CINCINNATI — The Cincinnati Public Schools Board of Education will consider making a COVID-19 vaccine mandatory among district staff.

The board's Policy and Equity Committee Thursday morning advanced the proposal to the full board. As proposed Thursday, the policy would require all district employees to receive one of the three available COVID-19 vaccines. The would-be deadline for employees to receive those shots was left unclear Thursday morning, as the full board still needs to consider the policy. Staff would have the option to apply for an exemption from the policy.

The measure will go to the full board for discussion next month.

The committee's ruling came days after the U.S. Food and Drug Administration granted full approval status to Pfizer's two-shot COVID-19 vaccine for people 16 years and older, with Moderna also in the process of applying for full FDA approval. According to Ohio law, school districts cannot require vaccines that are not FDA-approved.

Board member Eve Bolton said the decision could risk losing district staff but that it's worth the risk.

"People will quit, and we will lose staff, and I am willing to do that," Bolton said during Thursday's committee meeting.

Committee members stopped short of discussing specifics about requiring the vaccine for students old enough to meet the FDA approval's parameters, but Bolton said she'd be interested in the administration exploring the idea.

The full board of education will consider the policy at its next regularly scheduled meeting on Sept. 13.

The U.S. Food and Drug Administration’s approval of the Pfizer vaccine for those 16 and up Monday was enough to ease concerns for some of Cincinnati’s unvaccinated.

“I’m just like a lot of other people: They're scared, you know, to get them because I heard a lot of people having side effects from them,” said Bernice Childres, who received her first vaccine dose at a pop-up clinic in her Cincinnati neighborhood Monday, just a few hours after the FDA announcement.

Some have questioned whether the process was rushed. Tim Schroeder, with Covington, Kentucky-based CTI Clinical Trial and Consulting Services, has 35 years of experience and explained that the approval process did not skip steps.

FAQ: What does Pfizer approval mean for COVID vaccine?

“What we were able to do is compress steps, not skip steps, but the level of rigor, the level of scientific validity, is the highest it’s ever been,” said Schroeder. “These are the most studied vaccines in the history of the world when you think in terms of hundreds of millions of people who have received these vaccines under the emergency use authorization. In a typical year, when we do vaccine research for the influenza flu vaccine or rodovirus or respiratory syncytial virus, those are studied in a much, much smaller number of subjects for a much shorter period of time.”

The FDA granted Pfizer emergency use authorization for those 16 and up in December 2020. In May 2021, the FDA granted Pfizer emergency use authorization for those 12 and up. August 2021, the FDA approved Pfizer for those 16 and up.

Schroeder expects Moderna approval for those 16 and up in the coming weeks or months, followed by Johnson & Johnson. Then, approvals for those 12 and up. While waiting, he says, scientists will gather data to get emergency use authorization for those 5 and up.

“We have the highest level of confidence in the quality of the data,” said Schroeder.

Out of the counties we cover in Indiana, Kentucky and Ohio, Gallatin, Owen, Switzerland and Adams counties have the lowest vaccination rates. Transmission rates remain high in all the counties we cover. That’s according to the Centers for Disease Control and Prevention.

The Food and Drug Administration on Monday granted full approval to the Pfizer/BioNTech COVID-19 vaccine for people age 16 and older. This is the first coronavirus vaccine approved by the FDA, and is expected to open the door to more vaccine mandates.

"The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older," the FDA said in its announcement on Monday.

The Pfizer/BioNTech vaccine has been authorized for emergency use in the United States since mid-December for people age 16 and older. In May, the authorization was extended to those 12 and older.

"The vaccine also continues to be available under emergency use authorization, including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals," according to the FDA.

Out of more than 170 million people in the United States fully vaccinated against COVID-19, more than 92 million have received the Pfizer/BioNTech vaccine.

This weekend, officials familiar with the decision said they discussed how to prepare for the rollout once the FDA grants full approval, given it will be a major messaging opportunity to encourage vaccination.

U.S. Surgeon General Dr. Vivek Murthy told CNN Sunday that approval could encourage more people to get vaccinated, and more mandates.

