On Monday, May 10, the FDA extended the emergency use authorization given to the Pfizer-BioNTech COVID-19 vaccine to allow for the vaccination of kids between 12 and 15. This decision will allow middle school students to get vaccinated before the fall.
The emergency use authorization was granted after studies released by Pfizer claiming that the pharma company's coronavirus vaccine was 100 percent effective in adolescents.
Pfizer's trial involved 2,260 adolescents between the ages of 12 and 15, with around an even number of people getting the Pfizer vaccine and the placebo. According to the company, there were 18 cases of COVID-19 in the placebo group and zero in the vaccine group, resulting in a 100 percent efficacy in preventing illness. (Related: Two-year-old baby DIES during Pfizer's COVID-19 vaccine experiments on children.)
"Today's 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" claimed Acting FDA Commissioner Dr. Janet Woodcock. "Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data."
Pfizer CEO Albert Bourla lauded the FDA for giving the company the emergency use authorization, and said that it was a step forward in helping the country "broaden its vaccination program." Bourla hopes Pfizer's approval can get adolescents between 12 and 15 vaccinated before the beginning of the next school year in the fall.
President Joe Biden has issued a statement asking states to fast-track the distribution of vaccines among adolescents immediately. He has also hailed the emergency use authorization as "a promising development in our fight against the virus."
"If you are a parent who wants to protect your child, or a teenager who is interested in getting vaccinated, today's decision is a step closer to that goal," he said.
Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, told reporters that states will probably begin vaccinating 12- to 15-year-olds once the Centers for Disease Control and Prevention (CDC) provides its own approval.
The CDC's Advisory Committee on Immunization Practices is in the process of reviewing Pfizer's data regarding the vaccine's supposed effectiveness in young adolescents. After it reviews the data the members of the committee will vote on the FDA's recommendation.
If the vote passes, states will then be free to decide when to begin vaccinating young adolescents. The mass vaccination process could even begin as soon as the day after the CDC's vote.
Concerns have been raised regarding the mass vaccination of younger adolescents, especially since children face such a small risk of contracting COVID-19, let alone becoming severely ill or even dying from it. Of the more than 560,000 people in the United States who have supposedly died due to the coronavirus, only around 300 children are among them, according to the CDC.
Some people have argued on the basis of limited supply that the vaccines should not be given to children when more vulnerable populations still haven't been vaccinated, especially in the developing world.
"If I were to ask you if a 12-year-old with no medical issues or a 57-year-old healthcare worker who takes care of COVID patients every day should get vaccinated, the answer is very clear, right?" asked Dr. Craig Spencer, director of global health and emergency medicine at Columbia University Irving Medical Center.
Other people have asked whether it would be ethical to vaccinate children in the first place.
"It's very reasonable to say we're going to immunize children so that we're going to protect the rest of society, but ethically there has to be a benefit for the individual themselves," said Dr. James Conway, a pediatric infectious diseases specialist at the University of Wisconsin-Madison.
Dr. Anthony Fauci, chief medical advisor for the White House, said in April that if adolescents can begin getting vaccinated by the fall, elementary-age children may start getting their shots by early 2022. The FDA's approval of vaccinations for younger adolescents moves up the country's timeline by several months, meaning that vaccinations for children under 12 could be approved as early as the second half of the year.
In a slide presentation that accompanied Pfizer's earnings report on May 4, the company revealed that it expects to apply for authorization for its vaccine for use in young children and toddlers in September and infants in November. The pharma company has already begun the submission process seeking full FDA approval for the use of its vaccine in people 16 and up.
Moderna and Johnson & Johnson, the two other companies with vaccines in widespread use in the U.S., are also in the process of getting their drugs approved for use in younger age groups. Moderna has already completed its vaccine trials on 12- to 17-year-olds and is expected to submit its data to the FDA and the CDC in the coming weeks.
Learn more about how big pharma companies are testing their dangerous vaccines on children by reading the latest articles on Vaccines.news.