By continuing to browse this site you agree to our use of cookies. Radioactivity was measured in various organs at 0.25, 1, 2, 4, 8, 24, and 48 hours post-injection. However, for the typical 70 kg male, 0.5 mg represents a per-weight dose of 0.0071 mg/kg, or 7.1 g/kg. Unlike its clear articulation of two months for an EUA, the FDA has not committed to a clear minimum for approval. The median age was 22 years, but a quarter was below the age of 20. Inaccurate: The biodistribution study found that the injection site retained the highest concentration of lipid nanoparticles, not the ovaries. As of February 2021, Japan has 14 medical . The viral particles are unlikely to be confined to the muscles at the injection site; they are free to distribute across the body and drain through the lymphatic system; their apparent volume of distribution is likely to be very high. Li G, Cappuccini F, Marchevsky NG, Aley PK, Aley R, Anslow R, Bibi S, Cathie K, Clutterbuck E, Faust SN, Feng S, Heath PT, Kerridge S, Lelliott A, Mujadidi Y, Ng KF, Rhead S, Roberts H, Robinson H, Roderick MR, Singh N, Smith D, Snape MD, Song R, Tang K, Yao A, Liu X, Lambe T, Pollard AJ; COV006 study team. Study of DS-5670a (COVID-19 Vaccine) in Japanese Healthy Adults and Elderly Subjects. (The situation is similar in Europe, where four covid-19 vaccines have been granted conditional marketing authorisations, a fast track mechanism that can be used in emergencies. [8] Contents 1 Background 1.1 Vaccines on order ), As hundreds of millions of people around the world get vaccinated, it may seem like wordsmithing to highlight the fact that none of the covid-19 vaccines in use are actually approved. Through an emergency access mechanism known as Emergency Use Authorisation (EUA), the products being rolled out still technically remain investigational.3 Factsheets distributed to vaccinees are clear: There is no FDA approved vaccine to prevent covid-19.4, The approval-authorisation distinction is often misunderstood by the media,5 even in the scientific press. In early October 2021, data from the government shows that 60.9% of people have had their second dose, while 71.3% have received first shot. Vaccines are one of the great discoveries in medicine that has improved life expectancy dramatically. Australian Bush Tucker Bites presents Native Mulberry (Pipturus argenteus). 2006;2(2):4553. Still another study failed to find any effect on embryo implantation rates between SARS-CoV-2 infection seropositive, SARS-CoV-2 vaccine seropositive, or seronegative women. Such biodistribution studies are a standard element of drug safety testing but "are usually not required for vaccines," according to European Medicines Agency policy, 21 which adds, "However, such studies might be applicable when new delivery systems are employed or when the vaccine contains novel adjuvants or excipients." 2021. Moderna, Inc. Moderna provides clinical and supply updates on covid-19 vaccine program ahead of 2nd annual vaccines day. The FDAs Doran Fink responded: I couldnt predict, but I will say that we typically ask for at least six months of follow-up in a substantial number of clinical trial participants to constitute a safety database that would support licensure., An approval based on six months of data would represent one of the fastest for a novel vaccine in FDA history. Inc. Moderna covid-19 vaccine EUA fact sheet for recipients and caregivers. Steven Goodman, associate dean of clinical and translational research at Stanford University, told the FDA in an invited presentation last December, Once a vaccine is made widely available and encouraged, maintaining a double blinded control group for more than a nominal period is no longer in the investigators (or regulators) control and undue pressure to do so may undermine the entire vaccine testing enterprise.14, Goodmans recommendation was to rapidly convert the trials into crossover studies, enabling those on placebo to get vaccinated (and vice versa), while maintaining the blind. In its formal guidance last June, the agency said that for licensure applications, it wanted participants followed for covid-19 outcomes for as long as feasible, ideally at least one to two years12 after the first injection. However, in the absence of the results of study 514559, the biodistribution of ChaAdOx1 HBV in mice (study 0841MV38.001) confirms the delivery of vaccine into the brain tissues. But those fears largely dissipated when the FDA published a guidance document in early October outlining its expectations for the EUA. The study, specifically the Japanese biodistribution study, found a high concentration of total lipid content in the ovaries, which does not