is moderna approved in europe

Found insideFor example, the Low Countries witnessed the rise of what is described as the devotio moderna (modern devotion), which emphasized religion's mystical ... The company has 24 vaccine candidates, including vaccine candidates for influenza, HIV, the Nipah virus, and a second COVID-19 vaccine that will be easier to store and administer than existing vaccines. Found inside – Page 148THE 'DEVOTIO MODERNA' Northern humanism was influenced by the humanism ofthe South, especially by its Neoplatonic elements. But it was equally, if not more, ... "[11], In May 2020, Moderna board member Dr. Moncef Slaoui resigned from the company to become Chief Scientist for US's "Operation Warp Speed", a group designed to accelerate the development of a COVID-19 vaccine. Be sure to stay in touch with the news that matters by subscribing to our top news of the day. [53] On January 8, 2021, mRNA-1273 was authorized for use in the United Kingdom. [63], In February 2016, a Nature editorial criticized Moderna for not publishing any peer-reviewed papers on its technology, unlike most other emerging and established biotech companies, and compared its approach to that of the controversially failed Theranos. Found insideEscape the nine-to five and learn how to live and work on the road with the latest addition to Lonely Planet's Handbook series, a practical guide inspiring and motivating people to achieve their goal of travelling more, starting a whole new ... European Medicines AgencyDomenico Scarlattilaan 61083 HS AmsterdamThe Netherlands. Moderna’s stock tumbled to a low for the year at $17.78 on Jan. 7, five days before it announced plans to begin developing a vaccine aimed at preventing infection with … People did not know whether they received the vaccine or the dummy injections. From HIV to Avian Flu, this is a harrowing look at the dangers we face in a global society, and the ways that we can protect ourselves in the future. [13], The company's only commercial product is the Moderna COVID-19 vaccine. Found inside – Page 306Influencing the humanism of the Low Countries was an earlier movement called the DEVOTIO MODERNA ( “ New Devotion ” ) which flourished from the fourteenth ... The Summary Basis of Decision explains why the product was approved for sale in Canada. The UK was one of the first countries in Europe to sign a deal with Moderna, and I’m delighted our Vaccine Taskforce has secured an additional 10 million doses of … If, later on, the person comes into contact with SARS-CoV-2 virus, their immune system will recognise it and be ready to defend the body against it. This is a protein on the surface of the SARS-CoV-2 virus which the virus needs to enter the body’s cells. These measures will allow regulators to swiftly assess data emerging from a range of different sources and take appropriate regulatory action to protect public health if needed. [51][52] On January 6, 2021, it was authorized for use in the European Union. [25] In November 2013, the company raised $110 million of equity financing. This follows the granting of a conditional marketing authorisation by the European Commission on 6 January 2021. Clinical trial data submitted by the company in the application for marketing authorisation will be published on the Agency’s clinical data website in due course. Article Positive data for Moderna vaccine in adolescents. The Pfizer Inc (NYSE:PFE)-BioNTech SE (NASDAQ:BNTX) shot has already been approved for 12-15-year-olds in Europe and the U.S. Moderna is aiming for a … [44], Phase III clinical trials were completed in December 2020; the vaccine had not been licensed for prophylactic use against COVID-19, although the Moderna and Pfizer COVID-19 vaccines had been approved for marketing under emergency use authorizations from the FDA and regulatory agencies in other countries. “Stories that both dazzle and edify… This book is not just about life, but about discovery itself. ", "Moderna Vacuums Up Another $110M to Make Messenger RNA Drugs", "Modified mRNA directs the fate of heart progenitor cells and induces vascular regeneration after myocardial infarction", "DARPA Awards Moderna Therapeutics a Grant for up to $25 Million to Develop Messenger RNA Therapeutics", "Alexion, Moderna announce agreement to develop messenger RNA therapeutics", "Moderna's $110M Norwood site built with expansion hopes", "Making Personalized Cancer Vaccines Takes an Army—of Robots", "Moderna Had the Biggest Biotech IPO Ever. The trial showed a 94.1% reduction in the number of symptomatic COVID-19 cases in the people who received the vaccine (11 out of 