8/23/21 @ 1:50 p.m. - Below is a Press Release made available today on the Food & Drug Administration's website. As a reminder, vaccine locations can be located on the OneNassau website. Nassau County is also hosting After Hours Vaccination Events on Thursdays from 4:00-8:00 p.m. at the Yulee County Building located at 86026 Pages Dairy Rd., Yulee. This is for the Pfizer vaccine and is BY APPOINTMENT ONLY.
-Sabrina Robertson Public Information Officer FDA Approves First COVID-19 Vaccine Approval Signifies Key Achievement for Public Health For Immediate Release: August 23, 2021 Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals. “The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. 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,” said Acting FDA Commissioner Janet Woodcock, M.D. “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.” Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product. FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval. Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into - nor does it alter - an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart. “Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S." Source: https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine 8/16/21 @ 4:15 p.m. - On August 11th, we announced that OneNassau had coordinated an after hours COVID-19 vaccination event for Wednesday, August 18th at the Yulee County Building. Please be advised that there are now two dates for after hours vaccinations: Wednesday, August 18th AND Thursday, August 19th, both from 4:00-8:00 p.m.
The vaccine being offered is Pfizer and it is available to individuals 12 and over to receive their FIRST vaccination. The date and time for your second vaccine will be provided during your scheduled appointment for the first vaccine. Please note that vaccines for these after hours events are BY APPOINTMENT ONLY. To schedule an appointment, please visit the OneNassau website. If you have any questions about these two events, please call (904) 548-0900. -Sabrina Robertson Public Information Officer 8/11/21 @ 3:40 p.m. - One Nassau has coordinated an after hours COVID-19 vaccination event for Wednesday, August 18th from 4:00-8:00 p.m. at the community building located at 86026 Pages Dairy Rd. The vaccine being offered is Pfizer and is available to individuals 12 and over to receive their FIRST vaccination. The second dose will take place 3 weeks afterwards on September 8th at the same location.
Please note that vaccines are BY APPOINTMENT ONLY. To schedule an appointment, please visit the One Nassau website. Sabrina Robertson Public Information Officer 8/10/21 @ 10:00 a.m. - Below is a chart issued by the Florida Department of Health reflecting positive Covid-19 cases through August 5, 2021. Additional Covid-19 information about Covid-19 cases in Florida can be located on the Florida Department of Health's website under the "Weekly Florida COVID-19" Data Link. You can also obtain important updates from the One Nassau website. This includes the weekly Health Department updates (like the one below), tips on protecting yourself, and monthly Covid testing schedules. The Nassau County Department of Health remains the lead agency in all Covid-19 matters. If you have any questions, please contact them at (904) 875-6100. -Sabrina Robertson Public Information Officer ![]() 8/3/21 @ 1:15 p.m. - As COVID-19 cases in Nassau County continue to rise, the Florida Department of Health-Nassau, has provided the below reminders to help slow the spread.
Let's get back to the basics. To prevent infection and slow the transmission of COVID-19, do the following:
Vaccines help. We are fortunate to have vaccines locally that can prevent one from COVID-19 infections/symptoms. Get vaccinated to protect yourself and others. To find a location: Know Before You Go Trust your doctors. The Nassau Medical Society has endorsed COVID-19 vaccines and is encouraging all persons eligible to get vaccinated. Trusting your doctors will help us move towards a healthier community. As a reminder, the Florida Department of Health-Nassau (FDOH-N) is the lead agency on all COVID-19 related matters in Nassau County. As such, questions should be directed to their office at (904) 875-6100. You can also find updates and other information on the OneNassau website. This page is managed by Nassau County Emergency Management, however they work directly with FDOH-N to disseminate information to the public through the OneNassau Joint Partnership to ensure accurate and consistent messaging. -Sabrina Robertson Public Information Officer 7/20/21 @ 3:30 p.m. - The Nassau County Department of Health has issued this calendar reflecting schedules for COVID testing and vaccination locations over the next few weeks. If you have any questions, please contact the DOH-Nassau at (904) 875-6100.
-Sabrina Robertson Public Information Officer 7/9/21 @ 2:30 p.m. - We apologize for the delay in posting this update. Public Works conducted site visits at 8:00 a.m. this morning and determined that the following three roads are still underwater, but are passable:
M. Sikes Rd is underwater and is still closed. If you have any questions, please contact the Road & Bridge Department at (904) 530-6175. -Sabrina Robertson Public Information Officer 7/8/21 @ 4:30 p.m. - Below is a list of roads that have standing water but are passable as of 3:00 p.m. today:
M. Sikes Road is still closed. Nassau County Road & Bridge Department currently has seven (7) graders operating from 6am-8pm to address flooded roads and will continue this schedule through at least Sunday. The department has also been notified of a failed cross-drain and collapsed road on White Oak Place in Callahan (see photos below). Traffic has been diverted in this area. Their goal is to have a new pipe installed by tomorrow afternoon. If you have any questions, please contact Road & Bridge at (904) 530-6175. 7/8/21 @ 4:00 p.m. - Nassau County Emergency Management urges you to self-report storm damage from Tropical Storm Elsa to assist them in detailing damages within Nassau County. Please see their message below:
SELF-REPORT STORM DAMAGE If you experience Residential, Commercial, or Public Facility damage due to any Severe Thunderstorm (doesn’t have to be a named tropical system), please report it to the Emergency Operations Center. The best way to quickly report that damage is through our web-based report form on www.OneNassau.com or just go directly through this link: www.crisistrack.com/public/nassauFL/request.html If you cannot use your computer or smartphone to report damage, you can call the EOC at 548-0900 and our staff can help you. If the damage you notice may be life-threatening or dangerous to public safety (e.g., live power lines down, large branches or other debris in the road) please call 225-5174 so that emergency personnel can be dispatched to secure the area. -Sabrina Robertson Public Information Officer |
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