COVID-19 Vaccine in Oregon

COVID-19 Vaccine in Oregon

We all want to return to normal life as soon as possible. Safe and effective vaccines are the key to how we will slowly but surely achieve community immunity from COVID-19.

While the introduction of a vaccine is good news, it does not end the pandemic. It is going to take time for the vaccine to be widely available and widely distributed here in Oregon.

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.

shield with checkmark

Safety

Learn about the different vaccines in development, which are safe and effective.

Learn more about safety and effectiveness of vaccines
clipboard and pen

Prioritization

Oregon will use a phased distribution approach to ensure vaccination is done in a fair and equitable way.

Learn more prioritization and distribution
two people bumping elblows instead of shaking hands

Teamwork

Keep playing your part—your actions slow the spread of COVID-19.

Learn more about what you can do until you are vaccinated
hand holding syringe

Providers

Resources to support providers in COVID-19 vaccination efforts to achieve community immunity.

Learn more about providing vaccines in Oregon
shield with checkmark

Vaccine Safety & Effectiveness

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.

Vaccines are safe & effective

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.

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 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.

clipboard and pen

Vaccine Prioritization

Here’s how we plan to distribute the vaccine

We know it will take some time before every Oregonian who wants to get the vaccine can get their two shots. Oregon Health Authority will follow a phased approach to ensure we provide the first vaccines to critical health care workers who work with COVID-19 patients.

In line with CDC guidance, we will be prioritizing frontline health care workers and long-term care residents and employees as the first group to receive the vaccine. This includes our doctors, nurses, janitorial staff, and others who have the potential for direct or indirect contact with COVID-19 patients or infectious materials.

How our current supply of the vaccine is being distributed

Vaccine allocations per brand and per category
Allocations Date of Arrival
December 15 December 22 December 29
Pfizer 35,100 40,950 48,750*
Hospitals 24,375 35,100 42,900
Skilled Nursing Facilities 10,725 5,850 5,850
Moderna N/A 71,900 31,700*
Hospitals N/A 71,900 31,700

* Includes the second dose for patients that received vaccine from prior distribution.

Oregon's COVID-19 Vaccination Plan

The CDC asked all states to share a plan to distribute the vaccine. OHA submitted a draft plan. This plan is only a first step. OHA is developing the plan with input from health care professionals and community organizations.

Read Oregon's Draft Plan

COVID-19 Vaccine Advisory Community Council

We have also established a COVID-19 Vaccine Advisory Community Council that represents a diverse group of community members to help ensure we distribute the vaccine in a fair and equitable way for all the people of Oregon.

Read on to learn what to do until you're vaccinated.

two people bumping elbows instead of shaking hands

In the meantime,
here’s what we need to do together

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:

person wearing facemask

Wear our face covering when we are around people who don’t live in our home

five people with warning sign

Keep our gatherings small

house

Stay home when we are sick

hands and soap dispenser

Wash our hands often

two people spaced apart

Keep our distance from people we don’t live with



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

Printing requests: You can download materials on this page. OHA does not offer paper versions. Please feel free to print whatever you need.

Language access: OHA is working to provide original content in languages other than English. Many of the materials in our community resources section are available in multiple languages. OHA is also providing the Google™ Translate option to assist you in reading the OHA website in languages other than English. Google™ Translate cannot translate all types of documents and may not provide an exact translation. Anyone relying on information obtained from Google™ Translate does so at their own risk. OHA does not make any promises, assurances, or guarantees as to the accuracy of the translations provided.


Facebook Español Twitter YouTube