疫苗对新冠病毒的作用和价值?

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疫苗对新冠病毒的作用和价值?

现有的Pfizer和Moderna疫苗(两剂)有94-95%有效性，强生疫苗（1剂）也达到72%，安全性和效性都满足标准，已经通过FDA批准紧急使用。

疫苗可以有效阻止现在主要新冠病毒传播，并有一定效果阻断变异毒株的传播，从而控制新冠病毒的变异和传播。

Question 1:

多种疫苗的安全性比较？

疫苗都是针对S蛋白让人体免疫系统识别，从而产生记忆，等真正感染产生更快更有效的免疫反应来减轻或防止症状。让S蛋白在人体的表达形式有多种，比如 mRNA，腺病毒载体的DNA，或含有S蛋白的灭活病毒。各种疫苗理论上的安全性都很高。

安全性的担忧之一就是这些疫苗接种后有可能出现各种不同的副作用，常见的副作用是疼痛、疲倦、头疼、肌肉酸疼、发冷、发热、肿胀、关节疼、恶心等等。目前在全球接种疫苗最多的应属最先在欧美批准上市的辉瑞疫苗。关于这种疫苗的争议性极强的各种副作用常见诸于报端，美国CDC的“疫苗不良事件报告系统”（VARES）收到1913起疫苗接种后发生的死亡报告（截至3月15日，来自1.09亿剂接种的疫苗）。接种mRNA疫苗后出现的血小板减少性紫癜共报告36起。CDC对相关的临床信息进行了审查，包括死亡证明，尸体解剖和医疗记录等，没有发现可以表明接种疫苗导致患者死亡的证据。不过它在日本发生的严重过敏似乎比例略高，目前处于密切关注中。

Question 2:

打两针和间隔时间的问题？

Pfizer两针间隔21天，Moderna两针间隔28天。

Question 3:

过敏人群和孕期打疫苗的注意事项？

具体要看具体什么过敏病症，是季节过敏还是自身免疫疾病？最好咨询免疫科医生。

怀孕期间免疫系统也会有很大变化，副作用难以预计，理论上疫苗不会影响婴儿正常发育，甚至有一例孕妇打完疫苗后婴儿出生的脐带血里发现了抗体，但是实际应用最好等更多的临床数据。

Question 4:

打疫苗没反应是否意味着没有产生免疫？

从数据95%保护性来讲产生免疫概率还是很高的，如果不确定的话在1-2周之后可以做抗体测试。

Question 5:

打完第一针之后有可能因为免疫保护能力还不够，有概率还是会感染新冠，如果感染，是否还需继续打第二针？

有可能有保护作用，但是因为抗体还不高，所以还是需要第二针加强，增强对变异株的保护作用。

Question 6:

疫苗对变异株的作用？

具体也看哪种疫苗和最新研究，基本都达到60-70%的保护。

Question 7:

打完疫苗是否意味着不会受病毒感染，症状有什么影响和是否还会携带病毒？

打完疫苗意味着病毒侵染后免疫系统会做出更快更强的反应，并不意味着不会受到病毒感染，只是症状会减轻很多，现今疫苗基本都达到了90%以上的重症保护率。就算没有症状也有可能携带少量病毒，周围如果有易感人群有可能会感染。

Question 8:

流感疫苗有效性50-60% 差异是因为疫苗机制还是统计方式？

流感病毒非常容易变异，每年的流感疫苗是基于前一年的流感病毒，包括多种变异的毒株抗原进行疫苗更新制备和生产。因疫苗机制导致有效性局限于50-60%。新冠病毒变异较慢，制作疫苗针对s蛋白及其最近突变都比较有效，因此有效性远远高于50%。

Question 9:

Pfizer和Moderna现在是紧急使用通过，离FDA正式批准还有多远？

还需要大量临床试验，以往疫苗正式批准都需要3-5年时间，根据接种数量和临床试验设计离正式批准还需要时间。

Question 10:

Novavax的疫苗是不是从原理上安全性更好？而且看起来效果也很好

原理上都是表达s蛋白产生免疫，数据上没有太大可比性。

Question 11:

中国和美国疫苗参与临床试验的人差异多大？由此看各家疫苗对人种有没有差异？

原理上都是用不同平台针对s蛋白，还没有足够数据了解这些差异 。

从3期临床试验数据来看，辉瑞和Moderna疫苗的保护效率基本相同，都是94% ～95%，但是如果比较两款疫苗在不同种族人群中的保护率，辉瑞疫苗在包括印第安人、亚洲人、阿拉斯加和夏威夷土著人等人群中的保护率为89.3%，而Moderna疫苗对有色人种的保护率为97.5%，有人因此认为亚洲人应该首选Moderna疫苗，但是，这只是一个对数据的过分解读。在辉瑞疫苗的亚组分析中，亚洲人所在的分组中，对照组出现了9例感染，疫苗组只出现了1例感染，病例数太少，所计算出来的保护率并不可靠，保护率其实应该还是按总人群的数据来计算。

