近几年全球生物类似药发展如火如荼,各国出台积极政策响应与推动生物类似药的研发和应用,大型制药企业也通过一系列对生物医药公司的收购完成生物类似药研发先机的抢占。以Pfizer vs. Johnson案为研究对象,对美国生物类似药的保障政策...近几年全球生物类似药发展如火如荼,各国出台积极政策响应与推动生物类似药的研发和应用,大型制药企业也通过一系列对生物医药公司的收购完成生物类似药研发先机的抢占。以Pfizer vs. Johnson案为研究对象,对美国生物类似药的保障政策、诉讼案件发展和系列焦点问题进行整体描述与深入分析。研究发现,来自原研企业的竞争压力及临床对生物类似药可替代性的质疑与保守态度,都在一定程度上对类似药的应用和推广构成威胁,而其价格优势和越来越明朗的政策环境使得生物类似药的未来可期。展开更多
<strong>Purpose:</strong> Since the mRNA technology used to manufacture Pfizer-BioNTech COVID-19 Vaccine is new, it is still difficult to predict its consequences. However, many young people, especially in...<strong>Purpose:</strong> Since the mRNA technology used to manufacture Pfizer-BioNTech COVID-19 Vaccine is new, it is still difficult to predict its consequences. However, many young people, especially in developing countries, think that they are less susceptible to severe infection with the Coronavirus 2 (SARS-CoV-2), Therefore, they do not prefer to take the COVID-19 vaccines. Accordingly, studies in this aspect are necessary to increase people’s awareness of the acceptance of vaccination, especially for the youth. <strong>Patients and Methods:</strong> This study was conducted on healthy young adults of both sexes. Participants (n = 81) were received two doses of the Pfizer-BioNTech COVID-19 Vaccine. A paper questionnaire was prepared, the survey asks about the side effects related to receiving the Vaccine. All participants completed the questionnaire twice, once after the first dose and again after the second dose. Data were collected and statistically analyzed. <strong>Results: </strong>The most common side effects were Muscle pain, Tiredness, Headache, and Fever. Less common side effects were Chills, Fainted, Breathlessness, and Coughing. Rare side effects include nausea and vomiting, Diarrhea, Anaphylactic Reaction, and Swollen Lymph Nodes. Side effects that are strongly associated with females are Headache, and Joint pain, for males, Anaphylactic reaction. The study revealed a significant difference between the number of females (96.5%) and males (85%) who suffered from the side effects of the Pfizer-BioNTech COVID-19 Vaccine (P = 0.033). <strong>Conclusion:</strong> Most of the side effects reported in our study were consistent with Pfizer’s fact sheet for recipients and caregivers. Through our follow-up to the participants in the study, we noticed that the reported side effects were not too bad, and they were able to carry out their daily activities, so we recommend taking the vaccine, especially for young people.展开更多
文摘近几年全球生物类似药发展如火如荼,各国出台积极政策响应与推动生物类似药的研发和应用,大型制药企业也通过一系列对生物医药公司的收购完成生物类似药研发先机的抢占。以Pfizer vs. Johnson案为研究对象,对美国生物类似药的保障政策、诉讼案件发展和系列焦点问题进行整体描述与深入分析。研究发现,来自原研企业的竞争压力及临床对生物类似药可替代性的质疑与保守态度,都在一定程度上对类似药的应用和推广构成威胁,而其价格优势和越来越明朗的政策环境使得生物类似药的未来可期。
文摘<strong>Purpose:</strong> Since the mRNA technology used to manufacture Pfizer-BioNTech COVID-19 Vaccine is new, it is still difficult to predict its consequences. However, many young people, especially in developing countries, think that they are less susceptible to severe infection with the Coronavirus 2 (SARS-CoV-2), Therefore, they do not prefer to take the COVID-19 vaccines. Accordingly, studies in this aspect are necessary to increase people’s awareness of the acceptance of vaccination, especially for the youth. <strong>Patients and Methods:</strong> This study was conducted on healthy young adults of both sexes. Participants (n = 81) were received two doses of the Pfizer-BioNTech COVID-19 Vaccine. A paper questionnaire was prepared, the survey asks about the side effects related to receiving the Vaccine. All participants completed the questionnaire twice, once after the first dose and again after the second dose. Data were collected and statistically analyzed. <strong>Results: </strong>The most common side effects were Muscle pain, Tiredness, Headache, and Fever. Less common side effects were Chills, Fainted, Breathlessness, and Coughing. Rare side effects include nausea and vomiting, Diarrhea, Anaphylactic Reaction, and Swollen Lymph Nodes. Side effects that are strongly associated with females are Headache, and Joint pain, for males, Anaphylactic reaction. The study revealed a significant difference between the number of females (96.5%) and males (85%) who suffered from the side effects of the Pfizer-BioNTech COVID-19 Vaccine (P = 0.033). <strong>Conclusion:</strong> Most of the side effects reported in our study were consistent with Pfizer’s fact sheet for recipients and caregivers. Through our follow-up to the participants in the study, we noticed that the reported side effects were not too bad, and they were able to carry out their daily activities, so we recommend taking the vaccine, especially for young people.
