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Oregon's Vaccine Safety Response
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 panel will include experts appointed by all member states, and nationally recognized scientists with expertise in immunization and public health. This panel will review 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 is actively working to understand and communicate the safety and efficacy of these vaccines.
- Western States Scientific Safety Review Workgroup Finds that the Pfizer Vaccine is Safe for Public Use
Western States Scientific Safety Review Workgroup Recommends Moderna Vaccine, Confirms it is Safe and Efficacious
Western States Scientific Safety Review Workgroup Recommends Johnson & Johnson Vaccine, Confirms it is Safe and Effective
CDC Vaccine Safety Information: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html
CDC Vaccine FAQ: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html
OHA Vaccine FAQ: https://sharedsystems.dhsoha.state.or.us/DHSForms/Served/le2390u.pdf
Pause lifted on Johnson & Johnson vaccine; Oregon use pending Western States’ review
Today, a federal vaccine safety review panel recommended lifting the pause on the Johnson & Johnson COVID-19 vaccine for people 18 and older. Based on the panel’s recommendation, the U.S. Food and Drug Administration (FDA) lifted the pause and added a warning about the rare side effects of blood clots in women under the age of 50.
The Western States Scientific Safety Review Workgroup, composed of public health experts from Oregon, California, Washington and Nevada, will now convene to review the FDA’s decision to lift the pause. Once that review is completed, OHA will share those recommendations to clinicians and vaccine providers on plans for the resumption of the vaccine’s use and distribution in Oregon.
To learn more, read OHA’s full press release here.
Results from monitoring efforts are reassuring. Some people have no side effects. Many people have reported mild side effects after COVID-19 vaccination, like
- pain or swelling at the injection site,
- a headache, chills,
- or fever.
These reactions are common. A small number of people have had a severe allergic reaction (called “anaphylaxis”) after vaccination, but this is extremely rare. If this occurs, vaccination providers have medicines available to effectively and immediately treat the reaction.
After you get a COVID-19 vaccine, you will be asked to stay for 15–30 minutes so you can be observed in case you have a severe allergic reaction and provided treatment in the rare case it is needed.
Have you experienced a side effect following COVID-19 vaccination?
You can report it to VAERS.
- Based on evidence from clinical trials, the Pfizer-BioNTech vaccine was 95% effective one week after the second shot at preventing laboratory-confirmed COVID-19 illness in people without evidence of previous infection.
- The Pfizer-BioNTech vaccine is recommended for people aged 16 years and older. Learn more about how CDC is making COVID-19 vaccine recommendations and CDC’s vaccine rollout recommendations.
- Pfizer Fact Sheet
- Based on evidence from clinical trials, the Moderna vaccine was 94.1% effective two weeks after the second shot at preventing laboratory-confirmed COVID-19 illness in people who received two doses who had no evidence of being previously infected.
- The Moderna vaccine is recommended for people aged 18 years and older.
- Moderna Fact Sheet
Johnson & Johnson/Janssen
- The J&J/Janssen vaccine was 66.3% effective in clinical trials (efficacy) at preventing laboratory-confirmed COVID-19 illness in people who had no evidence of prior infection 2 weeks after receiving the vaccine. People had the most protection 2 weeks after getting vaccinated.
- The J&J/Janssen vaccine is recommended for people aged 18 years and older.
Find out more about the different vaccines, including vaccines still in the authorization process, from the CDC at this website.
Both Pfizer and Moderna boast over 94% efficacy rates. Comparatively the flu vaccine's efficacy rate is generally between 40-60%. The Pfizer and Moderna vaccines will be the first to use messenger RNA technology (or mRNA vaccines). It differs from traditional vaccines, which often use a weakened or dead version of a virus, or a laboratory-generated protein. mRNA
vaccines give our cells instructions for how to make a harmless protein that is
unique to the virus. Our bodies recognize that the protein should not be there and
build T-lymphocytes and B-lymphocytes that will remember how to fight the virus
that causes COVID-19 if we are infected in the future. Side effects after a dose of an mRNA vaccine are normally signs that your immune system is building protection for your body as a result of the vaccination. The benefit of mRNA vaccines, like all vaccines, is those vaccinated gain this protection without ever having to risk the serious consequences of getting sick with COVID-19. Both vaccines require 2 doses of vaccination to be effective.
On February 27th, 2021, the FDA issued an Emergency Use Authorization (EUA) for the single-dose Johnson & Johnson vaccine in individuals 18 years of age and older. The vaccine was 85% effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination. The Johnson & Johnson vaccine is based on the virus’s genetic instructions for building the spike protein. Unlike the Pfizer and Moderna vaccines, which store the instructions in single-stranded RNA, the Johnson & Johnson vaccine uses double-stranded DNA. This type of vaccine is referred to as an AD26 vaccine because. Researchers added the gene for the coronavirus spike protein to another virus called Adenovirus 26. Adenoviruses are common viruses that typically cause colds or flu-like symptoms. The Johnson & Johnson team used a modified adenovirus that can enter cells but can’t replicate inside them or cause illness. The terms of the EUA allow use of the vaccine while more data are gathered. The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021.
Emergency Use Authorization is a tool of the FDA to speed up processes when need is urgent and there are no available alternatives. This can be used to allow drugs to be utilized a different way than previously classified and it can cut red tape for new therapies. Clinical trials must be 2 months past phase 3 studies and documentation from all phases must be included in the application for emergency use. While the requirements stipulate sample groups to include at least 3,000 people; COVID vaccination trials have included tens of thousands of people. The FDA has also made all vaccination trials information available to corollary state bodies for a simultaneous review process.
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