辉瑞的官方响应
https://www.pfizer.com/news/announcements/pfizer-responds-research-claims
纽约州纽约市，2023年1月27日 - 最近有人提出与辉瑞公司的功能增益和定向进化研究有关的指控，该公司希望能澄清事实。
在辉瑞-生物技术公司COVID-19疫苗的持续开发中，辉瑞没有进行功能增益或定向进化研究。 在与合作者的合作中，我们已经进行了研究，原始的SARS-CoV-2病毒已经被用来表达令人担忧的新变体的尖峰蛋白。这项工作是在公共卫生当局确定了一个令人关注的新变体后进行的。这项研究为我们提供了一种方法，以快速评估现有疫苗诱导中和新发现的相关变体的抗体的能力。然后，我们通过同行评审的科学期刊提供这些数据，并将其作为确定是否需要更新疫苗的步骤之一。
此外，为了满足美国和全球对我们的口服治疗药物PAXLOVID(TM)的监管要求，辉瑞公司开展了体外工作（例如，在实验室培养皿中），以确定对nirmatrelvir（PAXLOVID的两种成分之一）的潜在抗性变异。 对于一个自然进化的病毒，例行评估抗病毒的活性是很重要的。 这项工作大多是利用计算机模拟或主要蛋白酶--病毒的非感染性部分--的突变来进行的。 在少数情况下，当一个完整的病毒不包含任何已知的功能增益突变时，这种病毒可以被设计成能够在细胞中评估抗病毒活性。此外，在我们安全的生物安全3级（BSL3）实验室中，用SARS-CoV-2和nirmatrelvir培养的细胞进行体外抗性选择实验，以评估主要蛋白酶是否可以突变，产生病毒的抗性菌株。 值得注意的是，这些研究是美国和全球监管机构对所有抗病毒产品的要求，由美国和世界各地的许多公司和学术机构进行。
植根于合理科学的事实信息对克服COVID-19大流行病至关重要，辉瑞公司仍然致力于提高透明度，帮助减轻这种疾病的破坏性负担。
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New York, N.Y., January 27, 2023 – Allegations have recently been made related to gain of function and directed evolution research at Pfizer and the company would like to set the record straight.
In the ongoing development of the Pfizer-BioNTech COVID-19 vaccine, Pfizer has not conducted gain of function or directed evolution research. Working with collaborators, we have conducted research where the original SARS-CoV-2 virus has been used to express the spike protein from new variants of concern. This work is undertaken once a new variant of concern has been identified by public health authorities. This research provides a way for us to rapidly assess the ability of an existing vaccine to induce antibodies that neutralize a newly identified variant of concern. We then make this data available through peer reviewed scientific journals and use it as one of the steps to determine whether a vaccine update is required.
In addition, to meet U.S. and global regulatory requirements for our oral treatment, PAXLOVID(TM), Pfizer undertakes in vitro work (e.g., in a laboratory culture dish) to identify potential resistance mutations to nirmatrelvir, one of PAXLOVID’s two components. With a naturally evolving virus, it is important to routinely assess the activity of an antiviral. Most of this work is conducted using computer simulations or mutations of the main protease–a non-infectious part of the virus. In a limited number of cases when a full virus does not contain any known gain of function mutations, such virus may be engineered to enable the assessment of antiviral activity in cells. In addition, in vitro resistance selection experiments are undertaken in cells incubated with SARS-CoV-2 and nirmatrelvir in our secure Biosafety level 3 (BSL3) laboratory to assess whether the main protease can mutate to yield resistant strains of the virus. It is important to note that these studies are required by U.S. and global regulators for all antiviral products and are carried out by many companies and academic institutions in the U.S. and around the world.
Fact-based information rooted in sound science is vitally important to overcoming the COVID-19 pandemic and Pfizer remains committed to transparency and helping alleviate the devastating burden of this disease.
【 在 Bulls23 的大作中提到: 】
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: 你去挖挖辉瑞那个新闻是不是真的吧
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: 真是人造的？
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