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The Race to Develop the Pfizer-BioNTech COVID-19 Vaccine: From the Pharmaceutical Scientists' Perspective.

ABSTRACT: At the outset of the coronavirus disease 2019 (COVID-19) pandemic, it was clear that a vaccine would be crucial for global health efforts. The Pfizer and BioNTech teams came together in a race against the virus, working to design, test, manufacture, and distribute a safe and efficacious vaccine in record time for people around the world. Here, we provide backstory commentary from the pharmaceutical scientist perspective on the challenges and solutions encountered in the development of the Pfizer-BioNTech mRNA COVID-19 vaccine (BNT162b2; b2; Comirnaty®; tozinameran). We discuss the foundational science that led to the decision to use an mRNA-based approach. We also describe key challenges in the identification of an optimal vaccine candidate and testing in clinical trials, the continuous efforts to improve the vaccine formulation in response to changing global health priorities and facilitate vaccine accessibility, and how vast quantities of vaccine doses were manufactured and safely delivered to every corner of the globe, all without compromising quality, science, and safety. The key to successfully delivering a safe and efficacious vaccine within nine months was a result of extraordinary, real-time, parallel effort and across-the-board collaboration between stakeholders on a global scale.

SUBMITTER: Lewis LM

PROVIDER: S-EPMC9482796 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

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The Race to Develop the Pfizer-BioNTech COVID-19 Vaccine: From the Pharmaceutical Scientists' Perspective.

Lewis Lavinia M LM Badkar Advait V AV Cirelli David D Combs Rodney R Lerch Thomas F TF

Journal of pharmaceutical sciences 20220918 3

At the outset of the coronavirus disease 2019 (COVID-19) pandemic, it was clear that a vaccine would be crucial for global health efforts. The Pfizer and BioNTech teams came together in a race against the virus, working to design, test, manufacture, and distribute a safe and efficacious vaccine in record time for people around the world. Here, we provide backstory commentary from the pharmaceutical scientist perspective on the challenges and solutions encountered in the development of the Pfizer ...[more]

PMID: 36130677

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Project description:IntroductionIn February 2021, New Zealand began its largest ever immunisation programme with the BNT162b2 mRNA coronavirus disease 2019 (COVID-19) vaccine.ObjectiveWe aimed to understand the association between 12 adverse events of special interest (AESIs) and a primary dose of BNT162b2 in the New Zealand population aged ≥5 years from 19 February 2021 through 10 February 2022.MethodsUsing national electronic health records, the observed rates of AESIs within a risk period (1-21 days) following vaccination were compared with the expected rates based on background data (2014-2019). Standardised incidence ratios (SIRs) were estimated for each AESI with 95% confidence intervals (CIs) using age group-specific background rates. The risk difference was calculated to estimate the excess or reduced number of events per 100,000 persons vaccinated in the risk period.ResultsAs of 10 February 2022, 4,277,163 first doses and 4,114,364 second doses of BNT162b2 had been administered to the eligible New Zealand population aged ≥5 years. The SIRs for 11 of the 12 selected AESIs were not statistically significantly increased post vaccination. The SIR (95% CI) for myo/pericarditis following the first dose was 2.3 (1.8-2.7), with a risk difference (95% CI) of 1.3 (0.9-1.8), per 100,000 persons vaccinated, and 4.0 (3.4-4.6), with a risk difference of 3.1 (2.5-3.7), per 100,000 persons vaccinated following the second dose. The highest SIR was 25.6 (15.5-37.5) in the 5-19 years age group, following the second dose of the vaccine, with an estimated five additional myo/pericarditis cases per 100,000 persons vaccinated. A statistically significant increased SIR of single organ cutaneous vasculitis (SOCV) was also observed following the first dose of BNT162b2 in the 20-39 years age group only.ConclusionsA statistically significant association between BNT162b2 vaccination and myo/pericarditis was observed. This association has been confirmed internationally. BNT162b2 was not found to be associated with the other AESIs investigated, except for SOCV following the first dose of BNT162b2 in the 20-39 years age group only, providing reassurances around the safety of the vaccine.

