With the U.S. facing the biggest surge of COVID-19 infections to date, the FDA has decided to amend the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to cover adolescents aged 12 to 15 and for some immunocompromised children between the ages of 5 and 11. The agency has also reduced the window between the second and third doses from six to five months.
“With the current wave of the omicron variant, it’s critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask-wearing and social distancing in order to effectively fight COVID-19,” said Acting FDA Commissioner Dr. Janet Woodcock.
To arrive at its decision, FDA analyzed real-world data from Israel, including 6,300 individuals between the ages of 12 and 15 who received a booster dose of the BNT162b2 vaccine at least five months after receiving a second dose.
The authorization for certain immunocompromised children aged 5 to 11 covers those who have received a solid organ transplant or have a condition that leads to a similar level of immunocompromise.
While a third dose of the Pfizer-BioNTech vaccine leads to a dramatic increase in antibody levels, data from the UK suggests that the protection may wane relatively quickly. For individuals who received three doses of BNT162b2, vaccine effectiveness against the omicron variant was approximately 70% between two and four weeks post-dose three. However, effectiveness fell to 45% after ten or more weeks.