Recently the FDA heard from 27 doctors, research scientists, professors, and consumer advocates. These experts presented serious concerns regarding the full approval of vaccines for COVID-19. These experts from all over the world presented a 20 page Citizen’s Petition with over 45 citations to back up their request. You can read the full petition and the references for the signers here.
In the petition, the signers pointed out that:
- The FDA should be provided with all vaccine data before approval. To date, this information hasn’t been made available in order to grant the EUA (Emergency Use Authorization).
- The EUA allows for the vaccine to reach the goals of being accessible to those who choose to receive it. Full approval isn’t necessary to meet this intent.
- Long-term studies should be finished before full approval. These studies are set to continue through 2022 and into 2023 for vaccines that currently have EUA approval.
- Safety and efficacy testing is thorough and complete for all populations: infants, children, adolescents, adults, elderly, immunocompromised, pregnant, nursing, etc. They believe this will ensure public confidence in the vaccines and the agencies that approve them. The benefits must be shown to outweigh the risks for each population in which it is approved.
- The new technology in the mRNA vaccines utilizing the spike protein need to have longer term safety and efficacy studies done and reviewed. Studies need to indicate where in the body the proteins travel, and what they do when they get there. These studies need to answer whether there is toxicity to any potential tissue the components of the vaccine may travel to. This reflects, in part, the concerns of the recent surge in myocarditis in young adults and teens who have received the vaccinations. You can read more about myocarditis here.
- A thorough investigation of all adverse reactions and deaths following COVID-19 vaccinations.¹
The list of concerns continued and included reasons as to why approval of the COVID-19 vaccine would be inappropriate.
What is their goal?
These doctors and researchers are among the top in their fields of medicine and pharmacology. They want to ensure the vaccine is rolled out appropriately, however, they are seeing the flaws in the systems. For example, the VAERS reporting system does not gain further information in adverse reactions, including deaths, following vaccination including medical history. In fact, the information is quite limited in investigating serious adverse events (SAE). The petitioners indicated better follow-up, including contacting family members is necessary.
The petitioners are concerned that not enough research has been done in the follow-up of these long-term studies. They are imploring the FDA to investigate and ensure the safety and efficacy of these vaccines. A few of the petitioners explained their stance in a recent op-ed piece released by the BMJ, a weekly, peer-reviewed, medical trade journal published by the British Medical Association. “The message of our petition is ‘slow down and get the science right—there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.’ We believe the existing evidence base—both pre- and post-authorization—is simply not mature enough at this point to adequately judge whether clinical benefits outweigh the risks in all populations.”²
Hold the Phone –Doc’s thoughts:
This vaccine campaign has attracted attention and opinions from all over the place. Here we have influential doctors and respected scientists who support vaccines, voicing concerns to slow down. In their own words, approving a COVID-19 vaccine now risks setting a precedent of lowered standards for future vaccine approvals.²
At The Wellness Way, we advocate for informed consent. Everyone should be able to know and understand the risks and benefits of any medical procedure. This is imperative to determine whether or not it is best for you or your family. These petitioners see that we can’t have vaccines rushed through approval just so that mandates would be easier to enforce or so the FDA approval will help reduce vaccine hesitancy. They see that the need for full studies need to be completed for safety and efficacy so that people will trust in approving agencies.² We believe these studies need to be available so that people can make educated decisions. We both agree that rushing the approval for these vaccines is absolutely the wrong move.