FDA approves expansion on vaccine eligibility and highlights clinical trial


Jessica Velazquez

Dr. Janet Woodcock and Dr. Peter Marks from the FDA address expanding the vaccine eligibility to 12 to 15 year olds and results from the clinical trial.

The Food and Drug Administration (FDA) announced the authorization of the Pfizer-BioNTech COVID-19 to 12-15-year-old individuals on May 10. Since the announcement, over 600,000 adolescents have received their first shot of the COVID-19 vaccine. The FDA’s expansion of the COVID-19 vaccine has raised questions such as, how effective is the vaccine?

The FDA held a virtual press conference yesterday to cover the authorization of the Pfizer-BioNTech COVID-19 vaccine for use in adolescents. Dr. Janet Woodcock, acting FDA commissioner, and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, discussed the clinical trial that tested the Pfizer vaccine on 12-15-year-olds. The FDA officials’ acknowledged that expanding vaccine eligibility brings the U.S. closer to a sense of normalcy and ending the pandemic.

“I would like to stress that adolescents, parents, and communities can have full confidence in our processes for reviewing this vaccine,” Woodcock said. “The FDA has done everything we can to ensure that the COVID-19 vaccine we have authorized has met our high standards of quality, safety, and effectiveness.”

The lack of trust some individuals have in the vaccine can stop them from getting vaccinated. The FDA looked at a clinical trial of more than 2,000 individuals who were 12 to 15 years old. Half of the participants received the Pfizer BioNtech COVID-19 vaccine and half received a placebo made of saline or saltwater.

“Now, to evaluate the vaccine’s effectiveness, the FDA looked at data about how participants’ immune system reacted to the vaccine,” Marks said. “The agency looked at the data from 190 vaccinated 12-15 and compared it to the immune response of 170 individuals who were 16-25 years old. The response was excellent in the 12-15-year-old individuals.”

FDA officials decided to test 12-15-year-olds because it was the easiest group to test since they know the same dose of vaccine can be used in those 16 years and older. In addition, the effectiveness of the vaccine has ignited questions about the results of the clinical trial.

“In the trial, we had 2,200 12-15-year-olds,” Marks said. “1,005 who got the vaccine and none of them got COVID-19, whereas 16 of the 978 adolescents [12 to 15-year-olds] who got the placebo [saline] got COVID-19.” 

The effectiveness essentially calculates out to 100% effective. Marks recognizes that this sort of effectiveness is not seen very often with other vaccines. 

With the increasing amount of vaccinations and more individuals becoming fully vaccinated, states like Illinois are lifting the mask mandate for those who are fully vaccinated. Woodcock and Marks addressed the topic of lifting mask mandates in schools for fully vaccinated individuals. 

“Masking rules and procedures are going to be up to the local jurisdictions,” Woodcock said. “The reason for that might be how much virus is circulating around in the community, what kind of virus, and how many people have been vaccinated in the community. There is a lot of variabilities there.” 

Each community will look to Centers for Disease Control and Prevention (CDC) guidance, what their state is saying, what the prevalence of the virus circulating, and what kind of variants are circulating in the community. Woodcock recognizes that the vaccine was powerful to the children who received it, and it seemed to protect them very well. 

FDA officials continue to advise all eligible individuals to get vaccinated to allow everyone to get back to their normal routine. 

“If you are now eligible for the COVID-19 vaccine I encourage you to talk to your parents about getting your vaccine and talk to your friends about getting theirs,” Woodcock said.