Project description:Introduction and importanceMessenger RNA vaccines, commonly known as mRNA vaccines, are the first COVID-19 vaccines that have been authorized and licensed in the United States. Two mRNA vaccines, BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) are available. Mass vaccination remains the most critical way to halt the spread of the COVID pandemic. The most common adverse effects of the COVID vaccines are headache, muscular soreness, weariness, redness, swelling, and tenderness at the injection site. The dermatological adverse effects of mRNA vaccines, on the other hand, are little understood. We present a case of bullous fixed medication eruption following delivery of the second dose of Pfizer's Covid-19 vaccination.Case presentationWe discuss the case of a 78-year-old man who went to the Emergency Department at King Fahad Medical City in Riyadh, Saudi Arabia, with numerous bullae throughout his extremities one day after receiving the second dosage of Pfizer Covid-19 vaccine. The bullae began three days before his presentation, and they were preceded by intense pruritus and urticated plaques. A skin biopsy was performed which revealed IgG (+1), IgM (+1), and C3 (+1) staining of the basement membrane. Another punch skin biopsy taken from an intact bulla was suboptimal compressing of dermal tissue only, revealing modest perivascular lymphocytic infiltrative and scattered eosinophils. This pathological picture with superficial perivascular inflammatory dermatitis, and the presence of eosinophils suggests drug-induced bullous pemphigoid. The patient was treated with topical and systemic corticosteroids, fusidic acid cream, and emollients after a confirmed diagnosis of bullous pemphigoid was obtained. He was hospitalized for 3 weeks as a case of severe sepsis due to a skin infection, and he was started initially on empiric antibiotics with piperacillin-tazobactam plus vancomycin that was later upgraded to meropenem and vancomycin based on the results of the blood and wound cultures. The patient suffered a pulmonary embolism on the second day of hospitalization and was placed on a heparin infusion that could potentially contribute to his death one month after discharge from our hospital.Clinical discussionBullous pemphigoid is the most frequent autoimmune bullous disease. It occurs in the elderly. The cause of this disease is unknown, although it sometimes can be triggered by taking certain medications. Two case reports have also revealed bullous pemphigoid eruption following immunization. One case report reported a 78-year-old lady with diabetes and Alzheimer's disease who developed tense bullae on her face and torso after getting the second dosage of the Pfizer-BioNTech COVID-19 Vaccine. Another case study described a 77-year-old male patient who developed generalized pruritis and bullae on erythematous bases one day after receiving the AstraZeneca COVID-19 vaccination. This new-onset bullous pemphigoid phenomenon has also been observed with other vaccinations such as rabies and swine flu.ConclusionAlthough uncommon, several dermatological side reactions like bullous eruptions have been reported following the mRNA Pfizer Covid-19 vaccination. According to this case report, Bullous pemphigoid might be caused by the mRNA- (Pfizer) Covid-19 Vaccine.

Project description:BackgroundThe Pfizer BioNTech COVID-19 vaccine was the first to receive emergency authorization and approval from the FDA. Therefore, it is preferred by most recipients; however, many people are concerned about the vaccine's side effects. At the time of the study, December 2021, Palestine lacked a national reporting system for monitoring adverse vaccine effects. Therefore, this study investigates the post-vaccine adverse events following the Pfizer/BioNTech COVID-19 Vaccine administration in Palestine and identifies the occurrence, extent, and severity among university staff, employees, and students at Birzeit University.MethodA questionnaire-based retrospective cross-sectional study was conducted using a university website (Ritaj), social media platforms (e.g., Facebook and Telegram), and in-person interviews. The Chi-square, Fisher's exact, and McNemar's tests were used to investigate significant relationships. Data were analyzed using SPSS version 22.ResultsIn total, 1137 participants completed the questionnaire, 33.2% were males, and the mean age was 21.163 years. All participants received at least one dose of the Pfizer-BioNTech COVID-19 vaccine. Approximately one-third of participants reported no adverse effects after receiving the first, second, or third doses (34%, 33.6%, and 32.5%, respectively). The most commonly reported adverse events were fever, chills, headache, fatigue, pain and swelling at the injection site, muscle pain, and joint pain. Allergic reactions were reported by 12.7% of the participants; furthermore, participants with a history of allergy or anaphylaxis before vaccination had a significantly higher tendency for post-vaccination allergic reactions. Eight participants reported rare side effects, including 7 (0.6%) cases of thrombocytopenia and one (0.1%) case of myocarditis. Males aged less than 20 years and smokers were significantly less likely to complain of adverse events. The number of reported side effects was significantly higher after the second vaccine dose than after the first dose. Finally, participants infected with COVID-19 before vaccination was significantly associated with side effects such as fever, chills, shortness of breath, and persistent cough.ConclusionIn this study, the most common post- BNT162b2 Vaccination reported self-limiting side effects similar to those reported by Pfizer/BioNTech Company. However, higher rates of allergic reactions were reported in this sample. Rare side effects, such as thrombocytopenia and myocarditis, were reported by 8 participants. COVID vaccines have been developed at an accelerated pace, and vaccine safety is a top priority; therefore, standard monitoring through a national adverse event reporting system is necessary for safety assurance. Continuous monitoring and long-term studies are required to ensure vaccine safety.

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The Race to Develop the Pfizer-BioNTech COVID-19 Vaccine: From the Pharmaceutical Scientists' Perspective.

Publications

The Race to Develop the Pfizer-BioNTech COVID-19 Vaccine: From the Pharmaceutical Scientists' Perspective.

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