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UPDATES AND COMMENTARIES
PFIZER’S COVID-19 VACCINE HAS A HIGH PROSPECT OF EFFICACY BUT POSES SIGNIFICANT CHALLENGES FOR EXTENDED APPLICATION.
Pfizer’s synthetic mRNA has demonstrated capacity to activate the immune system against SARS-Cov-2, but it comes with special challenges as it needs to be stored at minus 70 degrees Celsius (-94 F) or below - equivalent to an Antarctic winter. WHO’s senior officials have voiced concerns that special requirements for shipping and storage plus short shelf life represent significant challenges for application to some population groups and territories.
Remdesivir (Gilead Sciences-USA) and favipiravir (Toyama Chemical-Japan; Appili Therapeutics clinical trials, North America) are the antivirals most extensively-tested in COVID-19. Remdesivir is now the first FDA-approved treatment for use in adult and pediatric patients requiring hospitalization. click here to read more
Emergency Use Authorizations During the COVID-19 Pandemic Lessons From Hydroxychloroquine for Vaccine Authorization and Approval
JAMA, October 10, 2020
"Because COVID-19 vaccines are being developed at an unprecedented pace, and because their review will also occur during a pandemic and in a presidential election year, lessons from the hydroxychloroquine authorization may apply to the regulation of these vaccines...questions are being raised about the rigor and speed with which the FDA will assess the safety and efficacy of vaccines before granting marketing authorizations via EUAs or licensure"
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