PRIEDAS.
REIKALAVIMO Lietuvos Respublikos Seimui, Lietuvos Respublikos Vyriausybei,
Lietuvos Respublikos Prezidentui, 2021 m. kovo 5 d., Lietuva.
NAUDOTI ŠALTINIAI
- TARYBOS DIREKTYVA 1990 m. birželio 20 d. dėl valstybių narių įstatymų, reglamentuojančių aktyviuosius implantuojamus medicinos prietaisus, suderinimo (90/385/EEB)
- MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
- https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2020_guidance_classification_ivd-pdf
- https://www.ndr.de/nachrichten/niedersachsen/Braunschweiger-Klinik-stoppt-Impfung-mit-AstraZeneca-Mittel,astrazeneca162.html
Moderna“ COVID-19 vakcinos apžvalga ir šalutiniai poveikiai:
- ^ Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers). S. Food and Drug Administration.
- ^ Emergency Use Authorization. S. Food and Drug Administration.
- ^ Appendix B: COVID-19 frozen vaccine(s). Minnesota Department of Health.
- ^ Moderna Vaccine. Centers for Disease Control and Prevention.
- ^ Bell’s palsy.
- ^ Vaccines and Related Biological Products Advisory Committee Meeting Presentation. S. Food and Drug Administration.
- ^ COVID-19 vaccines and their extreme allergic reactions are far and few between — these are some of the side effects to watch out for. Business Insider India.
- ^ Andra Boston doctor who experienced reaction to Moderna vaccine has history of allergies. CTV News.
- ^ Marc Moderna COVID-19 vaccine causes swelling and inflammation in patients who have cosmetic facial fillers. ABC 7.
- ^ Julie Fauci said that he had few side effects after taking the Moderna coronavirus vaccine and that it’s ‘as good or better than an influenza vaccine’. The Insider.
- ^ About us.
- ^ Ewen COVID vaccine excitement builds as Moderna reports third positive result. Nature.
- ^ Paul Komesaroff, Ian Kerridge, Ross Upshur. We may have to accept a ‘good enough’ COVID-19 vaccine, at least in 2021. The
- ^ Moderna Announces Longer Shelf Life for its COVID-19 Vaccine Candidate at Refrigerated Temperatures.
- ^ Papildoma vaistinių preparatų stebėsena. Valstybinė vaistų kontrolės tarnyba.
„Pfizer“ Covid-19 vakcinos poveikiai:
- ^ Information for UK recipients on Pfizer/BioNTech COVID-19 vaccine. UK
- ^ I Priedas: Preparato charakteristikų santrauka. European Medicines Agency.
- ^ Covid-19 vaccine: First person receives Pfizer jab in UK. BBC
- ^ Pfizer-BioNTech COVID-19 Vaccine. S. Food and Drug Administration.
- ^ Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers). S. Food and Drug Administration.
- ^ Ekstrapoliacija reikšmė. Lietuvių kalbos žodynas.
- ^ FDA Briefing Document Pfizer-BioNTech COVID-19 Vaccine. Food and Drug Administration.
- ^ Bell’s palsy.
- ^ Alistair Analysis-World watches as first-mover Britain probes adverse reactions to Pfizer vaccine. Reuters.
- ^ Thomas Anaphylaxis Following m-RNA COVID-19 Vaccine Receipt. Centers for Disease Control and Prevention.
- ^ 88-year-old dies hours after vaccine; doctors stress he was seriously ill. The Times of Israel.
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- ^ Noah Weiland, Sharon LaFraniere, Mike Baker, Katie Thomas. 2 Alaska Health Workers Got Emergency
Treatment After Receiving Pfizer’s Vaccine. The New York Times.
- ^ Mary CDC reveals at least 21 Americans have suffered life threatening allergic reactions to Pfizer’s COVID vaccine – but officials beg people to get the shot and say problems are ‘rare’. Daily Mail.
- ^ Maayan Jaffe-Hoffman. Man’s fatal heart attack likely unlinked to vaccine he took 2 hours before. The Jerusalem Post.
- ^ Natalia Portuguese health worker, 41, dies two days after getting the Pfizer covid vaccine as her father says he ‘wants answers’. Daily Mail.
- ^ 4 People Died and 240 Got COVID19 in Israel After Being Injected with Pfizer Experimental mRNA Vaccine. Vaccine
- ^ After receiving vaccine, 62-year-old woman suffers allergic reaction. The Jerusalem Post.