"For businesses and universities that have been thinking about putting vaccine requirements in place in order to create safer spaces for people to work and learn, I think that this move from the FDA, when it comes, will actually help them to move forward with those kinds of plans," Murthy told CNN.

Murthy also noted "a small number of people" have been waiting for full approval before getting their shot and believes "this may tip them over toward getting vaccinated."

Why emergency use authorization came first

Due to the seriousness of the pandemic, vaccine makers originally applied for emergency use authorizations because the authorization process takes less time than what's required for full approval.

In July, drugmaker Pfizer announced that the FDA granted its vaccine a priority review, and the FDA had been pulling in extra help from across the agency to speed final approval of the vaccine, an agency spokeswoman told CNN in late July.

Emergency use authorization is what its name suggests — a medical product, such as a vaccine, that gets special FDA authorization to be used during an emergency. When the health emergency is over, "then any EUA(s) issued based on that declaration will no longer remain in effect," according to the FDA.

Among the two other coronavirus vaccines authorized for emergency use in the United States, Moderna has begun applying for full approval for its COVID-19 vaccine in people ages 18 and up. Johnson & Johnson has not yet filed for full FDA approval of its vaccine.

Some experts have pushed the FDA to approve vaccines quickly, as doing so could help combat vaccine hesitancy.

Full approval of the COVID-19 shots comes days after the Biden administration announced plans to offer booster doses to vaccinated adults starting Sept. 20 — pending approval by the FDA and recommendation from the Centers for Disease Control and Prevention.

FDA approval could fight vaccine hesitancy, experts say

Progressing from authorized to approved would allow manufacturers to market and directly distribute their vaccines — and perhaps sway skeptics hesitant to get the vaccines now.

A Kaiser Family Foundation survey of U.S. adults released in July found that among the one-third of adults surveyed who are not yet vaccinated, 16% said the vaccine was too new, too unknown or not tested enough.

Some said in this poll that they wouldn't get a vaccine until it is required. While companies are allowed to require the vaccine — and many large businesses, such as United Airlines, Disney, Walmart, Microsoft, Google and Facebook already have announced plans to do so — some experts believe more will make it a requirement once a vaccine is fully approved.

The Pentagon plans to make the vaccine mandatory for all active duty members of the U.S. military by the middle of September, or sooner, based on approval timing, Secretary of Defense Lloyd Austin said in a memo released earlier this month.

"I want you to know that I will seek the President's approval to make the vaccines mandatory no later than mid-September, or immediately upon the U.S. Food and Drug Administration (FDA) licensure, whichever comes first," the memo states.

Full FDA approval may also mean big changes in terms of vaccine requirements for staff and students in schools.

For instance, in Ohio, a House bill signed into law in July states that a public school or state institution of higher education shall not "require an individual to receive a vaccine for which the United States Food and Drug Administration has not granted full approval."

Across all 50 states, at least five routine childhood vaccines are generally required for children attending childcare or school, including those for diphtheria, pertussis, and tetanus or DTaP, chickenpox, polio and MMR. But those shots have all been fully approved by the FDA.

"COVID-19 is a little bit different from these other vaccines because of the way it had to be developed," Hemi Tewarson, executive director of the National Academy for State Health Policy, told CNN in July.

"That is a difference, I think, in some people's minds who have concerns around potential side effects for children," Tewarson said, noting that clinical trials for the EUA for children 12 and older were robust, and there were not significant side effects.

But full FDA approval of the Pfizer/BioNTech COVID-19 vaccine is for people age 16 and older — it's not yet available for all ages.

What does approval mean for kids?

As of now, the Pfizer/BioNTech COVID-19 vaccine is still only available for ages 12 and older in the United States.

Pfizer has said it expects to have vaccine trial data on children ages 5 to 11 by the end of September, and the company could apply to have its vaccine authorized for those younger ages shortly after. The company also has said data for even younger children, ages 2 to 5, could be available shortly after.

Moderna and Johnson & Johnson are also working on studies in children.

