Amid the growing concerns of the new, fast-spreading variant, Omicron, in the States, the federal regulators authorized the use of a single booster dose of Pfizer-BioNTech COVID-19 Vaccine to 16 and 17-year-old age group, at least six months after the completion of primary vaccination. The vaccine is approved for use under a mandated emergency use authorization (EUA).
Following the approval, the Centers for Disease Control and Prevention (CDC) strongly urged older teenagers to get their Pfizer vaccine booster shot at least six months after getting their initial two doses of COVID-19 Vaccination.
The CDC Director, Dr. Rochelle Walensky, in a statement, said, “We know that COVID-19 vaccines are safe and effective, and I strongly encourage adolescents ages 16 and 17 to get their booster if they are at least 6 months post their initial Pfizer vaccination series.”
Data Supporting Effectiveness
The FDA’s emergency approval, along with CDC recommendations, came shortly after the release of lab data findings by Pfizer and BioNTech indicating that the booster shots provide a high level of protection against the highly mutated variant of the virus.
Preliminary results suggest that the Omicron variant has considerably reduced the effectiveness of the first-two doses. A booster jab, on the other hand, provides nearly as much protection as two doses did against the original strain of the virus.
Dr. John Perez, Vice President of Pfizer’s vaccine clinical research program, told a CDC advisory committee that the booster was 95% effective at preventing symptomatic infection in a clinical trial of 10,000 participants aged 16 years and older.
FDA Evaluation of Benefits and Risks
The Food and Drug Administration has been slower to approve vaccines for the younger population than for older adults in the United States due to reported side effects by individuals who received the Pfizer-BioNTech COVID-19 Vaccine.
Concerns exist about myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart), conditions that most commonly affect young men.
Evaluation of additional real-world data revealed the most common side effects experienced by individuals who received a booster dose to be pain, redness, and swelling at the injection site, as well as fatigue, headache, muscle or joint pain, and chills.
This has enabled the FDA to reassess the benefits and risks of the use of the vaccine in a wider population.
However, after further consideration, the FDA has determined that the benefits of a single booster dose outweigh the associated risks of myocarditis and pericarditis in 16- and 17-year-olds. The shot is essential to ensure continued protection against COVID-19 and the potential health risks associated with it, including hospitalization and death.
In addition, the FDA and the Centers for Disease Control and Prevention have several systems in place to continually monitor the safety of COVID-19 vaccines and facilitate rapid detection and investigation of potential safety concerns.
Currently, scientists believe it is too early to consider a fourth dose or annual immunization, and more data needs to be collected.
As a precautionary measure, US public health authorities are calling everyone eligible to receive a booster shot, amid fears of a surge in COVID cases driven by the Delta variant and uncertainty about the future course of the pandemic due to the Omicron variant.
“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. With both the delta and omicron variants continuing to spread, vaccination remains the best protection against COVID-19”, said Janet Woodcock, M.D, Acting FDA Commissioner