到目前为止，欧洲药品管理局（EMA）宣布将在12月29日就批准疫苗上市做出决定。英国、美国和加拿大已经批准Biontech和辉瑞的疫苗并开始进行疫苗接种。
社民党籍卫生专家卡尔·劳特巴赫（Karl Lauterbach）批评欧洲药品管理局在批准疫苗方面落在其他国家的后面。他对德国（RND）表示，像英国那样紧急批准疫苗，从德国的法律角度来看也是可行的。但是德国并没有准备这样做，“因为根本就没有料到欧洲层面的疫苗审批会拖这么久”。
不仅政界，德国医院协会也在敦促加快疫苗审批速度。该协会主席格拉德·嘎斯（Gerald Gaß）表示：“我要问，我们真的必须要拖到12月29日才能在欧洲批准疫苗吗？”。如果能提前批准，“我们的流动医疗小组还可以在圣诞节去养老院为那里的老年人接种疫苗。”
德国卫生部长施潘预计到2021年夏末，德国约60%的居民可以接种新冠疫苗。这位基民盟政治家周一（12月14日）晚间在德国电视二台表示，根据目前的情况，预计夏季将能够提供大量疫苗，届时大部分人都可以接种。
The American College of Obstetricians and Gynecologists (ACOG), a professional membership organization for OB-GYNs, issued a practice advisory Sunday to say that both pregnant and breastfeeding people who are in the priority groups for the vaccine should receive doses as well.
“ACOG recommends that COVID-19 vaccines should not be withheld from pregnant individuals who meet criteria for vaccination based on [Advisory Committee on Immunization Practices]-recommended priority groups,” the statement read. “COVID-19 vaccines should be offered to lactating individuals similar to non-lactating individuals when they meet criteria for receipt of the vaccine based on prioritization groups outlined by the ACIP.”
What should pregnant people do?
The question of whether an expecting parent should receive a COVID-19 vaccine will eventually come down to a number of factors, including everything from the trimester, risk factors for COVID-19, ability to remain socially distanced in their lifestyle and occupation, guidance from federal and state officials and recommendations from a person’s own physicians, according to both Faden and Rao.
Overall, people should feel comfortable that a COVID-19 vaccine is safe, but parents-to-be might need to wait a bit before receiving one, according to Dr. Rashmi Rao, a maternal-fetal medicine specialist at UCLA Medical Center in Los Angeles.
“The message right now is that once it gets cleared from the FDA and vaccinations become available, if it’s safe to do so for the public, then I would recommend that you get your vaccination when you’re eligible,” she said. “However, if you’re pregnant, you will likely have to wait until you’re no longer pregnant or until we gather more data regarding safety and pregnancy.”
Similar to the flu vaccine, which was not tested on pregnant people in clinical trials, health experts will need to rely on continuously incoming data to make decisions around how safe the COVID-19 vaccines are during pregnancy. Officials are doing the same for the general population, considering the speed at which the COVID-19 vaccines were developed, according to Faden, who noted that people who are pregnant should not be “unnecessarily alarmed.”
“Vaccines are coming, and they’re coming before we have all of the information that we would like to have to make recommendations for pregnant people,” she said. “But this is the context in which decisions are being made and recommendations are being made for the general population, without all of the evidence we would like to have, which is why the studies will continue.”
The Society for Maternal-Fetal Medicine (SMFM) released a statement earlier this month encouraging expecting parents to “engage in shared decision-making” about the vaccine with their doctors.
“In general, SMFM strongly recommends that pregnant women have access to COVID-19 vaccines in all phases of future vaccine campaigns, and that she and her health care professional engage in shared decision-making regarding her receipt of the vaccine. … mRNA vaccines, which are likely to be the first vaccines available, do not contain a live virus but rather induce humoral and cellular immune response through the use of viral mRNA,” the society said in its statement. “Health care professionals should also counsel their patients that the theoretical risk of fetal harm from mRNA vaccines is very low.”
