By Anne Blythe
Pediatricians, pharmacies and county health departments could be ready by the end of next week to start vaccinating children from 5 to 11 years old if Pfizer’s kid-size dose of COVID vaccine gets the federal nods it needs.
A Federal Drug Administration advisory committee set the stage on Tuesday for the latest plot twist in the story of this long-running coronavirus pandemic.
More of the youngest among us soon could be better protected from severe illness related to COVID-19 if the FDA and Centers for Disease Control and Prevention follow through on the advisory committee’s unanimous recommendation to authorize lower dose Pfizer vaccines for emergency use in some 28 million children across the country.
“The FDA and CDC are still doing their work,” Mandy Cohen, secretary of the state Department of Health and Human Services, told reporters Wednesday during a briefing with the governor. “We think the earliest vaccines will be available will probably be the end of next week.”
In anticipation of that possibility, the state has been planning how to get some 400,000 initial doses distributed to 750 doctor’s offices, health care centers, pharmacies and elsewhere.
The state also is partnering with 10 community organizations to offer family vaccine events in areas where, historically, there have been health care access disparities.
Results from Pfizer’s trial of some 4,500 children ranging in age from 6 months to 11 years old showed that giving children a third of the COVID vaccine dose that adults get in each of the 2-shot regimens was 90 percent effective.
The CDC is expected to take up the issue on Nov. 2.
“What I can say is there is plenty of supply,” Cohen said. “Let the FDA and CDC do their work to review the evidence.”
For anyone worried about their child mistakenly getting an adult-sized dose when they take them to get vaccinated, the Pfizer packaging of the vaccines for 5- to 11-year-olds is a different color and size.
Once the green light is given, Cohen and Gov. Roy Cooper are encouraging parents to get their children vaccinated as quickly as possible.
“Getting school-aged kids vaccinated will help them to be safe in the classroom, play sports, participate in school theater, attend events, be with friends and support their mental health,” Cohen said. “I’m eager to get my daughters vaccinated once the FDA and CDC review the data and complete the process.”
He led a vaccine trial for children
Emmanuel “Chip” Walter, a pediatrician at Duke who led a trial examining the vaccine’s effectiveness of children, spoke with reporters on Wednesday morning about the findings.
“My advice to parents is this is the best way to protect your child from serious illness and potentially death from COVID, … get them vaccinated,” Walter said. “It’s the best tool we have. By all means I would recommend and suggest they get the vaccine.”
Some have raised concerns about cases of myocarditis, an inflammation of the heart muscle, that, while rare, have been seen after men and women have received an mRNA vaccine from Pfizer-BioNTech and Moderna. Federal health officials have noticed the issue in adolescent males and young men, but have not determined whether there is a direct correlation to the vaccine.
“The risk for developing myocarditis really seems to be greater after the second dose of vaccine; it’s more commonly seen in males, particularly young males within the ages of 16 to 30,” Walter said. “The rate in that particular group is about 40 per million second doses of vaccine received.”
More than 244 million doses of the Pfizer vaccine have been given in the U.S. to date according to the CDC, with 105.6 million who have received two doses.
“I think it’s really important to recognize that not all myocarditis is the same,” Walter said when that question arose on Wednesday. “You can develop myocarditis after developing COVID as a complication and that myocarditis from COVID is usually quite severe and makes people quite ill and causes a prolonged hospitalization.”
Walter added that the myocarditis that health care workers have seen after a vaccine “is generally fairly mild.” Sometimes that might lead to hospitalization, but the condition is easily treated, he added, once it’s recognized.
“So I think you have to weigh that risk of developing COVID – depending on the prevalence of COVID in your community – versus the risk of myocarditis from vaccine, which is exceedingly rare,” Walter said.
Nonetheless, as has happened throughout the pandemic, social media and other platforms rife with misinformation can sow confusion and mistrust that frustrates public health officials trying to get accurate information to households.
A Kaiser Family Foundation poll found that 34 percent of the parents of 5- to 11-year-olds surveyed in September would vaccinate their child right away, even after Pfizer released early reports of the effectiveness of a lower dose in younger children. Twenty-four percent of the parents polled said they definitely would not get their child vaccinated and 32 percent preferred to take a wait-and-see stance.
“We have to be able to afford children the same protection from COVID through vaccination that we afford to adults,” Walter said. “That is the right thing to do.”
Children accounted for nearly 25 percent of the COVID cases caused by the surge in late summer caused by the Delta variant .
“We’ve been kind of lulled by this thought that yes the pandemic is worse … for older adults and adults with comorbidities,” Walter said. “But children aren’t totally spared from COVID.
“When I last looked the other day there had been 750 deaths from COVID in children under age 18, 160 deaths in this age group for which we’re now considering approval or authorization of the vaccine, between the ages of 5 and 11,” Walter added. “And that’s way more deaths than occur due to influenza in a typical year. So if you kind of put it in that perspective in terms of health, we really do need to get children vaccinated.”
Overall, North Carolina is in much better shape in its battle against COVID than a month ago, when Cooper and Cohen gave their last pandemic update to reporters.
