Your browser doesn't support javascript.
Melting and Re-Freezing Leads to Irreversible Changes in the Morphology and Molecular-Level Dynamics of Pfizer-BioNTech COVID-19 Vaccine.
Mamontov, Eugene; Daemen, Luke L; Novak, Eric; Stone, Matthew B.
  • Mamontov E; Oak Ridge National Laboratory, Neutron Scattering Division, Oak Ridge, TN 37831, USA.
  • Daemen LL; Oak Ridge National Laboratory, Neutron Scattering Division, Oak Ridge, TN 37831, USA.
  • Novak E; Oak Ridge National Laboratory, Neutron Scattering Division, Oak Ridge, TN 37831, USA.
  • Stone MB; Oak Ridge National Laboratory, Neutron Scattering Division, Oak Ridge, TN 37831, USA.
Medicina (Kaunas) ; 57(12)2021 Dec 09.
Article in English | MEDLINE | ID: covidwho-1572556
ABSTRACT
Background and

Objectives:

As an mRNA-based vaccine, the Pfizer-BioNTech COVID-19 vaccine has stringent cold storage requirements to preserve functionality of the mRNA active ingredient. To this end, lipid components of the vaccine formulation play an important role in stabilizing and protecting the mRNA molecule for long-term storage. The purpose of the current study was to measure molecular-level dynamics as a function of temperature in the Pfizer-BioNTech COVID-19 vaccine to gain microscopic insight into its thermal stability. Materials and

Methods:

We used quasielastic and inelastic neutron scattering to probe (1) the vaccine extracted from the manufacturer-supplied vials and (2) unperturbed vaccine in the original manufacturer-supplied vials. The latter measurement was possible due to the high penetrative power of neutrons.

Results:

Upon warming from the low-temperature frozen state, the vaccine in its original form exhibits two-step melting, indicative of a two-phase morphology. Once the melting is completed (above 0 °C), vaccine re-freezing cannot restore its original two-phase state. This observation is corroborated by the changes in the molecular vibrational spectra. The molecular-level mobility measured in the resulting single-phase state of the re-frozen vaccine greatly exceeds the mobility measured in the original vaccine.

Conclusions:

Even a brief melting (above 0 °C) leads to an irreversible alteration of the two-phase morphology of the original vaccine formulation. Re-freezing of the vaccine results in a one-phase morphology with much increased molecular-level mobility compared to that in the original vaccine, suggesting irreversible deterioration of the vaccine's in-storage stability. Neutron scattering can be used to distinguish between the vibrational spectra characteristic of the original and deteriorated vaccines contained in the unperturbed original manufacturer-supplied vials.
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 / BNT162 Vaccine Type of study: Observational study / Prognostic study Topics: Vaccines Limits: Humans Language: English Journal subject: Medicine Year: 2021 Document Type: Article Affiliation country: Medicina57121343

Similar

MEDLINE

...
LILACS

LIS


Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 / BNT162 Vaccine Type of study: Observational study / Prognostic study Topics: Vaccines Limits: Humans Language: English Journal subject: Medicine Year: 2021 Document Type: Article Affiliation country: Medicina57121343