Even now, nearly one year into the coronavirus pandemic in the U.S., many questions remain about how pregnant people are impacted by COVID-19.
The CDC has shared data showing that people who are pregnant have a significantly greater risk for severe illness from COVID-19 when compared to nonpregnant people, but they are not at a greater risk for death.
“What I tell my patients is the one thing I know for sure is that pregnant women can get COVID,” Rao said. “We’re not seeing huge rates of any adverse fetal outcomes yet, but, again, that’s still to be determined, because we have a long way to go with collecting information.”
Rao said everyone, including pregnant people, needs to remain on guard when it comes to COVID-19 by continuing to follow safety protocols, including face mask wearing, social distancing and hand washing.
Malaysia’s Top Glove saw profits soar, and its stock price jump as much as 400 percent this year as countries worldwide rushed to buy protective gear as the coronavirus pandemic intensified.
But in interviews with AFP, the South Asian migrants working flat out to make the gloves – who typically earn around US$300 (K398,500) a month – described appalling living conditions, in cramped dormitories where up to 25 people sleep in bunk beds in a single room.
Some claim the company did not do enough to protect them despite repeated warnings.
The scandal has added to growing pressure on the firm, already under scrutiny after the United States banned the import of some of its gloves over allegations of forced labour earlier this year.
The infections also prompted factory closures and look set to have an impact on global supply.
Top Glove, which commands about a quarter of the world’s market, has warned of delays to deliveries and rising prices.
‘Didn’t keep workers safe’
More than 5000 workers – almost a quarter of the firm’s workforce – have tested positive after the outbreak at an industrial area housing factories and dormitories outside the capital Kuala Lumpur.
“The accommodation is so overcrowded,” said the Bangladeshi worker Kibria.
“The room itself is a bare minimum. It is quite impossible to maintain cleanliness when so many people live in a single room. It is like an army barracks – only less maintained.”
When the situation escalated last month, Top Glove began shifting infected workers to hospital and their close contacts to quarantine centres, reducing the numbers in dormitories.
Kibria, 24, was suspected of having COVID-19 so was first put in hospital, although he later tested negative and was moved to a hotel.
But critics say the actions were too little too late.
“The company had discussed decreasing people in the rooms before infections began but it never happened,” a Nepali production line worker, Karan Shrestha, said.
“The rooms stayed crowded – and in the end coronavirus cases started to increase.”
“The company didn’t keep the workers safe. They are greedy and were more concerned about their income and profits,” he added.
AFP used pseudonyms to protect the workers’ identities, as they were fearful about speaking out.
The company didn’t keep the workers safe. They are greedy and were more concerned about their income and profits. – Sheikh Kibria, migrant worker at Top Glove
‘Really scared’
As cases spiralled, the government ordered 28 Top Glove factories to close, out of the 41 it operates in Malaysia.
Authorities are planning legal action against the company over poor worker accommodations, which could result in heavy fines.
The firm, which has 21,000 workers who can produce 90 billion gloves a year, insists it is making improvements.
It has spent 20 million ringgit (K6.62 billion/US$5 million) purchasing new worker accommodations in the past two months, and plans to build “mega-hostels” kitted out with modern facilities that can house up to 7300 people.
“We are mindful there is much more to be done to uplift the standard of our employee welfare and promise to rectify shortcomings immediately,” said managing director Lee Kim Meow.
His comments came last week as the company announced a 20-fold jump in quarterly net profit to 2.4 billion ringgit.
For those campaigning for low-paid migrants, the controversy highlights how companies continue to put profits before people.
“The company, its investors and its buyers have prioritised the delivery of more gloves, more quickly and at higher profitability over the welfare of its mainly migrant worker labour force,” said Andy Hall, a migrant labour specialist who focuses on Asia.
Malaysia, a relatively affluent country of 32 million, has long attracted migrants from poorer parts of the region to work in industries ranging from manufacturing to agriculture.
