Pfizer-BioNTech Vaccine Gets FDA Nod For Use in Adolescents

The U.S. Food and Drug Administration (FDA) has okayed the use of Pfizer-BioNTech COVID-19 vaccine on adolescents aged between 12 and 15 years of age on an emergency use basis, a move that is aimed at the safe reopening of schools in the fall.

Previously, the emergency use authorization of the Pfizer-BioNTech was for people aged 16 and older. The U.S. Centers for Disease Control and Prevention’s vaccine advisory committee is scheduled to meet to review the decision to approve the vaccine on adolescents.

A big step for the country

“The FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic. … [this] action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations,” said Acting FDA Commissioner Janet Woodcock.

Woodcock described the vaccination of adolescents as a big step for the country.

In early March, Pfizer said that its clinical trials had shown that the vaccine was safe and 100 percent effective in children between the ages of 12 and 15. The vaccine is said to have an efficacy of 95 percent in adults.

A total of 2,260 adolescents were enrolled in the trial. 

Boost for reopening schools

The FDA said the Pfizer-BioNTech vaccine had met the statutory criteria to amend the EUA, and that the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks, supporting the vaccine’s use in this population.

“Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic. With science guiding our evaluation and decision-making process, the FDA can assure the public and the medical community that the available data meet our rigorous standards to support the emergency use of this vaccine in the adolescent population 12 years of age and older,” said Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research.

The emergency use authorization of the Pfizer-BionTech vaccine in adolescents will come as great news for President Joe Biden’s administration, which has been pushing for the reopening of schools for in-person learning. The Biden administration has already said it would pour $10 billion into COVID-19 testing for schools so that they can reopen. 

Between March 1 last year and April 30, 2021, approximately 1.5 million COVID-19 cases in individuals 11 to 17 years of age had been reported to the Centers for Disease Control and Prevention (CDC). Children and adolescents generally have a milder COVID-19 disease course as compared to adults. However, the risk of transmission of COVID-19 from kids to adults remains high.

The U.S. estimates that to achieve herd immunity, when enough people in a given community have antibodies against a specific disease, between 70 and 85 percent of the population have to be inoculated against COVID-19.

Vaccine hesitancy

But while the vaccination of kids is seen as a huge step, vaccine hesitancy among parents with children aged below 18 could undo all the progress made so far.

A Kaiser Family Foundation study found that three in 10 parents of children ages 12 and 15 say they will get their child vaccinated as soon as a vaccine is available; 25 percent say they will wait a while to see how the vaccine is working, while 18 percent plan to get their child vaccinated if their school requires it, and nearly a quarter say they will definitely not get their child vaccinated. 

Pfizer CEO Albert Bourla was quoted as saying: “What we can promise to our parents is that we have done very thorough examination, more thorough than in any other vaccine, exactly because of the visibility that this vaccination is having,”

Only Pfizer-Biontech, Moderna and Johnson and Johnson vaccines have been approved for administration in the U.S. The latter two can only be administered on people aged 18 and over.

Moderna is still studying the results of clinical trials of its vaccine in children aged 12 and above.

Israel, one of the countries with the highest vaccine rates in the world, struck a deal with Pfizer that will see its citizens immunized in lieu of statistical data. All the data shared with the pharmaceutical giant, which now has one of the most highly sought-after vaccines, will be available to the public as well.

The kind of information that Israel is expected to share with Pfizer includes the number of infection cases, the number of fatal incidents and fatalities, as well as how many people have thus far been vaccinated. Data regarding people that have suffered allergic reactions due to vaccination will also be shared. In return, Pfizer will send millions of extra doses to the country.