FDA Authorized Pfizer and Moderna Booster Shots

FDA Authorized Pfizer and Moderna Booster Shots

On 19 November 2021, the FDA authorized COVID-19 booster doses for everyone aged 18 or older who have already received two doses of an FDA-authorized or approved COVID-19 vaccine (Pfizer-BioNTech or Moderna). In addition to that, further clinical recommendations will be discussed.

Janet Woodcock, Acting FDA Commissioner, believes that the COVID-19 vaccines turned out to be the best and most efficient defense against COVID-19 so far. A single booster dose of either the Moderna or Pfizer-BioNTech vaccine can help adults 18 and older get prolonged protection against coronavirus and any possible serious consequences. Moreover, expanding eligibility will eliminate any doubt about who may receive a booster dose. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said this would also ensure that a booster dose will be available to anyone who may need it.

Booster doses have already been authorized for US individuals who are:

  • immunocompromised
  • 65 or older, and
  • younger adults with underlying conditions or at high risk due to their place of residence or work

Pfizer and Moderna are conducting studies to investigate the known severe risks of myocarditis and pericarditis. Furthermore, both the FDA and the CDC have established systems to monitor COVID-19 vaccine safety, allowing quick detection of potential safety concerns. Reportedly, the most frequent side effects in people who received a booster dose were redness, pain, and swelling at the site of injection, along with muscle or joint pain, headache, and chills. Individuals experienced swollen lymph nodes in the underarm more often after the booster than following the first series of two doses.

The decision to expand the eligibility of booster doses is based on the findings from clinical studies that demonstrated a booster dose restored vaccine effectiveness and lowered severe disease.

Photo by Braňo on Unsplash

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