Pfizer Requests FDA Approval for COVID Vaccine for Teens After Successful Trials

The U.S. pharmaceutical giant announced last month that their clinical trials found the jab to be safe for 12- to 15-year-olds in clinical trials, with Israel anticipated to be among the first countries to push ahead with inoculations

An employee holds a vial of COVID-9 vaccine in the Delpharm plant in Saint-Remy-sur-Avre, west of Paris, Friday, April 9, 2021 in Paris
An employee holds a vial of COVID-9 vaccine in the Delpharm plant in Saint-Remy-sur-Avre, west of Paris, todayCredit: Christophe Ena,AP

U.S. drugmaker Pfizer and its german partner BioNtech said on Friday they requested U.S. regulatory agencies to expand the emergency use of their COVID-19 vaccine in adolescents aged 12 to 15.

In March, the drugmakers said the vaccine was found to be safe, effective and produced robust antibody responses in 12- to 15-year olds in a clinical trial.

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Whether COVID-19 vaccines work and are safe to use on children is one of the big questions drugmakers are trying to answer. Inoculating children and young people is considered a critical step toward reaching “herd immunity” and taming the pandemic, according to experts.

The companies plan to request similar rulings by other regulatory authorities globally in the coming days.

It is unclear how long the regulator will take to review the data from the trial, although U.S. Centers for Disease Control director Rochelle Walensky told ABC news on Thursday that she expects the vaccine to be authorized for 12- to 15-year-olds by mid-May.

It is also unclear whether the regulator will require a meeting of the independent advisory board that recommended the original authorization in order for the companies to receive the nod in the younger age group.

The Pfizer/BioNTech two-shot vaccine is already authorized for use in people as young as 16.

Moderna Inc and Johnson & Johnson are also testing their vaccines in 12- to 18-year olds, and data from Moderna's trial could come soon.

Pfizer and Moderna have also launched trials in even younger children, aged six months to 11 years old. Both companies have said they hope to be able to vaccinate children under 11 as soon as early 2022.

Israel first in line

High school in Jerusalem last week.Credit: Emil Salman

Following the announcement by Pfizer in March, Israel's Health Minister Yuli Edelstein announced that Israel was ready to inoculate adolescents after FDA approval.

"Pfizer's announcement is amazing news for the citizens of Israel. Nothing is timelier than the acquisition of additional vaccines, so we can immediately begin vaccinating teens once the vaccine receives FDA approval," he said.

The Israel Pediatric Association also recommended vaccinating this age group as soon as FDA approval is finalized.

"We prepared a list of underlying conditions in children two months ago," the association said. "We urge all parents of children with underlying conditions to call their pediatricians now and find out if their children can be vaccinated."

There are approximately 600,000 young people ages 12 through 15 in Israel, and they would need to be inoculated for the country to reach herd immunity.

Experts in Israel's health system are in agreement that vaccinating this younger cohort will require targeted preparation and a public information effort. First of all, that’s because Israel, which has led the world in vaccinating its population against the coronavirus, will be the first country to begin vaccinating those under 16 at a time when most of the rest of the world is still focusing on older people. That is expected to prompt some concern among parents.

In addition, experience over the past several months has shown that, as the age groups eligible for vaccination have been expanded to younger people whose risk of serious illness is lower, they have tended to be less eager to get vaccinated. The falling rate of infection among the Israeli population as a whole may also lead some parents to believe that they can wait to have their children vaccinated.

While some parents may be hesitant about having children under 16 vaccinated, things looked different from the perspective of April of last year, when, at the height of the first wave of the pandemic, researchers from Western Galilee Hospital in Nahariya and Bar Ilan University’s medical school in Safed conducted a survey. At the time, there was no prospect of a vaccine on the horizon but interest in it was high.

Eighty percent of those who said they intended to get vaccinated against COVID-19 said they would have their children vaccinated if and when there was a vaccine appropriate for children. More than 90 percent of those who had their children vaccinated against the seasonal flu said they would also do so against the coronavirus.

“The name of the game is the safety of the vaccine,” said Dr. Amiel Dror, who directed the opinion survey. “More than 5 million people in Israel and more than 100 million in the U.S. have been vaccinated, and the bottom line is that side effects are mild and pass.”

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