UPDATE: FDA Panel Approves First COVID Vaccine
Nueces County Area Expects to Receive First Delivery on Monday, December 14
CORPUS CHRISTI, TX – The U.S. Food and Drug Administration panel met today to evaluate and approve the first COVID-19 vaccines in the United States. The reccommendation for approval of this COVID-19 vaccine (BNT162b2) marks one of the most important developments in recent history. The COVID-19 currently approved vaccine was created by the pharmaceutical company Pfizer (in partnership with the German firm BioNTech). Data collected during the clinical trials shows 95% relative risk reduction in COVID-19 infection.
Vaccine distribution is scheduled to begin next week. According to information received from the Department of State Health Services (DSHS), approximately 224, 250 doses of the Pfizer vaccine will be shipped to 34 Texas counties. Nueces County’s initial allocation will be about 6,000 doses.
City and County officials are relieved this day has come.
“Today is an incredible milestone in our ongoing fight against the coronavirus,” Nueces County Judge Barbara Canales said. “A vaccine is a way to fight back, or to use a sports analogy, to play offense. However, the old saying, ‘Offense wins games, defense wins championships’ applies. Our ability to win depends on all of us continuing to play strong defense while we ramp up our offense. We still need to do all we can to prevent getting the virus and to prevent spreading it. Today marks the day we go on the offensive against this relentless virus.”
“I am excited about the approval so residents can get the vaccine and go on with their life,” Mayor Joe McComb said. “I am hoping people’s hesitation is short lived and once the vaccine is available, and they will take advantage of it. The vaccine can prove to be lifesaving and avoiding getting sick is what matters”.
“After 10 long months of battling the COVID Pandemic, we are excited about moving into this next phase of saving lives and keeping our community safe,” City Manager Peter Zanoni said. “We know the vaccine will not eliminate the Pandemic instantaneously and so our City professional team lead by our Public Health District will continue to work hard in safeguarding all residents from the terrible virus.”
The determination to approve the vaccine took into consideration a series of documents that were made available to the public prior to the meeting today. The documents can be found on: https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-december-10-2020-meeting-announcement#event-materials.
The vaccine is expected to be shipped directly from the manufacturer and received by the approved vaccine providers within the week (December 14, 2020). Once the vaccine is received, Phase 1A will begin. Phase 1A includes:
First Tier 1: Health Care Workers Definition.
- Hospital staff working directly with patients who are positive or at high risk for COVID-19 includes:
- Physicians, nurses, respiratory therapists and other support staff (such as custodial staff)
- Additional clinical staff providing supporting laboratory, pharmacy, diagnostic and/or rehabilitation services
- Long-term care staff working directly with vulnerable residents.
- Direct care providers at nursing homes, assisted living facilities, and state supported living centers
- Physicians, nurses, personal care assistants, custodial, food service staff
- EMS providers who engage in 9-1-1 emergency services like pre-hospital care and transport
- Home health care workers, including hospice care, who directly interface with vulnerable and high-risk patients
- Residents of long-term care facilities
Second Tier: Staff in outpatient care offices who interact with symptomatic patients.
- Physicians, nurses, and other support staff (such as custodial staff)
- Clinical staff providing diagnostic, laboratory, and/rehabilitation services
- Non 9-1-1 transport for routine care
- Direct care staff in freestanding emergency medical care facilities and urgent care clinics
- Community pharmacy staff who may provide direct services to clients, including vaccination or testing for individuals who may have COVID
- Public health and emergency response staff directly involved in administration of COVID testing and vaccinations
- Last responders who provide mortuary or death services to decedents with COVID-19. Includes:
- Embalmers and funeral home workers who have direct contact with decedents
- Medical examiners and other medical certifiers who have direct contact with decedents
- School nurses who provide health care to students and teachers
Vaccine allocation was recommended by the Expert Vaccine Allocation Panel and Dr. John Hellerstedt, the Texas Commissioner of Health. As the availability and quantity of vaccine increases, the continuance of the phase approach is expected to move rapidly. The next FDA panel discussion for a separate vaccine made by Moderna will take place Thursday, December 17. If Moderna’s Vaccine also is approved for Emergency Use Authorization, the phase approach will add to the expedited response.