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  1. Pfizer–BioNTech COVID-19 vaccine - Wikipedia

    en.wikipedia.org/wiki/BNT162b2

    The vaccine is given by intramuscular injection. It is composed of nucleoside-modified mRNA (modRNA) encoding a mutated form of the full-length spike protein of SARS-CoV-2, which is encapsulated in lipid nanoparticles. Vaccination requires two ...

    • None
    • Comirnaty
    • AU: B1
    • Intramuscular
  2. COVID-19 vaccine - Wikipedia

    en.wikipedia.org/wiki/Covid-19_vaccine

    A COVID‑19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), the virus that causes coronavirus disease 2019 (COVID‑19).Prior to the COVID‑19 pandemic, an established ...

  3. Moderna COVID-19 vaccine - Wikipedia

    en.wikipedia.org/wiki/Moderna_COVID-19_vaccine

    The Moderna COVID‑19 vaccine (pINN: elasomeran [14]), codenamed mRNA-1273 and sold under the brand name Spikevax, [2] is a COVID-19 vaccine developed by Moderna, the United States National Institute of Allergy and Infectious Diseases (NIAID) and ...

  4. Oxford–AstraZeneca COVID-19 vaccine - Wikipedia

    en.wikipedia.org/wiki/Oxford–astrazeneca_covid-19_vaccine

    The Oxford–AstraZeneca COVID-19 vaccine, codenamed AZD1222, [5] and sold under the brand names Covishield [19] and Vaxzevria [1] [20] among others, is a viral vector vaccine for prevention of COVID-19.Developed by Oxford University and ...

  5. COVID-19 vaccination in Taiwan - Wikipedia

    en.wikipedia.org/wiki/COVID-19_vaccination_in_Taiwan
    • Timeline
    • Vaccine Orders and Arrival
    • Vaccination

    On 3 March 2021, the first shipment of the Oxford–AstraZeneca COVID-19 vaccine was delivered. The 117,000 doses are part of the 10 million doses of the vaccine that the Taiwanese government had previously ordered. On 18 March 2021, the AstraZeneca vaccine was approved by the government, and vaccinations commenced on 22 March 2021. The vaccine is free for all Taiwanese people and long-term residents.Health workers, other frontline workers and seniors were the first to be inoculated with the vaccine. On 5 May 2021, the Moderna COVID-19 vaccine was approved for emergency use,and the first batch of 150,000 doses was delivered on 28 May 2021. On 17 May 2021, 400,000 doses of the AstraZeneca vaccine that were ordered through COVAX arrived in the midst of Taiwan's largest COVID-19 pandemic. On 31 May 2021, Taiwan Centers for Disease Control announced that 10 million doses of domestically produced vaccines (Medigen and United Biomedical) had been pre-reserved. 5 million of each vaccine were...

    Vaccines Orders and Donations

    The Taiwanese government has ordered COVID-19 vaccines directly from the Oxford-AstraZeneca, Moderna, Medigen Vaccine Biologics Corp., and United Biomedical. The Taiwanese government has also ordered another 4.76 million dose of vaccine through the COVAX platform besides the direct orders from pharmaceutical companies. An additional 15 million doses of Pfizer-BioNTech COVID-19 vaccine purchased by Foxconn, Taiwan Semiconductor Foundry Company, and Tzu-Chi Foundationwere also been donated to t...

    Vaccination Plan

    The Taiwanese government has created a prioritization list for domestic COVID-19 vaccination plan, which includes 10 prioritized groups.

    Vaccination Appointment Platform

    On 6 July, the Central Epidemic Command Center (CECC) announced the creation of Taiwan Domestic COVID-19 Vaccination Appointment Platform, allowing the digitalization of COVID-19 vaccination sign up and appointments. The platform was created to simplify vaccination appointments and increase vaccine roll-outs. The platform is a four-step system. In the first step, individuals would need to sign up on the website and fill in the necessary information, such as their National Identification Card...

  6. RNA vaccine - Wikipedia

    en.wikipedia.org/wiki/RNA_vaccine
    • History
    • Mechanism
    • Delivery
    • Side Effects and Risks
    • Advantages
    • Vaccine Hesitancy
    • Efficacy of mRNA Vaccines For Covid-19
    • Self-Amplifying RNA (Sarna) Vaccines
    • See Also
    • Further Reading

    Early research

    The first successful transfection of mRNA packaged within a liposomal nanoparticle into a cell was published in 1989. "Naked" (or unprotected) mRNA was injected a year later into the muscle of mice. These studies were the first evidence that in vitro transcribed mRNA could deliver the genetic information to produce proteins within living cell tissue. At this time mRNA was proposed for immunizationpurposes. Liposome-encapsulated mRNA was shown in 1993 to stimulate T-cells in mice, and mRNA pro...

