Covid Blog
After vaccination
What you need to keep
What you can start doing
Additional and booster doses
Vaccination requirements
Healthcare Providers and Healthcare Staff
Do not send proof of vaccination (e.g. your vaccination card) to the Oregon Health Authority. Employees, contractors and volunteers should work with their employer to understand how and where to submit proof of vaccination.
Teachers and School Staff
COVID-19 Vaccination Requirements for Teachers and School Staff
Do not send proof of vaccination (e.g. your vaccination card) to the Oregon Health Authority. Employees, contractors and volunteers should work with their employer to understand how and where to submit proof of vaccination.
FAQ: COVID-19 Vaccination Requirements for Teachers and School Staff
Forms
Do not send exception request forms to the Oregon Health Authority. . Employees, contractors and volunteers should work with their employer to understand how and where to submit these forms.
Questions
Still have vaccine questions? 211 has answers. Email ORCOVID@211info.org for more information.
Safety
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.
The Pfizer COVID-19 vaccine has been given full approval from the U.S. Food and Drug Administration (FDA) for use in individuals 16 years of age and older.
The Pfizer vaccine continues to be available for individuals 12 through 15 years of age under the FDA's Emergency Use Authorization. The Moderna and Johnson & Johnson COVID-19 vaccines are available for use in individuals 18 years of age and older under the FDA's Emergency Use Authorization. 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 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.
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.
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.
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 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 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.
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.
Vaccine Distribution
Oregon's COVID-19 Vaccination Plan
The CDC asked all states to share a plan to distribute the vaccine. These plans have been developed with input from health care professionals and community organizations.
Read Oregon's Draft PlanOregon COVID-19 Vaccine Advisory Committee
We established a diverse, 27-person COVID-19 Vaccine Advisory Committee to help ensure we distributed the vaccine in a fair and equitable way for all the people of Oregon. The 27-member Committee convened for four formal business meetings during the month of January 2021 and held three optional information sessions to discuss topics related to vaccine delivery. On January 28, 2021, the VAC delivered its final recommendations for vaccine phases that would follow the vaccination of K-12 educators and staff, childcare providers and adults 65 and older.
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
: You can download materials on this page. OHA does not offer paper versions. Please feel free to print whatever you need.
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General vaccine questions: ORCOVID@211info.org