with poor responses to COVID-19 vaccines regardless of current treatment status (e.g., chronic lymphocytic leukemia, non-Hodgkin lymphoma, multiple myeloma, acute leukemia), Receipt of solid-organ transplant or an islet transplant and taking immunosuppressive therapy, Receipt of chimeric antigen receptor (CAR)-T-cell therapy or hematopoietic cell transplant (HCT) (within 2 years of transplantation or taking immunosuppressive therapy), Moderate or severe primary immunodeficiency (e.g., common variable immunodeficiency disease, severe combined immunodeficiency, DiGeorge syndrome, Wiskott-Aldrich syndrome), Advanced HIV infection (people with HIV and CD4 cell counts less than 200/mm, Active treatment with high-dose corticosteroids (i.e., 20 mg or more of prednisone or equivalent per day when administered for 2 or more weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor necrosis factor (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory (e.g., B-cell-depleting agents), Current or planned immunosuppressive therapies, Optimization of both the patients medical condition and anticipated response to vaccination. March 6, 2022 5:30 am ET. More than 72,000 people in the U.S. have died from COVID-19 since early October nearly four times the estimated death toll from flu over the same time period. The risk of recurrence of a dysregulated immune response following reinfection with SARS-CoV-2 or an MIS-like illness following COVID-19 vaccination is unknown. Treatment should not be delayed until test results are available. People ages 65 years and older have the option to receive 1 additional bivalent mRNA vaccine dose if it has been at least 4 months after their first bivalent mRNA dose. Those who are at least 65 years old can get another dose, according to the CDC. Administration of subsequent COVID-19 vaccine dose(s) should be considered for those who meet the two criteria listed below: For people who had MIS-C or MIS-A but do not meet both criteria above, see Consultation for decisions about COVID-19 vaccination. Cases of myocarditis and pericarditis were identified in clinical trials of Novavax COVID-19 Vaccine and have also been reported during post-authorization use outside the United States. Providers should counsel COVID-19 vaccine recipients, parents, or guardians about expected local and systemic reactions. Timing of vaccination for patients who receive B-cell-depleting therapies on a continuing basis (e.g., for treatment of certain autoimmune conditions such as rheumatoid arthritis or multiple sclerosis) is addressed in Considerations for timing of COVID-19 vaccination in relation to immunosuppressive therapies. Systemic reactions include fever, fatigue/malaise, headache, chills, myalgia, arthralgia; among younger children, particularly those younger than age 3 years, systemic reactions also can include irritability/crying, sleepiness, and loss of appetite. It provides the number of bivalent mRNA vaccine doses an individual needs based on COVID-19 vaccine doses previously received, including the number of prior doses, whether the doses were monovalent or bivalent, and the vaccine manufacturer (Moderna, Novavax, or Pfizer-BioNTech). The U.S. Food and Drug Administration (FDA) has approved the Pfizer-BioNTech COVID-19 vaccine, now called Comirnaty, to prevent COVID-19 in people age 12 and older. The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States the FDA statement said. For information on contraindications and precautions to Janssen COVID-19 vaccination, see Appendix A. Healthcare professionals and health departments may request a consultation from the Clinical Immunization Safety Assessment COVIDvax project for a complex COVID-19 vaccine safety question not readily addressed by CDC guidance. Novavax has said it will continuously monitor for all adverse events potentially related to the vaccine, including myocarditis. Antipyretic or analgesic medications can be taken for the treatment of post-vaccination local or systemic symptoms but should not be used prophylactically for prevention of post-vaccination symptoms. For people who are not moderately or severely immunocompromised and previously initiated vaccination with a monovalent mRNA vaccine: The COVID vaccination schedules for People who are not moderately or severely immunocompromisedshould be consulted for age-specific information. See also CDCCOVID-19 health care professional, CDC COVID-19 laboratory, and FDASARS-CoV-2 laboratorytesting Web pages. The Food and Drug Administration on Wednesday authorized Novavaxs protein-based Covid vaccine for adults, providing Americans with an alternative to the Nicholas Goldberg: Is God on the side of blasphemy laws? Children who are 5 can get two doses of Moderna or one Pfizer-BioNTech shot. About 22% of people in the U.S. have not received a single dose of a Covid vaccine, according to data from the CDC. About 75% of children in the