Washington and Other Western States Approve First COVID-19 Vaccine, Say Process Was Rigorous and Equitable – First Doses Arrive Monday

by Andrew Engelson

In an online news conference Sunday morning, Gov. Jay Inslee said he was "joyous" to announce that the federal government and Washington state have both authorized the Pfizer- BioNTech COVID-19 vaccine and that shipments of the first 60,000 doses could arrive in the state Monday. Immunizations could start as early as Tuesday for high-risk health care workers, staff and residents of long-term care facilities, and people in tribal communities, the governor said. He also said an independent review board from western states confirmed the transparency, rigor, and scientific independence of the federal approval process for the vaccine.

"Because there have been some questions raised about the federal approval process," Inslee said, "our state and the other states stood up an independent process so that we could give an added layer of assurance to Washingtonians that this was on the up and up."

The Western States Scientific Safety Review Committee, a group of 17 medical and vaccine experts from Washington, Oregon, California, and Nevada, has over the past 10 days reviewed the trial data provided by the manufacturer as well as the review process conducted by committees of the Food and Drug the Administration (FDA) and Centers for Disease Control (CDC). The regional review group, made up of medical professionals, epidemiologists, vaccine safety experts, and public health experts, was unanimous in its approval of the vaccine, and presented its findings to the governor this morning.

Kathy Lofy, state health officer for the Washington Department of Health (DOH), said during the call, "The process used by the FDA and CDC to make these decisions has been open, transparent, and scientifically rigorous. I believe without any reservations that the benefits of this vaccine far exceed any risks."

John Dunn, a vaccine expert who has previously worked with Kaiser Permanente on vaccine safety, and who was on the western states review panel agreed, saying during the call, " We concur in the work group's recommendation that the vaccine is both safe and effective. There are side effects, as with any other vaccines, but they're transient and comparable to the side effects we see with other currently licensed vaccines."

Dunn also noted that the trial found the Pfizer-BioNTech vaccine to be 95 percent effective, "which is terrific by any measure," he said.

The vaccines come at a critical time as the state reaches nearly 200,000 confirmed cases and 3,000 deaths since the first COVID-19 case in the U.S. was discovered in Washington state in January of this year.

Inslee was cautiously upbeat about the vaccine approval, saying "We now know we can see the harbor — it's in view, this vaccine. But we're not in port yet. This is not time to jump ship."

"We have demonstrated in the state of Washington that we have the resilience and the courage, that we have the diligence, and we have the compassion for our families to actually protect ourselves during the interim period — because we have demonstrated it," Inslee said. "We've demonstrated it in how we celebrate holidays and how we socialize with people — by avoiding in-person, inside events where this transmission can occur. We have what it takes to marry the genius of science with our own individual behavior to see us through."

Inslee noted that the western review group was given the task of confirming the FDA and CDC process as outgoing president Donald Trump made critical statements and appeared to meddle in the FDA review process.

"Look, you've gotta understand," Inslee said. "I've been as questioning and untrustful of this administration as maybe anyone in the country. So I've been very diligent in looking at every single decision through this lens of skepticism. But what we have demonstrated is that there is scientific certainty about the safety of this product. We are relying upon Washingtonians' commitment to following science and truth. And the truth is in the science; it is not in our fears. And the science, I'm hopeful, will give people great confidence."

Responding to a question from Austin Jenkins of Northwest Public Radio, Inslee spoke to the concerns communities of color might have about the safety and equity of the vaccine and its distribution. Inslee's remarks alluded to — but did not specifically call out — the racist history of vaccine studies, including the infamous Tuskeegee Syphilis study, in which some 600 Black men in Alabama were intentionally denied treatment for syphilis between 1932 and 1972 in order to provide a control study for a vaccine.

"We know that historically there have been great concerns in communities of color about some of the really sorrowful incidents that happened in the decades past," Inslee said. "… in the evidence I've been shown, or seen, there is safety throughout ethnic groups and we will simply share that information [in a way that is] as open and transparent as possible — while still recognizing the terrible things that happened in decades past. But I am hopeful that the understandable concern from those decades of experience does not infect us with the disease of passivity and more people lose their lives."

Inslee then pointed out that communicating with communities of color about the safety and effectiveness of the vaccine is critical — especially because Hispanic and Black communities have experienced higher rates of infection and in some cases, higher rates of fatalities.

"We do know that communities of color have been — which is a terrible misfortune — have had great, disparate rates of loss," Inslee said. "The loss of folks in the Hispanic community and the Black community from fatalities has significantly exceeded the proportion of the population they represent. So the communities of color may have more at stake in some sense than other communities because they've suffered so terribly because of the disparities in where people work and access to health care. So we are really hopeful that we'll have broad scale acceptance of this to save these folks in these communities. To not allow the sins of the past to result in increased rates of fatality in these communities."

Responding to questions about lack of studies for children under 16 or pregnant women, Ed Marcuse, a retired faculty member of the University of Washington Medical School, a frequent member of FDA and CDC vaccine review panels over the past 24 years, and a member of the western state review group, said that the federal panels reviewing the COVID-19 vaccine discussed these issues in depth. "There's no reason to withhold the vaccine from a pregnant woman who wishes to receive it," Marcuse said.

Inslee said that it will be up to independent medical organizations to determine who qualifies as a high-risk health care worker, though he indicated that the first to receive the vaccine will be front-line caregivers, such as those "who do intubations, who work routinely with people who've contracted COVID-19."

Michele Roberts, acting assistant secretary of DOH, noted that the first shipment of 62,000 vaccines will be distributed to 40 medical organizations in 29 counties, as well as one pharmacy that will be supplying long-term care facilities across the state, plus two tribal nations and one urban Indian health facility. Roberts also noted that another vaccine, manufactured by Moderna, was in the federal review process now and could be ready for distribution as early as December 21. "We're really excited about the potential for the Moderna vaccine. There's just less logistical barriers with the Moderna vaccine than with the Pfizer vaccine. And our initial allocation is much higher — it's 128,000 doses."

Inslee said there was no firm timeline or decision making process about who would qualify for the vaccine after this first round, and that state health officials were waiting for more guidance from federal health officials. "These are not easy decisions to make," he noted.

Gov. Inslee also said there were no laws on the books that he knew of that would allow employers to require employees to get the vaccine. "What we're depending on is people's voluntary decisions to protect themselves and their loved ones," he said. It's also unclear how quickly the state will receive quantities of the vaccine necessary to immunize most residents and stop the spread of COVID-19.

"Ultimately, our goal is to have about 70% immunity in our population," health officer Lofy said. "This is what experts feel is the level needed for herd immunity, which is the point at which outbreaks no longer occur in the population."

In his final comments, Inslee urged the state's residents to continue to be vigilant about mask wearing, social distancing, and avoiding gathering indoors over the holidays, noting that it will be months before the vaccine is widely available.

"So I'm most hopeful that as we follow the science, and we receive the vaccine, and while we're waiting for the total application [we'll all be] safe this holiday season. We have this bright light in the recognition that we have the end in sight. I hope everyone will take advantage of the great gifts we have, the gift of the vaccine and the gift of our own diligence. Those are going to do good things to save lives in this state."

Andrew Engelson is a Seattle-based freelance writer and editor.

Photo is attributed to Governor Jay & First Lady Trudi Inslee's photostream Flickr account under a Creative Commons 2.0 license.