#Covid vaccine license

#Covid vaccine license

For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA).

EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.įDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.” “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. Food and Drug Administration approved the first COVID-19 vaccine.

To be informed about updates and developments in the UNICEF COVID-19 Vaccine Market Dashboard, subscribe to our newsletter or read all previous issues.Today, the U.S. It further tracks globally reported vaccine deliveries and vaccine donations outside of COVAX. This information covers both UNICEF-procured doses and deliveries, as well as other national and institutional buyers participating in the COVAX Facility. It also includes country- and economy level data on vaccine deliveries and planned shipments over a seven-day period. The ‘Delivery’ tab of the dashboard provides daily updates on total COVAX vaccine deliveries, doses allocated, and doses ordered.

Vaccines secured and optioned through bilateral and multilateral supply agreements.

Reported global vaccine production capacity.

COVID-19 vaccine development and progress towards vaccine approvals.

From a global vaccine market perspective, it gives an overview of: The COVID-19 Vaccine Market Dashboard is the go-to public resource for the latest information on the world’s COVID-19 vaccine market and the COVAX Facility’s vaccine deliveries.