- ^ 21 residents of retirement home get coronavirus after receiving vaccine. The Jerusalem Post.
- ^ Tennessee nurse who fainted after COVID vaccine healthy and alive. The Jerusalem Post.
- ^ California nurse tests positive over a week after getting Pfizer vaccine. The Jerusalem Post.
- ^ Amy Hollyfield, Chris Nguyen, Lauren Gee. 1 dead, 44 emergency staff at San Jose hospital infected with COVID-19; inflatable Christmas costume may be to blame. ABC 7 News.
- ^ Heidi The love of my life, my husband Gregory Michael MD. Facebook.
- ^ Zachary Hundreds Sent to Emergency Room After Getting COVID-19 Vaccines. The Epoch Times.
- ^ Manas Mishra, Julie Steenhuysen. S. officials report more severe allergic reactions to COVID-19 vaccines. Reuters.
- ^ Thomas COVID-19: Single vaccine dose leads to ‘greater risk’ from new coronavirus variants, South African experts warn. Sky News.
- ^ Bulgaria Reports 4 Cases Of Side Effects From Pfizer Covid Vaccine.
- ^ „Pfizer“ skelbia, kad jų eksperimentinė COVID-19 vakcina buvo daugiau nei 90 proc. efektyvi.
- ^ Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study. Business
- ^ Fernando Polack, Stephen J. Thomas, Nicholas Kitchin, et. al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. The New England Journal of Medicine.
- ^ Katie Thomas, David Gelles, Carl Zimmer. Pfizer’s Early Data Shows Vaccine Is More Than 90%
Effective. The New York Times.
- ^ Erika Pfizer’s Covid-19 vaccine promising, but many questions remain. NBC News.
- ^ Peter Radical New Method Can Directly Edit Human Cells to Get Rid of Genetic Disease. Science Alert.
- ^ Pfizer Says Trials Show COVID Vaccine Is 90% Effective, But Questions Remain on Safety of Novel Tech. The Children’s Health Defense.
- ^ Robert Kennedy, Jr.. Vaccine Trial Catastrophe: Moderna Vaccine has 20% ‘Serious’ Injury Rate in
High Dose Group. The Children’s Health Defense.
- ^ Coronavirus: Commission approves contract with BioNTech-Pfizer alliance to ensure access to a potential vaccine. European
- ^ Ten threats to global health in 2019. World Health Organization.
- ^ Laura Adomavičienė. Kokios garantijos, kad skubiai kuriama vakcina nuo COVID-19 bus saugi?.
- ^ Lenktynės dėl COVID-19 vakcinos: kas prisiims riziką dėl jos saugumo?.
- ^ Gayle Fewer people say they would take a COVID-19 vaccine now than 3 months ago. World Economic Forum.
- ^ Sarah Pfizer Covid-19 vaccine has 95% efficacy and is safe, further analysis shows. The Guardian.
- ^ Michael Erman, Ludwig Burger. Pfizer-BioNTech vaccine deliveries could start ‘before Christmas’.
- ^ Joe Pfizer To Seek FDA OK For COVID-19 Vaccine ‘Within Days’. NPR.
- ^ Benjamin U.K. Approves Pfizer Coronavirus Vaccine, a First in the West. The New York Times.
- ^ Government to add COVID-19 to Vaccine Damage Payments Scheme. UK
- ^ Britain to cover COVID-19 vaccine side-effects under damages scheme.
„AstraZeneca“ COVID-19 vakcinos bendroji informacija ir sudėtis:
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- ^ Preparato charakteristikų santrauka. Valstybinė vaistų kontrolės tarnyba prie Lietuvos Respublikos sveikatos apsaugos ministerijos.
- ^ Papildoma vaistinių preparatų stebėsena. Valstybinė vaistų kontrolės tarnyba prie Lietuvos Respublikos sveikatos apsaugos ministerijos.
- ^ Hilary When will AstraZeneca’s COVID-19 vaccine be available in the US?. Insider.
- ^ Darius Tarasevičius. PAR stabdo skiepijimą „AstraZeneca“ vakcina. Verslo žinios.
- ^ „AstraZeneca“ vakcina Lietuvoje siūloma skiepyti ir vyresnius žmones. Verslo žinios.
