COVID-19 vaccine trials underway for children, pregnant women

No vaccine option available for anyone 15 or younger; FDA hasn’t recommended shots for expectant mothers

VIDEO: While there are now three COVID-19 vaccine options available in the U.S., there isn’t one for children.

JACKSONVILLE, Fla. – While there are now three COVID-19 vaccine options available in the U.S., there isn’t one for children and the Food and Drug Administration has not yet recommended any of them for pregnant women.

There are vaccine trials underway for both children and pregnant women.

News4Jax explains where companies and experts stand on vaccinating those two groups.

Vaccine option for children in the works

As more people become eligible to get COVID-19 shots, Pfizer, Moderna and Johnson & Johnson say they are working on a vaccine option for children.

Right now, there is no vaccine available for anyone 15 or younger, but Dr. Anthony Fauci is shedding new light on when we can expect one. Fauci said that based on the data we have right now, he believes elementary school children will be able to be vaccinated by early 2022, but for high schoolers, it could be as early as this fall.

While the number of children and teens who have tested positive for COVID-19 is fewer than the number of adults, “they are also very likely to be carriers and spread it to their grandparents and people they get in close contact with,” said Dr. Sunil Joshi, president of the Duval County Medical Society Foundation.

That’s one of the main reasons why Joshi recommends teens and children getting the vaccine when one becomes available.

Right now, the one-dose Johnson & Johnson shot and two-dose Moderna vaccine are approved for people 18 and older. The two-dose Pfizer vaccine is 16 and up.

Joshi explained why there need to be separate trials for children.

“Mainly because children’s immune systems are still developing, and they develop at a different rate,” he said. “As a result, how they respond to the vaccine can be significantly different than adults.”

He said the biggest difference in trials for adults and children is potentially the dosing.

“So in younger children, they may not receive the same amount of dose of the vaccine than an adult might receive,” Joshi said.

Pfizer currently has 2,300 volunteers between 12 and 15 in its vaccine trial. Moderna has 3,000 volunteers between 12 and 17. Both companies expect to have data from their trials by the end of June and will test on younger children if those results come back positive.

While Johnson & Johnson has not released a full plan yet, in the company’s emergency use authorization to the FDA, the company proposed testing its vaccine in infants and even newborns, but there is currently no timeline on that.

If all things go well in the trials, Fauci said, high schoolers should be able to get the vaccine sometime toward the beginning of the upcoming school year.

And just because the vaccine will be available doesn’t mean it will be mandatory. The decision of whether to do that comes down to the Florida Department of Health, and right now, the department has given no indication of whether it will be.

FDA has not yet OK’d the vaccine for pregnant women

The FDA has not yet recommended any of the three COVID-19 vaccine options available in the U.S. for pregnant women.

There is not a lot of data yet when it comes to pregnant women and the vaccine. That’s why medical experts are saying the decision needs to be made on a case-by-case basis.

“Ultimately, the choice is up to the pregnant woman, but you have to weigh the risks and the benefits of the vaccine,” Joshi said.

Pfizer will attempt to answer that question. The company announced in February that it has started a trial with 4,000 healthy pregnant women, but the trial is expected to last seven to 10 months, so a recommendation is not expected for a while.

Johnson & Johnson said it will start trials with pregnant women and infants but has not given a timeline on when those will begin.

There are now 3 COVID-19 vaccines available .. however, the Food and Drug Administration has not yet recommended ANY of them for pregnant women. News4Jax Consumer Investigator Lauren Verno tells us where medical experts and vaccine companies stand -- when it comes to expectant mothers.

“We do not have enough data to make a blanket recommendation,” Joshi said. “But you do have to keep in mind that there are some groups that might be an increased risk of having the virus and they’d be more likely be the ones we recommend the vaccine for.”

The American College of Obstetricians and Gynecologists and the Society of Maternal-Fetal Medicine said: “Given clear evidence of the dangers of COVID-19 in pregnancy, an absence of data demonstrating adverse effects associated with the vaccine in pregnancy, and in the interest of patient autonomy, ACOG and SMFM recommend that pregnant individuals be free to make their own informed decisions regarding COVID-19 vaccination.”

Here’s what the Centers for Disease Control and Prevention recommends as key considerations for pregnant women to discuss with their health care provider before getting the vaccine:

  • The likelihood of exposure to COVID-19.
  • Risks of the virus to them and potential risks to their fetus.
  • What is known about the vaccine, meaning how well it works to develop protection in the body, known side effects and lack of data during pregnancy.

However, the CDC does say that anyone who is trying to become pregnant should not be deterred from getting the Pfizer or Moderna vaccine. But, again, make sure to speak to your health care provider first.