Breaking News – After it got an EUA from the FDA, ACIP is voting today on whether or not to issue an interim recommendation for use of the Janssen 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.
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:
- Pfizer-BioNTech COVID-19 Vaccine (tozinameran) Consumer Information
- Pfizer-BioNTech COVID-19 Vaccine (tozinameran) Product Monograph
- Regulatory Decision Summary – Pfizer-BioNTech COVID-19 Vaccine – Health Canada
- Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
If you want even more information, you can review the Pfizer-BioNTech COVID-19 Vaccine FDA Briefing Documents and the:
- FDA – Pfizer-BioNTech COVID-19 Vaccine Fact Sheet for Healthcare Providers
- FDA – Pfizer-BioNTech COVID-19 Vaccine Fact Sheet for Recipients and Caregivers
- ACIP – COVID-19 ACIP Vaccine Recommendations
- MMWR – The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine — United States, December 2020
The FDA has posted similar briefing documents for the Moderna vaccine:
- FDA – Moderna COVID-19 Vaccine Fact Sheet for Healthcare Providers
- FDA – Moderna COVID-19 Vaccine Fact Sheet for Recipients and Caregivers
- FDA Briefing Document Moderna COVID-19 Vaccine
- FDA Sponsor Briefing Document Addendum Moderna COVID-19 Vaccine
- Vaccines and Related Biological Products Advisory Committee December 17, 2020 Meeting Briefing Document- Sponsor
- MMWR – The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Moderna COVID-19 Vaccine — United States, December 2020
And we have similar documents for the Janssen COVID-19 vaccine, which recently received EUA.
- FDA – Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers
- FDA – Janssen COVID-19 Vaccine Fact Sheet for Recipients and Caregivers
- FDA Briefing Document Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19
- ACIP – Overview of Janssen’s single dose COVID-19 vaccine, Ad26.COV2.S
- ACIP – GRADE: Janssen COVID-19 vaccine
- ACIP – Evidence to Recommendation Framework: Janssen COVID-19 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.
More on Vaccine Package Inserts
- Look Who’s Getting the COVID-19 Vaccine
- COVID-19 Vaccine Safety Monitoring Systems
- Fainting After Getting a COVID-19 Vaccine
- Deaths Following COVID-19 Vaccination – Understanding Background Rates
- The Truth About COVID-19 Vaccines
- COVID-19 Vaccine Update
- Show Me the Vaccine Insert!
- How to Read a Package Insert for a Vaccine
- Are Package Inserts Evidence That Vaccines Cause SIDS and Autism?
- Myths About Warnings and Adverse Reactions in the MMR Package Inserts
- Are Vaccines Evaluated for Mutagenicity, Carcinogenicity or Impairment of Fertility?
- Vaccine Information Statements
- FDA – Vaccines Licensed for Use in the United States
- FDA – Emergency Use Authorization for Vaccines Explained
- IAC – Package Inserts & FDA Vaccine Approvals
- CDC – What Clinicians Need to Know About the Pfizer-BioNTech and Moderna COVID-19 Vaccines
- ACIP – COVID-19 vaccine post-authorization safety monitoring update
- ACIP – Clinical Considerations for Populations Included in Phase 1a
- ACIP – Phased Allocation of COVID-19 Vaccines
- ACIP – Use of Pfizer-BioNTech COVID-19 Vaccine:Clinical Considerations
- CDC – What Clinicians Need to Know About the Pfizer-BioNTech COVID-19 Vaccine
- CDC – COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations
- Toolkit On Covid-19 Vaccine: Health Insurance Issuers and Medicare Advantage Plans