we don't know #whatsinthshots

First posted online: 17 March 2022

We don't know #WhatsInTheShots because the full quantitative composition is a trade secret. Pfizer's raw ingredients table 3.2.P.1-1 includes 7 redacted rows. I believe it may allude to 6 processing aids. These may include ethanol, citrate buffer, HEPES and EDTA.

Aside from processing aids, we don't know the additives, contaminants, concomitant components, degradants, residual solvents or other components (unredacted starting materials, residual catalysts or metal reagents, reaction by-products, raw material components).

We don't know the excipient compositions so we can't know the composition of the finished drug. We don't even know the quality control standards that apply to the modRNA drug substance, ALC-0159, ALC-0315 or DSPC since they do not comply with the European Pharmacopeia.

But we know that tetrahydrofuran, a suspected carcinogenic agent according to the European Chemicals Agency, is used as a solvent in the manufacture of PEGylated lipid ALC-0159. To reiterate, we are not entitled to know the purity of ALC-0159. It's a trade secret.

The SmPC only lists the excipients, but they're not pure and we're not entitled to their compositions. So it's meaningless when the MHRA insist there are no undisclosed "ingredients" on the basis of Pfizer's duty to disclose the excipients in the SmPC under the HMR (2012).

Pfizer list of excipients filed in their SmPC does not include manufacturing ingredients

Manufacturing ingredients "essentially removed" from the finished product have not been disclosed as ingredients

Suspected carcinogenic agent tetrahydrofuran is one such undisclosed manufacturing ingredient