Israel’s Health Minister Yuli Edelstein said Wednesday that adolescents in the Jewish State will be able to receive the Pfizer-BioNTech COVID-19 vaccine as soon as the US Federal Drug Administration (FDA) issues emergency authorization for its use.
The vaccine is safe and effective and produced “robust antibody responses” in 12 to 15-year-olds, Pfizer chairman and CEO Albert Bourla said in a statement, adding the company hopes to be able to start inoculations for teens before the next school year.
Pfizer and BioNTech announced “positive topline results of the pivotal COVID-19 vaccine study in 2,260 adolescents ages 12-15”, the companies said in a statement Wednesday. In the trial, 18 participants in the placebo group contracted coronavirus; no one became infected in the group that received the vaccine.
The vaccine was well tolerated with side effects similar to those seen in the age 16 to 25 year-old group, including injection site pain, headaches, fever and fatigue.
Bourla said the company plans to submit applications for emergency authorization of the vaccine for 12 to 15-year-olds with other regulators around the world as well.
“All participants in the trial will continue to be monitored for long-term protection and safety for an additional two years after their second dose,” the companies said.
“The Companies plan to submit these data to the FDA for a requested amendment to the Emergency Use Authorization of BNT162b2 to expand use in adolescents 12-15 years of age as quickly as possible.”
Infants to Age 11 Are Next
The move comes as Pfizer begins to evaluate the effectiveness of the vaccine of the next and final age group, that of infants age six months old up to and including children ages 11 years old.
“In March 2021 Pfizer and BioNTech dosed the first healthy children in a global Phase 1/2/3 continuous study to further evaluate the safety, tolerability and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine in children 11 years to 6 months old,” the company said in a statement.
“We anticipate results from this study will be available in the second half of 2021. If safety and immunogenicity is confirmed, and pending agreement with and endorsement from regulators, we hope to receive authorization for vaccination of these younger kids by early 2022.”
Israel’s Health Minister welcomed the announcement, calling it “terrific news.” Edelstein added, “There is nothing more in order now than a speedy approval of more vaccine procurements so we can be poised to vaccinate immediately upon FDA approval.”