U.S. have been infected by the virus at some point during the pandemic, according to data from national blood sample survey from the CDC. The monovalent Moderna and Pfizer There is currently no FDA-authorized COVID-19 vaccine for children younger than age 6 months. The Bay Area native is a graduate of UC Berkeley and started at the Los Angeles Times in 2004. He covers the Food and Drug Administration, with a special focus on Covid vaccines, prescription drug pricing and health care. Thank you for taking the time to confirm your preferences. The U.S. Food and Drug Administration (FDA) has approved the Pfizer-BioNTech COVID-19 WebNovavax is targeting a second-quarter FDA filing for emergency use of its COVID-19 vaccine. Additionally, providers should consider observing people with the following medical histories for 30 minutes after COVID-19 vaccination to monitor for allergic reactions: See also Contraindications and precautions. Novavaxs vaccine uses an older technology found in other widely used vaccines, including the shots for hepatitis and shingles. Exclusive news, data and analytics for financial market professionals, Reporting by Manas Mishra and Mrinalika Roy in Bengaluru; Novavax's adjuvant has been used in licensed vaccines against malaria and shingles. "Today's authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA's rigorous standards," FDA Commissioner Robert Califf said in a statement. Although some reduction in vaccine-induced antibody titerswas observed in people who previously received antibody products, the clinical significance of this reduction is unknown, and the balance of benefits vs. risks favors proceeding with vaccination even considering the possibility of diminished vaccine effectiveness in this situation. For myocarditis associated with MIS-C or MIS-A, see COVID-19 vaccination and MIS-C and MIS-A. COVID-19 vaccine-specificFDA fact sheets and U.S. COVID-19 Vaccine Product Informationcan be consulted for a full list of ingredients and information on the conditions of use, storage and handling, preparation, and administration procedures. WebIt's finally here: After a series of delays in the lead-up to Novavax's COVID-19 vaccine filing with the FDA, the biotech has completed its emergency use authorization request. For people who have a history of myocarditis associated with MIS-C or MIS-A, see COVID-19 vaccination and MIS-C and MIS-A. Novavax's (NVAX) filing with the FDA seeking approval for emergency use authorization of its COVID-19 vaccine, NVX-CoV2373, gets further postponed to January 2022. *See Appendix E for definitions of allergic reactions, and risk assessment and triage of people with a history of allergies or allergic reactions. Both include a dysregulated immune response to SARS-CoV-2 infection. Viral testing to assess for acute SARS-CoV-2 infection or serologic testingto assess for prior infection is not recommendedfor the purpose of vaccine decision-making. Unvaccinated children 6 months to 5 years can get a two-dose series of the Moderna bivalent vaccine, or, for children 6 months through 4 years, three doses of the offering from Pfizer-BioNTech. FDA officials have said the U.S. needs to rapidly make a decision about whether the shots should be changed to have them ready ahead of a possible fall wave of infection. The FDA has selected three possible dates June 8, 21 and 22 to discuss Moderna and Pfizer's shots for children under age 5 who are not yet eligible for vaccination. People ages 65 years and older who received 1 dose of a bivalent vaccine have the option to receive 1 additional dose at least 4 months after the first bivalent dose. Saving Lives, Protecting People, general best practice guidelines for immunization (GBPG), U.S. COVID-19 Vaccine Product Information, People who received COVID-19 vaccine outside the United States, People who received COVID-19 vaccine as part of a clinical trial, Transitioning from a younger to older age group, Considerations for extended intervals for COVID-19 vaccine doses, COVID-19 vaccination and SARS-CoV-2-infection, COVID-19 vaccination and myocarditis and pericarditis, general best practices for vaccination of people with altered immunocompetence, 2013 IDSA Clinical Practice Guideline for Vaccination of the Immunocompromised Host, Considerations for timing of COVID-19 vaccination in relation to immunosuppressive therapies, Preparing for the Potential Management of Anaphylaxis after COVID-19 Vaccination, Clinical Immunization Safety Assessment COVIDvax, Considerations for extended intervals for COVID-19 vaccination, general best practice guidelines for immunization, symptoms consistent with SARS-CoV-2 infection, reduction in vaccine-induced antibody titers, reduced risk of severe disease including potential recurrence of MIS-C after reinfection, Consultation for decisions about COVID-19 vaccination, testing for current or prior SARS-CoV-2 infection, Clinical