Considerations in Pfizer-BioNTech COVID-19 vaccine preparation in clinic: Quality vs quantity

Disclaimer In an effort to expedite the publication of articles , AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time.

Vaccine Quality Is a Key Factor to Determine Thermal Stability of Commercial Newcastle Disease (ND)Vaccines

Vaccination against Newcastle disease (ND), a devastating viral disease of chickens, is often hampered by thermal inactivation of the live vaccines, in particular in tropical and hot climate conditions. In the past, “thermostable” vaccine strains (I-2) were proposed to overcome this problem but previous comparative studies did not include formulation-specific factors of commercial vaccines. In the current study, we aimed to verify the superior thermal stability of commercially formulated I-2 strains by comparing six commercially available ND vaccines. Subjected to 37 °C as lyophilized preparations, two vaccines containing I-2 strains were more sensitive to inactivation than a third I-2 vaccine or compared to three other vaccines based on different ND strains. However, reconstitution strains proved to have a comparable tenacity. Interestingly, all vaccines still retained a sufficient virus dose for protection (106 EID50) after 1 day at 37 °C. These results suggest that there are specific factors that influence thermal stability beyond the strain-specific characteristics. Exposing ND vaccines to elevated temperatures of 51 and 61 °C demonstrated that inactivation of all dissolved vaccines including I-2 vaccine strains occurred within 2 to 4 h. The results revealed important differences among the vaccines and emphasize the importance of the quality of a certain vaccine preparation rather than the strain it contains. These data highlight that regardless of the ND strain used for vaccine preparation, the appropriate cold chain is mandatory for keeping live ND vaccines efficiency in hot climates.

VACCINE DEVELOPMENT- A COMPLEX SCIENCE

Several human vaccinations were created at the end of the nineteenth century, Smallpox, rabies, plague, cholera, and typhoid vaccinations are among them. Major things to acknowledge before vaccine preparation is that we have to isolate the antibody firstly which our body has produced against the pathogen and what is the composition of that antibody and also the structure of an antibody. A vaccine is administered to induce immunity in an individual’s body. Typically, the manufacture of vaccine uses viral or bacterial antigen in it. It may be killed or attenuated vaccine (live but less virulent). The foremost step to produce a vaccine is to select the strains for the vaccine and to culture the strain or microorganism. These two steps are collectively known as the upstream process. This is further followed by isolation and purification of the microorganism and then after the inactivation of the organism which is used for vaccine preparation formulation of vaccine begins. The last step is to check quality control and then further lot release; all of these steps are included in downstream processing. Mostly used vaccines lack efficiency, potency and safety. To take the vaccine preparation to next level, the introduction of monoclonal antibodies, recombinant DNA, and protein engineering have been accelerated knowledge of pathogenic mechanisms. This review provides a new approach to the development of the succeeding generation of vaccines.

Vaccine-Related Errors in Reconstitution in South Korea: A National Physicians’ and Nurses’ Survey

Vaccine-related errors (VREs) result from mistakes in vaccine preparation, handling, storage, or administration. We aimed to assess physicians’ and nurses’ experiences of VREs in South Korea, focusing on reconstitution issues, and to understand the barriers to and facilitators of preventing them. This was a cross-sectional study using an internet-based survey to examine experiences of reconstitution-related errors, and experience or preference with regard to ready-to-use vaccines (RTU) by physicians and nurses. A total of 700 participants, including 250 physicians and 450 nurses, responded to the questionnaire. In total, 76.4% and 41.5% of the physicians and nurses, respectively, reported an error related to reconstituted vaccines. All errors had been reported as experienced by between 4.9% and 52.0% of physicians or nurses. The errors were reported to occur in more than one in 100 vaccinations for inadequate shaking of vaccines by 28.0% of physicians and 6.9% of nurses, incomplete aspiration of reconstitution vials by 28.0% of physicians and 6.4% of nurses, and spillage or leakage during reconstitution by 20.8% of physicians and 6.9% of nurses. A total of 94.8% of physicians had experience with RTU vaccines, and all preferred RTU formulations. In conclusion, this study highlights the high frequency and types of reconstitution-related errors in South Korea. RTU vaccines could help reduce the time needed for preparation and reduce the risk of errors in South Korea.