On May 10, 2021 the U.S. Food & Drug Administration expanded emergency use for the Pfizer-BioNTech COVID-19 vaccine for adolescents as young as 12 years old. Initially, it was only approved for persons 16 an older; however, according to Acting FDA Commissioner Janet Woodcock, MD on (link below), the expansion is a “significant step in the fight against the COVID-19 pandemic.”

The FDA states that from March 1, 2020 through April 30, 2021, approximately 1.5 million COVID-19 cases were reported in persons ranging from 11 years of age to 17 years of age. While children and adolescents typically experienced milder symptoms than adults, the vaccine is seen as beneficial for individuals 12 years and older. The Pfizer-BioNTech COVID-19 vaccine has met the criteria required to amend the emergency use authorization (EUA) because the FDA believes the potential benefits of the vaccine outweigh the known and potential risks. Peter Marks, MD, PhD is the director of the FDA’s Center for Biologics Evaluation and Research and he says, “Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic.” The amendment for the expanded use was issued to Pfizer Inc. and is not an FDA approval of the vaccine.

The FDA’s safety data supporting the EUA in adolescents includes more than 2,200 participants ranging from 12 to 15. Approximately half of participants received the vaccine and the remaining participants received a saline placebo. After the second dose, the most commonly reported side effects in adolescents were pain at the injection site, fatigue, headache, chills, muscle and joint pain and fever and they were reported more after the second dose.

As with all vaccines, the Pfizer-BioNTech COVID-19 Vaccine should not be given to anyone with an allergy (or history of) to any component of the vaccine. For the complete FDA News Release, please visit:


In mid-April 2021, the Centers for Disease Control and Prevention paused the use of Johnson & Johnson’s Janssen (J&J/Janssen) COVID-19 Vaccine following reports of an increased risk of thrombosis with thrombocytopenia syndrome (TTS). TTS is a rare and serious conditions where blood clots due to a markedly reduced number of platelets. However, on April 23, 2021 the CDC and FDA recommended the use of the vaccine resume as the vaccine’s known and potential benefits “outweigh its known and potential risks for those recommended to receive it.” Most of the cases reported have been in adult women under the age of 50, so any patients who experience the symptoms below after receiving the J&J/Janssen COVID-19 Vaccine should seen medical care immediately:

  • Severe/persistent headaches
  • Blurred vision
  • Shortness of breath
  • Chest pain
  • Leg swelling
  • Persistent abdominal pain

Patients under the age of 50 should pay close attention for the development of one or more of these symptoms for a minimum of three (3) weeks after receiving the vaccine – especially adult women under the age of 50. For a complete review of the available data, please visit:,those%20recommended%20to%20receive%20it. or

About PGM

Physicians Group Management (PGM) is one of the fastest-growing medical billing companies in the United States.  For over 35 years, PGM has been providing medical billing and practice management services and software to physicians, healthcare facilities, and laboratories.  PGM’s current client base encompasses the full spectrum of medical specialties, including Internal Medicine, Dermatology, Plastic & Reconstructive Surgery, Pathology, EMS & Ambulatory Services, Cardiology, Nephrology, Urology, Pain Management, OB/GYN, Gastroenterology, Independent Laboratory, and many more.  PGM’s medical billing and practice management solutions include:

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Laboratory billing software that offers best-in-class systems to streamline, and manage and track, financial and administrative processes