. Structural changes in the brain may explain the persistent fatigue and neuropsychiatric complications tied to long COVID. The American public can trust that this vaccine, like all vaccines that are used in the United States, has undergone the FDAs rigorous and comprehensive scientific and regulatory review., FDA Evaluation of Available Effectiveness Data. Clinical trial results, published in The New England Journal of Medicine in December, found two doses of Novavaxs vaccine were about 90% effective. Across the country, 110 million Americans or more than half of those eligible to be boosted have yet to receive their first booster shot, according to data from the CDC. Ampoules of the Nuvaxovid vaccine against Covid-19 by Novavax are prepared for use. I am not receiving compensation for it (other than from Seeking Alpha). Stone Fox Capital Advisors, LLC is a registered investment advisor founded in 2010. For a year after the Food and Drug Administration's 2017 approval of . Additional data will be needed to know how well the vaccine performs against the Omicron variant and whether a booster will be needed, as has been the case with the mRNA vaccines. They made up about 70% of all new Covid cases in the U.S. for the week ending July 2, according to the CDC. The Novavax vaccine is already approved for emergency use in other countries, and US officials hope that a vaccine made with a more traditional process might sway some who have been hesitant to be immunized against COVID-19. The FDA's approval allows distribution of the vaccine to begin, but before health . The Food and Drug Administration is expected to authorize Novavax's coronavirus vaccine for emergency use as early as Wednesday, two people with knowledge of the matter . Lees ons privacybeleid en cookiebeleid voor meer informatie over hoe we uw persoonsgegevens gebruiken. If you have an ad-blocker enabled you may be blocked from proceeding. after vaccination [with Novavax] compared to mRNA vaccines, said Matthew Frieman, Ph.D., an associate professor of microbiology and immunology at the University of Maryland School of Medicine. Itchy Throat: Could It Be COVID-19 or Something Else? Novavaxs vaccine may be linked to a small but increased risk of myocarditis, according to an FDA briefing document. Unlike the latest boosters from Pfizer-BioNTech and Moderna, which . Stone Fox Capital launched the Out Fox The Street MarketPlace service in August 2020. The biotech saw revenues surge in 2022, but the global pandemic quickly ended, and the company never benefitted from the vaccine due to being late to the game. I am a writer, journalist, professor, systems modeler, computational and digital health expert, avocado-eater, and entrepreneur, not always in that order. The small biotech ended the year with a net loss of $182 million in the December quarter alone. In June, the FDAs external advisory committee of experts voted 21-to-0 with one abstention to recommend the agency authorize the Novavax vaccine. That will expedite its distribution worldwide in the fight against the Covid-19 pandemic. Sure, the FDA needs time to review all the data and information that Novavax submitted as part of the EUA application to feel confident about the safety and effectiveness of Nuvaxovid being used as a booster. The abstention came from Bruce Gellin, MD, MPH, chief of global public health strategy at the Rockefeller Foundation, who is a temporary VRBPAC voting member. Plus, other countries have already been using Nuvaxovid as a Covid-19 booster as @HarlotKnight, a Twitter account that describes itself as a journalist in a grunge band, has emphasized: For example, in April, the Japan Ministry of Health, Labour and Welfare (MHLW) had granted approval for the Nuvaxovid vaccine to be marketed both for primary immunization and boosters. Novavax has said it will continuously monitor for all adverse events potentially related to the vaccine, including myocarditis. Novavaxs vaccine is a two-dose regimen, with the doses given 21 days apart similar to the primary series regimens for the mRNA-based Pfizer-BioNTech and Moderna vaccines. Additional disclosure: The information contained herein is for informational purposes only. The key investor takeaway is that Novavax, Inc. is a highly risky stock due to cash burn and constant share dilution. Continued manufacturing problems led to a delay in winning regulatory approval, and by the . Around 12.6 million doses of the vaccine have been distributed in the European Union, but only around 220,000 doses of the two-shot inoculation have been administered there since it was launched in December. soared to amazing heights on exuberance around the approved covid vaccine, but now the gig is up. Berkeley Lovelace Jr. is a health and medical reporter for NBC News. As Novavax prepares to launch its initial shots in the U.S., the other vaccine manufacturers are working