FDA ADVISERS RECOMMEND GREENLIGHTING CORONAVIRUS VACCINES FOR YOUNG KIDS

Independent advisers to the Food and Drug Administration on Wednesday recommended the use of the Moderna and Pfizer-BioNTech coronavirus vaccines for babies and young children, a milestone in the nation’s efforts to combat a wily pathogen that continues to infect tens of thousands of people a day and upend the lives of families across the country.

The outside experts said the benefits of the vaccines outweighed the risks — the standard for an emergency use authorization. The vote was 21-0 for the vaccines from Moderna and from Pfizer and its German partner, BioNTech.

Children younger than 5

— a cohort estimated to number at least 19 million — are the only group in the United States who still do not have access to a vaccine.

Now, that is poised to change.

While the FDA does not always follow the recommendations of its advisers, it is expected to do so in this case, within a day or two. Assuming the Centers for Disease Control and Prevention and its advisers concur at a meeting scheduled for Friday and Saturday, the vaccines will be available by next week.

Many parents and pediatricians see the pending arrival of vaccines for young children as long overdue. Several frustrated parents have said their lives have turned into relentless risk assessments as most of the country has abandoned coronavirus restrictions.

“My own daughters have asked me what my recommendation is for my young grandchildren and, without hesitating, I recommended they get vaccinated the first day, if that’s humanly possible,” said Mark Kline, physician-in-chief and chief medical officer at Children’s Hospital New Orleans.

Kline expects a rush of parents seeking vaccinations, wanting to protect their children from a potentially serious illness — a rare but worrisome occurrence.

“We know there are some children who get severe disease who land in the ICU, who may even die from the disease,” Kline said.

Experts counter there are solid reasons it has taken so long to get vaccines for the youngest. Typically, scientists want to ensure vaccines and drugs are safe in adults before they are administered to children. The vaccine makers moved sequentially through age cohorts to determine the doses that provided a robust immune response with limited side effects.

In contrast to some families’ sense of urgency, most parents say they are not in a hurry to get their children vaccinated. In a recent Kaiser Family Foundation survey, only 18 percent said they plan to get their children vaccinated right away, while 27 percent said they will “definitely not” get their child vaccinated.

Throughout the day, the FDA advisers — the Vaccines and Related Biological Products Advisory Committee — debated the data and struggled to assess the benefits of a vaccine in an everchanging pandemic now marked by highly transmissible Omicron subvariants. While they all supported authorizing the vaccines, there were differences of opinion about how much the shots would help a population that already is at low risk of becoming seriously ill or dying of COVID-19.

Opening the meeting, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said 442 children younger than 5 had died of COVID-19, a higher number than for many other pathogens, including influenza, for which there are vaccines. He added it was important to avoid becoming numb to the deaths, adding that “each child who is lost essentially fractures a family.”

Overall, even amid extensive debate about the number of doses needed in a vaccine regimen and whether the shots produced a robustenough immune response, there was strong support for both vaccines. Several committee members said parents who have been waiting for the shots should have the option to get their children vaccinated, and be given a choice of products.

“Some parents are so concerned about the risk of exposure that they’re still completely isolating their children,” said Mark Sawyer, a professor of clinical pediatrics at the University of California San Diego’s School of Medicine. “The availability of these vaccines will liberate those children to some extent, whose parents will find relief and feel a little more comfortable to let their children start to socialize in the appropriate environment.”

Both pediatric vaccines met the FDA’s main test for effectiveness: Blood tests showed the shots generated enough virus-blocking antibodies to provide at least as much protection as the vaccines provide young adults.

Clinical trials provided limited “supportive evidence” on effectiveness by comparing the number of COVID cases among participants who received the vaccine with those who received saline shots, the agency said. The agency said it expects the vaccines to work better at preventing severe illness — a crucial measure — than at stopping any infection. The same is true in adults.

The Moderna regimen consists of two doses of 25 micrograms each — onequarter of the adult dose — given four weeks apart. It was shown to be 51 percent effective in preventing illness in children between 6 months and 2 years old and 37 percent effective in children 2 to 5 years old.

The Pfizer-BioNTech vaccine is three shots of 3 micrograms each, one-tenth the adult dose, with the third shot given at least two months after the second shot. Preliminary data suggested its efficacy against symptomatic illness is 80 percent. But FDA officials have said that estimate was based on so few cases that it will probably change.