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To combat the spread of COVID-19, FDA has revised the emergency use authorization for coronavirus vaccine to include its usage in the younger adolescent population.
On 3 January 2022, the Food and Drug Administration (FDA) modified the emergency use authorization (EUA) for the coronavirus vaccine amid the current wave of the omicron variant.
(a) Boosters are now approved for the younger adolescent population
Considering the outcomes of real-world data that incorporated safety data from more than 6,300 people (age 12 through 15 years) who were given a booster dose of vaccine at least five months after completing the primary 2-dose vaccination series, the amendment to vaccine's EUA was done.
According to FDA, the benefits of administration of booster dose outweigh the possible risks.
No safety concerns like myocarditis or pericarditis were witnessed following the use of booster dose.
(b) Booster dose interval updated to 5 months for individuals 12 years of age and older
A booster dose of the coronavirus vaccine significantly enhances a person's antibody response to combat the highly transmissible omicron variant. Approving the use of booster vaccination at 5 months (rather than 6 months) after completing the primary vaccination series may yield better protection against the omicron variant.
(c) Third primary series dose for immunocompromised children
Children (age 5-11 years) who have undergone solid organ transplantation, or who have compromised immune systems may not show adequate response to the 2-dose primary vaccination series. In order to grant maximum benefit from vaccination, FDA authenticated a 3rd primary series dose for this population. The efficacy of an additional dose in this pediatric population was projected from data in the adult population. Children who are not immunocompromised and are fully vaccinated do not require a 3rd dose.
On the basis of currently available data, FDA stipulates that the booster dose of authorized vaccines may aid to offer improved protection against both omicron and delta variants. Particularly, the omicron variant exhibits greater resistance to the antibody levels that are produced in response to the primary series dose.
Therefore, FDA has expanded the range of people that are eligible to get a booster dose, reduced the time interval between completion of primary series and booster dose and is also authenticating a 3rd vaccine dose for protection of immunocompromised children.
Redness, fatigue, pain, chills, headache, swelling at the injection site, joint pain, muscle pain, and swollen lymph nodes in the underarm were the most commonly reported adverse effects in people receiving booster doses.
US-FDA
Coronavirus (COVID-19) Update: FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine
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