Join date: Jun 19, 2022


Scientific advisers to the Centers for Disease Control and Prevention unanimously decided the benefits outweigh the risks for children under 5 despite some reservations about thin data on efficacy, and the agency’s director signed off on the shots.

The Centers for Disease Control and Prevention on Saturday recommended Covid vaccines for children as young as 6 months, who were among the last Americans to qualify for the shots. Parents should be able to start getting young children immunized as soon as Tuesday.

Federal regulators now have authorized the Moderna vaccine for children ages 6 months through 5 years, and the Pfizer-BioNTech vaccine for children ages 6 months through 4 years. (Pfizer-BioNTech’s vaccine has been available to children ages 5 and older since November.)

All children 6 months and older, including those who have already been infected with the coronavirus, should get a Covid vaccine, Dr. Rochelle P. Walensky, the C.D.C.’s director, said in a statement.

“Together, with science leading the charge, we have taken  another important step  forward  in our nation’s fight against Covid-19,” she said. “We know millions of parents and caregivers are eager to get their young children vaccinated, and with today’s decision, they can.”   


Following meetings on Friday and Saturday, the agency’s scientific advisers strongly backed the vaccines, despite reservations about the paucity of data, especially regarding the efficacy of the Pfizer-BioNTech vaccine.

The C.D.C. panel heard evidence supporting the effectiveness of the vaccines in the youngest children, but repeatedly pressed Pfizer on its estimates and noted that three doses of that vaccine would be needed, compared with two doses of the Moderna vaccine.

Both vaccines are safe, and both produced antibody levels similar to those seen in young adults. But the C.D.C. advisers wrestled with the difficulty of recommending two very different vaccines for the same population.

“The implementation of these two rollouts is going to be incredibly challenging,” said Katelyn Jetelina, a public health expert and author of the widely read newsletter “Your Local Epidemiologist.”

“There’s going to have to be a lot of proactive communication about the difference between the two and the implications of taking one over the other,” she said.

In its clinical trials, Moderna found that two shots of its vaccine, each with one-fourth of the adult dose, produced antibody levels that were at least as high as those seen in young adults.

The company estimated the vaccine’s efficacy against symptomatic infection at about 51 percent among children ages 6 to 24 months, and 37 percent among children ages 2 through 5.

The side effects were minor, although about one in five children experienced fevers. Efficacy against severe disease and death is assumed to be higher, similar to the effects seen in adults.

Based on those data, the F.D.A. authorized two shots of the Moderna vaccine, spaced four weeks apart.

The Pfizer-BioNTech vaccine also produced a strong immune response, but only after three doses, company officials told the scientific advisers on Friday.

Two doses of the vaccine were inadequate, they said — justifying the F.D.A.’s decision in February to delay authorizing the vaccine until regulators had data regarding three doses. Two doses may not have been enough because the company gave the children just one-tenth of the adult dose in each shot, some advisers said.

The vaccine has an overall efficacy of 80 percent in children under 5, Pfizer’s scientists claimed on Friday. But that calculation was based on just three children in the vaccine group and seven who received a placebo, making it an unreliable metric, the C.D.C.’s advisers noted.

“We should just assume we don’t have efficacy data,” said Dr. Sarah Long, an infectious diseases expert at Drexel University College of Medicine. But Dr. Long said she was “comfortable enough” with other data supporting the vaccine’s potency.

Three doses of the Pfizer vaccine produced antibody levels comparable to those seen in young adults, suggesting that it is likely to be just as effective.

“The Pfizer is a three-dose series, but as a three-dose series, it’s quite effective,” said Dr. William Towner, who led vaccine trials for both Moderna and Pfizer at Kaiser Permanente in Southern California.

Either vaccine would be better than none, Dr. Towner added. He predicted that some parents may opt for Moderna because bringing children to a pediatrician for two shots is easier than arranging for them to receive three.

The Pfizer vaccine was authorized for children 5 to 11 in November, but fewer than 30 percent in that age group have received two shots. In surveys conducted by the C.D.C., about half of parents said in February that they would vaccinate their children, but by May, only one-third of parents said they intended to do so.

The advisers debated whether vaccination enhances protection against severe disease in children who have already been infected. There is little information available from children aged 5 to 11, because of the poor uptake of vaccines in that age group.

