The Pfizer-BioNTech COVID-19 vaccine on Monday won full approval from the Food and Drug Administration for use in all people who are 16 and older.
In December, the two-dose vaccine was the first COVID-19 vaccine to be authorized for everyone 16 and older under an emergency-use order. The designation means the federal agency has gone through its standard process for approving vaccines and found the safety and effectiveness of the vaccine warrant full approval.
State and local politicians as well as health officials welcomed the decision on Monday.
Gov. Jay Inslee called the approval a “great milestone” that should give people more confidence in the vaccine that is not only safe but incredibly effective at protecting people from both the novel coronavirus and its subsequent variants.
“We can already see this in the fact that 95% of COVID hospitalizations in our state are among the unvaccinated. It is clear there is no safer, faster or more effective way to stop the transmission of this virus than through vaccination,” Inslee said in a news release. “Washingtonians can make informed decisions about getting this preventative treatment. Talk to your health provider about whether this is the right decision for you.”
Health officials are hoping the approval will boost confidence in the vaccine among those hesitant to get vaccinated due to how quickly the vaccines were developed.
“We are grateful for the FDA approval of the Pfizer COVID-19 vaccine for those 16 and older. This approval should increase public confidence in the safety of the vaccine and encourage more individuals to be vaccinated,” said Don Duffy, interim director at the Panhandle Health District, in a news release.
The Pfizer vaccine still is under emergency use authorization for those ages 12 to 15 years old. Later this year, Pfizer will apply for full approval for this age group as well, after six months of required data are available.
Federal officials reviewed thousands of documents, inspected manufacturing facilities and assessed the data and documents submitted by the companies. Clinical trials with thousands of participants found the Pfizer vaccine to be 91% effective at preventing COVID-19, the disease caused by the coronavirus.
Safety evaluations are not finished, however, and the FDA is requiring Pfizer to continue safety studies into the long-term effects of the vaccine when it comes to myocarditis symptoms as well as its impact on pregnant people.
“While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” Janet Woodcock, acting FDA commissioner, said in a statement. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
More than 204 million doses of the Pfizer vaccines have been administered nationwide, and more than 92 million Americans are fully vaccinated with the Pfizer vaccine.
Politicians and health officials from both sides of the political aisle applauded the approval.
U.S. Rep. Cathy McMorris Rodgers encouraged her constituents to get the vaccine .
“This approval will build more confidence and trust in the vaccines, which are safe and highly effective at preventing severe illness, hospitalizations, and death from COVID-19,” McMorris Rodgers said in a statement. “For anyone in Eastern Washington who hasn’t yet been vaccinated, I encourage you to talk to your doctor. Getting vaccinated is the best way to protect yourself and your family. It’s how we beat this pandemic and restore our way of life.”
Health officials and associations hope that the full approval will help sway some hesitant people to get their shots. A recent Kaiser Family Foundation poll found that some eligible residents in the “wait and see” group were waiting for full approval of the COVID vaccines.
“Three in 10 unvaccinated adults, rising to about half of those in the ‘wait and see’ group, say they would be more likely to get vaccinated if one of the vaccines currently authorized for emergency use were to receive full approval from the FDA,” the poll says. “However, this finding likely suggests that FDA approval is a proxy for general safety concerns.”
The American Medical Association, American Hospital Association and the American Nurses Association issued a joint statement noting the FDA’s critical step in the pandemic, with its full approval of the Pfizer vaccine.
“According to recent polling, 30 percent of unvaccinated people said they were waiting for vaccines to receive full approval before getting vaccinated,” a statement from the associations says. “We are there now; this vaccine is fully approved. If uncertainty was holding you back, now is the time to act. And if you still have questions about the vaccines or about COVID-19, please consult your health care professional.”
As of Aug. 16, 71.5% of Washington residents who are eligible have received at least one dose of a COVID-19 vaccine. In Spokane County, 57.8% of eligible residents have received at least one dose of a vaccine.
The Pfizer vaccine is available at most drugstores and some grocery stores in Spokane County as well as through your health care provider. Find a dose using in Washington by using the state’s vaccine locator tool or by calling (800) 525-0127.
Here’s a look at local numbersThe Spokane Regional Health District reported 258 new COVID-19 cases and five additional deaths on Monday. The district also reported 506 new cases of the virus over the weekend.
There have been 719 deaths due to COVID-19 in Spokane County residents.
There are 178 people hospitalized for the virus in Spokane hospitals.
The Panhandle Health District confirmed 114 new COVID-19 cases on Monday and over the weekend as well as eight additional deaths.
There have been 358 deaths due to COVID-19 in Panhandle residents.
There are 118 Panhandle residents hospitalized, and Kootenai Health is treating 90 COVID-19 patients currently.