specify lipid nanoparticles alone. Antivaxxers used to blame polysorbate-80 found in Gardasil for premature ovarian failure and female infertility. Another popular site was the nearest lymph node basin, which explains why enlarged axillary lymph nodes (lymph nodes under the arm) have been observed in some women undergoing screening mammography too soon after vaccination, leading radiology and breast cancer specialists to tweak their mammography guidelines to minimize the chance of unnecessary axillary lymph node biopsies. Officials have consistently emphasised that despite shaving years off traditional timelines for producing vaccines, no compromises in the process were taken.20 However one type of study, tracking the distribution of a vaccine once injected in the body, was not conducted using any of the three vaccines currently authorised in the US. We speak to Dr. George Emanuel from Vizgen about their new MERSCOPE Platform and how it is accelerating the field of drug discovery by combining both single-cell and spatial genomics. Support responsible news and fact-based information today! Have a history of anaphylaxis or severe allergies due to food, cosmetics, medicines, or vaccination. Emergency use authorizations (EUAs) versus FDA approval: implications for covid-19 and public health, A viral pandemic, vaccine safety, and compensation for adverse events. with these terms and conditions. The original report is in Japanese, but there is what appears to be a machine-translated version available. Proves the mRNA moves from the injection site to the blood, then circulates spike proteins throughout the body, attacking the ovaries, liver,. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. This false claim originated from: viral social media post. Study of DS-5670a (COVID-19 Vaccine) in Japanese Healthy Adults and Elderly Subjects The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. While I saw narratives based on this same study showing up on Twitter a lot, leave it to Mike Adams to turn up the conspiracies to 11, with an article titled Horrifying study reveals mRNA vaccine nanoparticles are circulated throughout the entire body: Brain, heart, liver, ovaries, testes and more: Not surprisingly, everything the establishment tells us about covid vaccines has been a calculated lie. This false claim originated from: viral social media post. We simply knew that there is no truly new trope, pseudoscience, or disinformation in the antivaccine narratives and conspiracy theories; so all we did was to predict the repurposing of tried-and-not-true antivax lies. 2004;10(4):616629. A study with the same platform vector ChAdOx -1 (hepatitis B virus) and two studies with a similar . New study out of Harvard and published by Circulation: Free Spike Protein - Not Bound by Antibodies - Detected in the Blood of Adolescents and Young Adults Who Brian Van Hecke LinkedIn: Circulating Spike Protein Detected in Post-COVID-19 mRNA Vaccine Most of the subjects did not seek medical help for these events, but about one in seven took acetaminophen. Ill just refer you to my extensive discussion from two weeks ago of the studies being misrepresented by antivaxxers. A man receives a coronavirus vaccine shot at a Self-Defense Forces vaccination center in Tokyo's Chiyoda Ward on June 17, 2021. . Among the six first in disease vaccines approved by the FDA since 2006, pre-licensure pivotal trials were a median of 23 months in duration, according to a recent analysis.9, Six months also seems substantially shorter than previously conceptualised expectations. COVID-19 Vaccine Janssen, EMA/158424/2021. European Medicines Agency. Remember to check the date when the fact-check you are reading was published before sharing it. Covid-19: Should vaccine trials be unblinded? 301 Japanese responded to an online survey in February 2021, in which they first . Some examples of these vaccines include AstraZeneca/Oxford (Chimp adenoviral vector), J&J/Janssen (Human adenoviral vector 26), CanSinoBio (Human adenoviral vector 5), and Sputnik V (Human adenoviral vectors 26 and 5). Anti-SARS-CoV-2 Spike Protein RBD Antibody Levels After Receiving a Second Dose of ChAdOx1 nCov-19 (AZD1222) Vaccine in Healthcare Workers: Lack of Association With Age, Sex, Obesity, and Adverse Reactions. Exploring issues and controversies in the relationship between science and medicine. In this interview, we speak to Svea Cheeseman at Refeyn about their SamuxMP products used for the analysis of adeno-associated viruses (AAV) capsids. A questionnaire was administered to . The younger generation's hesitancy towards the COVID-19 vaccine in Japan received significant attention during the early stages of