Moderna never submitted COVID-19 vax biodistribution study to FDA

A well being physicist at a nationwide US laboratory discovered Moderna by no means examined its COVID-19 mRNA SPIKEVAX for the place it might go within the physique, however the US Meals and Drug Administration accepted a Moderna examine of a distinct drug as an alternative.

The findings have been printed Tuesday in a report by Linnea Wahl . Wall is a well being physicist at Lawrence Berkeley Nationwide Labratory in California. Her report is the 91st in a collection primarily based on court-mandated disclosures by the FDA on the paperwork that they had when approving the mRNA COVID-19 vaccines.

The paperwork reveal an FDA reviewer particularly said, “A biodistribution examine was not carried out with mRNA-1273 vaccine [SPIKEVAX]. Outcomes from the biodistribution examine of a distinct vaccine . . . have been submitted in help of SPIKEVAX.”

Moderna researchers examined this fully totally different mRNA product within the blood of rats and examined its distribution in 13 totally different physique tissues. Regardless of this substitution, on December 18, 2020, the FDA approved emergency use of Moderna’s COVID-19 mRNA drug and granted full approval Jan. 31, 2022.

Earlier than the FDA approves a brand new drug for human use, producers want to indicate the place the drug goes within the physique, how lengthy it stays there, and the way it’s eliminated.

Usually, a gaggle of check animals, resembling mice, rats, or monkeys, obtain the identical drug on the similar dosage that’s proposed to be used in people. At common intervals, researchers sacrifice a subset of the animals and study how a lot of the drug has reached every tissue. A drug that biodistributes to organs outdoors of its meant objective is probably not protected for human use.

The FDA recommends biodistribution research for proposed medication that contain gene remedy. Because of this Moderna carried out a biodistribution examine in 2017 on their experimental drug (mRNA-1647) towards cytomegalovirus (CMV).

In a loophole, the FDA excludes ‘vaccines’ from requiring biodistribution research even when they embody gene remedy mRNA. Consequently, the researchers submitted the outcomes of a examine on a distinct mRNA drug (mRNA-1647) and requested FDA reviewers to simply accept it instead of one on mRNA-1273 (SPIKEVAX).

Moderna researchers advised FDA reviewers SPIKEVAX would distribute all through our our bodies in the identical method as a result of the 2 medication use the identical lipid nanoparticle formulation to encapsulate mRNA.

However Wahl reviews, “the substituted biodistribution examine itself didn’t present something like security. The supplies injected into the rats went in every single place.”

The substitute biodistribution examine was performed from August 23 by means of September 7, 2017. Right here, Moderna researchers injected 35 male rats with the CMV mRNA vaccine. At seven timed intervals (0, 2, 8, 24, 48, 72, and 120 hours), researchers sacrificed 5 rats to research their blood and tissues for the injected mRNA.

Tissues from 13 organs have been examined: lung, liver, coronary heart, kidney, lymph nodes, spleen, mind, abdomen, testes, eye, bone marrow, gut and injection web site muscle. Blood samples have been additionally taken.

The CMV mRNA drug distributed to the blood and all organs besides kidneys inside two to eight hours after injection. The spleen and the attention tissues had the mRNA at larger ranges than within the blood, suggesting that the drug concentrated there.

Regardless of such extensive distribution of this drug all through rats’ our bodies, the FDA reviewers accepted this examine as proof that Moderna’s SPIKEVAX was protected for people.

“Are the 2 medication comparable sufficient to help Moderna’s declare that they distribute all through the physique in the identical method? No. There are necessary variations between the 2 mRNA medication,” Wahl wrote. 

“In SPIKEVAX, the LNP capsule has 4 lipid elements [including]…SM-102,…A lot much less is thought concerning the LNP capsule of Moderna’s CMV mRNA drug. Moderna admits solely that the CMV mRNA drug is encased in an LNP shell that comprises their ‘normal proprietary’ SM-102-ionizable lipid.”

The genetic content material can also be totally different, Wahl explains. And measurement variations alone have been proven to have an effect on “liver uptake and accumulation and kidney excretion.”

“In SPIKEVAX, the contents of the LNP shell are the genetic sequence that codes for the SARS-CoV-2 spike protein. Against this, Moderna’s CMV mRNA drug consists of six totally different genetic sequences, all of which code for CMV proteins,” Wahl stated.

“Do the LNP particles of Moderna’s CMV and COVID-19 mRNA medication biodistribute equally? The FDA reviewers didn’t ask…Moderna changed apples with oranges.

As a result of no feminine rats have been injected, the likelihood that SPIKEVAX or its substitute would focus in ovaries was by no means established.

Helene Banoun made comparable observations final June in for the Worldwide Journal for Molecular Science. “The extensive and protracted biodistribution of mRNAs and their protein merchandise, incompletely studied resulting from their classification as vaccines, raises issues of safety,” she wrote.