Is this the Short, Sharp, Shocking Truth About the COVID Vaccines?

They were on the market from 2017, with breakthrough designation from FDA in 2014.

In 2014, US FDA awarded Breakthrough Designation to CAR T-cell Therapy

In 2017, the first CAR T-cell therapy was approved by FDA, Brand Name Kymriah, marketed by Novartis

“Novartis’ investigational chimeric antigen receptor T-cell (CAR-T) therapy, CTL019, has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) to treat adult patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL).”

On November 28, 2023, FDA issued this on the drug class:

“Investigating Serious Risk of T-cell Malignancy Following BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies”

This was followed up on April 18, 2024, with this:

FDA Requires Boxed Warning for T cell Malignancies Following Treatment with BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies

Questions that Arise

1. Is the side-effect profile for the vaccines proving to be identical to those on the Kymriah package insert (based on real-world evidence collected over 4 years)?:

As a reminder, this is the warning in the package insert for Kymriah.

“WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGICAL TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES

• Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving KYMRIAH. Do not administer KYMRIAH to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids. (2.3, 2.4, 5.1)

• Neurological toxicities, which may be severe or life-threatening, can occur following treatment with KYMRIAH, including concurrently with CRS. Monitor for neurological events after treatment with KYMRIAH. Provide supportive care as needed. (5.2)

• T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19- directed genetically modified autologous T cell immunotherapies, including KYMRIAH. (5.9)

• KYMRIAH is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the KYMRIAH REMS. (5.3)

2. The use of CRISPR (Clustered regularly interspaced palindromic repeats) gene-editing technology is common to the vaccines and CAR T-cell therapy. Was there, or is there now, sufficient evidence to support commercialisation of an experimental technology?

3. Was there enough consideration given to the extreme complexity and risk to patients safety associated with a biologic supply chain?

4. Given point 3, why was CAR T-cell therapy given accelerated development status in 2014?.

There are many more questions to be answered.

Now that Peter Marks has been fired from FDA:

Top FDA official overrules staff to approve gene therapy that failed trial

We should expect these questions to be answered under the new administration, and the signs are extremely encouraging!