Government Approval of COVID-19 Vaccines

United States

The world's eyes are on the United States, which led the breakneck pace of vaccine development via Operation Warp Speed.

An important concept to understand for Vaccine authorization, as well as other Covid treatments such as Paxlovid is the concept of Emergency User Authorization. To quote YaleMedicine, 'Put simply, an emergency use authorization (EUA) is a tool the Food and Drug Administration (FDA) can use to expedite the availability of medical products, including drugs and vaccines, during a public health emergency. An EUA can only be granted when no adequate, approved, available alternatives exist, and when the known and potential benefits outweigh the potential risks. An EUA also only lasts as long as the public health emergency for which it was declared.' –

Some have speculated if the demanding criteria of the Emergency Use Authorization in regards to 'no adequate, approved, available alternatives exist' impacted the development of treatment protocols using pre-existing generic medications.

Public Discussion and Recommendations

During the Advisory Committee on Immunization Practices (ACIP), the committee unanimously voted to approve a recommendation for the Pfizer-BioNTech COVID-19 vaccine for people age 16 and older despite discussion of six studies showing waning vaccine efficacy being presented only after the vote took place.1)

Late in 2021, the FDA and CDC stopped holding advisory committee meetings altogether.2)

Confusing or Misapplied Standards

Official contraindications for the Janssen quasi-vaccine warning about adverse events (AEs) such as thrombosis and myocarditis have not been similarly applied to other vaccines despite similar AE profiles.3)

CDC October 2020 Vaccine Forecast

In the United States, there is currently no authorized or approved vaccine to prevent coronavirus disease 2019 (COVID-19). Operation Warp Speed external icon has been working since the pandemic started to make a COVID-19 vaccine(s) available as soon as possible. CDC is focused on vaccine planning, working closely with health departments and partners to get ready for when a vaccine is available. CDC does not have a role in developing COVID-19 vaccines.

With the possibility of one or more COVID-19 vaccines becoming available before the end of the year, here are 8 things you need to know about where those plans currently stand. The safety of COVID-19 vaccines is a top priority.

The U.S. vaccine safety system ensures that all vaccines are as safe as possible. Learn how federal partners are working together to ensure the safety of COVID-19 vaccines.

The COVID-19 vaccines are the subject of great controversy during the SARS-CoV-2 pandemic.

CDC How Vaccines Work November 2021

COVID-19 vaccines help our bodies develop immunity to the virus that causes COVID-19 without us having to get the illness.

Different types of vaccines work in different ways to offer protection. But with all types of vaccines, the body is left with a supply of “memory” T-lymphocytes as well as B-lymphocytes that will remember how to fight that virus in the future.

It typically takes a few weeks after vaccination for the body to produce T-lymphocytes and B-lymphocytes. Therefore, it is possible that a person could be infected with the virus that causes COVID-19 just before or just after vaccination and then get sick because the vaccine did not have enough time to provide protection.

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