How is the COVID-19 vaccine considered safe if it hasn’t been approved yet? If it wasn’t approved, why would they recommend it for kids? I am really scared to get it because of this, help!

Great question! Unfortunately, there’s a lot of information circulating around social media about the COVID vaccines, so much so, that it can be hard to know what’s true and what isn’t.

For starters, there are only two vaccines available for children over the age of 12 years old; Moderna and Pfizer-BioNTech. However, all three vaccines in the US, Moderna, Pfizer-BioNTech, and Janssen (Johnson & Johnson, which is approved only for individuals over the age of 18 years old), received Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) for immediate administration.

So what does EUA mean? The FDA can grant EUA on things like medical interventions, medications, and vaccines, when there is a life-threatening public health emergency, like the COVID-19 pandemic. Regardless of whether or not a vaccine is given regular FDA approval or FDA EUA approval, they still go through rigorous testing and clinical trials, meaning there isn’t any corner cutting.

OK, so what’s the difference? There are only 2 major differences between FDA approval and EUA FDA approval. The first difference is that with EUA FDA approval, vaccine testing and vaccine production occur at the same time, this allows for quicker distribution once the vaccine is completely approved. The second difference has to do with which type of licensing is granted. When vaccine developers submit for FDA approval they submit a “Biologic License Application” (BLA). Once the application is reviewed (meaning they look at the same number of clinical trials and testing as a EUA vaccine) and the vaccine is deemed safe, they are granted FDA approval.  The same exact process has to occur when vaccine developers submit for a EUA approval it’s just done at a faster rate.

That being said, from a safety stand point both the Moderna and Pfizer-BioNTech vaccines are safe for people over the age of 12 years old and currently being studied for those under 12 years old. However, like with any vaccine, it’s always a good idea to talk your health care provider (HCP) if you have questions before rolling up your sleeve!