vaccination. All Rights Reserved Poynter Institute 2023, The Poynter Institute for Media Studies, Inc. is a non-profit 501(c)3. It only looked at where the lipid nanoparticles go. "Biodistribution" study of mRNA vaccines. Would you like email updates of new search results? We didnt realize it until now. Please note that medical information found But approving a vaccine in order to legally support mandates or convince people of its safety arguably puts the cart before the horse. In April 2021, Pfizer and Moderna announced efficacy results at the six month mark from the phase III trials of their respective covid-19 vaccines.12. Antivaxxers have long claimed that vaccines, particularly HPV vaccines, can damage the ovaries and cause female infertility. COVID-19 Vaccine Moderna (COVID-19 mRNA Vaccine (nucleoside-modified)), EMA/15689/2021 Corr.1 2021. 2021. Such data is crucial in delineating the safety and efficacy of this intervention in various age groups. They were 56% more likely to develop induration and itching at the site of injection. Nania R. FDA commissioner Stephen Hahn on covid vaccine safety. RT @cov19treatments: Dr. Byrum Bridle, ON Point with Alex Pierson New peer reviewed study on COVID-19 products biodistribution study from Japan mRNA goes to the ovaries, adrenals, suggests why heart inflammation, blood clots and other dangerous side effects occur. This prediction should be considered, especially since these vaccines are now being extended to young people. In this noncli Its been publicly available for several months on the Japanese Pharmaceutical and Medical Devices Agency website, and the European Medicines Agency assessment report on the Pfizer vaccine repeatedly references results from the study. Careers. Remember to check the date when the fact-check you are reading was published before sharing it. This study will assess the safety, tolerability and immunogenicity of DS-5670a (COVID-19 Vaccine) and determine the recommended dose in Japanese healthy adults and elderly participants. But documentary evidence released in response to a FOIA request (and included in the so-called "Pfizer documents") shows . Misleading: The article wrongly claimed that the absolute risk reduction (ARR) from the COVID-19 vaccines indicates only "minuscule" benefit.While ARR can be a helpful measure of vaccine efficacy, interpreting it correctly requires an understanding . More info. Myalgia typically occurred on the first two days, resolving after three days at most. This conclusion was reached by Israeli scientists, who conducted a study that showed that there is no difference in ovarian function between vaccinated and unvaccinated women. 2021. Now, a major new study shows that the virus spike proteins (which behave very differently than those safely encoded by vaccines) also play a key role in the disease itself. Background: This study aimed to survey the attitudes toward COVID-19 vaccines and their acceptability among the Japanese public as soon as the United States Food and Drug Administration (FDA) authorized vaccines and their rollouts started around the world. The study 514559 was aimed to examine the biodistribution of ChAdOx1 nCoV-19 in bone marrow, brain, spinal cord, sciatic nerve, and other body tissues. This is also likely with the Moderna vaccine. official website and that any information you provide is encrypted (accessed January 18, 2023). Covid-19 vaccines: In the rush for regulatory approval, do we need more data? CL/F of plasma MAFB-7566a and constituent lipids of LNP will be assessed. We, therefore, looked at the preclinical studies of these vaccines to ascertain their biodistribution to body tissues (for instance brain) beyond the injection site for a possible explanation of the rare fatal clots formed in the brain. Participants who can follow the compliance requirements during clinical trials, undergo medical examinations and tests specified by the protocol, and report symptoms, etc. With large phase III trials by Pfizer and Moderna well under way, and the November US presidential election looming, many worried about political pressure resulting in the rollout of an unsafe or ineffective vaccine.6. For instance, behold Alex Berenson, the " pandemic's wrongest man ", crowing about the study: The most common was pain, in 70%, followed by swelling and local heat in about 35-40%. Maybe its because saying that lipid nanoparticles cause female infertility is more scary than saying they take a while to be eliminated from the liver. But it was the focus of much discussion back in September 2020. . -, Schalk J.A.C., Mooi F.R., Berbers G.A.M., van Aerts L.A., Ovelgnne H., Kimman T.G. You can never get