with administration officials to settle on reformulated vaccine boosters that better target the mutating virus and are expected to be distributed later this fall. Nuvaxovid boosters could give the U.S. vaccination efforts a needed boost. Federal government signs deal to make Novavax COVID vaccine at Montreal facility . He praised the company's perseverance with the vaccine and said its data are impressive. Screen for heightened risk individual and entities globally to help uncover hidden risks in business relationships and human networks. The FDA also expects Novavax Inc. to continue their clinical trials to obtain additional safety and effectiveness data and pursue approval (licensure). GAITHERSBURG, Md. Because the Novavax vaccine is coming onto the scene late in the pandemic with the majority of vaccinated Americans receiving an mRNA vaccine its not clear what role this vaccine will play in the countrys COVID-19 response going forward. Americans have been ditching Covid-19 precautions such as face mask wearing as if they were furry boots, shutter shades, or neon activewear. If the Food and Drug Administration (FDA) accepts the group's recommendation and Centers for Disease Control and Prevention (CDC) advisers recommend it, Novavax would give the United States a fourth vaccine to battle the virus. The Covid-19 mRNA vaccines consist primarily of messenger RNA (mRNA) that serve as blueprints for your cells to manufacture spike proteins. . In its weekly update on variant activity, the CDC today said the BA.4 and BA.5 Omicron subvariants now make up 5.4% and 7.2% of sequenced samples, respectively, with the viruses present in all parts of the country. The trade name Nuvaxovid has not yet been approved by the U.S. Food and Drug Administration. 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 vaccine to be made available to the American public. Similarly, although over 61 million people, over the age of 50, are eligible to receive their second COVID-19 booster shot, just a third of people have actually done so. It is the fourth coronavirus vaccine available in the United States, and it uses . vaccines) in the U.S. since late 2020, most people due to get boosted now will have gotten the Covid-19 mRNA vaccines for their previous vaccinations. Novavax is the fourth COVID-19 vaccine to either get authorized or fully approved. Office of the Vice President for Research, University of Minnesota, Minneapolis, MN, 2023 Regents of the University of Minnesota. The stock soared to amazing heights on exuberance around the approved covid vaccine, but now the gig is up. All rights reserved. Two recent papers claim there are no differences between surgical masks and respirators for preventing the spread of respiratory diseases like COVID-19 and flu, but the articles are deeply flawed. (Photo by Patrick van Katwijk/Getty Images), Novavax announced that they had submitted a emergency use authorization (EUA) application, having received authorization for use in the European Union back in December 2021, the Japan Ministry of Health, Labour and Welfare (MHLW) had granted approval, a research letter recently published in the, only 4.4 million Americans have gotten the bivalent Covid19 mRNA boosters. In some ways, the Nuvaxovid vaccine is even less new than the Comirnaty and Spikevax vaccines, which are the seemingly rarely used formal names for the Pfizer-BioNTech and Moderna Covid-19 mRNA vaccines. The most commonly reported side effects by vaccine recipients included pain/tenderness, redness and swelling at the injection site, fatigue, muscle pain, headache, joint pain, nausea/vomiting and fever. If you'd like to learn more about how to best position yourself in under valued stocksmispriced by the marketheading into a 2023 Fed pause, consider joining Out Fox The Street., The service offers model portfolios, daily updates, trade alerts and real-time chat. The U.S. Department of Health and Human Services (HHS), in collaboration with the Department of Defense (DOD), today announced that it has secured 3.2 million doses of Novavax's COVID-19 vaccine. Please disable your ad-blocker and refresh. Novavax said its current cash flow . Myocarditis also occurs after coronavirus infections, at a higher rate than after vaccination, according to some data. And on September 12, the European Commission authorized the use of the Nuvaxovid Covid-19 vaccine as both a homologous (i.e., after the same type of vaccine, Nuvaxovid, was used for the primary series) and heterologous (i.e., after a different type of vaccine was used for the primary series) booster for adults 18 years of age and older. Its not as if the Nuvaxovid vaccine is completely new, despite its name starting with a new sound. The cases were similar to myocarditis after the mRNA COVID-19 vaccines developed by Pfizer/BioNTech and Moderna, and they raise "concern for a causal relationship" with Novavax's