The approval came after clinical trials showed 100% success in antibody responses among participating adolescents.
On Monday, the Food and Drug Administration authorized the Pfizer-BioNtech COVID-19 vaccine for emergency use amongst young adolescents 12-15 years old. Health experts believe this marks another significant effort to curb the spread of infectious disease.
"The FDA's expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic," said Acting FDA Commissioner Janet Woodcock, M.D. "Today's action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations."
This decision follows Pfizer after it was announced 100% efficacy of clinical trials in almost 2,000 adolescents in late March. The approval will now allow states to vaccinate middle school students before the start of the academic year.
Currently, the Pfizer vaccine requires two shots to be taken in a gap of three weeks to get its complete protection against the virus. This dosage is intended for people 16 years or older. On Wednesday, the Centers for Disease Control and Prevention (CDC) vaccine advisory committee will be reviewing the dose requirement for kids between 12-15 years. If approved, the vaccine distribution may start as early as this week.
Based on the safety data acquired from clinical trials of the Pfizer vaccine for kids 12-15 years old, some common side effects may last between 1-3 days that may include: pain at injection site, tiredness, headache, chills, muscle pain, fever, joint pain. Most symptoms are expected to occur after the second dose of the vaccine and are common, notes the FDA.
Johnson & Johnson is also conducting studies to observe the safety and effectiveness of their vaccines in young kids. The J&J vaccine trials started last month amongst teenagers 16-17 years. The trials will add younger kids of age 12 years if the data show an "acceptable safety profile," said the company.
Moderna announced in April their trials have already started with almost 3,000 young people between 12-17 years receiving doses. Moderna has planned a second phase of study where children as young as 6 months can be included.
However, Pfizer vaccines will be intended for children 12 years or older. The company plans to seek emergency use authorization among younger kids by September this year. The expansion to include different age ranges will cover children between 2- to 5-year-olds, 5- to 11-year-olds. Seeking emergency use authorization for infants may start by November, said the company.
The Pfizer-BioNTech COVID-19 vaccine is not advised for anyone with a known history of a severe allergic reaction, including anaphylaxis.
To boost the vaccine's availability, Pfizer has recently sought FDA's approval to store the vaccines at normal refrigerator temperature(36-46 degrees Fahrenheit) for up to four weeks. Generally, Pfizer vaccines need ultra-cold storage (-94 degrees Fahrenheit), but the company announced in February they could be safely stored in a typical home freezer (-13 to 5 degrees Fahrenheit) for up to two weeks.
Pfizer and BioNtech, its development and revenue sharing partner, have added $3.5 billion in global revenue in the first quarter of 2021, said Pfizer's Chairman and CEO Albert Bourla in a conference last week. The company has also shipped nearly 430 million doses to 91 countries and territories, cited Bourla.
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