The Food and Drug Administration on Monday granted full approval of the Pfizer vaccine, becoming the first COVID-19 vaccine to transition from an emergency authorization status to full FDA approval.

The full approval indicates that Pfizer has shown enough effectiveness and safety data to meet the stringent Biologics License Application requirements, which includes at least six months of safety data from a majority of the volunteers in a large, final stage clinical trial.

Pfizer's full approval will pave the way for further vaccine mandates in both the public and private sector. Some businesses and state leaders have held off thus far, signaling they'd wait for full approval before imposing tighter requirements.

Federal, state and local health officials have also expressed optimism that full approval will help dissolve some of the lingering hesitancy around taking a shot that until now has been only authorized for emergency use.

Acting FDA Commissioner Janet Woodcock called Monday's announcement a "pivotal moment" made possible by a "rigorous and thorough review" done in record time.

"Working around the clock, FDA staff were able to complete the evaluation of this biologics license application in just over three months," she said. "This is an unprecedented timeline given the volume of review and the meticulous manner in which it was done, but we want to underscore that our efforts to move as quickly as possible have in no way sacrifice scientific standards for the integrity of our process."

President Joe Biden said Monday, "If you're one of the millions of Americans who've said that they will not get the shot until it has full and final approval of the FDA -- it has now happened.

-ABC News' Sasha Pezenik

More than 180,000 new COVID-19 cases were reported among kids last week, reaching levels of the previous winter surge of 2020-2021, according to a new report from the American Academy of Pediatrics and the Children’s Hospital Association.

More than 4.59 million children have tested positive for COVID-19 since the onset of the pandemic. Last week, children represented 22.4% of all reported cases.

Severe illness due to COVID-19 remains "uncommon" among children, the two organizations wrote in the report. In nearly two dozen states, 0.2%-1.9% of all child COVID-19 cases resulted in hospitalization.

AAP and CHA, however, warned that there is an urgent need to collect more data on the long-term consequences of the pandemic on children, "including ways the virus may harm the long-term physical health of infected children, as well as its emotional and mental health effects."

-ABC News' Arielle Mitropoulos

The Pentagon will move forward with making the Pfizer vaccine mandatory now that it has been fully approved by the FDA, Pentagon press secretary John Kirby said Monday.

Defense Secretary Lloyd Austin announced on Aug. 9 that he would seek authorization to mandate the vaccine for the military unless the FDA approved it before Sept. 15.

“Now that the Pfizer vaccine has been approved, the department is prepared to issue updated guidance, requiring all service members to be vaccinated," Kirby said at a briefing. "A timeline for vaccination completion will be provided in the coming days."

-ABC News' Luis Martinez

All of New York City’s nearly 150,000 public school employees must receive at least one vaccine dose by Sept. 27, Mayor Bill de Blasio will announce Monday. The new vaccination policy will not allow weekly testing as an option.

At least 63% of New York City's Department of Education employees are already vaccinated, Schools Chancellor Meisha Porter said.

The previous requirement allowed for weekly testing of the unvaccinated, with unpaid suspensions for workers who didn't comply.

New York City's school year starts on Sept. 13.

-ABC News' Aaron Katersky

Japan has suspended the use of about 1.63 million doses of Moderna's COVID-19 vaccine due to reported contamination, as the country grapples with surging infections.

Japanese drugmaker Takeda Pharmaceutical Co., which is in charge of distributing the Moderna vaccine in Japan, said in a press release Thursday that it has received reports of foreign substances in some unused vials at multiple inoculation sites. Although some doses might have been administered, Takeda said there have been no reports of safety concerns tied to the affected vials so far.

After consulting with Japan's Ministry of Health, Labor and Wealth, Takeda said it decided as a safety precaution to stop using doses from three separate lots, manufactured in the same production line as the contaminated vials. The company said it has requested Moderna to conduct an emergency investigation into the issue.

For doses from non-suspended lots, Takeda urged people to check the vials for discolouration, foreign substances or other abnormalities before continuing to use. Meanwhile, the Japanese health ministry said it will work with Takeda to supply alternative doses in an effort to minimize the impact on the country's vaccination progress.

Moderna told ABC News that it has put the 1.63 million doses on hold in Japan after being notified that some of the vials may have been contaminated. One of the three lots received "several complaints of particulate matter" in its vials, the American drugmaker said, while the two other adjacent lots were put on hold out of "an abundance of caution" and for continued assurance of quality.

According to Moderna, the manufacturing issue may have come from one of the lines used at its contract manufacturing site in Spain. The Massachusetts-based company said it is looking into the contamination reports and "proactively communicating with Japan’s health authorities and its partners as the investigation proceeds." Moderna added that it remains "committed to working transparently and expeditiously" with its Japanese distribution partner and with regulators to address any potential concerns. No safety or efficacy concerns have been identified so far, the company said.

Moderna noted that the pause in Japan does not impact doses distributed in the United States, or put the American supply at risk in any way.