    Development

    Successful application of modified nucleosides as a medium to get mRNA inside cells without setting off the body's defense system was reported in 2005. The companies, BioNTech in 2008 and Modernain 2010, were started to develop mRNA biotechnologies. US government agency DARPA launched in 2010 a biotech research program called ADEPT as part of its mission to develop emerging technologies for the US military. DARPA recognized a year later the potential of nucleic acid technology for defense aga...

    Acceleration

    In December 2020, BioNTech and Moderna obtained approval for their mRNA-based COVID-19 vaccines. On 2 December, seven days after its final eight-week trial, the UK's Medicines and Healthcare products Regulatory Agency (MHRA), became the first global medicines regulator in history to approve an mRNA vaccine, granting emergency authorization for Pfizer–BioNTech's BNT162b2 COVID-19 vaccine for widespread use. On 11 December, the FDA gave emergency use authorizationfor the Pfizer–BioNTech COVID-1...

    The goal of a vaccine is to stimulate the adaptive immune system to create antibodies that precisely target that particular pathogen. The markers on the pathogen that the antibodies target are called antigens. mRNA vaccines operate in a very different manner from a traditional vaccine. Traditional vaccines stimulate an antibody response by injecting antigens, an attenuated virus (weakened or harmless virus), or a recombinant antigen-encoding viral vector (carrier virus engineered to have antigens)[citation needed]into muscles. These antigen-containing ingredients are prepared and grown outside the body. In contrast, mRNA vaccines introduce a short-lived[clarification needed] synthetically created fragment of the RNA sequence of a virus into the vaccinated individual. These mRNA fragments are taken up by dendritic cells – a type of immune system cell – by phagocytosis. The dendritic cells use their own internal machinery (ribosomes) to read the mRNA and produce the viral antigens tha...

    The method of vaccine delivery can be broadly classified by whether the RNA transfer to cells happens within (in vivo) or outside (ex vivo) the organism.

    Reactogenicity is similar to that of conventional, non-RNA vaccines. However, those susceptible to an autoimmune response may have an adverse reaction to RNA vaccines.The mRNA strands in the vaccine may elicit an unintended immune reaction – this entails the body believing itself to be sick, and the person feeling as if they are as a result. To minimize this, mRNA sequences in mRNA vaccines are designed to mimic those produced by host cells. Strong but transient reactogenic effects were reported in trials of novel COVID-19 RNA vaccines; most people will not experience severe side effects which include fever and fatigue. Severe side effects are defined as those that prevent daily activity.

    Traditional vaccines

    RNA vaccines offer specific advantages over traditional protein vaccines. Because RNA vaccines are not constructed from an active pathogen (or even an inactivated pathogen), they are non-infectious. In contrast, traditional vaccines require the production of pathogens, which, if done at high volumes, could increase the risks of localized outbreaks of the virus at the production facility. RNA vaccines can be produced faster, more cheaply, and in a more standardized fashion (with fewer error ra...

    DNA vaccines

    In addition to sharing the advantages of theoretical DNA vaccines over established traditional protein vaccines, RNA vaccines also have additional advantages over DNA vaccines. The mRNA is translated in the cytosol, so there is no need for the RNA to enter the cell nucleus, and the risk of being integrated into the host genome is averted. Modified nucleosides (for example, pseudouridines, 2'-O-methylated nucleosides) can be incorporated to mRNA to suppress immune response stimulation to avoid...

    There is misinformation implying that mRNA vaccines could alter DNA in the nucleus. mRNA in the cytosol is very rapidly degraded before it would have time to gain entry into the cell nucleus. (mRNA vaccines must be stored at very low temperature to prevent mRNA degradation.) Retrovirus can be single-stranded RNA (just as SARS-CoV-2 vaccine is single-stranded RNA) which enters the cell nucleus and uses reverse transcriptase to make DNA from the RNA in the cell nucleus. A retrovirus has mechanisms to be imported into the nucleus, but other mRNA lack these mechanisms. Once inside the nucleus, creation of DNA from RNA cannot occur without a primer, which accompanies a retrovirus, but which would not exist for other mRNA if placed in the nucleus. In November 2020, The Washington Postreported on novel mRNA vaccine hesitancy amongst healthcare professionals in the United States, citing surveys that "some did not want to be in the first round, so they could wait and see if there are potenti...

    It is unclear why the novel mRNA COVID-19 vaccines from Moderna and Pfizer–BioNTech have shown potential efficacy rates of 90 to 95 percent when the prior mRNA drug trials on pathogens other than COVID-19 were not so promising and had to be abandoned in the early phases of trials. Physician-scientist Margaret Liu stated that it could be due to the "sheer volume of resources" that went into development, or that the vaccines might be "triggering a nonspecific inflammatory response to the mRNA that could be heightening its specific immune response, given that the modified nucleoside techniquereduced inflammation but hasn't eliminated it completely", and that "this may also explain the intense reactions such as aches and fevers reported in some recipients of the mRNA SARS-CoV-2 vaccines". These reactions though severe were transient and another view is that they were believed to be a reaction to the lipid drug delivery molecules. Unlike DNA molecules, the mRNA molecule is a very fragile...