vaccine . Pfizer's and Moderna's vaccines have been associated with the heart inflammation condition, particularly in young men, though the complication remains rare. But the company, which had never produced a successful vaccine before, ran into a series of production issues and struggled for months to meet U.S. regulatory standards, falling well behind the pace set by competitors. Despite the quick development of the COVID-19 vaccine, no corners were cut. After reviewing the two-dose Novavax vaccine's safety and efficacy data, the FDA's panel of experts approved it for emergency use in adults ages 18 and older, recommending that doses be spaced three weeks apart. June 7 (Reuters) - Advisers to the U.S. Food and Drug Administration on Tuesday voted overwhelmingly to recommend that the agency authorize Novavax Inc's (NVAX.O) COVID-19 vaccine for use in adults, which the drugmaker hopes can become the shot of choice among some American vaccine skeptics. The company is preparing to file the FDA paperwork in coming weeks and could . Our experts continually monitor the health and wellness space, and we update our articles when new information becomes available. Erck, as well as outside experts, say the Novavax shot is important to the nations vaccination campaign because it may persuade people who have been unable or unwilling to get the mRNA shots to finally get vaccinated. Also, the additional costs place Novavax, Inc. in a more precarious financial position, though the company has a history of selling more shares and diluting shareholders. These offerings were completed at the end of 2022 prior to issuing this going concern statement. Wanneer u onze sites en apps gebruikt, gebruiken we, gebruikers authenticeren, veiligheidsmaatregelen toepassen en spam en misbruik voorkomen, en, gepersonaliseerde advertenties en content weergeven op basis van interesseprofielen, de effectiviteit meten van gepersonaliseerde advertenties en content, en, onze producten en services ontwikkelen en verbeteren. "Based on the data presented to the FDA's VRBPAC and the CDC ACIP, we believe our vaccine offers a broad, long-lasting immune response against a range of variants," Erck said. Its been available in the U.S. as a two-dose primary series for adults (meaning for adults who havent received any Covid-19 vaccines yet) since mid-July after receiving an EUA on July 13 from the FDA. Can Probiotics Help Prevent or Treat COVID-19 Infection? Novavax has been clobbered even though the company's Covid vaccine . A WHO spokesman says China informed the WHO about the case, which involves a 53-year-old woman, on Feb 24. Aircraft wastewater surveillance could be used with traveler-based surveillance to provide an early warning system for COVID-19 and other pathogens. U kunt uw keuzes te allen tijde wijzigen door te klikken op de links 'Privacydashboard' op onze sites en in onze apps. Wij, Yahoo, maken deel uit van de Yahoo-merkenfamilie. Novavax stock is one to avoid, even after crashing below $7 on the dire warning. Though COVID vaccines may utilize different delivery mechanisms, the end result is the same: cells in the body recognize that a spike protein (the spikes you see sticking out of the coronavirus in pictures) doesn't belong, and the immune system reacts by activating immune cells and producing antibodies to attack the real virus if you get exposed. Oct. 19 (UPI) --The FDA has authorized emergency use of a third dose of Novavax's Adjuvante vaccine as a COVID-19 booster shot for adults. Jim Lo Scalzo/ EPA-EFE The FDA Wednesday approved . The Department of Defense and the Department of Health and Human Services secured 3.2 million doses of Novavax in June in advance of the decisions by the FDA and CDC. 07/12/2022 12:55 PM EDT. "Todays authorization offers adults in the United States who have not yet received a Covid-19 vaccine another option that meets the FDAs rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization," FDA Commissioner Dr. Robert Califf said in a statement. Healthline Media does not provide medical advice, diagnosis, or treatment. "Having vaccine options likely plays role in improving vaccination coverage. Regarding our full year 2023 revenue, our performance will depend on our ability to deliver an updated version of our COVID-19 vaccine for the 2023 fall vaccination season. A number of health experts had expressed their hope that some of the individuals, who are still hesitant to be vaccinated, would be more inclined to get the Novavax vaccine, because it is based on a more traditional protein-based technology, one already used for the flu vaccine and other shots, while Pfizer and Moderna vaccine platforms tapped a new genetic technology with messenger RNA to produce their vaccines. At the meeting, the FDA asked the company to add myocarditis as a risk factor on its product insert. Data presented at the meeting also showed