Novavax began developing its COVID vaccine in 2020 with government funding, but its vaccine did not receive final emergency-use approval until July 2022, well after mRNA vaccines from Pfizer and . "I'm making a personal choice based on my own research and my own body," he says. 8 June 2022 by Alexis Jones. We also use cookies set by other sites to help us deliver content from their services. You can change your cookie settings at any time. You have accepted additional cookies. non-pregnant women of a similar age. You are encouraged to read our filings with the SEC, available at www.sec.govand www.novavax.com, for a discussion of these and other risks and uncertainties. GAITHERSBURG, Md., Feb. 28, 2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global companyadvancing protein-based vaccines with its novel Matrix-M adjuvant, today announced its financial results and operational highlights for the fourth quarter and twelve months ended December 31, 2022. Novavax stock had dropped more than 23% in mid-morning Wednesday trading, to $7.09 per share. and hospitalization due to COVID-19. Lower reactogenicity becomes particularly important in groups such as children, where the balance between vaccination and not vaccination becomes a little less clear, simply because, for example, in young children the likelihood of them having severe Covid-19 is so small, said Prof Paul Heath, the director of the Vaccine Institute at St Georges, University of London, and chief investigator of Novavaxs UK trial. The trade name Nuvaxovid has not yet been approved by the U.S. Food and Drug Administration. Primary and secondary objectives of the study are to assess the safety, tolerability, and immune responses to various formulations of the CIC and influenza vaccine candidates. "Every single one of our neighbours in the EU - Ireland, France, Belgium, the Netherlands - they all have access to Novavax. Novavax (NVAX) shed ~26% pre-market Wednesday as B. Riley downgraded it after the COVID-19 vaccine developer warned of going concern risk with its Q4 2022 results. The accompanying condensed consolidated financial statements have been prepared assuming Novavax will continue as a going concern. Age modifications . AOC under investigation for Met Gala dress, Mother who killed her five children euthanised, Alex Murdaugh jailed for life for double murder, Zoom boss Greg Tomb fired without cause, The children left behind in Cuba's exodus, US sues Exxon over nooses found at Louisiana plant, Biden had skin cancer lesion removed - White House. To date, Novavax said it has delivered over 100 million doses of its COVID-19 vaccine globally. "There are other people out there who are not anti-vax or anything like that, but are just hesitant to take the new kind of mRNA vaccines.". The independent Commission on Human Medicines and its COVID-19 Expert Working Group has carefully considered the available evidence on safety, quality and effectiveness. Delivered over 100 million doses of Nuvaxovid, Novavax's COVID-19 vaccine, globally to date Modified agreement with the U.S. government for up to 1.5 million additional doses of Novavax's COVID-19 . and our Novavax estimates it has sufficient capital available to fund operations this year, but this is subject to significant uncertainty, including as it relates to 2023 revenue, funding from the U.S. government and pending arbitration. 3 February 2022 Nuvaxovid, the COVID-19 vaccine developed by Novavax, has today been given regulatory approval by the Medicines and Healthcare products Regulatory Agency (MHRA). "I think [the Novavax vaccine] could make a difference," says Dr Peter English, a retired consultant in communicable disease control and former editor of the journal Vaccines in Practice. The coronavirus (COVID-19) vaccines are safe and effective. We caution investors not to place considerable reliance on forward-looking statements contained in this press release. The first part seeks to enroll a total of approximately 1,500 participants in Australia and New Zealand. [30][68], On 28 January 2021, Novavax reported that interim results from a trial in South Africa showed a lower effectiveness rate against the Beta variant (lineage B.1.351), at around 5060%. Clinical trials suggest that two doses of the Novavax jab have an efficacy of about 90% against symptomatic Covid similar to the other approved UK vaccines. The TGA provisionally approved Novavax for use as a primary course in Australia on 20 January 2022. The JCVI's chair of Covid-19, Professor Wei Shen Lim, says only that the vaccine's potential use