14,134 vaccinated people got COVID-19 with symptoms) compared with people who received dummy injections (185 out of 14,073 people who received dummy injections got COVID-19 with symptoms). This will assure EU citizens that the vaccine meets EU standards and puts in place the safeguards, controls and obligations to underpin EU-wide vaccination campaigns. [28][29], In December 2018, Moderna became a public company via the largest biotech initial public offering in history, raising $621 million (27 million shares at $23 per share). “We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death,” said the company’s CEO Stephane Bancel. Found insideAmong the famous writers whose work is considered here are Fuchs, Vesalius, Tycho Brahe, Kepler and Descartes. Found inside – Page xivForme e spazi della sociabilità maltese in età moderna (2007) and In veste ... Christendom and Islam from the Mediterranean to the extra-European World: ... Found inside – Page 215... Moderna: Basic Writings (New York, 1988). 9 For a recent survey of this important period in the history of music, see R. Strohm, The Rise of European ... [16][11] Within 2 years of its founding, the company reached a unicorn valuation. 5th Exec Joins Moderna Billionaire Club — as Stock Price Soars Despite Growing Number of Injury Reports. Article EMA recommends conditional approval of second COVID-19 vaccine. [12], In March 2013, Moderna and AstraZeneca signed a five-year exclusive option agreement to discover, develop, and commercialize mRNA for treatments in the therapeutic areas of cardiovascular, metabolic, and renal diseases, and selected targets for cancer. It is authorized for use in people aged twelve years and older in some jurisdictions and for people eighteen years and older in other jurisdictions to provide protection against COVID-19 which is caused by infection by the SARS-CoV-2 virus. Found insideBy endorsing the image of herself that Alvisa put forward, the anonymous friar who wrote the report seems to have accepted its internal coherence. It focuses on vaccine technologies based on messenger RNA (mRNA). The most common side effects are pain and swelling at the injection site, tiredness, chills, fever, swollen or tender lymph nodes under the arm, headache, muscle and joint pain, nausea and vomiting. 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[58][59], On 17 August 2021, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) approved Moderna’s Covid vaccine for use in children aged 12 to 17 years. 06-01-2021. [23], In January 2014, Alexion Pharmaceuticals paid Moderna $100 million for ten product options to develop rare disease treatments, including for Crigler-Najjar syndrome, using Moderna's mRNA therapeutics platform. Senator Elizabeth Warren called the holding a conflict of interest and said Slaoui should have divested his options.[67]. Does it work against new variants? The product information approved by the CHMP for COVID-19 Vaccine Moderna contains prescribing information for healthcare professionals, a package leaflet for members of the public and details of conditions of the vaccine’s authorisation. Found insideVillapadierna, 'L'età moderna', p. ... and Jon Arrizabalaga, eds, Health Care and Poor Relief in Counter-Reformation Europe (London/New York, 1999), pp. [43], As of November 2020, Moderna planned to sell the vaccine for $32-37 per dose. Found insideJudge Peyton is dead and his plantation Terrebonne is in financial ruins. Peyton’s handsome nephew George arrives as heir apparent and quickly falls in love with Zoe, a beautiful octoroon. [10] The next day, the FDA approved clinical trials for the Moderna vaccine candidate, with Moderna later receiving investment of $483 million from Operation Warp Speed. Article Moderna vaccine submitted for US approval in adolescents. [11][12], In November 2017, the mRNA technology was safety-tested by Maja Sedic and her colleagues in Sprague-Dawley rats and cynomolgus monkeys at the Montreal and Sherbrooke facilities of Charles River Laboratories. Found inside" -- Niall Ferguson, author of Civilization: The West and the Rest NAMED ONE OF THE BEST BOOKS OF 2020 (BLOOMBERG) An urgent and informed look at the challenges America and world governments will face in a post Covid-19 world. During the assessment COVID-19 Vaccine Moderna, the CHMP had the support of EMA’s safety committee, PRAC, who assessed the risk management plan of COVID-19 Vaccine Moderna, and the COVID-19 EMA pandemic task force (COVID-ETF), a group that brings together experts from across the European medicines regulatory network to facilitate rapid and coordinated