Hi there,
Earlier this week, the U.S. achieved public health history when the FDA fully approved the first ever COVID-19 vaccine. Dr. Joneigh Khaldun, MDHHS chief medical executive, made the following statement that rings true: “The FDA’s approval of this vaccine is an exciting milestone as we continue to battle the COVID-19 pandemic. Michiganders can be very confident that this vaccine meets the high standards for safety and effectiveness as required of approved products by the FDA.”
I am hopeful this will increase confidence in the people who have been hesitant to get vaccinated. A Kaiser Family Foundation poll in June 2021 found 30 percent of unvaccinated people said they would be more willing to get vaccinated following the FDA’s full authorization. Perhaps this will also hold true in Oakland County as we are still at a level of high transmission based on CDC’s level of community transmission tracker. Our current 7-day average positivity rate is currently 6.5% (8/19/21-8/25/21)
If you are not vaccinated or are immunocompromised seeking a third COVID-19 vaccine dose, check out our available vaccination locations or visit the State of Michigan’s COVID-19 vaccine finder to locate other convenient providers.
72.3% of our residents 16 years or older have received at least their first dose of COVID-19 vaccine. Visit the state’s COVID-19 vaccine dashboard and the Oakland County Vaccine Hub for even more vaccination data.
In good health,
Leigh-Anne Stafford Director, Health and Human Services
FDA fully approves Pfizer vaccine for 16 years and older
On August 23, the U.S. Food and Drug Administration (FDA) approved the first ever COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 vaccine, and will now be marketed as Comirnaty, in individuals 16 years of age and older. The vaccine continues to be available under emergency use authorization (EUA) for individuals 12 through 15 years of age and for a third dose in certain immunocompromised individuals.
Comirnaty and the Pfizer-BioNTech vaccine are both:
- The same vaccine as the one available under EUA for all age groups
- Administered the same (a series of two doses, three weeks apart)
- Used interchangeably to provide the COVID-19 vaccination series to different groups
All COVID-19 vaccines, including Moderna, Janssen/Johnson & Johnson, and Pfizer-BioNTech for individuals 12-15 years of age, have met the FDA’s rigorous, scientific standards for emergency use authorization and are expected for full FDA approval review in the future.
What’s the difference between FDA’s EUA authorization and full approval?
EUA’s can be used during public health emergencies to provide effective medical products provided the known and potential benefits outweigh the risks of the product. EUAs can be issued with only interim clinical trial results over a shorter period. FDA-approved products undergo the agency’s highest review process for quality, safety and effectiveness including completion of clinical trial results over more time.
The EUA for the Pfizer-BioNTech COVID-19 vaccine for individuals 16 years of age and older was based on clinical trials in approximately 18,000 individuals who received the vaccine and approximately 18,000 who received a placebo. The vaccine was 95% effective in preventing COVID-19 among these clinical trial participants with eight COVID-19 cases in the vaccine group and 162 in the placebo group. The duration of safety follow-up for the participants was two months after receiving the second dose.
To conclude full approval, follow-up data from this ongoing clinical trial was further analyzed for safety. Approximately 22,000 vaccinated and 22,000 placebo recipients 16 years of age and older were evaluated. More than half of the recipients were followed for safety for at least four months after the second dose. Overall, the vaccine was 91% effective, with 77 cases of COVID-19 occurring in the vaccine group and 833 COVID-19 cases in the placebo group. Overall, approximately 12,000 recipients have been followed for at least 6 months.
Visit FDA for more frequently asked questions about the full approval and EUA.
Understanding COVID-19 vaccine third vs. booster doses
An additional dose, or “third dose” of COVID vaccine (Pfizer or Moderna) is when someone’s immune response may not be strong enough to protect them after the first two initial doses. Right now, the only people eligible for a third dose of a COVID vaccine are individuals with moderate to severe immunocompromised conditions. This dose can be received 28 days after the second dose. Visit the Oakland County Vaccine Hub to find out who can get a third dose currently from the Health Division.
A booster shot is a dose of the COVID vaccine for people who built enough protection, but experts believe is now decreasing. The booster shot helps vaccinated people maintain protection. This shot is not available yet, but the goal is to start offering a COVID-19 booster shot beginning in the fall to individuals starting 8 months after they received their second shot. This is subject to authorization by the FDA and recommendation by CDC’s Advisory Committee on Immunization Practices.
Health Division upcoming vaccination sites
The following locations will offer COVID-19 vaccinations for individuals 12 years and older.
General vaccination sites
Eligible individuals are asked to pre-register if receiving a third dose at these locations:
-
Monday-Friday- 9 a.m. – 4:30 p.m.
-
Oakland County Health Centers (Pontiac & Southfield)
-
Saturday, Aug. 28
-
Believers Community Back to School Event (Pontiac), 2-6 p.m.
-
Prospect Missionary Baptist Church (Pontiac), 12-4 p.m.
-
Monday, Aug. 30
-
Hazel Park Community Center, 11 a.m.-3 p.m.
-
Tuesday, Aug. 31
-
Best Western Premier Hotel (Southfield), 9 a.m.-3 p.m.
-
Carnival Market (Pontiac), 12-3 p.m.
-
Welcome Missionary Baptist Church (Pontiac), 8 a.m.-noon
-
Trinity Missionary Baptist Church (Pontiac), 2-6 p.m.
-
Friday, Sept. 3-Monday, Sept. 6
- Arts, Beats and Eats (Royal Oak), 12-4 p.m.
For more details about these locations, click on our Get Vaccinated page. You can also call 800-848-5533, Monday through Friday, 8:30 a.m. to 5 p.m. for more assistance. COVID-19 vaccinations are provided at no cost.
OaklandCountyVaccine.com is the best place to receive the latest information.
|
