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The COVID-19 vaccination campaign in the United States is an ongoing mass immunization campaign for the COVID-19 pandemic in the United States.The Food and Drug Administration (FDA) first granted emergency use authorization to the Pfizer–BioNTech vaccine on December 10, 2020, [7] and mass vaccinations began four days later.
All RMPs for COVID‑19 vaccines will be published on the EMA's website. [136] The EMA published guidance for developers of potential COVID‑19 vaccines on the clinical evidence to include in marketing authorization applications. [137] In November 2020, the CHMP started a rolling review of the Moderna vaccine for COVID‑19 known as mRNA-1273 ...
The focus of Operation Warp Speed to deploy approved COVID-19 vaccines first for the American people raised ethical and logistical concerns that access to vaccines outside of the United States may be restricted during 2021, leaving low-to-middle-income countries with no or minimal supply. [85]
National regulatory authorities have granted full or emergency use authorizations for 40 COVID-19 vaccines.. Ten vaccines have been approved for emergency or full use by at least one stringent regulatory authority recognized by the World Health Organization (WHO): Pfizer–BioNTech, Oxford–AstraZeneca, Sinopharm BIBP, Moderna, Janssen, CoronaVac, Covaxin, Novavax, Convidecia, and Sanofi ...
“We are still awaiting more information from the FDA, including when the current 2023-2024 vaccine will be deauthorized and when states will be allowed to place orders for the new 2024-2025 ...
The Public Readiness and Emergency Preparedness Act (PREPA), passed by the United States Congress and signed into law by President of the United States George W. Bush in December 2005 (as part of Pub. L. 109–148 (text)), is a controversial tort liability shield intended to protect pharmaceutical manufacturers from financial risk in the event of a declared public health emergency.
With the Delta coronavirus variant posing a serious risk to unvaccinated Americans, some experts are calling for the FDA to fully approve the Pfizer and Moderna COVID-19 vaccines, which are ...
On 4 February 2020, US Secretary of Health and Human Services Alex Azar published a notice of declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID‑19, covering "any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID‑19, or the transmission of SARS-CoV-2 or a virus ...