"Does getting full approval for an adult vaccine, does that matter in terms of speeding up the process for approval for the childhood vaccines? I think the answer to that question is probably no," Dr. Paul Offit, a prominent member of the FDA's vaccine advisory committee and director of the Vaccine Education Center at the Children's Hospital of Philadelphia, told CNN previously.

Overall, "this is all sort of new territory — the notion of emergency use authorization obviously is new, certainly for vaccines that have been used to this extent."

CNN —

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To date, more than 339 million doses of COVID-19 vaccine have been administered to give people protection from the coronavirus; several studies show that the three vaccines authorized for emergency use in the U.S. work and are safe; and the government continues to give them out in schools and at ball fields, and yet, not one has been formally approved by the U.S. Food and Drug Administration.

By all accounts, the approval process for the vaccines is moving faster than it ever has before. However, the FDA has yet to disclose a timeline for when its work will be complete and data is still being reviewed.

On Wednesday, President Joe Biden told CNN's Don Lemon during a CNN Townhall that he expects COVID-19 vaccines could get full approval "quickly."

"They're not promising me any specific date, but my expectation, talking to the group of scientists we put together... plus others in the field, is that sometime, maybe in the beginning of the school year, at the end of August, beginning September, October, they'll get a final approval," Biden said.

Earlier Wednesday, the National Institutes of Health Director Dr. Francis Collins told CNN's Jim Acosta that full approval could come in the "next couple of months."

Pfizer's timeline

Vaccine maker Pfizer appears to be the furthest along in the process.

In July, the company announced that the FDA granted its vaccine a priority review, so that sets the regulatory clock for six months, meaning technically the company should know if it has approval by January. A standard review is 10 months.

The acting commissioner of the FDA, Dr. Janet Woodcock, has said the FDA intends to complete the review in advance of its January deadline.

"So, we all know that's not going to take that long," said Melissa Tice, program director of regulatory affairs and assistant professor of clinical research and leadership at George Washington University School of Medicine & Health Sciences.

Because the FDA has already reviewed the manufacturing materials and has been reviewing clinical data all along, Tice said, "We don't expect it to go the full six-month priority review clock."

Tice says she thinks full approval for Pfizer's vaccine could come in September. Some experts like Dr. Paul Offit, the director of the Vaccine Education Center think it may be as early as August.

Moderna's timeline

For vaccine maker Moderna, the company told CNN Wednesday that it does not have a specific time frame for approval. It is still working with the FDA on what's called a rolling submission for approval -- it shares new data with the agency as it is generated.

"We are still in the process of completing our rolling submission, which we announced on June 1st. It is not complete at this time," Ray Jordan, a spokesperson for Moderna said. "It's not the case that the FDA has our final submission and that we are waiting to hear from them."

Moderna expects it may have its materials complete this fall. The time frame for approval would then be subject to the FDA regulatory review process, Moderna said.

Where the process is now

Historically, getting a vaccine licensed by the fall would be fast, especially with as much as the FDA has to review.

At this point, what takes time is that the agency has to go through absolutely everything, it cannot skip a page, and there is a lot of everything.

"When we were reviewing applications back when they were on paper, there was so much, it would not fit on the freight elevator. That's how big the application is, you have lots of data to review," said Norman Baylor, who had run the FDA's Office of Vaccines Research and Review and been through this process several times. He's the current CEO of Biologics Consulting.

The COVID-19 vaccines received authorization based on interim data that showed the vaccines were safe and effective for only about three months. "Although, when something's 95% effective, you can assume it's probably going to be highly effective for a while," Offit said.

For full approval, the FDA has at least six months of efficacy data to review. "People are saying 'why is it taking so long?' Well, the FDA wants to make sure that it has a protective duration, long-term effect," Tice said. "It's not that the agency, I think, has any concerns about the vaccine per se, they just per licensure requirements, you have to have this additional data."

"The FDA does not cut corners on making sure of the quality, the purity, the potency of your products."

Offit believes the data review should go pretty quickly since the FDA has been getting data all along. What often takes time is that the FDA has to also validate the process that makes the vaccine for it to be licensed. Every step has to be validated.