that the vaccine was safe, with similar side effects as the mRNA vaccines. Before buying or selling any stock, you should do your own research and reach your own conclusion or consult a financial advisor. T he ever-evolving landscape of Covid-19 vaccines shifted again on Monday, with Moderna winning full approval for its jab from the Food and Drug Administration, and Novavax submitting a long . Meanwhile, the protection offered by peoples primary series vaccinations or previous infections from 2021 may have waned significantly by now. Novavax is a COVID-19 vaccine that uses . The Food and Drug Administration (FDA) yesterday approved an emergency use authorization (EUA) for the Novavax COVID-19 vaccine, bringing a fourth vaccine to the US market against the backdrop of a BA.5 Omicron subvariant surge and lagging vaccine and booster dose uptake.. Rollout awaits CDC recommendation. The small biotech continues to dilute shareholders via near-endless share issuances, and no guarantees exist that the company will have a successful 2023 vaccine update. The Novavax COVID-19 Vaccine, Adjuvanted is administered as a two-dose primary series, three weeks apart. While the company has provided the FDA with updated data, including the vaccines effectiveness against the Omicron variant, those data werent available for the external advisers at the time of their vote. 13,14 Accordingly, development of effective and safe vaccines that provide broad immunization against susceptible strains . The company has also faced supply chain and clinical trial delays. A Department of Health and Human Services (HHS) spokesperson noted that supply is likely to be limited in the near term. The new variants are known to be more transmissible and are thought to have immune evasion properties, but so far, there is no sign that they cause more severe disease. In using an old standby technology, Nuvaxovid vaccines dont have to be kept as cold as the Covid-19 mRNA vaccines need to be kept, making Nuvaxovid vaccines a whole lot easier to transport and store. This could help vaccination efforts better reach those who may be currently harder-to-reach, such as low income or rural locations that may not have the freezers needed to store the Covid-19 mRNA vaccines. Apart from supportive care, there is only one drug approved, an antiviral (remdesivir), which can be used as a medical treatment for people with COVID-19, and an FDA emergency use-authorized nonvaccine antibody combination (casirivimab and imdevimab) to prevent infection. Though, investors did have nearly a year to unload shares above $200 in another prime sign of how taking advantage of market opportunities is a must versus stubbornly holding a stock for the long term. Novavax, up for FDA authorization, will be a good booster option. The expected authorization comes after two years of setbacks for Novavax, once considered among the most promising Covid vaccine developers. combined NanoFlu-Covid19 vaccine could potentially go through the FDA approval process. Nearly fifteen months after the first coronavirus vaccine gained emergency use authorization by the US FDA (and 555 million jabs in American arms later), Maryland-based Novavax is one step closer . T he Food and Drug Administration announced Wednesday that it has authorized a booster shot for Novavax's Covid-19 vaccine. In late-stage clinical trials with more than 25,000 participants spanning the U.S. and Mexico, the vaccine was more than 90 percent effective at preventing Covid-19 infections and 100 percent effective at preventing hospitalizations. Cohen said his experience with the Novavax clinical trial suggests that some people may indeed prefer this vaccine over the mRNA vaccines. Patients have generally fewer adverse reactions like pain at the injection site, fever, headache, etc. The FDA subsequently added the 12-to-17 year age group to this EUA in August, as I reported then for Forbes. This vaccine also doesnt have PEG [polyethylene glycol], which is a chemical [used as a stabilizer] in the mRNA vaccines, and something people can be allergic to, he added. I wrote this article myself, and it expresses my own opinions. 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. The vaccine company Novavax, which manufactures COVID-19 vaccines, says it has "substantial doubts" about its own ability to stay in business long term. After a study from Australian scientists determined the effectiveness of the Novavax vaccine underperformed against the mRNA-based vaccines from these larger biotechs, the company faces an even bigger uphill battle in 2023. Meanwhile, the FDA authorized vaccines from Moderna, Pfizer-BioNTech and Johnson & Johnson, and hundreds of millions of shots were rolled out for the Biden administrations vaccination campaign. But the Biden administration earlier this week purchased 3.2 million doses of the vaccine in anticipation of the shot