Why the Covid-19 vaccine for infants takes longer than the vaccine for adults

“I really wanted to do something before I tried to get my kids back into the classroom, but unfortunately I couldn’t,” said senior vice president Dr. Emily Chapman. Chief Medical Officer of Children’s Minnesota.

Infant Covid-19 vaccine timeline

Trial data for the Covid-19 vaccine for young children are still being collected. Once the vaccine company has obtained the test results, it must submit the information to the US Food and Drug Administration. The US Food and Drug Administration evaluates vaccines for approval.

Former FDA Commissioner Dr. Scott Gottlieb, who is currently on the board of directors of Covid-19 vaccine maker Pfizer, said at CBS’s Face the Nation on Sunday that the company is likely to be able to submit data for ages 5-11. rice field. Ask for approval “at some point in September” and then apply for emergency use of the vaccine “as early as October”.

“It will put us in a time frame when the vaccine may be available at some point in late fall, probably early winter depending on the time it takes the FDA to review the application,” Gottlieb said. Said.

There is no formal schedule after the company submits it to the FDA. Emergency use considerations can take several weeks.

Dr. Stanley Perlman, a member of the FDA’s Vaccine and Related Biologics Advisory Board, a pediatrician, and a professor of microbiology and immunology at the University of Iowa Healthcare, said: .. “Obviously we want to do it as soon as possible, but we want to do it right.”

When asked Wednesday whether the Covid-19 vaccine would be approved for infants before the Thanksgiving Day, Dr. Anthony Forch, director of the National Institute for Allergic Infectious Diseases, asked CNN’s Wolf Blitzer to do so. He said he was, but ahead of the FDA he didn’t want to get.

“They should be at least one company and have the data by the end of September,” Fauci said.

“The data is then presented to the FDA, which decides whether to allow it under an emergency use authorization or other mechanism.”

Dr. Rochelle Wallensky, director of the CDC, said at the National PTA City Hall on Wednesday that he hopes the Pfizer vaccine will be available to children in 2021.

“Everyone is urgently looking at this. Everyone is aware of how important it is for those children to have access to the vaccine,” she said when asked about the timeline. “My understanding of the timeline is pretty much in line with what is being said. Mid-autumn is my understanding, early autumn is when we expect to see the data, and then it’s It’s in the hands of the FDA, and I’m looking forward to the end of the year. “

Data for ages 2-5 may arrive shortly after data for older children. For the youngest children, Pfizer told CNN that sufficient research could be done by October or November, and shortly thereafter requested the FDA to grant emergency use.

Moderna’s trial is ongoing, but a few months behind Pfizer. Johnson & Johnson does not expect multiple trials for children to begin until fall.

Why Vaccines for Toddlers Take Time

Hundreds of millions of adults have been vaccinated, proving that the Covid-19 vaccine is safe and effective, but these results do not replace the research needed for children.

“As long as we are willing to start vaccination of our children, it is of utmost importance to take this time to ensure that science is rigorous,” said Chapman, Minnesota. I did.

For the children’s version of the Covid-19 vaccine, scientists use the results of adult and complete pediatric trials.

Doing adult research speeds up the process. For people as young as 12 years old, companies could perform a function called “immune bridging,” according to Pearlman, without having to enroll the 30,000 people needed for an adult exam. The data showed that the immune response was comparable to adults in this age group.

Companies are taking a similar approach to younger children, but in early August, the FDA asked for six months of follow-up safety data instead of the two months it asked for adults. We also asked Pfizer and Moderna to double the number of children between the ages of 5 and 11 in clinical trials.

The CDC vaccine adviser said in June that there was likely to be a link between the mRNA Covid-19 vaccine and the very rare cases of heart inflammation in adolescents and young adults. The benefits of are still clearly outweighing the risks. Cases of inflammation appeared to be mild and they resolved spontaneously or quickly with minimal treatment.

At the Texas Children’s Hospital, interim pediatrician Dr. James Versalovich said it was okay to hire more children for the Pfizer and Moderna exams. Many trial sites have long waiting lists. However, the expansion of the trial has added at least one month to the research process.

“Everyone agreed that it was worth making the exam more robust data and providing parents across the country with that extra level of security. It would lengthen the exam, but only a little,” Versaro said. Bitch said.

“Children are not small adults”

Vaccine trials in children actually begin in adults.

“Usually, all vaccine candidates, even in other conditions, are evaluated first in adult patients and then gradually at a younger age,” said the Pfizer vaccine trial at Omaha Children’s Hospitals and Medical Centers. Explained Dr. Calisimonsen, who is leading the. .. “We can’t assume that children’s medications are as safe or tolerated as adults,” she said.

It’s because of biology.

“As we like to say in pediatrics: kids are not small adults. kids are kids,” Versalovic said. “Their bodies are well developed and will react differently, and we need to treat them differently.”

Upon reaching the children’s stage of the test, scientists make their best-informed guesses about which doses are safe and generate an immune response. Levels and timing are based on the development stage.

“Overall, our children have a very active and responsive immune system, so low vaccine doses are likely to provoke the child’s proper response to fight the infection. “Chapman said.

As with any vaccine test, it must go through a three-step study before it can be approved by the FDA. A first-stage test to see if the vaccine is safe for about 20-100 healthy children.

Because these are rapid exams, scientists have combined Phase 2 and Phase 3 of the exam to allow more steps to be performed in parallel, Versalovic said. At these stages, scientists monitor safety and test whether the child’s immune system responds to the vaccine. At this stage, scientists are recruiting hundreds or even thousands of children. Some people get the vaccine, others get the placebo. Compare the results.

Only after these steps are completed can an entity seek approval or approval from the FDA.

If approved by the FDA, the vaccine will be the focus of experts on the CDC’s Immunization Implementation Advisory Board. The committee also has formal recommendations on the delivery, storage, timing, distribution, and administration of vaccines. The Commission’s recommendations become official when the CDC Director reviews and approves them.

According to experts, children will be able to stay at Covid-19 for free during the months between these. Adults, however, need to help them.

“The best we can do for them is to surround them with vaccinated adults,” Chapman said. “And surround them with masked people and keep them on as much as possible.”