Still have vaccine questions? 211 has answers. Email ORCOVID@211info.org for more information.
The Food & Drug Administration requires rigorous safety testing before it will grant an Emergency Use Authorization (EUA). Tens of thousands of people from many diverse backgrounds, age groups and geographic locations participated in COVID-19 vaccine testing.
Based on the data collected, the federal Food and Drug Administration authorized three different vaccines for emergency use in the United States: the Pfizer-BioNTech vaccine, the Moderna vaccine and the Johnson & Johnson vaccine. The Western States Scientific Safety Review Workgroup, comprised of nationally acclaimed scientists with expertise in immunizations and public health, also independently reviewed the vaccine data collected and determined all three vaccines were safe and effective.
Millions of Americans have now been vaccinated, and strict ongoing safety checks have revealed no concerns.
Note: The Pfizer, Moderna and Johnson & Johnson vaccines have been authorized for emergency use by the U.S. Food and Drug Administration (FDA), under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 and older for Pfizer, and 18 years of age and older for Moderna and Johnson & Johnson. So far, they have not been approved or licensed by the FDA. The emergency use of these products is only authorized for the duration of the COVID-19 emergency declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the Food Drug & Cosmetic Act unless the declaration is terminated or authorization revoked sooner.
Vaccine makers submit an Investigational New Drug application to the U.S. Food and Drug Administration (FDA). The application describes the vaccine and how it is manufactured. Also included are
information about the vaccine's safety and ability to produce an immune response in laboratories as well as the proposed clinical protocol for studies in humans.
FDA Phase 1 Clinical Trials
FDA Phase 2 Clinical Trials
FDA Phase 3 Clinical Trials
If successful, the vaccine maker submits a license application to FDA that provides efficacy and safety information FDA makes a risk/benefit assessment and decides whether to recommend or oppose the
approval of a vaccine. Also, during this stage, the proposed manufacturing facility undergoes a pre-approval inspection during which production of the vaccine as it is in progress is examined in detail.
Following FDA's review of a license application, the vaccine maker and FDA may present their findings to the Vaccines and Related Biological Products Advisory Committee (VRBPAC). This committee is a group
of non governmental and non-industry scientists, physicians, statisticians, and a consumer representative that provides advice to the FDA regarding the safety and efficacy of the vaccine for the proposed use.
Vaccine approval also requires that the product be labeled to allow health care providers to understand the vaccine's proper use, including its potential benefits and risks, to safely deliver the vaccine
to the public. The vaccine and the manufacturing processes are approved by FDA during a pandemic. A vaccine may receive an Emergency Use Authorization (EUA) before getting approval. Once a vaccine is
licensed, researchers continue to monitor people who receive it to make sure it Is safe and effective.
Once FDA approves a vaccine, the U.S. Centers for Disease Control and Prevention provides guidance on whether and how products should be used by public health. CDC guidance is informed by an outside
advisory committee called the Advisory Committee on Immunization Practices (ACIP). ACIP independently reviews the vaccine safety and efficacy data, as well as epidemiologic data describing which groups
are most at risk and likely to benefit from vaccination.
The government uses the Vaccine Adverse Event Reporting System to identify problems after a vaccine is given to the public. This system allows additional formal studies on a vaccine to continue once it is
on the market. Unlike other medications and devices, vaccines are closely monitored for safety and effectiveness after they become available to the public. VAERS is one of
multiple monitoring systems used to monitor vaccine safety.
During a pandemic, a vaccine may receive Emergency Use Authorization (EUA) before being approved through a standard application. The FDA Commissioner may authorize medical products or unapproved uses of approved medical products to be used in a public health emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions when there are no available alternatives, and when the benefits of using a new medical product outweigh their risks.
For more information, visit the FDA website.
Governor Kate Brown announced that Oregon is joining other western states to review the safety and efficacy of COVID-19 vaccines
once approved by the FDA. The Scientific Safety Review Workgroup includes Oregon, Washington, California, Nevada and Colorado.
The Western States Scientific Safety Review Workgroup confirmed the Pfizer vaccine is safe and effective.
The Western States Scientific Safety Review Workgroup confirmed the Moderna vaccine is safe and effective.
The Western States Scientific Safety Review Workgroup confirmed the Johnson & Johnson vaccine is safe and effective.
The panel includes experts appointed by all member states, and nationally recognized scientists with expertise in immunization and public health. This panel reviews all publicly available data concurrently with
federal reviews and will present a report as soon as possible after the FDA approves a vaccine. This will happen for all approved COVID-19 vaccines.
This is an added layer of independent expert review that will help build confidence in the vaccine and bring an additional layer of scrutiny to this important process. OHA is engaging with communities and groups
that are most affected by COVID- 19, and we have heard that Oregon communities have questions and concerns about the safety of the vaccine. We want to give our community the highest confidence in a COVID-19
vaccine. This panel is another step to do that.
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General vaccine questions: ORCOVID@211info.org