Question 12:

中美疫苗在生产中质量控制比较？

的确不同药厂生产线不同，但是都有GMP标准，具体数据无法得知。

Question 13:

哪类疫苗以后发展前景比较好？

mRNA疫苗平台比较新，基于更多数据会有更多认识。生产制作外部lipid nanoparticles是现成的，只需根据毒株变异改变mRNA序列，更新换代效率可能更高。相比较基于蛋白的疫苗的变化会影响理化性质，针对新变异株生产有可能更需要时间。

Question 14:

有选择的情况下Pfizer和Moderna有什么差别？

Moderna和Pfizer都是使用相同原理和制备的mRNA疫苗，但是moderna剂量高，有些人反应第二针之后的副作用可能更强。也有人反应Pfizer接种后局部皮肤和疼痛更强，不过这些都是每个人的反应，没有足够数据进行科学统计比较，还需要等更多人打完进行数据追踪和统计分析。

最新消息说：

A key difference between the two mRNA vaccines

Pfizer and Moderna both developed mRNA vaccines for COVID-19. They use messenger RNA to induce the body to produce a key protein found on the surface of the coronavirus. Then, the immune system creates antibodies that recognize that protein, thus preparing the body to fight off the coronavirus. But their vaccines are not identical. One of the big differences from the start has been their storage temperature requirements. And that's where Pfizer's weakness lies.

For longer periods, Comirnaty must be stored at ultra-cold temperatures -- between minus 112 degrees Fahrenheit and minus 76 degrees Fahrenheit. The vaccine may be kept at standard refrigerator temperatures for five days.

As Pfizer has collected more data, it has been able to loosen some guidelines for shorter-term storage. For instance, the company earlier this year said its vaccine may be stored at relatively higher temperatures (minus 13 degrees Fahrenheit to 5 degrees Fahrenheit) for two weeks. These are temperatures that standard pharmaceutical freezers can maintain. The Food and Drug Administration approved those new storage guidelines.

So, pharmacies and healthcare facilities can easily store the Pfizer vaccine for 19 days. I'm counting the refrigerated temperature period and the pharmacy freezer temperature period.

Easier from the start

Moderna's mRNA-1273 has offered an easier storage profile from the start. Right now, the guidelines say it can be kept at standard refrigerator temperatures (35.6 degrees Fahrenheit to 46.4 degrees Fahrenheit) for as long as one month. It can be stored for as long as seven months in a standard freezer. But this week, Moderna said further research showed that mRNA-1273 can be safely maintained at refrigerator temperatures for up to three months. The FDA still must approve those new guidelines.

Moderna also is studying new formulations of its coronavirus vaccine that would further improve its storage profile.

The possibility that Moderna's COVID-19 vaccine could be stored for as long as three months in a standard refrigerator could give it an even bigger leg up in the marketplace. Pfizer ensures the safe transport of its vaccine with special thermal containers. But in smaller healthcare settings, the problem is on-site storage. Many doctors' offices or pharmacies may prefer to stock up on a vaccine that can be kept in a refrigerator for a long period of time. They may have limited freezer space -- or no freezer space at all.

And in some countries, temperature requirements could be decisive when it comes to which vaccine governments and healthcare providers choose. Nigeria, for instance, said earlier this year it would favor vaccines that require less cooling.

An evolving vaccination situation

When COVID-19 vaccines first began to roll out, countries were aiming simply to vaccinate as many people as possible, as rapidly as possible. So, they ordered what was available. But as various vaccine makers continue to ramp up production and refine their offerings, countries will have more choices -- and a bit more time to consider those options. This is when Moderna could take the lead.

Will this mean major market dominance for Moderna and a big loss of revenue for Pfizer? No. True, mRNA-1273 could move into the top spot due to its easier storage requirements. But if that happens, Pfizer's Comirnaty will remain close behind it. No single company can make enough doses to vaccinate the more than 7.8 billion people in the world with the necessary speed. Moderna and Pfizer each aim to produce 3 billion doses of their coronavirus vaccines next year, and each requires a person to get two doses. So even if a country prefers Moderna's vaccine, for example, it likely will still have to order some doses from another vaccine maker to cover all its citizens.

The Moderna vaccine's easier-to-manage temperature requirements won't upend Pfizer's prospects for billions in dollars of sales of Comirnaty. But this latest news is likely to lead to a boost in orders for mRNA-1273, and may significantly increase Moderna's product sales over the long term.

LarryWet

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