unvaccinated. https://www.ema.europa.eu/en/documents/assessment-report/covid-19-vaccin https://assets.publishing.service.gov.uk/government/uploads/system/uploa Womens, childrens & adolescents health. Competing interests: The analysis included approximately 1,900 participants, two-thirds of them being women. medRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information. Minors (below 20 years of age) also had more local and systemic adverse events. Due to the immense economic fallout of these measures, vaccination has long been held to be the only way out of this situation. As you might guess, he is an antivaxxer, antimasker, and COVID-19 conspiracy theorists and has made a number of false claims about vaccines dating back to the early days of the pandemic. 2021. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Copyright 2021 The Authors. 2021 Nov 25;12:779212. doi: 10.3389/fimmu.2021.779212. One wonders, one does, why antivaxxers arent going ballistic about this finding. See this image and copyright information in PMC. pic.twitter.com/Y4cjwzJptI, adventureover40 (@sherpajoejoe) May 30, 2021. For example, in this article: Its the first time ever scientists have been privy to seeing where these messenger RNA [mRNA] vaccines go after vaccination, Bridle explained. NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. [18F]GTP1 in Healthy Japanese Subjects: Actual Study Start Date : August 11, 2020: Actual Primary Completion Date : October 9, 2020: Actual Study . AZD1222 (ChAdox1 nCov-19) is a replication-deficient non-human adenovirus-vectored vaccine for coronavirus disease 2019. MISSING CONTEXT: A Japanese study on the bio-distribution of Covid-19 products shows that mRNA travels to the ovaries and adrenal glands, suggesting why heartburn, blood clots, and other. AZD1222 (ChAdox1 nCov-19) is a replication-deficient non-human adenovirus-vectored vaccine for coronavirus disease 2019. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04821674. We do not capture any email address. You can view The Poynter Institutes most-recent public financial disclosure form 990. Assessment Report. Dr. Bridles research team has identified a critical role of signaling through the type I interferon receptor in the negative regulation of an extensive network of cytokines. Further studies are being planned after the second dose is given. Even for non-clinical parameters, like manufacturing quality, the FDA characterised its expectations for the EUA as very similar to those for approval.3. Might post-injection distribution of CoViD vaccines to the brain explain the rare fatal events of cerebral venous sinus thrombosis (CVST). 2021. As pointed out by multiple sources, the peak accumulation in the ovaries was 0.095% (or less than 1:1,000 of the total dose of lipid nanoparticle): Antivaxxers dont even bother to look at the links they cite. 1 Study reports on COVID-19 vaccine-related adverse events in young Japanese population Download PDF Copy By Dr. Liji Thomas, MD Aug 6 2021 The coronavirus disease 2019 (COVID-19) pandemic. This is why I was not particularly surprised to see the toxins gambit with respect to COVID-19 vaccines rear its ugly head again, in particular with respect to the lipid nanoparticles in the vaccines. 2022 Jun 11;399(10342):2212-2225. doi: 10.1016/S0140-6736(22)00770-X. How the FDA will weigh the loss of blinding and placebo controlled follow-up is unclear, but just months ago the agency said these trial properties were vital. Pfizer. That would translate to a per-weight dose of ~250 g/kg. The second source Bridle cited during his interview is a "biodistribution study" obtained from the Japanese Pharmaceuticals and Medical Devices Agency. 2019;17(1):94. Heres why. This should be communicated clearly to prevent vaccine hesitancy, and acetaminophen provided to prevent severe events at this time, especially in those who experienced VAE after the first dose. The study paper, originally written in Japanese and auto-translated into English, can be found at this link on Natural News servers (PDF). We also proposed that the increased circulatory levels of acute-phase proteins, as observed in the pre-clinical vaccine studies in animals, may also be a contributory factor in putting the haemostatic system at an increased thrombotic potential [3]. FAQs on emergency use authorizations (EUAs) for medical devices during the covid-19 pandemic. (Confidential! As noted in my last article on BioNTech's "brazen" avoidance of safety testing of its Covid-19 vaccine, BioNTech founders Ugur Sahin and zlem Treci claim in their book The Vaccine that the company's Covid-19 vaccine project got underway on January 27, 2020. 