Pfizer Appears Slightly Ahead Of Moderna In COVID-19 Vaccine Race
Neither has announced a firm timeline, and the difference between Pfizer's 'October' and Moderna's 'November' could be mere hours or a few weeks, but Pfizer, by dint of luck or experience, is now in a position to offer the more optimistic projection on when it will seek an EUA. Both firms release their Phase III trial protocols, which seem in line with US FDA guidance.
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COVID-19 Vaccine Race: With Moderna EUA, US FDA Finally Gets Some Bragging Rights
US FDA’s global first for Moderna’s vaccine gets a small mention as agency looks to pharmacovigilance, follow-up studies for both coronavirus inoculations that have now been authorized. Moderna's 18 December EUA comes after an even faster review than for Pfizer/BioNTech's vaccine.
COVID-19 Vaccines Blaze New Path In the History Of Vaccine Development
Vaccine experts, including R&D leaders at Pfizer and Sanofi, describe what has been unique in developing a vaccine for the novel coronavirus, lessons learned from previous vaccines, and challenges that lie ahead.
EUA For COVID-19 Vaccine Would Mean Fewer Patient-Years Of Follow-Up But More Pharmacovigilance
US FDA plans to leverage large safety surveillance databases to make up for the fact that a vaccine authorized for emergency use likely would have only one-quarter to one-half as much safety data follow-up as a typical vaccine licensed under a BLA, says CBER director Peter Marks.