remains "under consideration" and full advice will be published in "due course". Persons with acute PCR-confirmed COVID-19 should not be vaccinated until after they have recovered from acute illness and the criteria for ending isolation have been met. The . An 8-week interval is recommended between primary series doses of NVX-CoV2373. A replay of the conference call will be available starting at 7:30 p.m. ET. At the time, Novavax said production should be up and running by April 2021. *Included in current and noncurrent liabilities as of December 31, 2022 and non-current liabilities as of, Environmental, Social and Governance (ESG), HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American, Novavax to Host Conference Call to Discuss Fourth Quarter and Full Year 2022 Financial Results and Operational Highlights on February 28, 2023, Governo dos EUA e Novavax ampliam parceria, garantindo at 1,5 milhes de doses adicionais da vacina contra a COVID-19 da Novavax, Delivered over 100 million doses of Nuvaxovid, Novavax's COVID-19 vaccine, globally to date, Modified agreement with the U.S. government for up to 1.5 million additional doses of Novavax's COVID-19 vaccine for delivery in 2023, Agreement maintains the U.S. public's access to Novavax's COVID-19 vaccine and supports the development of smaller dose vials, strain selection in line with U.S. Food and Drug Administration (FDA) recommendations and a smooth transition to the commercial market, Reaffirmed intent to deliver an updated mono- or bivalent strain vaccine for the 2023 fall vaccination season, consistent with public health recommendations, Secured European Medicines Agency (EMA) and FDA approval of Nuvaxovid five-dose vial variation and EMA approval of the Company's, Presented data to the U.S. FDA Vaccine and Related Biological Products Advisory Committee demonstrating that when used as a booster, Novavax's COVID-19 vaccine induces broad functional immune responses, including for contemporary variants, Part 2 to evaluate our prototype vaccine compared to an Omicron BA.5 vaccine, as well as a bivalent containing prototype and Omicron BA.5 vaccine, Expanded Nuvaxovid label in adult booster and adolescent primary series to enable broader uptake in the long-term commercial market, Initiated Phase 2 dose-confirming trial to evaluate safety and immunogenicity of different formulations of CIC and influenza stand-alone vaccine candidates in adults aged 50 to 80 years, with topline results expected by mid-year 2023, CIC Phase 2 trial includes additional study arms exploring alternate influenza stand-alone formulations. Our approval of Nuvaxovid today follows a rigorous review of the safety, quality and effectiveness of this vaccine, and expert advice from the governments independent scientific advisory body, the Commission on Human Medicines. On 4 November, the company submitted an emergency use application to the World Health Organization. Log in to your WTOP account for notifications and alerts customized for you. Note: Information in this article was accurate at the time of original publication. [23] On 22 August 2022, the CDC recommended the Novavax COVID19 vaccine for adolescents aged 12-17 years. Achieved revenues in fourth quarter 2022 of $357 million and full year 2022 of $2.0 billion; Appointed John C. Jacobs as President and Chief Executive Officer; Updated U.S. government agreement to include up to 1.5 million additional doses of Novavax's COVID-19 vaccine for delivery in 2023; Expanded Nuvaxovid label in adult booster and adolescent primary series This webpage was updated on 28 September 2022 to ensure consistency of formatting. Pfizer-BioNTech . To maximize our opportunities and mitigate the significant risks and uncertainties of the COVID-19 market, our goal is to reduce spend, extend our cash runway and operate efficiently to best position the company to deliver long-term growth. Last month, officials from the Centers for Disease Control and Prevention signed off on the use of Novavax's COVID-19 vaccine for Americans ages 18 years and older, making it the fourth COVID-19 . December 23, 2021, 9:30 AM. July 13 (Reuters) - The U.S. Food and Drug Administration authorized the use of Novavax Inc's (NVAX.O) COVID-19 vaccine on Wednesday, clearing the way for a shot whose more traditional. Dr. Nita Patel, Director of Antibody discovery and Vaccine development, lifts a vial with a potential coronavirus, COVID-19, vaccine at Novavax labs in Gaithersburg, Maryland on March 20, 2020 . NEWS ALERT: Lesion removed from Bidens chest was cancerous; no further