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Special Storage and Adverse Reactions for First COVID-19 Vaccine Approved by the FDA


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 the vaccine to individuals who have a history of serious allergic reaction to any component of the vaccine. ....

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FDA Clears First COVID-19 Vaccine Under an Emergency Use Authorization


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 have minimized exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. ....

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