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Frontiers of COVID-19: Scientific and Clinical Aspects of the Novel Coronavirus 2019 ; : 575-594, 2022.
Article in English | Scopus | ID: covidwho-20242405

ABSTRACT

This chapter discusses the COVID-19 vaccines that have received emergency use approval (EUA) or full approval from stringent regulatory authorities (SRA) or World Health Organization (WHO) Emergency Use Listing (EUL). WHO's EUL procedure assesses the quality, safety and efficacy of COVID-19 vaccines and allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines. In addition, the chapter explains how these vaccines have been developed in a significantly shorter timeline as compared to other vaccines. Knowledge gaps and topics for further research have also been identified, including the durability and duration of protection, the need for a booster, long-term safety and efficacy against emerging SARS-CoV-2 variants. Information on COVID-19 vaccines were systematically gathered from the official websites of the World Health Organization, US Food and Drug Administration (US FDA), European Medicines Agency (EMA), UK Medicines and Healthcare products Regulatory Agency (MHRA), Health Canada, Therapeutic Goods Administration, and other stringent regulatory authorities as defined by the WHO Secretariat. Of the over 300 vaccine candidates, approximately 100 are in clinical trials while 18 have been authorized for use. Of these, 8 COVID vaccines have been reviewed under the WHO EUL procedure and have been determined to meet WHO standards for protection against COVID-19 while others are under review. Further research on these COVID vaccines are underway as part of the EUL process, the company producing the vaccine commit to continue to generate data to enable full licensure and WHO prequalification of the vaccine. © The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerland AG 2022.

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