FDA Expands Booster Doses to People 16 Years and Older
Food and Drug Administration (FDA), now states that anyone 16 or 17 years old can receive a booster dose Pfizer BioNTech COVID-19 vaccination.
The decision expands the agency’s emergency use authorization for booster doses, which it issued on Nov. 19 for adults 18 and older. The FDA advises booster recipients to receive the second dose within six months of receiving the initial two vaccine shots.
This decision was made as Omicron variant concerns continue to grow. Pfizer BioNTech also announced that the booster dose significantly increases the protection of vaccine recipients against this variant. According to the companies, lab tests showed that people who received booster doses had higher amounts of antibodies capable of neutralizing Omicron virus in blood than people who got two doses.
“As people gather indoors with family and friends for the holidays, we can’t let up on all the preventive public health measures that we have been taking during the pandemic,” said acting FDA commissioner Dr. Janet Woodcock in a statement announcing the expanded authorization. “With both the Delta and Omicron variants continuing to spread, vaccination remains the best protection against COVID-19.”
The FDA used data on the safety and effectiveness for the extra dose of vaccine for people aged 18 and over to make its decision. It concluded that boosters would be safe for 16- and 17 year olds. This is the most serious concern for the younger population. The vaccine can cause inflammation of the heart tissue. FDA scientists looked at real data collected from young people who had been vaccinated and concluded that there was no significant risk.
“Since we first authorized the vaccine, new evidence indicates that vaccine effectiveness against COVID-19 is waning after the second dose of the vaccine for all adults and for those in the 16- and 17-year old age group,” said Dr. Peter Marks, director of the Center for Biologics and Evaluation and Research at the FDA, in a statement. “A single booster dose of the vaccine for those vaccinated at least six months prior will help provide continued protection against COVID-19 in this and older age groups.”