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Article Type: News

Emergency Use Authorization Issued for Pfizer’s COVID-19 Vaccine

On Dec. 11, 2020, the U.S. Food and Drug Administration (FDA) announced an emergency use authorization (EUA) for a COVID-19 vaccine developed by Pfizer. An EUA allows for lifesaving medical products to become available during public health emergencies after a rigorous review of scientific evidence and extensive clinical trials proving that the product’s benefits outweigh its known and potential risks.

This authorization means the vaccine can begin its initial limited distribution to the highest risk populations, beginning with health care workers whose roles involve high exposure risk and includes older adults living in long-term care facilities. The vaccine will not initially be available to the general public.

According to the EUA granted by the FDA, the Pfizer vaccine’s clinical trials included approximately 44,000 participants who voluntarily received the vaccine and were closely monitored to measure the vaccine’s safety and effectiveness. These clinical trials have shown the vaccine to be safe and more than 90% effective with no serious side effects.

Full FDA approval of a COVID-19 vaccine requires the completion of all three phases of clinical trials and the submission of exhaustive data that demonstrates its safety and effectiveness.

In preparation for the EUA and potential FDA approval of a vaccine, the AdventHealth COVID-19 Vaccine Task Force has assembled leaders and experts across all areas of the organization to coordinate the clinical and logistical components of each vaccination phase. Each phase of the vaccine’s initial rollout is prioritized by the level of exposure risk and vulnerability to the coronavirus, starting with health care workers and older adults living in long-term care facilities.

“The announcement of this EUA is a significant step in a journey to accrue more tools that help us protect people from COVID-19,” said David Moorhead, MD, chief clinical officer for AdventHealth. “The detailed, publicly available data on this vaccine shows that it can safely and effectively save lives.”

As subsequent phases of the vaccine’s rollout continue toward its eventual availability to the general public, it is imperative to rely only on evidence-based information when making decisions about the COVID-19 vaccine. To help mitigate the pandemic and keep communities safe, the public is urged to take all the proper precautions to protect themselves and others, while being careful to avoid misinformation that can contribute to vaccine hesitancy and high-risk behaviors that can increase potential exposure to the virus.