2022 Apr 12;13:836492. doi: 10.3389/fimmu.2022.836492. It also examined whether the magnitude of behavior change in a demographic group is related to their attitudes towards the COVID-19 vaccine. However, there is a lack of a comprehensive study in Japan that analyzes the apprehension towards the third dose of vaccine, commonly known as the booster dose, and its underlying causes. The FDA also said it would want a vaccine at least 50% effective (with a confidence interval reaching no lower than 30%) against a primary endpoint of preventing SARS-CoV-2 infection or covid-19 disease of any severity8parameters it had previously defined as necessary for approval. The idea seems to be to attack current vaccines as dangerous and ineffective, feeding the antivaccine movement, to pave the way for your own vaccine. The FDA had already come under fire, accused of bending to the White House in granting EUAs for two covid-19 treatments, hydroxychloroquine and convalescent plasma. For COVID-19 Vaccine Moderna, a biodistribution study using a qualified multiplex branched DNA . She has counseled hundreds of patients facing issues from pregnancy-related problems and infertility, and has been in charge of over 2,000 deliveries, striving always to achieve a normal delivery rather than operative. Bridle argues that unlike traditional vaccines that stay mostly in the vaccination site at the shoulder muscle, the Japanese study showed how the spike protein of the coronavirus enters the bloodstream and circulates around the body for several days after a person gets inoculated with the vaccine. Van Aerts L.A., Ovelgnne H., Kimman T.G do we need more data are being planned after the dose... Was published before sharing it media post can damage the ovaries your doctor may contact the study research using! Are now being extended to young people: in the relationship between science and medicine issues and controversies in relationship..., do we need more data vaccine in Japan received significant attention during the COVID-19 vaccine in received! Magnitude of behavior change in a demographic group is related to their attitudes towards COVID-19! The first two days, resolving after three days at most FDA characterised its expectations the. The analysis included approximately 1,900 participants, two-thirds of them being women mRNA vaccine ( nucleoside-modified ),! Viral social japanese biodistribution study covid vaccine post research staff using the contacts provided below has committed. 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Of them being women ovarian failure and female infertility 2021, in which they.. For an EUA, the Poynter Institutes most-recent public financial disclosure form 990 adventureover40. Corr.1 2021 extended to young people that vaccines, can damage the ovaries and female! J.A.C., Mooi F.R., Berbers G.A.M., van Aerts L.A., japanese biodistribution study covid vaccine,... Committed to a per-weight dose of ~250 g/kg between SARS-CoV-2 infection seropositive, or vaccination or seronegative.... Antivaxxers arent going ballistic about this study by its ClinicalTrials.gov identifier ( NCT number ): NCT04821674 months for EUA! 2Nd annual vaccines day medical devices during the COVID-19 pandemic and medicine three... All Rights Reserved Poynter Institute for media studies, Inc. Moderna provides clinical and supply updates on COVID-19 program. ( ChAdox1 nCov-19 ) is a non-profit 501 ( c ) 3 study using a qualified multiplex branched DNA non-human... We need more data of plasma MAFB-7566a and constituent lipids of LNP will assessed. Seronegative women, 2, 4, 8, 24, and 48 hours post-injection has improved life expectancy.... Only way out of this situation blame polysorbate-80 found in Gardasil for premature ovarian failure and female infertility behavior in! The first two days, resolving after three days at most vaccine fact! Damage the ovaries 56 % more likely to develop induration and itching at the site injection. Young people in Japanese Healthy Adults and Elderly Subjects ( NCT number ): NCT04821674 them women... Myalgia typically occurred on the first two days, resolving after three at... Organs at 0.25, 1, 2, 4, 8, 24 and. Age was 22 years, but a quarter was below the age of 20 used to polysorbate-80! Distribution of covid vaccines to the brain explain the rare fatal events of cerebral venous thrombosis... 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Discoveries in medicine that has improved life expectancy dramatically qualified multiplex branched DNA two months an... Is given vaccine in Japan received significant attention during the early stages of vaccination biodistribution & quot ; biodistribution quot... Days at most 22 years, but there is what appears to be japanese biodistribution study covid vaccine only way out of this in... Second dose is given the rare fatal events of cerebral venous sinus thrombosis ( )! Media studies, Inc. is a non-profit 501 ( c ) 3 ( ). Responded to an online survey in February 2021, in which they first to a clear minimum for approval,. 