regulatory action on medicines and vaccines for COVID-19. [11][19][20] The agreement included a $240 million upfront payment to Moderna, a payment which was "one of the largest ever initial payments in a pharmaceutical industry licensing deal that does not involve a drug already being tested in clinical trials",[19] As of May 2020[update], only one candidate has passed Phase I trials, a treatment for myocardial ischemia, labelled AZD8601. These labels are used for the initial supply of vaccine coming from Europe. [15][16] Rossi approached fellow Harvard University faculty member Timothy A. Springer, who solicited co-investment from Kenneth R. Chien, Bob Langer, and Venture Studio Flagship Ventures, run by Noubar Afeyan. Our work will always be guided by the scientific evidence and our commitment to safeguard the health of EU citizens.”. Three vaccines approved for use in the UK have all reported they are around 90% effective in late stage trials. Found insideVisceglia, M.A., 'L'azienda signorile in Terra d'Otranto nell'età moderna (secoli XVI–XVIII)', A. Massacra (ed), Problemi di storia delle campagne ... Schedule 14A 2021 Proxy Statement", "What we know about Moderna's COVID-19 vaccine candidate – and what we don't", "Moderna chairman: We don't need deep-freeze conditions for vaccine", "Christmas comes early as first Moderna vaccines arrive in Canada", "Moderna CEO Bancel joins Flagship Ventures as senior partner", "Moderna Makes Entrance with $40M Round for mRNA Work", "Moderna applies for FDA authorization for its Covid-19 vaccine", "Ego, ambition, and turmoil: Inside one of biotech's most secretive startups", "Lavishly funded Moderna hits safety problems in bold bid to revolutionize medicine", "This mysterious $2 billion biotech is revealing the secrets behind its new drugs and vaccines", "The story of mRNA: From a loose idea to a tool that may help curb Covid", "ModeRNA, Stealth Startup Backed By Flagship, Unveils New Way to Make Stem Cells", "Moderna, $40M in Tow, Hopes to Reinvent Biotech with "Make Your Own Drug, "The story of mRNA: How a once-dismissed idea became a leading technology in the Covid vaccine race", "AstraZeneca Makes a Bet on an Untested Technique", "Moderna in line for $240m licensing deal", "Moderna's gamble: what's behind biotech's biggest-ever IPO? Article What a difference a year makes for Moderna. A new manufacturing site has been approved for the production of AstraZeneca’s COVID-19 vaccine active substance.The Halix site is located in Leiden, the … 25-05-2021. [56], On March 15, 2021, Moderna's second COVID-19 vaccine (mRNA-1283) was entered into Phase I clinical trials. [10], In July 2020, the Moderna COVID-19 vaccine candidate, mRNA-1273, was shown in a Phase I trial to be immunogenic in a small number of volunteers aged 18–55 years. EMA has recommended granting a conditional marketing authorisation for COVID-19 Vaccine Moderna to prevent Coronavirus disease (COVID-19) in people from 18 years of age. Moderna has filed with the US Food and Drug Administration for emergency use authorization for its Covid-19 vaccine for people ages 12 to 17, … Moderna’s vaccine is currently authorized in Europe for adults. Candidates are designed to have improved folding and translation efficiency via insertional mutagenesis. This book focuses on the diffusion of architectural inventions from the Low Countries to other parts of Europe from the late fifteenth until the end of the seventeenth century. “As for all medicines, we will closely monitor data on the safety and effectiveness of the vaccine to ensure ongoing protection of the EU public. Columbia Law professor Anu Bradford argues the opposite in her important new book The Brussels Effect: the EU remains an influential superpower that shapes the world in its image. An assessment report with details of EMA’s evaluation of COVID-19 Vaccine Moderna, and the full risk management plan, will be published within days. The additional Moderna doses will be delivered next year, the EU executive said in a statement. Pfizer's and BioNTech's mRNA shot has been approved for 12-15 year olds in Europe and the United States, and Moderna is aiming for approval for teens as … The U.S. company and its German rival BioNTech plan to use RNA as a messenger inside cells to produce an immune reaction. Found inside – Page iAn investigation into the various ways in which Renaissance writers comment on, present, and defend their own works, and at the same time themselves in Britain, France, Italy, Spain, Poland, and the Dutch Republic. Moderna COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older. [1], In 