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Where Are the COVID-19 Package Inserts?

Breaking News – After it got an EUA from the FDA, ACIP issued an interim recommendation for use of the Moderna COVID-19 vaccine in persons aged ≥18 years for the prevention of COVID-19. (see below)

As we prepare for the first COVID-19 vaccines to arrive, some of you might be looking for COVID-19 vaccine package inserts and COVID-19 vaccine information statements.

Others are likely aware that we won’t see them until each vaccine is formally approved by the FDA and is ready to be distributed.

Where Are the COVID-19 Package Inserts?

But the first COVID-19 vaccines have been approved and the first doses are already being given in several countries, including the UK, Canada, and now the US.

The COVID-19 mRNA Vaccine BNT162b2 package leaflet has been published in the UK. Look for a package insert from the FDA as soon as it is approved in the US.
Look for a package insert from the FDA as soon as it is approved in the US.

And that’s why we are starting to see the first “package inserts,” including the COVID-19 mRNA Vaccine BNT162b2 package leaflet with information on who should and shouldn’t get vaccinated, vaccine ingredients, use, and possible side effects, etc.

Similarly, there is a more detailed information statement for health professionals.

And from Canada, where the Pfizer-BioNTech COVID-19 vaccine was just approved, we have the:

If you want even more information, you can review the Pfizer-BioNTech COVID-19 Vaccine FDA Briefing Documents and the:

The FDA has posted similar briefing documents for the Moderna vaccine:

And once other vaccines get an ACIP recommendation, the FDA and CDC will likely post a package insert and vaccine information statement for each vaccine.

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