But in adults, an infection with the earlier Omicron variant has not been enough on its own to protect from the newer versions.

Vaccinations would still be needed to protect children from future variants, the experts concluded. “That combined protection is really the safest and the most effective,” said Dr. Sara Oliver, a C.D.C. scientist who led the discussion on Saturday.

Parents of the youngest children may be more willing to opt for a Covid vaccine if it can be offered alongside other routine immunizations, Dr. Towner said.

“That’s the area that a lot of people are not sure of right now,” he said. “I’m hoping there’ll be some guidance offered around that.”

— Apoorva Mandavilli

Here are 4 takeaways from the C.D.C. approving vaccines for childre

With the Centers for Disease Control and Prevention formally recommending Moderna and Pfizer-BioNTech vaccines for children as young as 6 months old, parents across America should be able to start getting their youngest children immunizations by Tuesday.

All children 6 months and older, including those who have already been infected with the coronavirus, should get a Covid vaccine, Dr. Rochelle P. Walensky, the C.D.C.’s director, said in a statement on Saturday.

On Friday, the Food and Drug Administration authorized the Moderna and Pfizer-BioNTech vaccines for very young children.

Scientific advisers to the C.D.C. unanimously voted to recommend Moderna and Pfizer-BioNTech vaccines after three and a half hours of discussion on Saturday.

Here are four key takeaways from that meeting.

The benefits outweigh the risks.

Experts at the meeting considered that over two million children of ages 6 months to 4 years had been infected, 20,000 had been hospitalized and 200 had died from the virus — and many of those experts explained that the benefits of vaccinating young children outweighed possible risks.

Several experts said that, although we did not know what kind of variants we could expect in the future, the vaccinations would save lives.

“This is an opportunity that one does not get very often: the prevention of children’s deaths. We know this disease is killing children,” said Dr. Beth Bell, a member of the C.D.C.’s Advisory Committee on Immunization Practices. “And we can help prevent those deaths through this vaccine.”

The labels on the Pfizer-BioNTech vaccine need further guidance.

Concerns were raised about incorrect labeling on packaging for the Pfizer-BioNTech vaccine. The label states that the vaccine can be given to children between the ages of 2 and 5 years old, but the C.D.C. has now approved the vaccine for children between the ages of 6 months and 4 years. (The Pfizer-BioNTech vaccine had already been approved for children ages 5 to 11 years old.)

The more reliable indicator that the vaccine is approved for children as young as 6 months is its maroon cap. The vaccine for children between 5 and 11 years old has an orange cap.

Additionally, the label states that the vaccine can be stored only for six hours after dilution, but this is also incorrect, according to the C.D.C. The vaccine can be stored for up to 12 hours after adding saline to generate 10 doses.

Pediatricians and pharmacists have to change their mind-set about wasting vaccines.

Pharmacists and doctors have been trained to never waste a single dose of any vaccine. With the pandemic, and the early scarcity of vaccines, wasting vaccines became even more unthinkable. However, getting as many of the youngest Americans vaccinated as possible may turn that notion on its head.

The vaccine vials have 10 doses. Once a vial is opened, it must be used within 12 hours, after which it has to be discarded. Providers will be encouraged to vaccinate children even if it means using only one or two doses from a vial.,55192317.html

Providers may have been averse to wasting vaccines in the past, but they should not “feel guilty about having to open a vial to administer two doses or one dose,” said Dr. José R. Romero, the newly appointed director of the National Center for Immunization and Respiratory Diseases. “It’s important to get shots into arms and take advantage of every opportunity.”

There is confusion about how to vaccinate young children who are immunocompromised.

Immunocompromised people are generally given an extra dose of vaccine for their primary series. The Pfizer-BioNTech vaccine for young children requires three doses, and the Moderna vaccine requires two doses — but it remains unclear whether immunocompromised young children should get three doses of either vaccine or four of Pfizer and three of Moderna.

Some at the meeting believed that there simply was not enough data on young children who are immunocompromised to make these assessments. Detailed guidelines about vaccinating immunocompromised children are expected to be issued later.

C.D.C. Recommends 2 Covid Vaccines for Very Young Children

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