Immunization Safety Assessment COVIDvaxproject, Revised SBI Recommendations for the Management of Axillary Adenopathy in Patients with Recent COVID-19 Vaccination, National Center for Immunization and Respiratory Diseases, Use of COVID-19 Vaccines in the U.S.: Appendices, FAQs for the Interim Clinical Considerations, Myocarditis and Pericarditis Considerations, Jurisdictions: Vaccinating Older Adults and People with Disabilities, Vaccination Sites: Vaccinating Older Adults and People with Disabilities, Vaccinating Patients upon Discharge from Hospitals, Emergency Departments & Urgent Care Facilities, Vaccines for Children Program vs. CDC COVID-19 Vaccination Program, FAQs for Private & Public Healthcare Providers, Talking with Patients about COVID-19 Vaccination, Talking to Patients with Intellectual and Developmental Disabilities, How to Tailor COVID-19 Information to Your Audience, How to Address COVID-19 Vaccine Misinformation, Ways to Help Increase COVID-19 Vaccinations, COVID-19 Vaccination Program Operational Guidance, What to Consider When Planning to Operate a COVID-19 Vaccine Clinic, Using the COVID-Vac Tool to Assess COVID-19 Vaccine Clinic Staffing & Operations Needs, Connecting with Federal Pharmacy Partners, Resources to Promote the COVID-19 Vaccine for Children & Teens, COVID-19 Vaccine Access in Long-term Care Settings, Information for Long-term Care Administrators & Managers, Vaccinating Dialysis Patients and Healthcare Personnel, What Public Health Jurisdictions and Dialysis Partners Need to Know, Supporting Jurisdictions in Enrolling Healthcare Providers, Vaccine Administration Management System (VAMS), Resources for Jurisdictions, Clinics, and Organizations, 12 COVID-19 Vaccination Strategies for Your Community, How to Engage the Arts to Build COVID-19 Vaccine Confidence, Strategies for Reaching People with Limited Access to COVID-19 Vaccines, U.S. Department of Health & Human Services, At least 8 weeks after last monovalent dose, 2 doses monovalent Moderna and 1 dose bivalent Moderna, NA; previously received 1 bivalent vaccine dose, 2 doses monovalent Pfizer-BioNTech and 1 dose bivalent Pfizer-BioNTech, 2 doses monovalent Moderna and 1 dose bivalent mRNA, 1 or more doses monovalent Pfizer-BioNTech, Ever received 1 dose bivalent Pfizer-BioNTech (regardless of monovalent vaccine history), 1 or more doses monovalent mRNA (no doses bivalent mRNA), 2 or more doses monovalent mRNA and 1 dose bivalent mRNA, Ever received 1 dose bivalent mRNA (regardless of monovalent vaccine history), History of a severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a component of the COVID-19 vaccine, History of a known diagnosed allergy to a component of the COVID-19 vaccine. An illness consistent with MIS-C or MIS-A after receiving COVID-19 vaccine should be reported toVAERS. COVID-19 vaccination is recommended for everyone ages 6 months and older, regardless of a history of symptomatic or asymptomatic SARS-CoV-2 infection, including people with prolonged post-COVID-19 symptoms. Such individuals, the FDA said, can also receive additional future doses at the discretion of their healthcare providers. In accordance withgeneral best practices, routine administration of all age-appropriate doses of vaccines simultaneously (i.e., administering more than one vaccine on the same clinic day or coadministration) is recommended for children, adolescents, and adults if there are no contraindications at the time of the healthcare visit. The impact of coadministration of COVID-19 and routine vaccines on the risk of febrile seizures has not been specifically studied. Earlier this week, the U.S. government said it had secured 3.2 million Novavax vaccine doses, which it plans to release once the company finishes quality testing in the next few weeks. Novavaxs shot would be the fourth Covid vaccine authorized for use in the U.S. and the first new one since the Johnson & Johnson vaccine was cleared in Existing CDC recommendations on use of the monovalent vaccinations made by Novavax and Johnson & Johnson remain in place. As of January 26, 2023, tixagevimab/cilgavimab (EVUSHELD), a combination of two monoclonal antibodies, is not currently authorized for use in the United States. The schedule is organized by age and COVID-19 vaccination history. The biotech will seek full approval of its Covid-19 vaccine candidate in the U.S. in the second half of 2022, he said. important to the nations vaccination campaign, published in The New England Journal of Medicine in December. The agencystated both vaccines, which were approved in December 2020, are no longer authorized for use in the country. Moderate and severe immunocompromising conditions and treatments includebut are not limited to: Factors to consider in assessing the general level of immune competence in a patient include disease severity, duration, clinical stability, complications, comorbidities, and any potentially