- ^ Adam Covid-19 vaccine trial participant had serious neurological symptoms, but could be discharged today, AstraZeneca CEO says. STAT.
- ^ Proband von Pharmakonzern AstraZeneca erkrankt “Unerwartete Nebenwirkungen”: Briten stoppen Corona-Impfstoff-Test.
- ^ Elizabeth Cohen, John Bonifield. Internal AstraZeneca safety report sheds light on neurological condition suffered by vaccine trial participant.
- ^ Georgina Hayes, Max Stephens. Oxford University Covid-19 vaccine trials resume. The
- ^ Bill A 28-year-old volunteer in AstraZeneca’s coronavirus vaccine trial has died, but a report says he was in the control group and given a placebo. Business Insider.
- ^ Darius Tarasevičius. „AstraZeneca“ vakcinos bandymo metu mirė savanoris. Verslo Žinios.
- ^ Elizabeth Experts have questions about AstraZeneca’s vaccine data. CNN.
- ^ Eric AstraZeneca and Pfizer Ask India for Emergency-Use Covid-19 Vaccine Authorizations. The Wall Street Journal.
- ^ Noah AstraZeneca’s COVID-19 vaccine partner in China plagued by scandal. New York Post.
- ^ Sui-Lee Wee, Javier C. Hernandez. Scandal Dogs AstraZeneca’s Vaccine Partner in China. The New York
- ^ David China Investigates Vaccine Maker After Deaths of Infants. The New York Times.
- ^ Merryn Voysey, Sue Ann Costa Clemens, et. al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. The
AstraZeneca“ kompanijos skaidrumas ir patikimumas:^
- Veryga: Lietuva sudarė sutartį įsigyti COVID-19 vakcinos. Made in Vilnius.
- ^ Vyriausybė skyrė 20 tūkst. eurų vakcinos nuo koronaviruso atgabenimui į Lietuvą. Lietuvos Respublikos sveikatos apsaugos ministerija.
- ^ Pharmaceutical Giant AstraZeneca to Pay $520 Million for Off-label Drug Marketing. The United States Department of Justice.
- ^ Julia AstraZeneca to pay £12m in redundancy costs to former staff. The Telegraph.
- ^ Thomas AstraZeneca Pays $5.5 Million to Resolve FCPA Offenses. Policy & Medicine.
- ^ In the Matter of ASTRAZENECA PLC Respondent. Securities and Exchange Commission.
- ^ Richard L. Cassin. AstraZeneca pays $5.5 million to resolve China, Russia FCPA offenses. The FCPA Blog.
- ^ Nate Raymond. AstraZeneca to pay $5.52 million to resolve SEC foreign bribery case. Reuters.
- ^ Nate Raymond. AstraZeneca pays $26 million to settle South Carolina lawsuit. Reuters.
- ^ AstraZeneca Pays $103 Million For Price Fixing Cancer Drug. Manufacturing.net.
- ^ Šarūnas Černiauskas. Teismo smūgis farmacininkams. Diena.lt.
- ^ AstraZeneca Lietuva. AstraZeneca.
- ^ Pascal Soriot. Wikipedia.
- ^ Andrew Ward. Pascal Soriot on his rise to become CEO of AstraZeneca. Financial Times.
- ^ Sabah Meddings. Salary size matters, says Astra Zeneca boss on £9.4m. The Times.
- ^ James Gallagher. ‘There’s no point giving free cancer drugs to Africa’. BBC News.
- ^ Pascal Soriot. World Economic Forum.
- ^ Jeremy Kahn. Under fire, AstraZeneca CEO defends transparency of COVID-19 vaccine trials. Fortune.
- ^ Elizabeth Cohen. Experts have questions about AstraZeneca’s vaccine data. CNN.
- ^ Adam Feuerstein. Covid-19 vaccine trial participant had serious neurological symptoms, but could be discharged today, AstraZeneca CEO says. STAT.
- ^ Phase III Double-blind, Placebo-controlled Study of AZD1222 for the Prevention of COVID-19 in Adults.
Clinical Trials.
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- ^ Merryn Voysey, Sue Ann Costa Clemens, et. al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. The Lancet.
- ^ Ludwig Burger, Pushkala Aripaka. AstraZeneca to be exempt from coronavirus vaccine liability claims in most countries. Reuters.
