As we work to make vaccines widely available, the fastest way to get our schools, businesses and communities back open is to keep working together. We’re going to have to continue to use the tried-and-true methods we know stop the spread of this disease: wear a face covering, limit group size, keep distance, wash hands and stay home when sick.
Learn about the different vaccines in development, which are safe and effective.
Oregon will use a phased distribution approach to ensure vaccination is done in a fair and equitable way.
Keep playing your part—your actions slow the spread of COVID-19.
Resources to support providers in COVID-19 vaccination efforts to achieve community immunity.Learn more about providing vaccines in Oregon
Vaccines undergo rigorous scientific testing to ensure their effectiveness and safety.
There are multiple COVID-19 vaccines in development. The federal Food and Drug Administration and the Western States Scientific Safety Review Workgroup have approved the Pfizer-BioNTech vaccine and are currently reviewing the Moderna vaccine. More may come later.
The Pfizer and Moderna vaccines are safe and effective. Both vaccines were found to be over 94 percent effective and neither reported serious safety issues. The vaccines were tested in large-scale research, which
included adults from all backgrounds.
Due to the global pandemic, both vaccines were tested on many more people than a typical vaccine trial: the Pfizer vaccine was tested in 43,000 people and the Moderna vaccine was tested in 30,000 people.
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
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 COVID-19 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.
Read on to learn how vaccination will be prioritized.
Until we vaccinate enough Oregonians to stop the spread of
COVID-19, we are going to have to keep doing what we’re doing.
We are all going to have to continue to:
Wear our face covering when we are around people who don’t live in our home
Keep our gatherings small
Stay home when we are sick
Wash our hands often
Keep our distance from people we don’t live with
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