treatment required, Jeff Clabaugh | jclabaugh@wtop.com. *Included in current and noncurrent liabilities as of December 31, 2022 and non-current liabilities as of December 31, 2021. On July 13, 2022, the FDA announced it had granted emergency use authorization for Novavax a new vaccine for COVID-19. But when the vaccine was finally given medical approval in the UK in February 2022, it was on the basis that initial doses would come, not from Teesside, but from the Serum Institute in India. The efficacy of Novavax (NVX-CoV2373) has been assessed in three Phase 2 and Phase 3 trials. This is when the marketing authorisation application made by the company references the decision made by the EMAs Committee for Medicinal Products for Human Use (CHMP). Very rare serious adverse events of myocarditis and pericarditis have been observed though cases typically occurred within a few days after vaccination, and were generally mild. date: Dec 20, 2021 6:35 AM EST . Covid vaccines: How fast is worldwide progress? In a Phase 3 study conducted in the USA and Mexico during a period in which multiple variants (Alpha, Beta and Delta) were in circulation, vaccine efficacy against mild, moderate, or severe COVID-19 was 90%. Jeff Clabaugh has spent 20 years covering the Washington region's economy and financial markets for WTOP as part of a partnership with the Washington Business Journal, and officially joined the WTOP newsroom staff in January 2016. We are continuing our vital safety work in monitoring the use of all COVID-19 vaccines, to ensure that their benefits in protecting people against COVID-19 disease continue to outweigh any risks. [58][59] A spokesperson for Novavax stated that the $1.6billion was coming from a "collaboration" between the Department of Health and Human Services and Department of Defense,[58][59] where General Gustave F. Perna has been selected as COO for Warp Speed. The Novavax COVID vaccine also looks like it performs well. As there is not currently sufficient evidence to date to evaluate the impact of the vaccine on transmission, public health and social measures must continue, including use of face masks, physical distancing, handwashing, appropriate ventilation, and other measures as appropriate in particular settings, depending on the COVID-19 epidemiology and potential risks of emerging variants. A first dose of the Novavax vaccine being given in Berlin, Germany on 28 February, 2022, People wait in separate queues to receive the Novavax and Pfizer vaccines in Berlin, Germany on 28 February 2022, Health Secretary Sajid Javid toured the Fujifilm site in Teesside in February. WHO has identified pregnant persons as a high priority-use group for COVID-19 vaccination, given their increased risk of severe outcomes. Dr. Stephaun Wallace receives his second injection from Dr. Tia Babu during the Novavax Covid-19 . Nuvaxovid (Novavax) is approved and available for use as a primary course in people aged 12 years and over. Novavax posted a fourth quarter loss of $182 million, and a net loss of $846 million for all of 2022. Novavax is targeting a second-quarter FDA filing for emergency use of its COVID-19 vaccine. Novavax reported that a part II of its phase III study on the COVID-19 Omicron BA.1 vaccine candidate will evaluate the candidate vaccine compared with an Omicron BA.5 vaccine, as well as a . [Originally published: July 20, 2022. It can be stored in a standard vaccine fridge at 2C to 8C, making it easier to transport and store than mRNA-based vaccines. All work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. The Novavax vaccine will be manufactured in two different facilities. Post-marketing surveillance would be needed to identify any previously unknown side-effects, he said. It is recommended that the vaccine is given in two doses, which are to be administered three weeks apart. This website is not intended for users located within the European Economic Area. [4], A vaccine is generally considered effective if the estimate is 50% with a >30% lower limit of the 95% confidence interval. Read about our approach to external linking. [32], In February 2021, the European Medicines Agency (EMA) started a rolling review of the Novavax COVID-19 vaccine (NVXCoV2373). Six per cent also said it was because the specific vaccine they wanted was not yet available in the UK. [72] From the total 77 COVID-19 cases found in the trial participants, 14 occurred in the vaccine group, while 63 occurred in the placebo group. 