FDA Fully Approves Pfizer Vaccine: What It Means For Colorado

COLORADO — The U.S. Food and Drug Administration fully approved the Pfizer-BiNTech's coronavirus vaccine Monday for people ages 16 and older, and Gov. Jared Polis said he's hopeful that the approval will cause vaccination rates to rise in Colorado.

“I know that some people were waiting for full FDA approval to get vaccinated, and now that day is finally here and you can start the protection clock today,” Polis said in a statement.

“This remains a pandemic of the unvaccinated and we know that the Delta variant has threatened our progress, our economy and way of life and the FDA approval of the vaccine is a step forward.”

It has now been nine months since the vaccine was made available and more than 3.5 million Coloradans have received at least one dose, state public health data shows. Around 3.2 million Coloradans are fully immunized.

From Jan. 1 through Aug. 16, 98 percent of COVID-19 cases reported in Colorado have been among the unvaccinated, public health officials said.

“We want Coloradans to be as comfortable as possible in getting vaccinated against COVID-19," said Dr. Eric France, chief medical officer at the Colorado Department of Public Health and Environment. "For some Coloradans who have been on the fence that may mean choosing a vaccine that has been fully approved by the FDA. Coloradans now have that choice with the Pfizer vaccine. Our state is fortunate that our supply is robust enough that Coloradans have many options for the vaccine.

“We also want to remind everyone that all three of the available vaccines have gone through rigorous testing, and more than 362 million doses have already been administered in the United States. Scientists and doctors throughout the country agree that all of the available vaccines are safe and effective, and it’s much safer to choose to be vaccinated than risk getting COVID-19.”

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More than 200 million Pfizer doses already have been administered in the U.S. — and hundreds of millions more worldwide — since emergency use began in December.

"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," said acting FDA Commissioner Janet Woodcock. "Today's milestone puts us one step closer to altering the course of this pandemic in the U.S."

The U.S. becomes the first country to fully approve the shot, according to Pfizer. CEO Albert Bourla said in a statement he hoped the decision "will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives."

The FDA, like regulators in Europe and much of the world, initially allowed emergency use of Pfizer's vaccine based on a study that tracked 44,000 people 16 and older for at least two months — the period when serious side effects typically arise.

That's shorter than the six months of safety data normally required for full approval. So Pfizer kept that study going, and the FDA also examined real-world safety evidence in deciding to fully license the vaccine for people 16 and older, those studied the longest. Pfizer's shot still has emergency authorization for those ages 12 to 15.

Even after hundreds of millions of shots, serious side effects — such as chest pain and heart inflammation in teens and young adults — remain exceedingly rare, the FDA said.

As for effectiveness, six-month tracking of Pfizer's original study showed the vaccine remained 97 percent protective against severe COVID-19. Protection against milder infection waned slightly, from a peak of 96 percent two months after the second dose to 84 percent by six months.

Those data came before the extra-contagious delta variant began spreading, but other data from the Centers for Disease Control and Prevention shows the vaccine is still doing a good job preventing severe disease caused by that mutant.

Reporting and writing from The Associated Press was used in this report.