Del markerio (Tag) naudojamo vakcinose:
- https://bioprocessintl.com/bioprocess-insider/regulations/regeneron-and-pfizer-sued-for-unauthorised-reagent-use/?fbclid=IwAR1aGUUm5-LAkNIPMGL7WT3iec5wbGMTlQFyKTkZPXhIdMaRxy7gwM6Fs4o
- https://www.moleculardevices.com/sites/default/files/en/assets/newsletter/november-2020.html#gref
- https://www.tmc.edu/news/2020/07/fireflies-help-kindle-new-tests-and-treatments-for-covid-19/
- https://www.promegaconnections.com/choices-for-measuring-luciferase-tagged-reporter-pseudotyped-viral-particles-in-coronavirus-research/
- https://worldwide.promega.com/Applications/virus-detection-assay-coronavirus-detection-covid-19-sars-cov-2/sars-cov-2-viral-research-vaccine-therapeutic-development/
- https://www.promegaconnections.com/crispr-cas9-knock-in-tagging-simplifying-the-study-of-endogenous-biology/?utm_campaign=pharma_crispr&utm_medium=social&utm_source=promegaconnections_07_01_2 020
- https://www.modernatx.com/sites/default/files/US10703789.pdf
- https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52015XG1217(01)&from=FR
- https://www.wsj.com/articles/moderna-and-pfizer-are-reinventing-vaccines-starting-with-covid-11605638892
- https://apps.who.int/iris/bitstream/handle/10665/259671/9789241550048-pdf;jsessionid=0DE17E493C9C85BEB7DF5FEC5855F720?sequence=1
- https://www.brinknews.com/crispr-and-the-fight-against-covid-19/
- https://innovativegenomics.org/projects/crispr-based-dna-vaccine-enhancer-covid-19/
- https://www.rochester.edu/newscenter/covid-19-rna-coronavirus-research-428952/
- https://www.ft.com/content/c4ca8496-a215-44b1-a7eb-f88568fc9de9
- https://pubmed.ncbi.nlm.nih.gov/32707833/
- https://www.ema.europa.eu/en/documents/product-information/comirnaty-epar-product-information_lt.pdf
- https://www.nvi.lt/covid-19-mrnr-vakcina-pakuotes-lapelis-informacija-vartotojui/
- https://pfe-pfizercom-d8-prod.s3.amazonaws.com/2020-11/C4591001_Clinical_Protocol_Nov2020.pdf
- https://www.ema.europa.eu/en/documents/assessment-report/covid-19-vaccine-moderna-epar-public-assessment-report_en.pdf
- https://www.ema.europa.eu/en/documents/product-information/covid-19-vaccine-astrazeneca-epar-product-pdf
Nano daleles:
- https://www.hse.gov.uk/nanotechnology/understanding-hazards-nanomaterials.htm
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1584248/
- https://www.researchgate.net/publication/283788431_Environmental_Hazards_and_Risks_of_Nanomaterial s
- https://www.ohsrep.org.au/nanotechnology_-_a_new_hazard
- https://journals.sagepub.com/doi/full/10.1177/2397847317726352
- https://www.hindawi.com/journals/jnt/2015/861092/
- https://www.sciencedirect.com/science/article/pii/B9780128135860000079
- https://ec.europa.eu/health/scientific_committees/opinions_layman/en/nanotechnologies/l-2/6-health-effects-nanoparticles.htm
- https://www.technologyreview.com/2006/11/17/130765/facing-the-dangers-of-nanotech/
- https://www.dw.com/en/germany-warns-over-dangers-of-nanotechnology/a-4814083
EU ir LT dokumentai:
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- https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:324:0121:0137:LT:PDF
- https://eur-lex.europa.eu/legal-content/LT/TXT/PDF/?uri=CELEX:31990L0385&from=LT
- https://lrv.lt/uploads/main/meetings/docs/1926288_imp_570a6d55fa2b449a44e8e45d0e77a219.pdf
- https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2020_guidance_classification_ivd-pdf
- https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/TAIS.336532?jfwid=9o5pdsp1s
- https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/TAIS.379198?jfwid=-c12gjpyc5
- https://www.eulac-permed.eu/index.php/what-is-personalised-medicine/
- https://www.icpermed.eu/en/icpermed-medicine.php
- https://cordis.europa.eu/project/id/602139
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