soon receiving a green light from the agency. Effective subunit vaccines have also been developed for pertussis (whooping cough), hepatitis B, and other diseases, giving this type of vaccine a strong track record. Before shots can be administered, the FDA must authorize the vaccine and the Centers for Disease Control and Prevention (CDC) needs to green light its use. Novavax, Inc. has over $400 million in quarterly operating expenses now leading to a big part of the going concern issue. Many also agreed that the efficacy profile looked similar to earlier approved mRNA vaccines, and some noted the benefits of a different vaccine that has easier storage requirements and less reactogenicity for those who are sensitive to mRNA vaccine side effects. As a prime example, the company recently raised ~$250 million via a concurrent convertible debt offering and a public offering of 8.5 million shares at just $10 per shares. The site is secure. COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19 and I encourage anyone who is eligible for, but has not yet received a COVID-19 vaccine, to consider doing so.. Achieved revenues in fourth quarter 2022 of $357 million and full year 2022 of $2.0 billion. Still, the Novavax vaccine offers a fourth option at a time when White House officials are stressing vaccinations and boosters as key to preventing severe infection that could lead to hospitalization or death, even as the BA.4 and BA.5 subvariants of the Omicron strain dominate infections across the country. Last week, the two subvariants were under the threshold of 1% and weren't listed separately. Als u uw keuzes wilt aanpassen, klik dan op 'Privacyinstellingen beheren'. Advisers to the U.S. Food and Drug Administration on Tuesday voted overwhelmingly to recommend that the agency authorize Novavax Inc's COVID-19 vaccine for use in adults, which the drugmaker hopes . Novavaxs vaccine uses an older technology found in other widely used shots, offering people an alternative to the mRNA-based Pfizer and Moderna vaccines. Its more traditional technology and easy storage attracted big global investment but, as year two of the pandemic draws to a close, the company struggles with regulators, disappoints hopeful governments, and lags far behind its competitors. The FDA has approved previous COVID shots within days of panel votes, with distribution quickly following. If the FDA gives the green light, the first 100 million . The group raised concerns about a small number of Guillain-Barre syndrome cases in vaccine recipients and wanted more data, especially on efficacy in those at highest risk. Novavaxs COVID-19 vaccine has cleared the Food and Drug Administrations (FDA) vaccine advisory committee, but still has more waiting to do as the agency reviews changes to the companys manufacturing process. This is not the first time Novavax has struggled to move its vaccine forward. He covers the Food and Drug Administration, with a special focus on Covid vaccines, prescription drug pricing and health care. As we see BA.5 rise across the country, we encourage all Americans to get vaccinated if they havent already, Ashish Jha, the White House Covid response coordinator, said in a press briefing on Tuesday. This protein subunit vaccine delivers purified copies of the spike protein of SARS-CoV-2, the coronavirus that causes COVID-19. Novavax, Inc. Feb 28, 2023, 16:02 ET. With the. Approximately 21,000 vaccine recipients had at least two months of safety follow-up after their second dose. In addition, in late May, the company announced it began a clinical trial to test an updated vaccine designed to target the omicron variant. Officials have received a growing number of reports of XDR Shigella, which is highly transmissible and resistant to commonly recommended antibiotics, in adults. Als u uw keuzes wilt aanpassen, klik dan op 'Privacyinstellingen beheren'. Investors should have huge concerns about execution in this category due to the need to constantly update the covid vaccine to cover new strains while facing bigger biotechs with more established vaccines. Early indicators suggest that the authorization has yet to convince a large swath of the 26 million unvaccinated American adults to get the shot. He previously covered the biotech and pharmaceutical industry with CNBC. 24/7 coverage of breaking news and live events. The FDA authorized the vaccine on Dec. 11 -- barely over three weeks later. On this page. vaccines) in the U.S. since late 2020, most people . The Food and Drug Administrations independent vaccine advisory committee voted unanimously in favor of having all COVID-19 vaccines in the United, You may wonder whether supplementing with vitamin D can help reduce your risk of contracting the new coronavirus that causes COVID-19. Novavax and Sanofi are a year behind other drugmakers in delivering a Covid-19 vaccine. STRF/STAR MAX/IPx 2021 1/29/21 Novavax