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Anonymous ID: dd02d0 Sept. 22, 2021, 4:28 a.m. No.14635602   🗄️.is 🔗kun

https://biontech.de/how-we-translate/mrna-therapeutics

Our mRNAs all contain basic structural elements that we believe are critical for successful development:

 

5’ cap: Incorporation of a unique cap analogue into the mRNA helps to achieve superior translational performance by stabilizing the mRNA molecule and directing the immune response.

3’ untranslated region: The composition and structure of the 3’ untranslated regions of the mRNA molecule are important determinants of the intracellular stability of mRNA.

Poly(A) tail: We have performed extensive research on the structure of the poly(A) tail and the translational performance of mRNA and customized our template design accordingly.

 

Our deep and broad expertise in the targeted delivery of mRNA therapeutics is a key strength of BioNTech

A mRNA drug needs to be appropriately formulated in order to be protected from degradation by extracellular RNAses. The right formulation is critical to ensure the appropriate delivery of the RNA to the intended site of action.

We employ multiple mRNA delivery formulations, each designed for different functions and optimized for therapeutic product needs based on the intended application and route of delivery:

Lipoplex: Our lipoplex formulation, or LPX, embeds the mRNA between a lipid bilayer, which is used for our FixVac and iNeST platforms. We use a proprietary size- and charge-based non-viral mRNA lipoplex that was developed to deliver mRNA to dendritic cells in lymphoid compartments such as the spleen for optimal antigen presentation and immune response activation.

Lipid Nanoparticles (LNPs): For other applications, we encapsulate our mRNA in lipid nanoparticles, or LNPs. These formulations are suitable for our RiboMab, RiboCytokine and rare disease protein replacement platforms. Our LNP formulations can be adjusted according to our needs for delivery to particular target tissues, such as the liver in the case of our rare disease protein replacement platform.

Polyplexes: Our portfolio also comprises polyplexes, which are being utilized in certain of our discovery programs, in which the mRNA is bound to a polymer and then forms nanoparticles.

Anonymous ID: dd02d0 Sept. 22, 2021, 4:33 a.m. No.14635612   🗄️.is 🔗kun

https://www.fda.gov/media/151733/download

August 23, 2021 Summary Basis for Regulatory Action - Comirnaty

(b)(4)

Anonymous ID: dd02d0 Sept. 22, 2021, 4:36 a.m. No.14635616   🗄️.is 🔗kun   >>5622 >>5623

Considering the data submitted to support the safety and effectiveness of COMIRNATY that have been presented and discussed in this document, as well as the seriousness of COVID-19, the Review Committee is in agreement that the risk/benefit balance for COMIRNATY is favorable and supports approval for use in individuals 16 years of age and older.

 

PEDIATRIC REQUIREMENTS

  1. Deferred pediatric study C4591001 to evaluate the safety and effectiveness of

COMIRNATY in children 12 years through 15 years of age Final Protocol Submission: October 7, 2020 Study Completion: May 31, 2023 Final Report Submission: October 31, 2023 12. Deferred pediatric study C4591007 to evaluate the safety and effectiveness of

COMIRNATY in children 6 months to <12 years of age Final Protocol Submission: February 8, 2021 Study Completion: November 30, 2023 Final Report Submission: May 31, 2024 13. Deferred pediatric study C4591023 to evaluate the safety and effectiveness of

COMIRNATY in infants <6 months of age Final Protocol Submission: January 31, 2022 Study Completion: July 31, 2024 Final Report Submission: October 31, 2024

Anonymous ID: dd02d0 Sept. 22, 2021, 4:39 a.m. No.14635623   🗄️.is 🔗kun

>>14635616

>Deferred pediatric study C4591023 to evaluate the safety and effectiveness of COMIRNATY in infants <6 months of age

August 23, 2021

https://www.nowgrenada.com/wp-content/uploads/2021/08/FDA-August-23-2021-Approval-Letter-Comirnaty-or-pfizer-vaccine.pdf