With masks coming off in several states and many COVID restrictions lifting in the US, many are anxiously awaiting news that children under the age of 5 could be eligible for vaccination.
Already, Chicago has lifted its masking and vaccination mandates and Illinois has lifted its indoor mask and school mask mandates. On Monday, Chicago Public Schools began a mask-optional policy.
The changing guidelines surrounding COVID not just in Illinois have many parents questioning how best to protect their kids.
While the race is on to get the youngest members of the population vaccinated, which vaccine will work best?
Up until now, Pfizer’s COVID vaccine has been the only one approved for emergency use in the US for children between the ages of 5 and 17.
But Pfizer’s rollout to those under the age of 5 was delayed, it opened a window for Moderna’s trial to catch up.
In January, Moderna said it expects to have data from its own trial of younger groups soon.
“For the 2- to 5-year-olds, we have completed a study in that age group,” Dr. Paul Burton, Moderna’s chief medical officer, told TODAY at the time. “That study is fully enrolled and should complete and we should have data in the next month or so. We’ll then take those data to the FDA and other regulators around the world.”
The company said in a statement in January that it anticipated data in children between the ages of 2 and 5 years old would be released in March.
“If the data is supportive and subject to regulatory consultation, Moderna may proceed with regulatory filings for children 2-5 years of age thereafter,” the statement read.
Parents of children under 5 will need to wait until at least April for Pfizer’s vaccine, after the company pulled its request from the FDA earlier this year, citing the need to wait for data surrounding a third shot.
Earlier this year, the Food and Drug Administration, worried about the omicron variant’s toll on kids, had taken the extraordinary step of urging Pfizer to apply for OK of the extra-low dose vaccine before it’s clear if tots will need two shots or three. The agency’s plan could have allowed vaccinations to begin within weeks.
But in February, the FDA reversed course and said it had become clear the agency needed to wait for data on how well a third shot works for the youngest age group. Pfizer said in a statement that it expected the data by early April.
FDA’s vaccine chief Dr. Peter Marks said he hoped parents would understand that the agency’s decision was part of its careful scientific review of the evidence Pfizer has submitted so far.
That information “made us realize that we needed to see data from a third dose from the ongoing trial in order to make a determination,” Marks told reporters. “We take our responsibility for reviewing these vaccines very seriously because we’re parents as well.”
Meanwhile, data posted online last month showed two doses of the Pfizer-BioNTech COVID-19 vaccine offer almost no protection against coronavirus infection in kids ages 5 to 11, but did offer protection against serious illness.
Researchers from the New York State Department of Health found that the vaccine’s effectiveness dropped to 12% from 68% in the age group in December and January when the omicron variant of the coronavirus began circulating widely in the United States.
The Pfizer shots still offered protection against serious illness from COVID, the researchers found, with protection against hospitalization declining to 48 percent from 100 percent over the same time period.
As for the Moderna vaccine, it is expected the company will continue with two smaller doses for children aged 2 to 5. While adults receive two initial doses of 100 micrograms of the Moderna vaccine, kids in the 2- to 5-year-old group would receive just 25 micrograms in each dose, Burton told TODAY, noting that further information would be available once the trial data is released.
Currently, the authorization of Moderna’s Covid-19 vaccine for teenagers is on hold as the Food and Drug Administration reviews the risk of a rare but serious form of heart inflammation that’s affected mostly young men who got the company or Pfizer’s shots.
Moderna applied for emergency approval of its COVID vaccine for 12- to 17-year-olds in June, but the FDA told the company in October that its review of the vaccine for kids wouldn’t be finished before January.
Then, the US Centers for Disease Control and Prevention said last month that younger males should consider waiting longer between doses of Pfizer’s and Moderna’s vaccines to reduce the rare risk of heart inflammation. The CDC said males ages 12- to 39-years-old should consider waiting eight weeks between the first and second doses of their primary COVID vaccination series.
Recently, the European Medicines Agency authorized Moderna’s coronavirus vaccine for children aged six to 11, in addition to recommending booster shots of Pfizer’s vaccine for those aged 12 and over.
At a press briefing earlier this month, the EU regulator’s vaccines chief Dr. Marco Cavaleri said the Moderna vaccine for younger children will be a half-dose of what is given to older teens and adults. He said research showed young children had an immune response comparable to that seen in older populations “as measured by the level of neutralizing antibodies” against the COVID-19 virus.
Cavaleri said data from countries including Israel and the US in more than 400,000 children showed that a third dose of the Pfizer-BioNTech vaccine in children 12 was safe and effective.
“No new safety signal was identified,” he said, adding that scientists looked in particular for cases of heart and chest inflammation, side effects that have previously been linked to the shot. “Those cases were very rare and most (people) recovered without intervention.”
The nation’s 18 million children under 5 make up the only age group not yet eligible for vaccination.
Children are typically at much lower risk of severe coronavirus disease but are still vulnerable amid high levels of transmission. Still, data from the Centers for Disease Control and Prevention showed 336 kids from newborns to 4 years old have died of COVID since the start of the pandemic.