"Whether it's the computers that are being used or cleaning out the vats, or whatever it is, it's a lot of boxes to tick to ensure that there's consistency in each lot to the next," Offit said.

That means an interdisciplinary team of FDA experts is pouring through millions of documents, running their own analysis, getting any clarification that it needs from the vaccine companies, and giving the manufacturing process a thorough inspection.

And it's not just one FDA person that does the review, Baylor said. There's a secondary and tertiary review. So a clinician would review the material and then a supervisor would need to review it and then it goes up to the division director.

"We have some reviewers who are reviewing long into the night, really, this is not a 9 to 5 review," Baylor said. "The public is not aware, but yes people are giving up their vacations, working on weekends, Saturdays and Sundays. You're working into the night."

"The FDA is not sitting down twiddling their thumbs," Baylor said.

Calls to move faster

While historically, the process has moved quickly, for some it's not fast enough.

Dr. Eric Topol wrote an editorial for the "New York Times" earlier this month that argued that the millions of people who have gotten these mRNA vaccines demonstrate these vaccines work. "This is the most studied biologic in the history of mankind for safety and efficacy," Topol told CNN.

"I have been frustrated because I know it should have been approved by now," Topol said. "Janet Woodcock made a statement that this was 'among the highest priorities.' No, it has to be the number one priority."

In response to Topol's editorial, the FDA's current Director of the Center for Biologics Evaluation and Research, Peter Marks argued that "any vaccine approval without completion of the high-quality review and evaluation that Americans expect the agency to perform would undermine the FDA's statutory responsibilities, affect trust in the agency and do little to help combat vaccine hesitancy."

Why full approval matters

Yet, as vaccination rates have dropped dramatically in the U.S., some have pointed to approval as one sure way to speed up the process.

A Kaiser Family Foundation survey of U.S. adults released this week found that among the one-third of adults surveyed who are not yet vaccinated, 16% said the vaccine was too new, too unknown or not tested enough. Some said in this poll that they wouldn't get a vaccine until it is required. While companies are allowed to require the vaccine, experts believe more will make it a requirement if -- and when -- it gets full approval.

"If it was approved with the full approval from FDA -- which we all anticipate may be coming pretty soon...Maybe in the next couple of months -- then the legal ability to mandate becomes a lot stronger," Collins, the NIH director, said.

CINCINNATI — Ohio Gov. Mike DeWine during a visit Friday to Cincinnati's West Side offered some speculation on a question many have been asking as COVID-19 vaccine supply begins to outpace demand.

Can an employer mandate their employees receive the coronavirus vaccine?

"I think you're going to see private businesses more inclined maybe to make that an order," DeWine said.

All three types of COVID-19 vaccine available in the U.S. today -- Pfizer/BioNTech, Moderna and Johnson & Johnson -- are on the market with emergency use authorization. That's just one step away from full approval from the Food and Drug Administration.

With Pfizer now poised to request full approval of its vaccine, it could open doors for employers to compel their employees to receive the vaccine in order to go back to work, DeWine said, because full FDA approval would close some liability loopholes companies currently face if they were to mandate a emergency-approved inoculation.

"I talked to somebody literally two hours ago on the phone, private business," DeWine said Friday. "I wasn't encouraging it or not, and this person said to me, 'July one. We've already told our folks everybody's got to be vaccinated.'"

But business owner Tim Meehan said a vaccine requirement makes him uneasy. He and his partner Halle visited Deerfield Cinema today, enjoying a movie now that they're fully vaccinated themselves.

"I know that's a personal choice," Tim Meehan said. "I think it's important to get the vaccine, but I don't know about forcing employees to get it."

Cincinnati Health Commissioner Melba Moore supports people getting vaccinated but is wary of mandates, too.

"I don't like the stick approach," Moore said. "Let me give you the science and the information, and let's do what we need to do to get back to what this new normal is going to be."

As part of that approach, Moore's health department will throw a block party Saturday in Hartwell at 8725 Vine Street. A vaccine clinic offering the single-dose Johnson & Johnson shot will operate from 10 a.m. to 5 p.m., with walk-up appointments available until 4 p.m. There will be food and live music.