says their two-shot vaccine for COVID-19 shows an efficacy rate of 89.3% in a major Phase 3 clinical trial and . Management doesn't expect vaccine sales during Q1, with an anticipation for a seasonal shift starting in Q2, leading to substantial cash burn in the 1H of the year before the company even knows the level of vaccine sales for the rest of the year. Among these participants, approximately 17,200 received the vaccine and approximately 8,300 received saline placebo. Infections are rare and can be severe or fatal, but so far scientists don't see genetic changes that pose an increased threat to people. Novavax experienced delays in early 2023 in manufacturing BA.5 clinical trial materials, which could potentially delay regulatory approval from the FDA for our vaccine candidate for the fall 2023 . The biotech doesn't make any case in why patients will prefer the Nuvaxovid vaccine over ones from Pfizer and Moderna already well established in the developed markets. All quotes delayed a minimum of 15 minutes. The company's Covid-19 shot, available in the U.S. under the Food and Drug Administration's emergency use authorization, has not yet earned a full regulatory approval from the agency. Novavaxs vaccine uses an older technology found in other widely used vaccines, including the shots for hepatitis and shingles. Biotech company Novavax has revealed its COVID-19 vaccine can generate effective . on Friday they filed an application to the U.S Food and Drug Administration (FDA) for a full approval of their . In fact, Nuvaxovid has been available in other countries for even longer, having received authorization for use in the European Union back in December 2021 and in Japan in April 2022. Novavax, Inc. provided the following somewhat shocking statement to investors with the Q4 2022 earnings release: The company suggests having sufficient capital to fund operations for the next year, but the uncertainty around the covid vaccine and the Gavi lawsuit raises questions regarding a going concern. "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. The unexpected data was delivered to a panel convened by the FDA to recommend booster plans for later this year. At the FDA meeting, Novavax presented data showing that its vaccine was safe and effective. The amazing part about this statement is that Novavax ended 2022 with a cash balance of $1.3 billion. Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. read more. However, experts say that although overall uptake may still be limited, there some Americans who have been vaccinated with Moderna, Pfizer, or Johnson & Johnson's COVID-19 vaccines, may feel more inclined to receive Novavax's booster. Maryland-based Novavax is hoping to gain a foothold within the roughly 27 million U.S. adults who are yet to be vaccinated, particularly those who do not want to receive a vaccine like the Pfizer (PFE.N)/BioNTech (22UAy.DE) or Moderna Inc (MRNA.O) shots based on groundbreaking messenger RNA (mRNA) technology. The sluggish start may be, in part, due to the fact that the vaccines were not immediately made available after authorization, and thus, there could be some reporting delays. This generates a protective immune response without causing illness. In addition, a study published earlier this year in the New England Journal of Medicine found that the vaccine was 90.4 percent effective against laboratory-confirmed, symptomatic infection, and 100 percent effective against moderate and severe disease. On the Q4'22 earnings call, CFO James Kelly highlighted why major concerns exist considering the company already in financial distress still needs to deliver an updated version of the covid vaccine for 2023: I'd like to first discuss these uncertainties and then share with you immediate actions we have taken to mitigate these concerns and improve our financial position. HHS said in a statement on Monday that it is coordinating with Novavax "to receive a limited quantity of vaccine and will make that vaccine available to the American public" once those steps are complete. How Long Does the Omicron Variant Last on Surfaces. I am hopeful that this [vaccine] will convince people hesitant to mRNA vaccination [to get vaccinated], for whatever reason they are hesitant, said Frieman. The shot has already been cleared for use in more than 40 countries, as well as the European Union, but manufacturing problems have hampered the company's efforts to be authorized in the U.S. Hannah Beier/Bloomberg via Getty Images, FILE. In addition, the Novavax vaccine may work as a booster for the mRNA vaccines, he said, because it stimulates the immune system in a slightly different way. FDA Approves Novavax COVID-19 Vaccine, but Feds Undecided on Who It's for Plus: The story of a 10-year-old rape victim who sought an abortion is confirmed, inflation hits a record .
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