By Tim Mastro

DOVER — The U.S. Food and Drug Administration formally approved Pfizer’s COVID-19 vaccine on Monday, replacing the emergency use authorization granted by the agency last December.

Pfizer’s COVID-19 vaccine is the first to be subject to a full review by the FDA. The approval puts the vaccine on par with other marketed vaccines.

The FDA’s full approval applies to people 16 and older. The vaccine continues to be available under the EUA for individuals between the ages of 12-15 and for the administration of a third dose in certain immunocompromised individuals.

“This is another milestone in our battle against COVID-19 and our fight to end this pandemic,” said Dr. Janice E. Nevin, president and CEO of ChristianaCare, in a statement. “We’ve known for months now that the COVID-19 vaccines are safe and effective, as billions of people worldwide have been fully vaccinated, and serious side effects have been extremely rare. This final step in FDA approval for the first of the COVID-19 vaccines is a symbol of what we can achieve together and addresses the concerns of those who were reluctant to get vaccinated while it was under EUA. With the current surge from the delta variant and the unvaccinated, the vaccine represents hope.

Moderna’s COVID-19 vaccine remains under FDA’s review. Johnson & Johnson, maker of the third option in the U.S., said it hopes to be approved later this year.

Delaware has received more dose of the Pfizer vaccine than any other COVID-19 vaccines, with a total of 746,475 — 461,430 doses shipped directly to the state and 285,045 more via the Federal Pharmacy Program.

The full approval has the potential to boost public confidence in the vaccine and opens the way for more universities, companies and local governments to make vaccinations mandatory.

The Pentagon promptly announced it will press ahead with plans to require members of the military to get vaccinated amid the battle against the extra-contagious delta variant while New York City announced all public school teachers and other staffers will have to get vaccinated.

More than 200 million Pfizer doses have been administered in the U.S. under special emergency provisions — and hundreds of millions more worldwide — since December. In going a step further and granting full approval, the FDA cited months of real-world evidence that serious side effects are extremely rare.

President Joe Biden said that for those who hesitated to get the vaccine until it received what he dubbed the “gold standard” of FDA approval, “the moment you’ve been waiting for is here.”

“Please get vaccinated today,” he said.

Pfizer CEO Albert Bourla called the FDA’s action “an important milestone that I think will unlock some of the more skeptical minds.”

Pfizer said the U.S. is the first country to grant full approval of its vaccine, in a process that required a 360,000-page application and rigorous inspections. Never before has the FDA has so much evidence to judge a shot’s safety, the company said.

The FDA, like regulators in Europe and much of the rest 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 time period when serious side effects typically arise.

That is 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 reaching Monday’s decision, the FDA said serious side effects remain very rare, such as chest pain and heart inflammation a few days after the second dose, mostly in young men. As for effectiveness, six months into Pfizer’s original study, the vaccine remained 97% protective against severe COVID-19. Protection against milder infection waned slightly, from a peak of 96% two months after the second dose to 84% by six months.

Both Pfizer and Moderna have vaccine studies underway in youngsters, and they are using lower doses than those available for people 12 and older.

Pfizer’s Bourla said he expects study results from those between the ages of 5-11 by the end of September, but data for those younger than 5 will take a couple of months.

Reporting from the Associated Press contributed to this story.