Vaccines Arrive; Watch Fred Hutch Webinar on Vaccine Safety and Development

People in Phase 1a will begin to receive vaccinations this week.

On December 14, the Pfizer-BioNTech COVID-19 vaccine arrived in Washington and first doses will be administered starting this week, thanks to Operation Warp Speed.

Emergency Use Authorization and Multi-State Workgroup Approval

On December 12, the FDA issued an Emergency Use Authorization (EUA) for use of the Pfizer-BioNTech COVID-19 vaccine in people aged 16 and older. On December 13, the Western States Scientific Safety Review Workgroup, of which Washington is a member, also announced approval of the vaccine.

Pfizer-BioNTech COVID-19 Vaccine

The Pfizer-BioNTech COVID-19 vaccine is a two-dose vaccine, given 21 days apart.

Clinical trial data show the vaccine is 95% effective at preventing COVID-19 infection starting 7 days after the second dose. Individuals will not be considered fully protected until 1 to 2 weeks after they receive the second dose. The clinical trials revealed no major unanticipated adverse events.

“The data we are seeing from Pfizer and Moderna are clear, transparent and demonstrated safe and effective,” said Dr. Moncef Slaoui, Operation Warp Speed Chief Science Advisor

Gen. Gus Perna, Operation Warp Speed Chief Operating Officer added, “Don't allow one headline to determine what you're going to do. There is so much available information. I encourage everybody, as individuals, to inform themselves and then make the decision that is best for you and your family.”

Washington Phase 1A

The state expects to receive 62,400 doses of vaccine this week. The first distribution will go to 17 sites across 13 counties. The federal government has estimated a total distribution of 222,000 doses of the Pfizer vaccine by the end of December with regular weekly shipments beginning in January.

The first doses of vaccine will go to people in Phase 1a. This phase includes high-risk workers in health care settings, high-risk first responders, and patients and staff of long-term care facilities. The state estimates around 500,000 people in Washington will be eligible for the vaccine in phase 1a. Read more details about phase 1a here.

The state will share more about who will be vaccinated in later phases from guidance made by the CDC's Advisory Committee on Immunization Practices. You can view the interim plan on their coronavirus vaccine webpage, www.CovidVaccineWA.org.

Vaccine Development and Safety

With how quickly vaccine makers developed COVID-19 vaccines, many have wondered how vaccines are developed and the safety protocols required when developing vaccines. There are several resources to help answer those questions.

Vaccine Development and Safety Webinar with Fred Hutch Experts

The State DOH, in partnership with The Fred Hutchinson Cancer Research Center and the Latino Center for Health, will host two online panel discussions to answer frequently asked questions about vaccines in the era of COVID-19.

The webinars will feature trusted medical experts from around Washington state, such as virologist Dr. Larry Corey, M.D., who has been integral to Fred Hutch’s COVID-19 vaccine research and Phase III trials, along with physicians who administer vaccines every day. The webinars, one presented in English and one in Spanish, will take place at the following times:

December 15, 5:00 p.m. Making Sense of Vaccines During COVID-19. Register here

• Panelists: Dr. Larry Corey, Dr. Ben Danielson, Dr. Gretchen LaSalle, Moderator: Louis Shackelford

December 17, 6:30 p.m. Vacunas contra el COVID: Verdades, mitos y preguntas with the Latino Center for Health. Register here.

• Panelists: Leo Morales, MD, PhD, Matías Valenzuela, PhD, Julian Perez, MD, Santiago Neme, MD, MPH, Moderator: Pablo Gaviria

If you are unable to attend, a link to a recording of the webinar will be emailed to those who registered.

CDC: 8 Things to Know about the U.S. COVID-19 Vaccination Program

Now that there is an authorized and recommended vaccine to prevent COVID-19 in the United States, here are 8 things you need to know about the new COVID-19 Vaccination Program and COVID-19 vaccines.

What is an EUA?

The first COVID-19 vaccine is being used under an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). An EUA is a mechanism to facilitate the availability and use of vaccines and other medical countermeasures during public health emergencies. Under an EUA, the FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met.

The FDA will evaluate EUA requests and determine whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to FDA. Click here to watch a video about EUAs.

COVID-19 Vaccine Rigorously Tested

Clinical trials evaluated investigational COVID-19 vaccines in tens of thousands of study participants to generate the scientific data and other information needed by FDA to determine safety and effectiveness. These clinical trials are being conducted according to the rigorous standards set forth by the FDA. Click here to read more.

V-Safe

The CDC has also developed v-safe, a new smartphone-based, after-vaccination health checker for people who receive COVID-19 vaccines. This additional layer of safety monitoring helps increase the CDC’s ability to rapidly detect any safety issues with COVID-19 vaccines. V-safe will also remind you to get your second COVID-19 vaccine dose if you need one.