The FDA approved an emergency use authorization (EUA) for remdesivir to treat hospitalized patients with severe COVID-19. The U.S. Government will control distribution through AmerisourceBergen or government agencies based on hospital allocations set by the Federal Emergency Management Agency (FEMA). The allocation plan was approved by the White House Coronavirus Task Force. AmerisourceBergen will be told by FEMA which hospitals to send remdesivir to and how much of the drug to send. FEMA and HHS are developing a long-term strategy for allocation strategy of remdesivir. No list is posted regarding which hospitals will receive remdesivir or how much a hospital will receive. AmerisourceBergen contacts hospitals to let them know they will be receiving a drug supply. If you have not heard from AmerisourceBergen, you can ask about your hospital’s status by emailing the wholesaler at firstname.lastname@example.org You will need to provide your facility name, ship to address with zip code, your Health Industry Number and your DEA number. Gilead is setting up agreements with pharmaceutical manufacturers to produce remdesivir for Europe, Asia and the developing world through 2022 in order to meet global needs.
BioNTech and Pfizer initiated a 200 patient, Phase I/II trial in Germany in April and a second 360 patient Phase I/II trial in the U.S. in May. Four vaccine candidates are being tested. Three require two doses, while the fourth contains self-amplifying mRNA and requires a single dose. Pfizer expects initial data from the trials in May or June with a successful vaccine candidate moving to larger trials and possibly emergency use or accelerated approval in the 4Q20.
Sanofi and GlaxoSmithKline have agreed to work together to develop a vaccine for COVID-19. The companies will use Sanofi’s S-protein COVID-19 antigen based on the company’s recombinant DNA tech in combination with GSK’s pandemic adjuvant technology. The recombinant DNA platform is the same one used to create the quadrivalent influenza vaccine FluBlok. GSK’s vaccine adjuvant reduces the amount of antigen required for a dose enabling a quicker way to scale up production. Both companies have the capacity to manufacturer vaccines on a global scale and project the capacity to manufacturer over a billion doses. The companies plan to initiate a large Phase I/II trial with several hundred patients in September 2020. A Phase III trial is planned for late 2020 or early 2021. The companies hope to a BLA in the second half of 2021.
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