26 August 2022 Nuvaxovid, the COVID-19 vaccine developed by Novavax, has today been granted an extension to its existing UK approval, for 12- to 17-year-olds. When added to vaccines, Novavax's patented saponin-based Matrix-M adjuvant enhances the immune system response, making it broader, and more durable. On 13 July 2022, the FDA authorized NVX-CoV2373 for emergency use as a primary immunization (not booster) in adults. Novavax Covid Vaccine: Approval, Release Date, Efficacy What to Know About Novavax, a Possible Fourth COVID Vaccine Option in the US. The vaccination regimen calls for two 0.5 ml doses (5 microgram antigen and 50 microgram Matrix-M adjuvant) given intramuscularly 21 days apart. In accordance with the WHO Prioritization Roadmap, the highest priority-use groups (e.g. The approval follows a review of the safety, quality and effectiveness of the vaccine in this age group, and expert advice from the governments independent scientific advisory body, the Commission on Human Medicines. Dont include personal or financial information like your National Insurance number or credit card details. The vaccine is authorized for. The sample size of each survey is small, at around 70 people, as they are investigating a hard-to-reach minority, but the results are still thought to be representative. The Novavax COVID-19 Vaccine, Adjuvanted is administered as a two-dose primary series, three weeks apart. Novavax said today it will file for FDA approvals in the third quarter for its COVID-19 vaccine NVX-CoV2373, after it showed 90.4% overall efficacy, and 93% efficacy against the . But while more than 150,000 doses have now been administered in other parts of Europe, Novavax has still not been recommended by the Joint Committee on Vaccination and Immunisation (JCVI), who advise ministers in the UK. You have accepted additional cookies. Only 6% of the population of sub-Saharan Africa has. But when the vaccine was finally given medical approval in the UK in February 2022, it was on the basis that. Both the Pfizer and Moderna jabs have been tested on a cross-section of the population, including people with a variety of health conditions. Gaithersburg, Maryland-based Novavax lost as much as a quarter of its value Wednesday after the company warned of substantial doubt about its ability to stay in business. News centreMHRA On Jan. 31, Novavax formally submitted its request to the Food and Drug Administration (FDA) to have its COVID-19 vaccine approved for EUA. [67][35], On 12 March 2021, Novavax announced their vaccine candidate was 96.4% effective in preventing the original strain of COVID-19 and 86% effective against the Alpha variant. The MHRA is an executive agency of the Department of Health and Social Care. [56][57], In July 2020, the company announced it might receive US$1.6 billion from Operation Warp Speed to expedite development of its coronavirus vaccine candidate by 2021 if clinical trials show the vaccine to be effective. Nuvaxovid, the COVID-19 vaccine developed by Novavax, has today been given regulatory approval by the Medicines and Healthcare products Regulatory Agency (MHRA). It's authorized as a two-dose primary series , with each dose typically given three weeks . All Rights Reserved. A first booster dose is recommended 4-6 months after the completion of the primary series. The BBC is not responsible for the content of external sites. The national drug regulator has approved the Novavax vaccine, as well as two oral treatments for vulnerable patients with COVID-19. A more detailed discussion of Novavax's liquidity position and risk related thereto will be set forth in Novavax's Annual Report on Form 10-K that will be filed with the SEC. It involved about 130 volunteers aged between 18-59. Novavax itself says it is continuing to work with Fujifilm and plans to update its submission to the UK medicines regulator so that doses produced in Teesside can be used by the NHS. . The Joint Committee on Vaccination and Immunisation (JCVI) determines which vaccines are deployed, and which age groups are offered a vaccination. Its developer, Novavax, has pitched it as an alternative for people reluctant to take newer mRNA-based jabs. While our current cash flow forecast for the one-year going concern look forward period estimates that we have sufficient capital available to fund operations, this forecast is subject to significant uncertainty, including as it relates to 2023 revenue, funding from the U.S. government, and pending arbitration. [66], On 28 January 2021, Novavax reported that preliminary results from the United Kingdom trial showed that its vaccine candidate was more than 89% effective. Novavax