Pfizer vaccine receives full FDA approval, Henry Mayo reports death

Registered Nurse Trish Thuy Mai of Carbon Health prepares a dose of COVID-19 vaccine at an all-day, pop-up vaccination site organized by Assembywoman Suzette Valladares which was held at American Family Funding in Valencia on Saturday, 0711721. Dan Watson/The Signal

The U.S. Food and Drug Administration granted full approval to Pfizer-BioNTech’s COVID-19 vaccine Monday for ages 16 and up, as Henry Mayo Newhall Hospital reported an additional death related to COVID-19.

The vaccine had previously been granted an emergency use authorization, which is typically used during public health emergencies until a product can be fully vetted.

The emergency use authorization will remain in place for the vaccine’s use for individuals 12-15 years of age and for third doses for certain immunocompromised individuals, according to FDA officials.

Acting FDA Commissioner Janet Woodcock called the approval a milestone, adding in a prepared statement, “While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product. While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

FDA-approved vaccines are reviewed for quality, safety and effectiveness, and the Pfizer vaccine’s licensing approval was announced after the vaccine underwent another thorough evaluation of safety and effectiveness data by a panel of scientific and medical experts.

“We are also grateful to the FDA for their thoughtful analyses and review processes to ensure that we can have the highest confidence that the vaccine is safe and effective,” L.A. County Health Officer Dr. Muntu Davis said in a statement. “I hope the milestone of this vaccine’s full approval gives those that were waiting to get vaccinated the confidence to now take this important step.”

The Pfizer vaccine is one of three in use in the U.S. Moderna has also applied for full approval, while Johnson & Johnson has not yet applied for full approval and its vaccine remains in use under emergency authorization.

The additional COVID-19-related death brings Henry Mayo’s total to 156 since the onset of the pandemic, according to hospital spokesman Patrick Moody.

Hospital officials have previously stated that the best way to prevent a hospitalization due to COVID-19 is to get vaccinated.

Public Health officials also released the following updated COVID-19 statistics Monday:

Countywide COVID-19 cases reported in the past 24 hours: 2,331

Total COVID-19 cases in L.A. County: 1,385,505

New deaths related to COVID-19 reported in the past 24 hours: 7

Total COVID-19 deaths in L.A. County: 25,078

Hospitalizations countywide: 1,722

Hospitalizations at Henry Mayo Newhall Hospital as of Aug. 23: 35, with 1,402 discharged since the onset of the pandemic.

COVID-19 cases reported in the Santa Clarita Valley in the past 24 hours: 104, 77 of which came from the city of Santa Clarita

Total COVID-19 cases in the SCV: 32,351

Total COVID-19 deaths in the SCV as of Aug. 21: 312

Percentage of vaccinated people (at least one dose) in the city of Santa Clarita as of Aug. 15: 73.3%*

Percentage of vaccinated people (at least one dose) in the SCV as of Aug. 15: 69.9%*

*Percentages now include vaccination rates for people between the ages of 12 and 15.

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