Where does the US stand on Covid-19 vaccines for children under 5 – CBS Baltimore

(CNN) – A month after the US Food and Drug Administration delayed key steps in approving the Covid-19 vaccine for children under the age of 5, more parents are eager to get the vaccine. ever.

Dr. Daniel Leonard, a children’s hospital that is working on testing the Pfizer/BioNTech vaccine for these children, said people are driving in from several far-flung states to participate.

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“We’re here in south-central Nebraska, and while a lot of people might not think this will be the epicenter of scientific progress, the flow I’ve had with people from Colorado, Minnesota, Wisconsin, Iowa — some drive eight or nine hours each way overnight to participate in the study,” he said. “They are dedicated.”

About 18 million U.S. children under the age of 5 are still not eligible for a protective Covid-19 vaccine. Children are less likely to be hospitalized or die from Covid-19 than adults, but at least 400 children aged 4 and under have died from Covid-19, according to the report. US Centers for Disease Control and Prevention.

Experts say the waiting time for a vaccine may not be long.

Moderna has said that it expects to report trial data in children 2 to 5 years old in March and that it may seek FDA permission “if the data support it and in consultation with the law.” Moderna’s Covid-19 vaccine is currently only authorized in the United States for adults.

Pfizer CEO Albert Bourla said on Sunday that he expected a vaccine for children aged 6 months to 4 years “likely by May, if it works”.

“And we’ll be ready to produce,” Bourla added on CBS’s “Face the Nation.” Pfizer’s Covid-19 vaccine has been approved for use in people under the age of 5.

Johnson & Johnson, another authorized Covid-19 vaccine company in the United States, has been running a late-stage trial of the vaccine for 12 to 17-year-olds but not for this group of children.

Waiting for more data

For a while, it looked like the US would soon have a vaccine for children under the age of 5 in the early months of 2022.

Initially, the Pfizer and BioNTech vaccines for this age group were tested with only two doses, but the results were not what scientists had hoped for and the companies said they would test a third dose. But at the request of the FDA, the companies filed a request for an emergency use authorization for two doses of the vaccine and said they would resume testing a third dose once the two doses move through the regulatory process.

In mid-February, plans changed again. Peter Marks, director of the FDA’s Center for Biological Evaluation and Research, said the agency needs to see data from an ongoing trial of a third dose of the vaccine in these young children in order to proceed. to emergency use authorization. The February 15 meeting of the FDA’s Advisory Committee on Vaccines and Related Biological Products was postponed.

After all, families will have to wait for data on the third dose.

Dr. William Towner, principal investigator of the Pfizer and Moderna pediatric Covid-19 vaccine trials at Kaiser Permanente in Southern California, said: the trial. “I think the data is pretty strong that for children, this would be a series of three doses.”

Dr. James Versalovic, director of pathology at Texas Children’s Hospital, where several pediatric trials of Pfizer and Moderna are underway, agreed to two doses of the drug. “The data were not as robust as we expected for the immune response, especially with children between the ages of 2 and 4.

Scientists who are doing trials with the youngest children benefit from observing what happens to other age groups. After seeing a breakthrough infection in 2021, scientists quickly realized that adults and adolescents needed a booster dose, says Versalovic.

“Keeping these lessons in mind, we just pivoted at the end of December and went on a full run with a third dose and followed these kids throughout the trial,” he said. Children who have received the third dose should be monitored for at least two months before data can be submitted to the FDA.

Investigators around the country confirmed that they were working as quickly and carefully as possible to collect the data. Bourla said Sunday that the company should have data on a three-dose vaccine trial for this age group by April.

“Studies have to be done correctly, and if it takes a little longer, that’s okay; do it right,” said Dr. Sharon Nachman, a pediatric infectious disease specialist at Stony Brook University who is working on the Pfizer trials. “I think they need to carefully assess what the immune response is. How long it lasts? And really, what does that third dose mean? ”

Another Pfizer investigator, Dr. Jennifer Nayak, a pediatric infectious disease specialist affiliated with Strong Memorial Hospital at the University of Rochester Medical Center, said evaluating all the data rather than some data would make more sense.

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“Really, what it’s about is trying to get as much data as possible and be as careful as possible and make the best recommendations,” says Nayak.

Dr. Jonathan Hand, an infectious disease specialist who worked on the Pfizer trial in New Orleans with the Ochsner Medical Center, said that all the careful work during this trial will make parents Peace of mind when there is a vaccine.

“Data integrity and patient safety are critical to this process,” he said.

Investigators say the good news is that they did not see any safety issues.

“The data is pretty clear that there is good safety. Dr. Janet Englund, who is conducting the Pfizer trial at Seattle Children, said.

Update Variations

The biggest questions remain are exactly how protective the vaccine is, what is the right vaccination schedule and what is the right dose.

The results to be published in the coming weeks and months will answer that question.

“We have always said that the number one goal is to prevent hospitalization, but families want them to prevent transmission in the household, especially if there are people in the household who are at risk,” says Englund. sick like old people”.

One challenge is that the vaccine is being tested in what scientists call a “different virus era”. The Covid-19 vaccine was developed based on the original variant and tested in the Delta booster. Now, the researchers are gathering data on the third shot while the Omicron variant predominates.

“Omicron changed all bets,” says Towner. “Omicron has been highly mutated and is clearly spreading very quickly.”

If allowed, it is possible that young children could be vaccinated on a different schedule from what adults and adolescents receive. Instead of waiting four or five months before getting a third dose, like in older adults, they can get a third shot two months after the second.

“Children are not simply small adults. They grow and develop throughout childhood,” says Versalovic. That affects how the vaccine works.

Another Pfizer investigator, Dr. Yvonne Maldonado, chief of the Division of Infectious Diseases in the Department of Pediatrics at Stanford Medicine and chair of the committee of the American Academy of Pediatrics, said they should know what they have early. “I think we are getting closer to some answers,” she said.

As with any vaccine trial, Dr. Claire Boogaard, pediatrician and medical director of the Covid-19 vaccine program at the National Children’s Foundation in Washington, said it’s important to remember that Scientists are still learning about the disease as they work to combat it. With variations, a lot can change quickly.

“We wanted to encourage people to just be flexible, because that’s really what the science asks for,” Boogaard said. “The reality is, there’s a lot of variables going on.”

All of the scientists who worked on these trials said they understood the parents’ desire to protect their children. When the FDA adjourned the meeting of vaccine advisers, Marks said he understood the frustration of parents.

In the meantime, he urges parents to continue taking Covid-19 precautions: Make sure everyone around the child is vaccinated and relies on a “mask procedure.” , though that “became more difficult as mask regulations fell.

As soon as the FDA receives the data it needs to make a decision on vaccines for younger children, it will proceed “very quickly,” Marks said.

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