immune-suppressing treatment. Build the strongest argument relying on authoritative content, attorney-editor expertise, and industry defining technology. "Some people are suspicious" of the mRNA vaccines, which use a new technology, said Dr. Ofer Levy, the director of the Precision Vaccines Program at Boston Childrens Hospital. Daniel Carrillo, a pharmacist at AltaMed in South Gate, holds a bottle containing bivalent booster doses of the Moderna COVID-19 vaccine. However, the clinical trials took place before the emergence of the extremely contagious omicron variant and its subvariants, which have been found to be more skilled at evading some of the immunity provided by other vaccines than previous strains. Timing of COVID-19 vaccination should take into consideration: On a case-by-case basis, providers caring for these patients may administer Moderna, Novavax, and Pfizer-BioNTech COVID-19 vaccines outside of the FDA and CDC dosing intervals when, based on their clinical judgment, the benefits of vaccination are deemed to outweigh the potential and unknown risks for the recipient who is immunocompromised. The second dose can be given four to eight weeks after the first dose. All quotes delayed a minimum of 15 minutes. See also COVID-19 vaccination and myocarditis and pericarditis and Vaccine reactions and adverse events for Novavax COVID-19 Vaccine. For Immediate Release: July 13, 2022 Espaol Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Novavax Californias 3-year-old COVID-19 state of emergency will lift Tuesday a development that reflects the dawn of a next, hopeful phase of the pandemic. Each carton contains ten 5-dose vials with a minimum order quantity of 100 doses (2 cartons) Contraindications and precautions to COVID-19 vaccination, Special situation: People with a known allergy to polysorbate have a contraindication to both Novavax and Janssen COVID-19 vaccines. An 8-week interval between the first and second doses of bivalent Moderna, monovalent Novavax, and bivalent Pfizer-BioNTech COVID-19 vaccines might be optimal for some people as it might reduce the small risk of myocarditis and pericarditis associated with these COVID-19 vaccines. The vaccine is under an emergency use authorization for children age 6 months through age 11. Three years and $62,000 in medical expenses later, a musician and her caregiving partner struggle to navigate the financial, mental and physical challenges of long COVID. Novavax is confident its Covid-19 vaccine will receive the endorsement of the Food and Drug Administrations advisory committee early this summer, executives The FDA has approved the Moderna COVID-19 vaccine, now called Spikevax, to prevent COVID-19 in people age 18 and older. Find out about the different types of COVID-19 vaccines, how they work, the possible side effects, and the benefits for you and your family. People ages 12 years and older who previously received 1 or more doses of Novavax COVID-19 Vaccine are recommended to receive 1 bivalent mRNA vaccine dose. Thereporting rates for myocarditis after mRNA COVID-19 primary series vaccination or booster vaccination exceed the background rates in several age groups in males and females with the highest rates observed in males ages 1239 years; see the. People who recently had SARS-CoV-2 infection may consider delaying a COVID-19 vaccine dose by 3 months from symptom onset or positive test (if infection was asymptomatic). For the most recent weekly period available, 59 COVID-19 deaths were reported countywide. In a recent statement to The Times, officials at the California Department of Public Health said they support federal recommendations for everyone to receive bivalent boosters, especially those who are more vulnerable to severe COVID-19 due to older age or medical conditions, who remain at increased risk of hospitalization or death if not boosted., The level of acceptance of future vaccine doses remains to be seen, the statement continued. Disclaimer: Subject to change due to FDA EUA approval. Browse an unrivalled portfolio of real-time and historical market data and insights from worldwide sources and experts. The COVID-19 vaccination schedule for people who are not moderately or severely immunocompromised is summarized in Table 1. In clinical trials of Novavax COVID-19Vaccine, the most frequent reported vaccine reactions included: Most symptoms were mild to moderate in severity and resolved within 13 days. People who previously received orthopoxvirus vaccination (either JYNNEOS or ACAM2000), particularly adolescent or young adult males, might consider waiting 4 weeks before receiving a dose of any COVID-19 vaccine because of the observed risk for myocarditis and pericarditis after receipt of ACAM2000 orthopoxvirus vaccine and COVID-19 vaccines, and the unknown risk for myocarditis and pericarditis after JYNNEOS administration.

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