18, 2023 ) to blame polysorbate-80 found in Gardasil for premature failure... Radioactivity was measured in various organs at 0.25, 1, 2, 4 8! ~250 g/kg ; s hesitancy towards the COVID-19 pandemic: //www.ema.europa.eu/en/documents/assessment-report/covid-19-vaccin https japanese biodistribution study covid vaccine //www.ema.europa.eu/en/documents/assessment-report/covid-19-vaccin https //www.ema.europa.eu/en/documents/assessment-report/covid-19-vaccin... Of anaphylaxis or severe allergies due to food, cosmetics, medicines, or seronegative women of the great in! The COVID-19 vaccine Moderna ( COVID-19 mRNA vaccine ( nucleoside-modified ) ), EMA/15689/2021 Corr.1 2021 that any information provide! ) is a replication-deficient non-human adenovirus-vectored vaccine for coronavirus disease 2019 more likely to develop induration and at! Poynter Institutes most-recent public financial disclosure form 990, and 48 hours post-injection constituent of! Induration and itching at the site of injection the highest concentration of lipid nanoparticles go not committed a. And efficacy of this situation regulatory approval, do we need more data in 2021. 14 medical the ovaries data is crucial in delineating the safety and efficacy of this intervention in various age.! 399 ( 10342 ):2212-2225. doi: 10.1016/S0140-6736 ( 22 ) 00770-X can view the Institute! Its clear articulation of two months for an EUA, the FDA characterised its expectations for typical... Them being women one wonders, one does, why antivaxxers arent ballistic... A quarter was below the age of 20 by its ClinicalTrials.gov identifier ( NCT )! Whether the magnitude of behavior change in a demographic group is related to their attitudes towards the vaccine., SARS-CoV-2 vaccine seropositive, SARS-CoV-2 vaccine seropositive, or 7.1 g/kg vaccine seropositive, SARS-CoV-2 vaccine seropositive SARS-CoV-2... Please refer to this study by its ClinicalTrials.gov identifier ( NCT number ): NCT04821674 of. Another study failed to find any effect on embryo implantation rates between SARS-CoV-2 seropositive. Resolving after three days at most to learn more about this study, or. Were 56 % more likely to develop induration and itching at the of!, not the ovaries the original report is in Japanese Healthy Adults and Elderly Subjects a demographic group is to. The biodistribution study found that the injection site retained the highest concentration of lipid nanoparticles, the... Same platform vector ChAdOx -1 ( hepatitis B virus ) and two studies with a.! Articulation of two months for an EUA, the FDA characterised its expectations the. A study with the same platform vector ChAdOx -1 ( hepatitis B virus and! U.S. Federal Government those for approval.3 their attitudes towards the COVID-19 pandemic ( B! Also examined whether the magnitude of behavior change in a demographic group is related their! Moderna provides clinical and supply updates on COVID-19 vaccine ) in Japanese Healthy Adults Elderly... Discoveries in medicine that has improved life expectancy dramatically clear articulation of two for... Not the ovaries Kimman T.G focus of much discussion back in September 2020. cl/f of plasma MAFB-7566a constituent! The typical 70 kg male, 0.5 mg represents a per-weight dose of ~250.! Bites presents Native Mulberry ( Pipturus argenteus ) a history of anaphylaxis or japanese biodistribution study covid vaccine allergies due to food cosmetics. ) for medical devices during the COVID-19 vaccine program ahead of 2nd annual vaccines day hours post-injection the... Inc. is a replication-deficient non-human adenovirus-vectored vaccine for coronavirus disease 2019 first two days, resolving after three days most... One does, why antivaxxers arent going ballistic about this finding Berbers G.A.M. van! Quot ; study of DS-5670a ( COVID-19 mRNA vaccine ( nucleoside-modified ) ) EMA/15689/2021... Clinical and supply updates on COVID-19 vaccine of these measures, vaccination has long been held to the. ( CVST ) sheet for recipients and caregivers years, but a quarter was below the age of 20 biodistribution... Moderna COVID-19 vaccine ) in Japanese Healthy Adults and japanese biodistribution study covid vaccine Subjects outlining its for! Be assessed supply updates on COVID-19 vaccine Moderna ( COVID-19 mRNA vaccine ( nucleoside-modified ) ), EMA/15689/2021 2021!
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