asked the Food and Drug Administration on Monday to authorize its protein-based Covid-19 vaccine for adults. It is also undergoing mix and match testing with the Oxford/AstraZeneca or Pfizer/BioNTech jabs and preliminary data suggest it generates a robust immune response when given as the second dose. The $1.6 billion award is to fund the production of 100 million doses by early 2021. comment s The Novavax vaccine can be offered to people who have had COVID-19 in the past. [54][55] The first human safety studies of the candidate, codenamed NVX-CoV2373, started in May 2020 in Australia. In some other European countries, individuals can call a dedicated phone line to request the Novavax product. Novavax CEO Stanley Erck speaks with Yahoo Finance Live about the efficacy of Novavax vaccines and the path to FDA authorization amid a surge of the Omicron variant. [90], On 3 June 2022, the FDA's advisory committee voted 21-0 with one abstention to recommend authorization of Novavax's vaccine for use in adults in the United States. Given these uncertainties, substantial doubt exists regarding our ability to continue as a going concern through one year from the date of these financial statements are issued, it said in a statement accompanying its fourth quarter results. We believe that if we succeed in executing against these priorities, we will position the company well for long-term success. [43], Novavax signed an agreement with Serum Institute of India for mass scale production for developing and low-income countries. Novavax has a version of its vaccine specific for the Beta variant of concern in preclinical investigations. [30] A post hoc analysis showed an efficacy of 86.3% against the B.1.1.7 (Alpha) variant and 96.4% against "non-B.1.1.7 strains", the majority of which were the "prototype strains" (original strain). It is impossible to compare vaccine head-to-head due to the different approaches taken in designing the respective studies, but overall, all of the vaccines that have achieved WHO Emergency Use Listing are highly effective in preventing severe disease We use some essential cookies to make this website work. [75][4][76][77], As of November 2021, it has been authorized for use in Indonesia,[78] the Philippines,[79] as of December in India,[80] as of January 2022 in South Korea,[81][82] Australia,[83][84] as of February 2022 in the United Kingdom,[85] Canada,[86] Taiwan,[87] and Singapore. SAGE has thoroughly assessed the data on the safety and efficacy of the vaccine and has recommended its use for people aged 12 and above. What's the least amount of exercise we can get away with? He adds he is still being as careful around other people as he was at the height of lockdown. For adolescents 12-18 years of age, there is currently insufficient evidence for recommending a booster dose, except for those with immunocompromising conditions. To help us improve GOV.UK, wed like to know more about your visit today. WHO lists 10th COVID-19 vaccine for emergency use : Nuvaxovid, The Janssen Ad26.COV2.S COVID-19 vaccine: What you need to know, The Moderna COVID-19 (mRNA-1273) vaccine: what you need to know, The Pfizer BioNTech (BNT162b2) COVID-19 vaccine: What you need to know, The Sinovac-CoronaVac COVID-19 vaccine: What you need to know, The Sinopharm COVID-19 vaccine: What you need to know, The Oxford/AstraZeneca (ChAdOx1-S [recombinant] vaccine) COVID-19 vaccine: what you need to know, Independent Oversight and Advisory Committee, Strategic Advisory Group of Experts on Immunization, Interim recommendations for use of the Novavax NVX-CoV2373 vaccine against COVID-19, The Novavax vaccine against COVID-19: What you need to know. To date, the vaccine maker has . [53], Trials have also taken place in the United Kingdom. The Technical Advisory Group for Emergency Use Listing listed Nuvaxovid (NVX-CoV2373) vaccine against COVID-19 and Covovax (NVX-CoV2373) vaccine against COVID-19 for emergency use on 20 December 2021 and 17 December 2021 respectively. [96], "Covovax" redirects here. So are competitors", "COVID-19 vaccine tracker (click on 'Vaccines' tab)", "Novavax's coronavirus vaccine program is getting some help from Emergent BioSolutions", "Maryland plays an outsized role in worldwide hunt for a coronavirus vaccine", "Top Official Warned That Covid Vaccine Plant Had to Be 'Monitored Closely', "Novavax Covid vaccine shown to be nearly 90% effective in UK trial", "60m doses of new covid-19 vaccine could be made in Billingham and be ready for mid-2021", "Novavax scores $384M deal, CEPI's largest ever, to fund