Covid疫苗已经在美国的成年人提供了一年多的成年人,但仍有很多问题。哪些疫苗已全额批准?我们什么时候会看到批准5岁以下儿童的疫苗?还有什么新疫苗吗?
要了解更多,我们与之交谈Julie Swann. Swann is a systems engineer with expertise in public health and issues related to contagious disease. In 2009, she served at the Centers for Disease Control and Prevention as a science advisor for the H1N1 pandemic response. Swann is the department head and A. Doug Allison Distinguished Professor of the Fitts Department of Industrial and Systems Engineering at NC State.
这篇文章是a series of Q&Asin which NC State experts address questions about COVID-19.
摘要:When people started getting COVID-19 vaccines in the U.S., it was done under an emergency use authorization (EUA). Which vaccines have now received full approval?
威恩:This information is changing all the time! As of today, both Moderna and Pfizer vaccines have received full approval from the FDA (respectively, for age 18 and up, and ages 16 and up). Just recently, Pfizer has added a request for full approval for adolescents age 12 to 15. One can find this information on websites from the FDA, the CDC, or news organizations, although it can be difficult to keep up with it.
TA:Does this mean that we have more data on how safe they are and how well they work?
威恩:We have a lot of data about the vaccine safety and effectiveness! Full approval (or, a Biologics License Application) has standards that are even higher than for emergency use, which already has requirements on safety, effectiveness, and manufacturing quality. The manufacturer submits additional data and analysis on potential safety events, distribution of the product, and studies after the EUA authorization. The FDA also does its own analysis of the vaccine for safety and effectiveness. For the EUA, we already had data from tens of thousands of participants who had received the vaccine, and now we have had it for millions and millions of doses in the U.S. and beyond.
TA:Where do things stand regarding vaccine approval for really young kids?
威恩:The Pfizer vaccine was approved for children aged 5 to 11 in October 2021. Many parents and caregivers are really looking forward to being able to vaccinate their younger children also! The Pfizer request for children under age 5 is currently anticipated in early April. This delay allowed Pfizer to give young children in the trial a third dose to increase effectiveness of the vaccine. We have not seen significant safety issues, but it appears a third dose is needed to ensure sufficient protection. Parents will need to hold on a little while longer, but this should also provide additional evidence that thorough reviews are being conducted.
TA:我看到有一个新的Covid-19疫苗叫做Novavax出来。它与已经使用的疫苗有何不同,如现代,辉瑞或约翰逊和约翰逊?
威恩:在高水平,现代人,辉瑞和J&J疫苗都是给我们细胞的指示,以产生一个SARS-COV-2蛋白,尖刺蛋白。我们的免疫系统然后学会靶向穗蛋白作为外国的刺激蛋白。当SARS-COV-2病毒击中我们时,免疫系统已经用防御工具制备。它攻击尖峰蛋白并让您免于生病,或者如果没有接种疫苗,至少会像你那样生病。
NovaVav在其技术中类似于更传统的疫苗,但它沿着类似的系列作为所述Covid-19疫苗的工作。关键差异是NovaVavax疫苗isSARS-COV-2尖峰蛋白本身,而不是如何制造它的说明。这只是蛋白质 - 不是活着或灭活病毒。疫苗相对容易分配,因为冷链要求并不像mRNA和腺病毒矢量疫苗一样严格[诸如现代人,辉瑞和J&J疫苗]。如果有人对mRNA疫苗过敏,它们可能不是NovaVax,因为它不含聚乙二醇[在一些Covid-19疫苗中用作稳定剂的成分]。它似乎对我们所看到的所有变种非常有效so far.
(作为侧面说明,NovaVax疫苗使用蛾细胞产生蛋白质和树皮,以便成分促进免疫应答。基于烟草植物的颗粒存在其他疫苗。我认为是一种令人惊叹的事情,我想we will find the work on vaccines over the last couple of years will allow science to solve problems that we couldn’t before!)
TA:Are there any other COVID vaccines forthcoming?
威恩:绝对地!一些新疫苗将尝试通过较低的价格进行竞争,而其他疫苗则可能争取全球范围缩放的制造和分销系统,包括低资源设置。还有在药物形式和鼻喷雾中测试疫苗的公司。This graphicby a media organization is an overall summary of vaccines in various stages. It can be hard to keep up with it all, especially since some vaccines have been tested and authorized in other countries that we are not using here. I am particularly interested in ones that can help make sure we vaccinate people around the globe, as in places like India there is still a long way to go. Longer term, researchers are trying to determine whether a vaccine could prevent severe disease not only from multiple variants, but even different types of coronaviruses. I also expect some of the technology will also advance our understanding of preventing other diseases. We should keep in mind that there are a number of diseases that kill many children (malaria) or affect the ability of humans to successfully reproduce (Zika), or cause lifelong effects (some tick-borne diseases). The advances in vaccine technology could also move forward treatments for cancer.
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