Coronavirus disease 2019 (COVID-19): Vaccines to prevent SARS-CoV-2 infection
Vaccination preventing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are considered the most promising approach to manage the pandemic. Developing SARS-CoV-2 vaccine is going on at an unprecedented speed.
In the US, added to the traditional process for licensing a vaccine, the FDA can make vaccines that permit specific safety & efficacy profiles available faster through an emergency use authorization (EUA). As regard vaccines allowed under EUA, physicians should explain to the potential recipients that the vaccine didn’t licensed yet, the reason(s) it is not licensed, and what are the expected information the FDA is waiting for before commencing a full-licensed vaccine; a signed informed consent document is currently NOT warranted.
- World Health Organization. Director-General's remarks at the media briefing on 2019-nCoV on 11 February 2020. http://www.who.int/dg/speeches/detail/who-director-general-s-remarks-at-the-media-briefing-on-2019-ncov-on-11-february-2020 (Accessed on February 12, 2020).
- World Health Organization. Draft landscape of COVID-19 candidate vaccines. https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines (Accessed on October 20, 2020).
- College of Physicians of Philadelphia. The History of Vaccines: Vaccine Development, Testing, and Regulation. https://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation (Accessed on October 20, 2020).
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- Brighton Collaboration. Accelerated Assessment of the Risk of Disease Enhancement with COVID-19 Vaccines, March 2020. https://brightoncollaboration.us/brighton-collaboration-cepi-covid-19-web-conference/ (Accessed on October 20, 2020).
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