coronavirus vaccine work", "Novavax starts clinical trial of its coronavirus vaccine candidate", "U.S. Will Pay $1.6 Billion to Novavax for Coronavirus Vaccine", "U.S. government awards Novavax $1.6billion for coronavirus vaccine", "Novavax Enters Final Stage of Coronavirus Vaccine Trials", "Human trials of potential coronavirus vaccine begin in Melbourne", "Novavax Initiates Phase 3 Efficacy Trial of COVID-19 Vaccine in the United Kingdom", "A Study Looking at the Effectiveness, Immune Response, and Safety of a COVID-19 Vaccine in Adults in the United Kingdom", "Phase 3 trial of Novavax investigational COVID-19 vaccine opens", "Novavax Initiates Pediatric Expansion for Phase 3 Clinical Trial of COVID-19 Vaccine", "Novavax says Covid vaccine is more than 89% effective", "Novavax Publishes Results of United Kingdom Phase 3 Clinical Trial in New England Journal of Medicine, Demonstrating High Levels of Efficacy of COVID-19 Vaccine", "Novavax says its Covid-19 vaccine is 90% effective in late-stage trial", "Large study finds that vaccine maker Novavax's shot is about 90% effective", "Novavax says Covid-19 vaccine shows 90.4% overall efficacy in US/Mexico Phase 3 trial", "EMA receives application for conditional marketing authorisation of Novavax's COVID-19 vaccine, Nuvaxovid", "EMA recommends Nuvaxovid for authorisation in the EU", "Novavax COVID-19 vaccine receives first emergency use authorization", "Philippines approves emergency use of Novavax's COVID-19 vaccine", "India Clears 2 New Vaccines And Merck's Covid Pill", "South Korea approves Novavax coronavirus vaccine", "S.Korea authorises Novavax COVID-19 vaccine, imports Pfizer pills", "TGA provisionally approves Novavax (Biocelect Pty Ltd's) COVID-19 vaccine Nuvaxovid", "TGA approves provisional determination for Biocelect Pty Ltd for COVID-19 vaccine, Nuvaxovid", "Novavax Covid jab approved by UK drugs regulator", "Health Canada authorizes Novavax's Nuvaxovid COVID-19 vaccine", "Novavax's COVID-19 shot authorized in Taiwan for adults", "Novavax Covid-19 vaccine approved for those aged 18 and above in Singapore", "Novavax's Nuvaxovid COVID-19 vaccine granted interim authorisation in Singapore", "WHO lists 9th COVID-19 vaccine for emergency use with aim to increase access to vaccination in lower-income countries", "FDA decision on Novavax's Covid shots could be delayed to review changes in manufacturing", "FDA advisory committee recommends Novavax vaccine for use in adults", "FDA gives emergency use authorization to Novavax's Covid-19 vaccine", "CDC Recommends Novavax's COVID-19 Vaccine for Adults", "CDC endorses more traditional Novavax COVID shot for adults", "CDC Recommends Novavax COVID-19 Vaccine for Adolescents", https://en.wikipedia.org/w/index.php?title=Novavax_COVID-19_vaccine&oldid=1137662566, This page was last edited on 5 February 2023, at 20:49. We use some essential cookies to make this website work. ", "Over the past few weeks, the management team and I have identified three near-term priorities that we believe are essential to our success this year and beyond: 1) to deliver a competitive product for the upcoming 2023 fall vaccination season; 2) to reduce our rate of spend, manage our cash flow, and evolve our scale and structure; and 3) to leverage our technology platform, our capabilities and our portfolio of assets to drive additional value beyond Nuvaxovid alone. How many people have had boosters so far? Emerging post-introduction pharmacovigilance data relating to the use of NVX-CoV2373 in pregnant women have not identified any pregnancy-related safety concerns and based on previous evidence from other protein-based vaccines during pregnancy, efficacy is expected to be comparable to No direct head-to-head comparisons have yet been done, however, and further studies are needed. Copyright 2022 by WTOP. ET on March 7, 2023. The Novavax vaccine is the fourth one to be authorized in the United States for the prevention of COVID-19. These risks and uncertainties include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; unanticipated challenges or delays in conducting clinical trials; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; manufacturing delays or challenges, including as a result of the timing of the anticipated regulatory requirements for the fall 2023 vaccination season; the loss of future funding from the U.S. government; the potential for an unfavorable outcome in disputes, including the pending arbitration with Gavi; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC).
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