The number of people walking into emergency departments with COVID symptoms has dropped dramatically, as have the numbers of new lab-confirmed cases each day and hospitalized patients.
“North Carolina’s fight is not over,” Cooper said. “We’re making great progress, but hospitalizations and deaths are still too high.”
Since March 2020, when North Carolina reported its first lab-confirmed case of COVID-19, there have been more than 1.47 million cases reported. On Tuesday, there were 2,160 new cases reported.
Though there were 1,406 people in the hospital battling illnesses related to COVID-19, that number was down significantly from Sept. 25, when 3,123 people were hospitalized.
North Carolina is approaching a new milestone of 18,000 deaths related to COVID-19. As of Wednesday, the state was fewer than 100 deaths from that grim mark.
“Although every death is painful and now often avoidable, we felt a renewed sense of hope over the last month as North Carolina’s COVID-19 numbers have continued their steady improvement,” Cooper said. “You the people of North Carolina who have gotten vaccinated, followed safety measures, deserve the lion’s share of the credit along with our health care professionals.”
“We are grateful to see this latest surge in COVID-19 taper off,” Cooper added later. “And as we try to drive down our numbers, we know what works. Vaccines. The more people who get their shots, the less COVID we’ll have.”
Are you eligible for a booster?
As many parents contemplate when and where to get their children vaccinated, others across the state who have been vaccinated are weighing whether they’re eligible for boosters that have been recommended by federal and state health officials.
Cohen, who received a Johnson & Johnson vaccine in early March, said she got a Moderna vaccine as a booster last week.
The FDA and CDC issued guidelines on Oct. 21 about who is eligible for a booster shot. The agencies said people could get a different vaccine from the one they initially received after a “mix and match study” showed extra protection from COVID was gained even if a different vaccine was administered.
The CDC recommended a booster shot for the nearly 15 million people who got the one-dose Johnson & Johnson vaccine if at least two months have passed since the initial dose, saying that such a boost could substantially increase protection from COVID.
Some who received the single dose shot are switching to mRNA vaccines offered by Moderna or Pfizer with a goal of getting even more protection.
Keeping track of all the recommendations can be dizzying.
People who are 65 and older, those between 50 and 64 with certain underlying health conditions, and adults over 18 who live in nursing homes and other long-term care facilities all are at higher risk of getting COVID-19, according to the guidelines.
Anyone in the groups who got the Moderna or Pfizer vaccines should get a booster shot six months after their initial series.
Cohen recommended that North Carolinians go to a DHHS quiz to find out whether they should get a booster.
As of Wednesday, 67 percent of the adult population in North Carolina was fully vaccinated, a number that is not as high as Cohen or Cooper would like to see.
Cohen said Wednesday that 42 percent of North Carolinians ages 12 to 17 are fully vaccinated and only 46 percent of those who are 18 to 24 are fully vaccinated.
Pediatricians and others who provide health care to school-aged children will be key to boosting trust and an understanding about any recommendations that come from the FDA and CDC in the coming week, Cohen said.
“It’s where our families and our children have gotten vaccinated for many other types of vaccinations that they get in early childhood,” Cohen said. “It’s again going to be a place where I think there will be trusted messengers.”
Coronavirus by the numbers
According to NCDHHS data, as of Tuesday afternoon:
- 17,935 people total in North Carolina have died of coronavirus.
- 1,472,655 have been diagnosed with the disease. Of those, 1,404 are in the hospital. On Aug. 1, 1,390 people were hospitalized, before the Delta save. The hospitalization figure is a snapshot of people hospitalized with COVID-19 infections on a given day and does not represent all of the North Carolinians who may have been in the hospital throughout the course of the epidemic.
- North Carolina started tracking COVID-19 re-infections in the case counts on Oct 4, 2021. All told North Carolina has tracked 10,812 reinfections, 200 of those were in people who were previously vaccinated. Ninety-four people who were reinfected with COVID-19 have died.
- 1,422,175 people who had COVID-19 are presumed to have recovered. This weekly estimate does not denote how many of the diagnosed cases in the state are still infectious. Nor does it reflect the number of so-called “long-haul” survivors of COVID who continue to feel the effects of the disease beyond the defined “recovery” period.
- To date, 19,012,089 tests have been completed in North Carolina. As of July 2020, all labs in the state are required to report both their positive and negative test results to the lab, so that figure includes all of the COVID-19 tests performed in the state.
- People ages 25-49 make up the largest group of cases (39 percent). While 13 percent of the positive diagnoses were in people ages 65 and older, seniors make up 75 percent of coronavirus deaths in the state.
- 522 outbreaks are ongoing in group facilities across the state, including nursing homes and correctional and residential care facilities, that’s up from 107 outbreaks in early August.
- As of Wednesday, 415 COVID-19 patients were in intensive care units across the state. On Aug. 1, 372 patients were in ICUs.
- As of Aug. 17, 6,177,877 North Carolinians have received at least one dose of a coronavirus vaccine. Eighty-nine percent of people over the age of 65 have been completely vaccinated, while 55 percent of the total population is fully vaccinated.