As the first doses of COVID-19 vaccine began to ship across the United States, Gov. Jay Inslee on Sunday announced that the Pfizer-BioNTech vaccine had won the approval of an independent group of scientists in Western states, paving the way for some Washington residents, mostly health care workers, to receive inoculations.
“We are ready to go. We believe that we can take our first shipments hopefully tomorrow and the first vaccinations start in our state safely as early as Tuesday,” Inslee said during a Sunday news conference.
The 17-member COVID Vaccine Scientific Safety Review Workgroup “gave their unanimous recommendation” to their states’ governors Sunday morning, Inslee said.
“I am extremely confident Washingtonians can begin to use this vaccine in a safe fashion,” he said, adding that would receive the vaccine himself when it was his turn.
The independent COVID review group was designed to add an additional layer of assurance that vaccines approved for COVID-19 are safe and effective. Inslee in October joined the governors of California, Nevada and Oregon in appointing experts to the panel.
The group formed in response to some people’s concerns about the pace of vaccine development and critics’ concerns that the White House was pushing an aggressive timeline on vaccines for political reasons, rather than following science.
President Donald Trump has said no president has ever “pushed” the federal Food and Drug Administration (FDA) so hard, and has shared rosy predictions on the timeline for vaccine approval and accused the FDA of a “political hit job” for implementing rules that would push the timeline for a vaccine past Election Day.
Concerns among vaccine experts eased when the FDA pushed the approval process to after the election and both Pfizer and Moderna exceeded most scientists’ expectations. Both vaccine makers reported results from clinical trials saying their vaccines were about 95% effective and data suggested no major safety concerns.
Independent advisory committees to the FDA and the federal Centers for Disease Control and Prevention (CDC) each recommended emergency use of the Pfizer vaccine. Moderna will go through a similar review process next week.
But on Friday, in the hours before the Food and Drug Administration was expected to grant emergency approval for Pfizer’s vaccine, Trump called the agency “a big, old, slow turtle” in a tweet, telling its commissioner to “get the dam vaccines out now.” News outlets reported FDA Commissioner Stephen Hahn had been told his job was in jeopardy if the agency did not approve Pfizer’s vaccine before Saturday. Hahn’s agency sent word of official approval Friday night.
Public health experts have been concerned the appearance of political influence could erode public trust and make vaccinating large swaths of the public — and potentially driving out COVID-19 — more difficult.
Inslee said the Western state scientists’ approval confirmed that the FDA and CDC “did their jobs, in this case, without political intrusion.”
Washington’s two representatives on the safety review workgroup gave hearty endorsements of the vaccines’ use.
“Having looked personally at all the data and reviews … I’m looking forward to being vaccinated as soon as I’m eligible,” said Dr. John Dunn, the medical director of preventive care at Kaiser Permanente Washington.
Dr. Ed Marcuse, a pediatrician who has said he worked on vaccines for about 50 years and served on prior FDA and CDC advisory committees, said he “looked forward” to his own vaccination, adding that the emergency authorization process for Pfizer’s vaccine was comparable to typical vaccine licensing processes and adhered to transparency standards.
“I hope this gives people confidence, which is necessary in the success of the vaccination process,” Inslee said.
If protection from vaccines lasts long enough, the goal of vaccination will be to reach population, or herd, immunity. These terms describe when a large enough proportion of society is immune from infection and even those without immunity are indirectly protected because the virus cannot be readily transmitted from person to person.
It’s an uncertain and moving target, but many scientists think roughly 70% of the population must be immune to reach population immunity. It could require vaccinating three-quarters of U.S. residents, or more, to reach the mark.
Dr. Kathy Lofy, the state’s health officer, said it was difficult to set specific goals around vaccination rates and progress toward herd immunity at this point, because federal officials have not given many long-term estimates on how many doses Washington will receive.
Convincing enough Washington residents that vaccination is in their interest, and their community’s interest, will be a significant challenge for the medical community and for state health leaders.
Beyond logistics and distribution, Inslee said he viewed the role of state government now is to “share scientific information” about vaccination with communities across the state, promising a “vigorous communications effort” from the Washington Department of Health.
The health department, when it published its interim vaccine distribution plan in October, outlined its strategy to promote vaccination, including a 10-week paid advertising campaign involving Facebook, Instagram, billboards, TV, radio, newspapers and other information sources.
Inslee acknowledged the potential for particular concern or distrust in vaccination among some people in communities of color, where histories of medical exploitation have often eroded people’s trust in government and the medical community.
Inslee said Pfizer’s clinical trial showed little difference in efficacy and safety across different ethnic and racial groups, and said the health department would work to communicate transparently with communities of color while acknowledging “terrible things that have happened in decades past.”
“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 said, adding that communities of color had suffered “great disparities of loss” from COVID-19, due to health and social inequalities.
Vaccines on Sunday began to ship across the United States from a Pfizer facility in Michigan. The first 62,400 doses have been directed to 40 facilities in 29 counties, including hospitals, one pharmacy, two tribal nations and an urban Indian health facility, according to Michele Roberts, the state Department of Health’s acting assistant secretary. Most doses next week will go to health care workers.
Between Pfizer’s vaccine, and the Moderna vaccine that awaits emergency approval, state officials expect more than 400,000 doses from the federal government by the end of 2020, which will go to hospitals for health care workers and residents in long-term care facilities.
State officials last week further refined which health care workers should get the first doses, asking hospitals to use “clinical judgment” to direct the vaccine to those with the highest risk, including people who treat patients face-to-face, testing site staffers and first responders with the most risk of exposure.
UW Medicine will be among the first sites in Washington state to receive doses of vaccine. The hospital system on Saturday opened registration for its highest-priority staffers and plans to begin vaccinating those people Thursday, according to an email sent to staffers from Dr. John Lynch, medical director of infection prevention and control at UW Medicine’s Harborview Medical Center.
Staffers highest in priority include those working in units that regularly care for patients with COVID-19, emergency units, COVID-19 testing sites, labs and vaccination staff, COVID-19 screeners and safety officers, according to the email.
“For months, this is the news we have been waiting for and it’s finally arriving,” Lynch wrote.
If the Moderna vaccine receives federal emergency authorization, doses of that vaccine could begin to flow into Washington state as soon as Dec. 21, Roberts said. That vaccine can be shipped in smaller batches and does not need to be stored in temperatures as cold as the Pfizer vaccine, and so presents fewer logistical complications.
“We’ll be able to get that vaccine to a much broader reach across the state,” Roberts said.