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HHS, DOD collaborate with Merck to continue the development and large-scale manufacturing of investigational COVID-19 treatment The U.S. Department of the Health and Human Services (HHS) and the Department of Defense (DOD) jointly announced an agreement with Merck to support advanced development and large-scale manufacturing of the their investigational therapeutic MK-7110 to treat hospitalized patients with severe or critical COVID-19. The investigational therapeutic is a promising first-in-class fusion protein and immune modulator. Immune modulators have the potential to minimize the damagi...

U.S. Department of Defense Department of the Health and Human Services (HHS) and the Department of Defense (DOD) jointly announced an agreement with Merck to support advanced development and large-scale manufacturing of the their investigational therapeutic MK-7110 to treat hospitalized patients with severe or critical COVID-19. The investigational therapeutic is a promising first-in-class fusion protein and immune modulator. Immune modulators have the potential to minimize the damaging effects of an overactive immune response to COVID-19. This overactive response can contribute to the severi...

Trump Administration purchases additional 100 million doses of COVID-19 investigational vaccine from Pfizer The Trump Administration, through the U.S. Department of Health and Human Services (HHS) and Department of Defense (DOD), will purchase an additional 100 million doses of COVID-19 vaccine from Pfizer. On Dec. 11, the U.S. Food and Drug Administration (FDA) authorized the vaccine for emergency use and doses began shipping immediately. The vaccine is being provided at no cost to Americans. Vaccine administration costs for private-sector administration partners are covered by healthcare pa...

Limitations and Safety Concerns of the Pfizer Vaccine  The FDA's Advisory Committee on Immunization Practices (ACIP) panelists met Dec. 11 and recommended approval of the vaccine for those age 16 and older. The panel said clinicians need more guidance on whether to use the vaccine on pregnant or breastfeeding women, the immunocompromised, those who have a history of allergies and those under age 16.  The FDA-issued healthcare provider information sheet on the vaccine said there is not enough data to recommend vaccinating those women or the immunocompromised, and also advises against giving ...

Storage and Handling and the Pfizer mRNA COVID-19 Vaccine The vaccine uses messenger RNA, which is extremely fragile and requires very cold storage temperatures and can be damaged by light. This is the is the first ever messenger RNA vaccine to gain FDA clearance.  Cartons of Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vials are shipped in thermal containers with dry ice. Once received, hospitals need to remove the vial cartons immediately from the thermal container and store in an ultra-low temperature freezer between -112ºF to -76ºF (-80ºC to -60ºC). Vials must be kept frozen and ha...