Vaccines for children under 5 still going through FDA authorization process

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SAN FRANCISCO (KCBS RADIO) – The FDA is still considering approving a COVID-19 vaccine for kids under 5, the last age group still waiting to get vaccinated.

The delay is troubling as cases continue to rise despite the relaxing of several COVID-19 protocols in recent months, particularly masking mandates for indoors spaces.

"I think the FDA is doing the best they can to really make sure the data are complete and really reflect all the stuff they need to know before they consider these vaccines for the under 5-year-olds," said Dr. Yvonne Maldonado, professor of health and infectious diseases, pediatrics, epidemiology, and population health at Stanford University on KCBS Radio's "Ask an Expert" on Friday.

"But a lot of this really just has to do with the process of getting kids vaccinated in the clinical trials," she told Holly Quan and Jason Brooks.

Most of the key companies developing these vaccines for children are still in the processing of completing and compiling the data from their clinical trials.

Just this week, on Monday, Moderna finally submitted all of the necessary data for their clinical trials for children from the ages of 6 months to 17 for the FDA to review.

"Moderna doesn’t have any of their vaccines approved yet for anyone under the age of 18," she said, while Pfizer still hasn't completed submitting all of their data for the under 5-year-olds.

It's trickier to assess dosage for children, because size changes considerably with age. The smallest dose being considered is three micrograms, for the youngest age group. The second larger dose of 10 micrograms, which has been approved for those ages 5 to 11, caused unwanted side effects in the next youngest age group, said Maldonado.

But the smallest dose, three micrograms on a typical two dose regiment was found not to produce enough antibodies needed to be effective, she said. Which led to Pfizer discussing a possible three dose regiment for that youngest age group.

This is not the case for Moderna, she said. Their doses are typically much stronger and so far their two dose regiment appears to create the necessary antibody response to be effective.

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Pfizer's data will hopefully be soon available in the next month or so.

The FDA looks at three key points when considering the authorization of a vaccine, said Maldonado.

"The first of course is always safety," she said. "We know that safety is foremost for any product that you give, especially to healthy children."

That is the major factor that the FDA as well as the CDC will be considering with this round. As of right now, there are no indications that there is any concern about the safety of these vaccines.

"With one very small exception, and that's myocarditis," said Maldonado. "In the 12-29-year-old boys and young men."

That risk comes down to about 11 cases per 1 million doses given, she said. "So it's really on the very rare end but still something to watch."

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Another key point they are considering is the antibody response – is a person going to generate antibodies with this vaccine, which by now is relatively clear that these vaccines protect people against infection and severe disease.

The third point is the vaccine's efficacy – whether or not the reduction of cases in these trials can actually be measured, said Maldonado.

Sometimes that isn't possible because there might just not be enough COVID-19 circulating in the test population.

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