    Self-amplifying RNA (saRNA) is a technology similar to mRNA, except the saRNA produces multiple copies of itself in the cell before producing proteins like mRNA does. This allows smaller quantities to be used and has other potential advantages. saRNA vaccines are being researched, including development of a malaria vaccine.

    Sahin U, Karikó K, Türeci Ö (October 2014). "mRNA-based therapeutics--developing a new class of drugs". Nat Rev Drug Discov. 13 (10): 759–80. doi:10.1038/nrd4278. PMID 25233993.

  7. List of COVID-19 vaccine authorizations - Wikipedia

    en.wikipedia.org/wiki/List_of_COVID-19_vaccine_authorizations

    National regulatory authorities have granted emergency use authorizations for twenty-one COVID-19 vaccines.Six of those have been approved for emergency or full use by at least one WHO-recognized stringent regulatory authority ...

  8. Moderna - Wikipedia

    en.wikipedia.org/wiki/Moderna
    • History
    • Criticism
    • See Also
    • External Links

    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. In September 2018, Thrillist published an article titled, "Why This Secretive Tech Start-Up Could Be The Next Theranos", criticizing its reputation for secrecy and the absence of scientific validation or independent peer-review of its research, though having the highest valuation of any U.S. private biotech company at more than $5billion. A former Moderna scientist told Stat: "It's a case of the emperor's new clothes. They're running an investment firm, and then hopefully it also develops a drug that's successful."

  9. Pfizer - Wikipedia

    en.wikipedia.org/wiki/Pfizer

    Pfizer Inc. (/ ˈ f aɪ z ər / FY-zər) is an American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City.The name of the company commemorates its co-founder, Charles Pfizer ...

  10. Emergency Use Authorization - Wikipedia

    en.wikipedia.org/wiki/Emergency_Use_Authorization
    • Use
    • History of Legal Authority For EUAs
    • Applicability and The Animal Efficacy Rule
    • Use During Pandemics
    • See Also

    A review article by Rizk et al provides a summary of the US experience in 2020 with pharmacological EUA approvals during the COVID-19 pandemic.It also provides a description of, and clinical rationale for, the EUA-approved drugs during the pandemic and concluding reflections on the EUA program and its potential future uses. After initial authorizations for serious diseases such as pandemic influenza and emerging diseases, EUAs were also authorized for medical countermeasures (MCMs) principally in response to public health emergencies such as bioterrorism, including chemical, biological, radiological and nuclear (CBRN) threats. Subsequent legislative authorities expanded the latitude of the class of drugs eligible for consideration, and the range of testing to which the drug or therapy has been subjected. The scope and applicability of EUAs is also affected by presidential executive orders (Title 3 of the Code of Federal Regulations), which may affect the definition of the situations...

    In the United States, EUAs are authorized by Section 564 of the Federal Food Drug and Cosmetic Act (FDCA) of 1938 (Public Law 75-717) as added and subsequently amended by the Project BioShield Act of 2004 (S. 15, Public Law 108-276) for funding of the development and procurement of medical countermeasures against CBRN threats, the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (H.R. 307, Pub.L. 113–5 (text) (pdf)), the 21st Century Cures Act of 2016 (H.R. 34, Public Law 114-255) and Pub.L. 115–92 (text) (pdf)of 2017 (no short title).

    EUAs may be applied to drugs, devices or biological product. EUAs may either permit the emergency use of an unapproved drug, device or biologic product, or permit an unapproved use of an approved drug, device or biologic product. Furthermore, drugs, devices or biologic productsmay or may not have undergone human efficacy trials, due to risk, feasibility or ethical considerations. Drugs, devices or biologic products which have only been tested or approved under the animal efficacy rule are loosely known as animal products. Under certain conditions, an EUA may authorize the emergency use in humans, of drugs, devices or biologic products approved under the animal efficacy rule. EUAs may also only be implemented during the period of a public health emergency as defined by a declaration of the Secretary of Health and Human Services (HHS). Conditions determining the applicability of suchdeclarations may be specified by federal statute. Code of Federal Regulations or an presidential execut...

    In response to requests from the U.S. Centers for Disease Control and Prevention (CDC), on April 27, 2009, the FDA issued Emergency Use Authorizations to make available diagnostic and therapeutic tools to identify and respond to the 2009 swine flu pandemic under certain circumstances. The agency issued these EUAs for the use of certain powerful antiviral drugs, and for the quantitative PCR swine flu test. On February 4, 2020, the Secretary of HHS declared the public health emergency for the novel SARS-CoV-2 virus, which causes the disease COVID-19, for deployment of the FDA EUA for certain medical devices involved in the diagnosis of COVID-19. In February 2020, The FDA issued an EUA for COVID-19 testing CDC test kits for COVID-19. In 2020, the FDA issued EUAs for remdesivir, convalescent plasma, Fresenius Propoven 2% emulsion (propofol), hydroxychloroquine (revoked, although its license for established indications remains), and bamlanivimab – all in response to the COVID-19 pandemic...