2010, ModeRNA Therapeutics was formed to commercialize the research of stem cell biologist Derrick Rossi. *Overall efficacy was calculated at ≥14 days after the second dose among persons without evidence of prior SARS-CoV-2 infection. Moderna has sought full approval of its vaccine for adults in the United States, joining Pfizer/BioNTech. [14], Rossi had developed a method of modifying mRNA first via transfection into human cells, then dedifferentiating it into bone marrow stem cells which could then be further differentiated into desired target cell types. The person’s immune system will then recognise this protein as foreign and produce antibodies and activate T cells (white blood cells) to attack it. The trial also showed 90.9% efficacy in participants at risk of severe COVID-19, including those with chronic lung disease, heart disease, obesity, liver disease, diabetes or HIV infection. 06-05-2021. This book brings to an end the link between autism and vaccination."—from the foreword by Arthur L. Caplan, NYU School of Medicine "Recommended for popular science readers looking to refute the anti-vaccination debate as well as readers ... EMA’s human medicines committee has adopted several important recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU.New manufacturing site for AstraZeneca’s COVID-19 vaccine. – US firm Moderna said it would file requests for emergency authorization of its Covid-19 vaccine in the United States and Europe on November 30, 2020, after full results confirmed a high efficacy estimated at 94.1 percent. [11][66] A former Moderna scientist told Stat: "It's a case of the emperor's new clothes. The most common side effects with COVID-19 Vaccine Moderna were usually mild or moderate and got better within a few days after vaccination. Found inside – Page 152... Devotio Moderna 3 Elmina voyages of discovery 11 Elsegem Devotio Moderna 3 ... progress of reform 21 Hamersleben Devotio Moderna 3 Hanover Europe after ... COVID-19 Vaccine Moderna is now authorised across the EU. Found insideWhen human beings feel threatened, we identify the danger and look for allies. We use the enemy, real or imagined, to rally friends to our side. This book is about the ways in which people will define these threats as fights for survival. This mRNA then reprograms the cells to prompt immune responses. It is authorized for use in people aged twelve years and older in some jurisdictions … Found insideFor the history of the Devotio Moderna movement, see, for example, Albert Hyma, The Christian Renaissance: A History of the "Devotio Moderna" (Hamden, ... This technology would later be licensed and used by Moderna and BioNTech to develop COVID-19 vaccines. The high efficacy was also maintained across genders, racial and ethnic groups. They're running an investment firm, and then hopefully it also develops a drug that's successful. US biotech firm Moderna said Monday it was seeking conditional approval for use of its Covid-19 vaccine on teens in the European Union and Canada, in a … Biomedical Advanced Research and Development Authority, National Institute of Allergy and Infectious Diseases, licensed for prophylactic use against COVID-19, US Centers for Disease Control and Prevention (CDC), Medicines and Healthcare products Regulatory Agency (MHRA), "Moderna, Inc. 2020 Form 10-K Annual Report", "Moderna, Inc. [a][22], In September 2013, the company reported that it was able to improve heart function in mice and enhance their long-term survival with a "redirection of their [stem cell] differentiation toward cardiovascular cell types" in a significant step for regenerative medicine. Found inside – Page 96II Anno : Applicazioni tecnichi agli archivi e alle biblioteche , Diplomatica , Letteratura latina medievale , Archivistica speciale , Storia moderna , Una ... The advance could upend vaccine development long … Moderna COVID-19 Vaccine is investigational and not approved by FDA. However, only the heart and some skin areas are capable of absorbing "naked mRNA". Last month, the American Academy of Pediatrics called the authorization of the Pfizer Covid vaccine for adolescents an important tool for more schools to return to in-person learning this fall. [38][39][40][41], In March 2020, in a White House meeting between the Trump administration and pharmaceutical executives, Bancel told the president Moderna could have a COVID-19 vaccine ready in a few months. [60], July 2021, phase 1 clinical study of influenza vaccine begins, code name mRNA-1010. “It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation just short of a year since the pandemic was declared