COVID-19 Vaccine in Oregon


Questions


Still have vaccine questions? 211 has answers. Email ORCOVID@211info.org for more information.

Vaccines are safe and effective

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.

application form

Vaccine Application

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.

PHASE1

Safety Trials

FDA Phase 1 Clinical Trials

Typical size
20-100 volunteers
Focus
Researchers continue to ask basic safety questions and identify whether the vaccine produces an immune response. They watch for serious side effects. If side effects are noticed, they look at whether the dose (amount or concentration) changes the side effects observed.
Oversight
Each clinical trial has a Data Safety Monitoring Board (DSMB). This group is made up of non-governmental and non-industry healthcare providers, vaccine experts, immunologists and statisticians. This group can pause, modify or stop a study if they are worried about safety or how well the vaccine is working FDA provides regulatory oversight.
phase 2

Expanded Trials

FDA Phase 2 Clinical Trials

Typical size
Hundreds of volunteers
Focus
Researchers continue to ask whether the vaccine is safe and produces an immune response. They watch for serious side effects. In this phase researchers begin to determine whether the immune response is strong enough to create immunity by looking at antibody levels. The larger group size allows researchers to start comparing and contrasting how well the vaccine works in different groups, such as men and women, racial and ethnic groups, and people of different age groups.
Oversight
Each clinical trial has a Data Safety Monitoring Board (DSMB). This group is made up of non-governmental and non-industry healthcare providers, vaccine experts, immunologists and statisticians. This group can pause, modify or stop a study if they are worried about safety or how well the vaccine is working. FDA provides regulatory oversight.
phase 3

Efficacy Trials

FDA Phase 3 Clinical Trials

Typical size
Hundreds to thousands of volunteers
COVID Vaccine Trial
Many of the COVID-19 vaccine trials are much larger than a typical phase 3 clinical trial, with some studies enrolling as many as 30,000 to 60,000 volunteers.
Focus
Scientists give the vaccine to thousands of people and wait to see how many become infected, compared with volunteers who received a placebo. These trials can determine if the vaccine protects against the coronavirus in large numbers of people. In June, the FDA advised vaccine makers that they would want to see evidence that vaccines can protect at least 50% of those who receive it. In addition, Phase 3 trials are large enough to reveal evidence of relatively rare side effects that might be missed in earlier studies.
Oversight
Each clinical trial has a Data Safety Monitoring Board (DSMB). This group is made up of non-governmental and non-industry healthcare providers, vaccine experts, immunologists and statisticians. This group can pause, modify or stop a study if they are worried about safety or how well the vaccine is working. FDA provides regulatory oversight.
approval

Approval Process

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.

cdc logo

CDC Recommendation

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.

alert

Vaccine Adverse Event Reporting System (VAERS)

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.


Accessibility: For individuals with disabilities or individuals who speak a language other than English, OHA can provide information in alternate formats such as translations, large print, or braille. Contact the Health Information Center at 1-971-673-2411, 711 TTY or COVID19.LanguageAccess@dhsoha.state.or.us

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General vaccine questions: ORCOVID@211info.org