Pfizer FDA-approval push for 5-and-older vaccine sets stage for K-12 immunizations fight

NCDHHS secretary Mandy Cohen watches as Gov. Roy Cooper during a press conference at UNC Health in Chapel Hill, NC Thursday, Dec. 7, 2020 where frontline healthcare workers are among some of the first recipients of the Pfizer COVID-19 vaccine. Pool photo

RALEIGH — With Pfizer and German company BioNTech requesting FDA approval of a COVID-19 vaccine for children ages 5 to 11, K-12 parents may find their state attempting to add the vaccination to the immunizations required to attend public school.

“It is a question of days, not weeks,” said Pfizer chairman and CEO Albert Bourla in a Sept. 26 ABC News interview about his company seeking FDA approval for the vaccine for school-aged children.

And Bourla made good on his timeline, as his company submitted a vaccine for approval just two days later, on Sept. 28.

The Food and Drug Administration (FDA) approved a Pfizer-BioNTech COVID-19 vaccine for emergency use in children ages 12 to 15 years old in May of this year. The FDA granted full approval of the COMIRNATY vaccine for children 16 and older in late August. COMIRNATY is the marketing name given to the vaccine, but the formula is apparently identical to the one currently being administered under emergency-use authorization.

Dr. Robert Malone, the doctor who invented the mRNA technology currently used in certain COVID-19 vaccines like the Pfizer shot, said in an interview earlier this year that he thinks there isn’t enough data about the risks for children. He also doesn’t believe kids should be forced to get the shot.

On Oct. 1, California Gov. Gavin Newsom announced his state would be the first to impose a vaccine mandate on all K-12 public school students once government agencies finish with the approval and vetting processes.

Newsom’s move has parents in other states wondering if their children will also be forced to get the shot in order to attend school.

At Gov. Roy Cooper’s Sept. 21 COVID-19 press briefing, both he and N.C. Health and Human Services (NCDHHS) Secretary Mandy Cohen were asked by North State Journal about whether or not they will seek to add the COVID-19 vaccine to the K-12 immunizations list.

In North Carolina, the state Commission on Public Health is the only body other than the General Assembly which can alter the required immunization list for K-12 public school students.

Cooper said that “we are very excited that children 5 through 11 with this news that the vaccine can be effective for them.” He did not answer whether or not his office would push for the K-12 immunizations list to be altered, and he turned the question over to Cohen.

“I think that we’re still waiting to make sure… I think there are a lot of steps in a process before we would get to that, including seeing these vaccines be available for our students,” Cohen said. “So, that is the process, but, obviously, those vaccines are not available yet.”

She added that there are “no plans at this time” to ask the Public Health Commission to add the COVID-19 vaccine to the list of requirements for K-12 students and that “we’ll step through that [process] as we go forward.”

The N.C. Commission on Public Health (NCCPH) is a 13-member panel overseen by NCDHHS. Four members are appointed by the North Carolina Medical Society and nine are appointed by the governor. Each member serves a four-year term.

Per state statute, NCCPH can add an immunization or an additional dose of a vaccine. The commission is “authorized to exempt from the new requirement children who are or who have been enrolled in school (K-12) on or before the effective date of the new requirement.” The new immunization or dose must be FDA approved, according to statute.

At the August meeting of the NCCPH, members discussed adding the COVID-19 vaccination to the list of required immunizations, but eventually tabled the topic until its next meeting set for Oct. 15.

Dr. Kelly Kimple, a representative from NCDHHS, gave an update to the NCCPH at the August meeting. During that presentation, Kimple said that “Multiple CDC, other medical and public health leaders” were in support of COVID-19 vaccinations for kids 12 and up and that they “should receive the vaccination outweigh[s] the other serious complications.”

Sheets first asked if the commission could move to recommending adding to the immunizations list after the vaccine gets FDA approval. He then suggested requiring the vaccination is similar to requiring other vaccinations currently required.

“If we recommend vaccination for stuff like meningitis and everything else, then I think recommending that the schools require COVID, I don’t think is unreasonable,” Sheets said.

Chaplin countered, asking whether or not they could make that move without it being approved or proposed by the state’s director of health.

The NCCPH’s counsel spoke up about the question of authority, stating that “the committee has the authority to adopt vaccines.” He added there were “debates about the authorities” of the commission that needed to be clarified.

“I just think there’s a lot of information that we need before we can make a determination regardless of how we may feel about it,” Chair May said after some back and forth about the commission’s authority.

Chaplin replied that he “couldn’t agree more” and that the question really was, “do we have the ultimate authority to initiate it now without going through the chain of command”? He also questioned if they could propose a rule for public comment in an emergency setting.

North Carolina Teacher Alliance president Amy Marshall sees a fight ahead for any attempt to require the COVID-19 vaccination for public school students. A rival to the union-tied North Carolina Association of Educators, Marshall launched the organization in March of this year.

“The NC Public Health Commission consists of 13 members, nine of whom are governor-appointed,” said Marshall. “Wouldn’t it be better if the N.C. legislature had decision-making power on what immunizations are required for public school kids, rather than that decision-making power being solely with an entity whose partisan positions are governor-appointed?”

Marshall added, “We need more checks and balances there” and said her organization doesn’t support a COVID-19 vaccine mandate in N.C. schools for students.

“It’s one thing for an adult to consent to getting a new-technology vaccine knowing there are no long-term studies on the safety of it,” said Marshall. “The fact is, we don’t have long-term studies on the effects of mRNA vaccines on kids, and mRNA vaccines are the only ones available to kids right now.”

“Hopefully the Novavax traditionally prepared COVID-19 vaccine will be released in the U.S. later this year, which I think more people would be comfortable getting for themselves and their kids,” Marshall said.

She added that she hopes to see the legislature take some action, possibly with a bill creating a joint-decision-making process on school-immunization decisions.

Some media outlets have reported increases in the number of school-aged children testing positive for COVID-19; however, the number of tests being administered to children have also risen with the return to in-person school. Many schools in North Carolina serve as testing sites and state guidance dictates students have to be tested if exposed.

CDC data for hospitalization of children aged 0-17 shows a peak on Sept. 9 and a consistent decline. That peak, when compared to other age groups, is nearly flat.