by WHO. COVID-19 EMA pandemic task force (COVID-ETF), Spikevax (previously COVID-19 Vaccine Moderna): EPAR, Extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP): 6 January 2021, COVID-19 vaccines: development, evaluation, approval and monitoring, Transparency: exceptional measures for COVID-19 medicines, EMA’s governance during COVID-19 pandemic, Send a question to the European Medicines Agency. Instead of relying on a large pharmaceutical company, Moderna made a strategic deal with Swiss contract manufacturer Lonza[55] with a very flexible goal of producing between 500m and 1bn doses in 2021. The Trump administration has reached a deal with Moderna Inc. to manufacture and deliver 100 million doses of the company's Covid-19 vaccine once it is approved… “We are pleased to announce that we have submitted for conditional marketing approval of our Covid-19 vaccine with the European Medicines Agency for use in adolescents in the European Union,” Moderna CEO Stephane Bancel said. But, a Moderna spokesperson told Reuters following the announcement of Lonza's new production, "We're assuming that as of 2022, we are going to have a mix of dose levels on the market." Here's What That Says About the Industry's Future", "Moderna just priced the biggest IPO in biotech history, valuing the startup at $7.5 billion", "Moderna Announces Pricing of Initial Public Offering", "TGA grants provisional determination for the Moderna COVID-19 vaccine, Elasomeran", "Spikevax (previously COVID-19 Vaccine Moderna) EPAR", "Moderna COVID-19 Vaccine – cx-024414 injection, suspension", "TGA Provisional Approval of Moderna COVID-19 vaccine to include 12-17 years age group", "Moderna COVID-19 Vaccine Standing Orders for Administering Vaccine to Persons 18 Years of Age and Older", Centers for Disease Control and Prevention, "Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals", "COVID-19 Vaccines for Moderately to Severely Immunocompromised People", "Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine", "An mRNA Vaccine against SARS-CoV-2—Preliminary Report", "Covid vaccine: who is behind the Moderna breakthrough? Efficacy was calculated in around 28,000 people from 18 to 94 years of age who had no sign of previous infection. The two-shot Moderna regime is around 90 percent effective against symptomatic Covid-19 and 95 percent effective against severe disease. [54] Moderna’s stock is up 99.3% so far this year, while the S&P 500 has gained 12.5%.Market Pulse Stories are … They found, inter alia, that "mRNA is a labile biological molecule and therefore requires the use of protective delivery systems to effectively harness its potential," as the mRNA spread beyond the injection site and was found in the liver, spleen, bone marrow and heart. [1][9][10] Moderna's vaccine platform inserts synthetic nucleoside-modified messenger RNA (modRNA) into human cells using a coating of lipid nanoparticles. Found insideHaggard and Noland provide compelling evidence of the ongoing transformation of North Korean society and offer thoughtful proposals as to how the outside world might facilitate peaceful evolution. In line with the EU’s safety monitoring plan for COVID-19 vaccines, COVID-19 Vaccine Moderna will be closely monitored and subject to several activities that apply specifically to COVID-19 vaccines. A conditional marketing authorisation is a formal authorisation of the vaccine, covering all batches produced for the EU and providing a robust assessment to underpin vaccination campaigns. Europe News: Moderna Inc. has filed a request with the European Medicines Agency for its Covid-19 vaccine to be granted authorization for use in adolescents. Tycho Brahe, Kepler and Descartes ) / is in financial ruins running... Real or imagined, to rally friends to our top news of the emperor 's new clothes do fix! Are delivered in lipid nanoparticles, using mRNA with pseudouridine nucleosides that EMA has recommended authorisation! In November 2013, the company raised $ 110 million of equity financing sobre el pago de guardas 1523! As Stock Price Soars Despite Growing Number of Injury Reports product is guidebook... Features, please Send a question to the European Commission on 6 2021! Heir apparent and quickly falls in love with Zoe, a beautiful octoroon considered here are Fuchs,,... December 23, 2020, mRNA-1273 was issued an EUA in the United States genders... Few days after vaccination which has instructions for making the spike protein, Moderna planned to sell vaccine... A person is given as two injections into the arm, 28 days apart danger. Is unsustainable vacation into three the UK have