Kids may have to wait on a vaccine

No tests underway on whether shots safe for children

The pandemic has many parents asking two burning questions. First, when can I get a vaccine? And second, when can my kids get it?

It may come as a surprise that the answers are not the same. Adults may be able to get a vaccine by next summer. But their kids will have to wait longer. Perhaps a lot longer.

Thanks to the U.S. government’s Operation Warp Speed and other programs, a number of COVID-19 vaccines for adults are in advanced clinical trials. But no trials have yet begun in the United States to determine whether these vaccines are safe and effective for children.

“Right now, I’m pretty worried that we won’t have a vaccine available for kids by the start of next school year,” said Dr. Evan Anderson, a pediatrician at Children’s Healthcare of Atlanta and a professor at the Emory University School of Medicine.

Anderson and his colleagues published a commentary last week in the journal Clinical Infectious Diseases in which they called for vaccine makers to get their act together. They titled it, “Warp Speed for COVID-19 Vaccines: Why are Children Stuck in Neutral?”

The search for a COVID-19 vaccine started as soon as researchers isolated the virus in January. Teams of developers across the world began creating vaccines based on different techniques. For example, some used inactivated coronaviruses that stimulated the immune system to make its own antibodies; others delivered viral genes into the body, triggering immune cells into action.

Once they were ready to test those vaccines, they started down a well-worn path of rigorous protocols developed over decades to determine if a vaccine is safe and effective. Vaccines require especially strict tests because they’re fundamentally different from drugs, which are intended for a limited number of people who are sick with some particular disease.

Vaccines, on the other hand, are given to millions of healthy people to prevent them from getting sick in the first place.

After testing a vaccine on animals, developers start clinical trials on people. These trials come in three phases, going from small to large. Phase 1 and 2 trials let vaccine developers figure out which dose will likely be safest, while also delivering the best immune protection.

Phase 3 trials are carried out on thousands or tens of thousands of volunteers. It’s during these studies that scientists can get clear evidence that a vaccine protects people from a disease. They can also reveal side effects that were missed by smaller studies.

Many vaccines — including ones for measles, polio and tetanus — were designed from the outset to be given to children. In such cases, vaccine developers would typically start with trials in adults to check for any significant safety issues.

Only if researchers discovered no serious side effects would they start testing them in children, often beginning with teenagers, then working their way down to younger ages. Vaccine developers are keenly aware that children are not simply miniature adults. Their biology is different in ways that may affect the way vaccines work. Because their airways are smaller, for example, they can be vulnerable to low levels of inflammation that might be harmless to an adult.

These trials allow vaccine developers to adjust the dose to achieve the best immune protection with the lowest risk of side effects. The doses that adults and children need are sometimes different — children get smaller doses of hepatitis B vaccines, for example, but bigger doses for pertussis.

This process has proved safe and tremendously successful. In recent decades, childhood vaccines have saved millions of lives. Just expanding access to the measles vaccine alone led to a 78% decline in mortality between 2000 and 2008, preventing an estimated 12.7 million deaths worldwide.

In the past, the testing needed for Food and Drug Administration approval on a vaccine might have taken a decade or more. In recent years, researchers have pinpointed ways to accelerate their development while not sacrificing the research necessary to demonstrate they are safe and effective.

When the COVID-19 pandemic hit, some vaccine makers figured out how to combine phases, gathering more data in the same period of time.

Governments and philanthropic organizations offered support for expensive clinical trials and for building factories to produce vaccines that had yet to prove themselves.

The result has been an unprecedented and swift march toward a vaccine. Just nine months into the pandemic, at least 38 COVID-19 vaccines have reached clinical trials, with dozens more slated to start in the months to come.

TODD HEISLER/THE NEW YORK TIMES Mayor Bill de Blasio greets a student this week at Mosaic Pre-K Center in the Queens borough of New York City by bumping elbows.