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COVID-19 vaccine clinical research uses clinical research to establish the characteristics of COVID-19 vaccines. These characteristics include efficacy, effectiveness, and safety. As of November 2022, 40 vaccines are authorized by at least one national regulatory authority for public use: [1] [2] one DNA vaccine: ZyCoV-D [3]
In September 2023, the FDA approved an updated a monovalent (single) component Omicron variant XBB.1.5 version of the vaccine (Spikevax 2023-2024 formula) as a single dose for individuals aged twelve years of age and older; [203] and authorized the Moderna COVID-19 Vaccine 2023-2024 formula under emergency use for individuals aged 6 months ...
The COVID-19 pandemic, and sequencing of the causative virus SARS-CoV-2 at the beginning of 2020, led to the rapid development of the first approved mRNA vaccines. [44] [45] BioNTech and Moderna in December of the same year obtained approval for their mRNA-based COVID-19 vaccines.
These technologies generally can be grouped into three approaches: polymerase chain reaction (PCR), hybridization, and next-generation sequencing (NGS). [22] Currently, a lot of PCR and hybridization assays have been approved by FDA as in vitro diagnostics. [47] NGS assays, however, are still at an early stage in clinical diagnostics. [48]
Hence, developing a therapy against COVID-19 was progressing at a pandemic speed, yet there is no effective therapy approved by food and drug administration (FDA). Vaccines seem promising and currently include Pfizer-BioNTech vaccine, Moderna vaccine, Oxford/AstraZeneca vaccine, and the Janssen vaccine.
The FDA is reversing course on its COVID vaccine guidance: Rather than having a vaccine that targets the older JN.1 variant, the FDA said fall 2024 vaccines should target a newer strain of the virus.
The Enzyme Commission refers to this family as SARS coronavirus main proteinase (M pro; EC 3.4.22.69). The 3CL protease corresponds to coronavirus nonstructural protein 5 (nsp5). The "3C" in the common name refers to the 3C protease (3C pro ) which is a homologous protease found in picornaviruses .
National regulatory authorities have granted full or emergency use authorizations for 40 COVID-19 vaccines.. Ten vaccines have been approved for emergency or full use by at least one stringent regulatory authority recognized by the World Health Organization (WHO): Pfizer–BioNTech, Oxford–AstraZeneca, Sinopharm BIBP, Moderna, Janssen, CoronaVac, Covaxin, Novavax, Convidecia, and Sanofi ...
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