Come for the Bernie memes, stay for the science. Now that I have you all here, lets talk about the differences between Emergency Use Authorization (EUA) and Approval. By now, you've heard that Pfizer and Moderna's #COVID19 have been authorized for emergency use under EUA ... 1/n

2/n...but what does this mean exactly? When drugs/vaccines (even devices but the language is a bit different so I wont get into that) go through the FDA review process under normal circumstances they are generally seeking 'approval'. Approval means that the FDA has reviewed

3/n...the submitted data on safety and effectiveness and has found it to be sufficient to essentially allow a drug or vaccine to be used in the population as intended. This means several studies ranging from animal studies to in human studies have been conducted and completed.

4/n...under emergency use the FDA still reviews data submitted in support if the drug/vaccine. Safety & efficacy remain the forefront concerns. EUA means that data submitted might be more limited then what we would expect under normal circumstances. But don't panic. EUA is good.

5/n...the standard approval process is timely, and when there is an emergency time becomes extra precious. This is not say that the vaccine is rushed-it isn't, it just means that things have been done a little differently then usual, and they were done differently to save lives.

6/n...this doesn't mean that the trials are in anyway less well-designed, it just means we have less data. It also means that the potential benefits of the vaccine have been decided to outweigh the potential and known risks of what its like without one. But because we still

7/n...need the data we would generally ask for, careful continuous collection of that data and monitoring is occurring (and truth be told even with approved drugs there is always surveillance), this data is reviewed to continue to assess our use of the drug/vaccine

8/n...so all of this may still sound similar. In a nut shell the Regulatory Affairs Professional Society boils it down to this. https://www.raps.org/news-and-articles/news-articles/2020/4/why-fdas-issuance-of-euas-are-not-approvals-and-wh

9/n...so while a normal approval would mean that we are convinced there is a benefit, a EUA means it is reasonable to say that there is a benefit, especially in light of the risks without this new drug/vaccine. More information here https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained

10/n...back to why this doesn't equal rushed. First, science and regulatory policy are partners which means they go great together but they are still individuals. The science behind the vaccine has to consider the regulations in which its being made but frankly the actual science

11/n...end of it really doesn't care. Whether or not a vaccine will work is up the magic that happens in the lab, which is not magic at all and is instead, a careful analysis and culmination of scientists knowledge applied to driving unknowns into knowns.

12/n...the efficacy of these vaccines occurred BEFORE the EUA, or else they would have never submitted the EUA. Without it, there would be no EUA. Further, the scientists behind these vaccines have committed their lives works to science which means you can trust they are working

13/n...to make it safe. While mRNA is new, Moderna has been working on their mRNA platform for years, Pfizer also has expertise that made their speed possible and for that I am grateful. And while they are only under EUA now, a path to approval means the same data will be there

14/n... when they apply, this means at the time of approval we will have that same substantial evidence which can help us to even fine tune our use and recommendations.

15/n... Don't forget there are several more vaccines on their way! Multiple vaccines options means we don't have all our eggs in one basket, each vaccine may offset a weakness of the other. For example, Pfizer's cold chain makes distribution https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-tracker

16/n...tricky but Moderna's slightly less demanding cold chain makes it easier. Newer options may do without any cold storage and may potentially offer us a 1 shot option. Hopefully, with the info above you will be able to observe and engage with the EUA process for these.