How To Submit a Public Comment Re: Sars-CoV-2 Fall 2023 Updated Booster

Comments must be submitted by September 8th, 2023 11:59 EST

Rumors and hints from Paul Offit and Eric Feigl-Ding have been circulating that ACIP may decide not to make the updated (XBB.1.5) Sars-CoV-2 booster widely available. If this vaccine is demonstrated to be safe and effective, yet withheld by the CDC/ACIP their actions will go down in history has a massive public health blunder that will further death and disability caused by Sars-CoV-2 infection.

Public comments about this can be made until September 8th, 2023 11:50 EST and here is how to do it:

1. Go to this CDC Website: https://www.cdc.gov/vaccines/acip/meetings/index.html

2. Click on Public comments tab:

   

3. For written public comments scroll down and follow the link to “Federal eRulemaking Portal” and use the CDC docket number provided: CDC–2023–0060. To apply to speak go to Step 6.

   

4. Once you follow the link you will be taken to this page where you will search by docket number.

   

   

5. The returned search should look like this, click on comment and follow the instructions.

If it is helpful to you, I have the reasons I am commenting at the bottom of this page.

6. If you wish to apply to make an oral comment scroll down from the first ACIP page (Step 3) until you see this part of the page and hit request, or go directly to the registration page by following this link: https://www2.cdc.gov/vaccines/acip/acip_publiccomment.asp

7. Follow the registration instructions. You will be notified on September 11th, the day before the meeting if you are selected to speak. Speaker slots are 3 minutes.

Why am I passionate about the fall Sars-CoV-2 booster being available to the general public?

If the data for the updated Sars-CoV-2 vaccines targeting the XBB.1.5 variant submitted to the FDA show that the vaccine is safe and effective in prevention of infection and severe disease I strongly believe it should be made widely available for the following reasons:

1. Prior vaccines provide minimal protection from current circulating variants.

2. Prior infection is not protective of recurrent infection with reinfection being reported as rapidly as 16 days after recovery.

3. Prior infection does not prevent Sars-CoV-2 reinfection and multiple infections increase risk of long COVID (PASC or post-acute sequelae SARS-CoV-2 infection) as well as significant organ system damage and immune system damage.

4. Vaccination reduces spread by reducing virus loads and in many cases preventing infection, this also protects the elderly and immunocompromised populations in which the vaccine may not work as well as a healthy adult.

5. Development of PASC is directly correlated to severity of Sars-CoV-2 infection which can be safely reduced by vaccination.

6. Healthy adults and children have been hospitalized and have died from Sars-CoV-2 infection, vaccination reduces this likelihood. Prior infection does not guarantee improved outcomes from repeat infections.

7. Healthy adults and children have developed ‘long COVID” or PASC and prior infection does not necessarily prevent potential life-long PASC. Vaccination significantly reduces development of PASC as demonstrated in the Delta wave.

8. Repeat infection causes cardiac damage and pre-disposes people to increased rates of heart attack for up to 6 months post infection and possibly longer. Reducing severity of disease and minimizing infection will reduce virus induced cardiac damage and post-infection cardiac events.

9. Sars-CoV-2 infection causes central nervous system damage and triggers early Alzheimer’s /dementia symptoms and diagnosis.

10. We are only 3 years into the spread of Sars-CoV-2 and there are numerous studies showing immune system dysregulation and disfunction post COVID infection. Sars-CoV-2 infection is already linked to the development of some autoimmune diseases (Type 1 Diabetes) as well as cancer in previously healthy children and adults. Repeat infections are likely to increase the likelihood of the development of autoimmune disease and possibly cancer. Both cancer and autoimmune disease can take years to develop, we are only at the beginning of scientific study in these areas. However, minimizing infection and the impact of infection will likely protect the population from in general from higher rates of autoimmune disease and cancer.

11. We are just starting to understand the significance of Immune system dysregulation caused by Sars-CoV-2 which includes lymphopenia, low T cell counts, high T cell exhaustion markers, failure of antigen presenting cells to produce important cytokines such as IFN-g that are necessary to fight off viruses and are critical in cancer responses. Significant perturbations in human immune responses have been documented out to 18 months post infection.

12. Sars-CoV-2 death rates are still significantly higher than Influenza, for which vaccines are readily available to all members of the public.

If ACIP does not make a safe and effective vaccine widely available to the population they are actively preventing protection from a virus that causes life-long debilitating multi-organ damage and death with additional health consequences that science is just starting to define. This would be the first and only vaccine demonstrated to be safe and effective, that protects the population from virus acquired life-long disability actively withheld from the public.

Each of the above statements has numerous associated peer-reviewed publications supporting the summary of the literature. I am a PhD Immunologist with experience in studying viruses and human disease and have compiled over 100 supporting references. Your comment section does not allow for them here, I will provide these upon request.