News: COVID-19 Vaccine Approval & Distribution Process

There is now more information available about the Covid vaccine distribution process that we would like to present to you.  The information and process will continue to evolve over the next several weeks and months. 

  1. We anticipate that the Pfizer mRNA vaccine will be approved for use in the United States by the FDA on December 10th and the Moderna mRNA vaccine will be approved by December 17th.
  2. Distribution and administration of these vaccines with be a coordinated effort by Federal, State, and Local governments.
  3. This process will take months. Other vaccines may become available during this time and may have a different mechanism of distribution.

What is the process for approving the vaccine?

  1. The Food and Drug Administration (FDA) is a federal organization that is responsible for approving use of a “candidate” vaccine. 
  2. They have teams of career scientist experts that oversee the process that the manufacturer goes through to test and produce the vaccine.
  3. The first step is to have a Safety Monitoring Board take the data from the company.  This group is independent of the company and the FDA. They work with the company to ensure efficacy and safety prior to the data being presented to the FDA for review.
  4. Once the information is given to the FDA for review, they have their own process to review safety and efficacy of the information including their own independent group of advisors.

The Center for Disease Control (CDC) is another federal agency in charge of public health policy and recommendations.  The Advisory Committee for Immunization Practice (ACIP) has started to formulate a policy for distribution of the newly approved vaccines.

  1. Phase 1a will include health care workers and residents of long-term care facilities (this includes 24 million people nationally)
  2. Phase 1b will include essential workers such as first responders, food handlers, educators, and others.
  3. Phase 1c will include adults with high-risk medical conditions and adults over age 65.

Governor Pritzker presented the State of Illinois plan on December 4th:

  1. He announced that the state will have its own independent review of the vaccine’s safety and efficacy data.
  2. Illinois has 655,000 front line healthcare workers.
  3. Illinois has 110,000 long term care residents.
  4. The federal government has allocated 109,000 doses of vaccine (remember each person needs 2 doses of the vaccine for full immunization) to the State of Illinois when final authorization of the vaccine is made.  There will be additional vaccine available each subsequent week. 

Conclusions to be made at this time:

  1. Experts are indicating that the mRNA vaccines from Pfizer and Moderna will be both highly effective and safe.  Although the process is not complete, we should be confident that it is a thorough, independent, and transparent process for making this assessment.
  2. Barring any surprise information, we should ALL be willing to receive the vaccine when it becomes available.  The Pfizer and Moderna vaccines are considered equivalent.   
  3. The process of getting everyone vaccinated will take months.  The amount of vaccine available as well as the priority list will take time to implement before its available to the general population.
  4. You can see that just Phase 1a will take several weeks to months.
  5. Two doses of the vaccine will need to be given 3-4 weeks apart.  It then takes an additional 2-3 weeks for the body to achieve full immunity.
  6. Other vaccines may only require a single dose.  We will present that information when it is available.

 
There is tremendous enthusiasm and excitement about the upcoming release of the COVID vaccines.  It is an amazing achievement of modern science to make it available within a year.  Getting everyone vaccinated is going to take significant time and it will be managed by the state and local government.  There currently is no plan to have it available in doctors’ offices.
 
We need to be prepared to stay safe for several more months through Wearing a mask, Watching distances, and Washing hands.  The type of “herd immunity” needed to return to life without these safety measures will require at least 70% of the population to be immunized.
 
There is a light at the end of the tunnel.  For now, the virus continues to be extremely active and dangerous.  Please stay safe!  We will continue to keep you updated.