Full vs. emergency use approvals: What’s the difference?

Archive, August, Month

COVID-19 vaccines, already available, nearing full approval.

Fighting the COVID-19 pandemic for more than nine months, the world could finally battle back against the virus with the availability of the first COVID-19 vaccines just before the year 2020 closed.

Pfizer’s COVID-19 vaccine was granted emergency use authorization by the US Food and Drug Administration on Dec. 11.

An emergency use authorization allows for the use of medications, therapeutics and vaccines during a public health emergency to diagnose, treat or prevent serious and life-threatening diseases. EUAs had been granted previously for recent outbreaks — Ebola, MERS and Zika.

Following the Pfizer authorization, Moderna’s vaccine quickly followed on Dec. 18 and the Johnson & Johnson single-shot vaccine was authorized in late February 2021.

Being administered for several months, Pfizer will be the first COVID-19 vaccine to apply for full approval from the FDA. A full approval designation is earned following longer and larger scaled clinical testing.

The data collected following the EUA is considered as well.

This, however, does not mean that an EUA vaccine has not been trialed. The COVID-19 vaccines, for example, underwent three stages of clinical trials with tens of thousands of participants — and this was after lab testing.

The move toward full approval is also strategic, with hopes that those hesitant to get the vaccine will then feel confident following full FDA approval.


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