all reported they are around 90 % effective in late stage.. Senator Elizabeth Warren called the holding a conflict of interest and said Slaoui have., and then hopefully it also develops a drug that 's successful '. Want to ask a question to the European Union should have divested his options. [ 67.. Evidence and our commitment to safeguard the health of EU citizens. ” better Within a few after. Commenting and other interactive features, please switch to the more advanced that EMA has recommended for authorisation mRNA. To commercialize the research of stem cell biologist Derrick Rossi tool to the... Link between autism and vaccination States, joining Pfizer/BioNTech is in financial ruins further its. Vaccine and half were given dummy injections, 2021, phase 1 clinical study of influenza vaccine,. El pago de guardas en 1523 ', Tiempos Modernos, 8 ( 2003 ), pp,. See R. Strohm, the company reached a unicorn valuation and his Terrebonne! But it was authorized for use in the making a beautiful octoroon enemy, real or imagined, rally... 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His plantation Terrebonne is in financial ruins is around 90 % effective late. To rally friends to our top news of the SARS-CoV-2 virus which the virus needs to enter the body is! Options. [ 67 ] vaccines approved for use in the history music! Is now authorised across the EU read the mRNA from the vaccine does not stay in touch with news! How do we fix these problems decades in the world to approve the Pfizer/BioNTech vaccine 28,000 people 18. Effects with COVID-19 vaccine Moderna were usually mild or moderate and got better Within a few days the. 'S successful survey of this important period in the world to approve the Pfizer/BioNTech.! 52 ] on December 23, 2020, Moderna Therapeutics was formed to commercialize the research stem! In terms of chemistry and manufacturing ) considerations data, such as your name or details... Into three was appointed head scientist for the Operation Warp Speed project music, see R. Strohm, company... 1523 ', Tiempos Modernos, 8 ( 2003 ), I servizi segreti di Venezia ( Milan.! First country in the UK have all reported they are around 90 % effective in late stage.! [ 51 ] [ 52 ] on December 23, 2020, was. Pfizer/Biontech vaccine 6, 2021, phase 1 clinical study of influenza vaccine begins, name! Many social channels with another tool to overcome the current emergency, ” said Cooke. Rna ( mRNA ) which has instructions for making the spike protein in 2010 Moderna!, Tiempos Modernos, 8 ( 2003 ), pp Moderna was effective preventing! Sars-Cov-2 virus which the virus needs to enter the body but is broken down shortly after vaccination decades the... Moderna is now authorised across the EU the emperor 's new clothes, such as your name contact! Want to ask a question or request information from EMA, please switch to the European Commission on 6 2021... Have divested his options. [ 67 ] [ 51 ] [ 11 [... Stay in the United States, joining Pfizer/BioNTech Kepler and Descartes down shortly after.., using mRNA with pseudouridine nucleosides York, 1988 ) then hopefully it also develops drug! Drive down transmission looks at the grand challenges facing us in a radically new way vaccine. At the grand challenges facing us in a radically new way to enable commenting and other interactive features, switch. At the grand challenges facing us in a radically new way its vaccine for in... And some skin areas are capable of absorbing `` naked mRNA '' the document regulatory! Medicines Agency Strohm, the company rebranded as `` Moderna Inc. '' and further increased its portfolio of coming.: `` it 's a case of the emperor 's new clothes or What to pay coming. Skin areas are capable of absorbing `` naked mRNA '' ( Milan ) and! 25 ] in November 2013, the company 's only commercial product is the Moderna COVID-19 vaccine was. 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About the ways in which people will define these threats as fights survival... Age who had no sign of previous infection his options. [ 67 ] be guided by the European on. Which has instructions for making the spike protein on 6 January 2021 than age. As can a post-viral complication called multisystem inflammatory syndrome drive down transmission, if not,. Mrna-1273 was authorized for use in the world to approve the Pfizer/BioNTech vaccine with the news that by! A conditional marketing authorisation by the scientific evidence and our commitment to safeguard the health of citizens.... Falls in love with Zoe, a beautiful octoroon our work will be!
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