More Data Before COVID Vax Get Full Approval!

A number of weeks ago, our friends at ANH International released a white paper detailing how autoimmune patients are at an increased risk of serious adverse events from COVID vaccination. As such, autoimmune patients have a legitimate medical reason to seriously consider not receiving the COVID vaccine, despite strong societal pressure to do so in order to fully participate in the re-opening of the country. Part of the reason for this caution is that there is still so much we don’t know, as these vaccines were developed and authorized under an accelerated timeframe. This lack of data makes informed decisions about risk and benefit difficult, if not impossible, for many patients, including autoimmune patients.

This position is reinforced by a petition submitted to the FDA by a group of highly respected, credentialed experts asking for at least two years of data before the FDA considers granting full approval to COVID vaccines. Write to the FDA in support of this critically important effort!

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Please obtain more data before COVID vaccines receive full approval

Dear [Decision Maker],

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I'm writing in support of a recently submitted petition calling for at least two years of data before the FDA considers granting full approval to COVID vaccines.

Among other things, the petition urges the FDA to ensure that there is substantial evidence for safety and effectiveness that outweighs harms in special populations such as infants, children, adolescents, the immunocompromised, those with cancer, pregnant women, frail older adults, and patients with autoimmune disorders. These patients were excluded from the ongoing phase III trials of COVID vaccines, and the experts point out that "there is reason to believe the effects of the product may differ from the populations enrolled in the trial."

The petition also calls for additional study of the safety of the spike protein, which the COVID vaccines instruct human cells to produce. This is in light of recent evidence of systemic circulation of the lipid nanoparticles we reported on recently. These nanoparticles carry the instructions for cells to make the spike protein of the COVID virus. There is evidence that the spike protein on its own can damage endothelial cells (the cells that line blood vessels). There may be differences in how wild virus spike proteins and vaccine-induced spike proteins behave in the body, but to dismiss the concern without further evidence would be irresponsible.

These and many other questions must be answered before the FDA even considers granting full approval to COVID vaccines, which Pfizer and Moderna have already applied for. There seems to be a consensus that, while it is an open question as to whether the government or businesses can mandate COVID vaccines while they operate under EUA, full approval from the FDA could spur more businesses, schools, and other entities to require the shot. We've already seen a number of universities say that they will require the shots for students only after they receive full approval. This reinforces the need to acquire more data on special populations to ensure their safety.

For these reasons, please acquire at least two more years of data on the groups mentioned in the petition to ensure the safety and effectiveness of COVID vaccines before granting full approval, since such a determination will undoubtedly lead to many more people being vaccinated.

Sincerely,
[Your Name]
[Your Address]
[City, State ZIP]
[Your Email]