Top Glove says the vast majority of workers who tested positive have already been released from hospital, and some factories are now reopening.
But some workers remain terrified at the prospect of returning to the production line, despite the company trying to enforce social distancing and providing protective gear.
“If we work in the factory, I would be really scared,” said Salman from Bangladesh, speaking from his hostel.
“Even with extra safety, it is really tough to prevent an outbreak.”
Ngày 14/12, Tổ chức Y tế Thế giới (WHO) cho biết đã nắm được thông tin xuất hiện một biến thể mới của virus SARS-CoV-2 gây bệnh viêm đường hô hấp cấp COVID-19 tại vùng England của Anh, song không có bằng chứng biến thể này hoạt động khác các chủng virus SARS-CoV-2 đang tồn tại.
Phát biểu tại một cuộc họp báo ở Geneva (Thụy Sĩ), Giám đốc phụ trách chương trình khẩn cấp của WHO – ông Mike Ryan, nêu rõ: “Chúng tôi được biết biến thể mới của virus xuất hiện ở 1.000 người tại England. Các nhà chức trách đang xem xét mức độ ảnh hưởng của điều này. Chúng ta đã phát hiện nhiều biến thể, loại virus này phát triển và biến đổi theo thời gian.”
两款领先的新冠疫苗的初期研究结果强劲，其影响已远远超越这场疫情本身，预示着以基因为基础的技术时代已经到来，有望给癌症、心脏病和其他传染病提供新的治疗方法。
这项尚未得到验证的技术以传递基因指令的分子载体命名，被称作信使核糖核酸（简称信使RNA），长期以来一直是困扰研究人员的一大难题。监管机构从未批准过mRNA疫苗，但现在却成为Moderna、辉瑞公司(Pfizer Inc., PFE)及其合作伙伴BioNTech所研制的新冠疫苗的基础。
近日，这两款疫苗在预防有症状的新冠感染方面均显示出90%以上的有效性。这与部分传统疫苗的效力相一致，而研发却只花了很短的时间。
“这是21世纪的科学，”范德比尔特大学医学院(Vanderbilt University School of Medicine)预防医学教授威廉·沙夫纳(William Schaffner)说。他表示，基于mRNA的新冠疫苗所呈现出来的积极数据，预示着这项技术可能具有对抗未来传染病暴发的潜力。
自从新冠病毒成为全球性的威胁以来，卫生健康方面的权威人士已将疫苗视为世界重回正轨的关键。疫苗对确保足够多的人免受病毒侵害有非常重要的作用，有了疫苗的保护，病毒就不会轻易传播，甚至不会传播到没有免疫力的人群中去。目前约有50种基于不同技术的候选疫苗进入了临床试验阶段。
通常情况下，疫苗需要几年时间才能推向市场。如果按照传统技术来推进，研究人员要花时间来开发并培育病毒或病毒中的蛋白质，经过注射后让身体产生免疫反应。麻疹、带状疱疹和其他传统疫苗都是使用非活性或经过弱化的病毒来诱导人体建立免疫保护系统的。
传统疫苗的制造通常是在受精鸡蛋胚胎或大型生物反应器中进行的，费时费力。2013年发表在国际生物学杂志《PLOSOne》上的一篇研究报告显示，研发出可以成功注射的疫苗往往要花十多年甚至更久。
而信使RNA却可能利用人体自身的分子机能缩短疫苗的开发时间，其本质是引导细胞制造出与病毒内蛋白质类似的蛋白质物质，从而触发人体的免疫反应。
信使RNA是细胞中的一种核糖核酸，是天然存在的物质，就像分子中的工蜂携带着镌刻在DNA上的指令，让细胞来遵循。鉴于RNA的这一作用，长期以来，科学家们一直认为可以重新利用RNA，将细胞变成微型药物或疫苗工厂。
有了mRNA，疫苗研发就不再是科学方面的挑战，而变成一个工程方面的问题。公司一旦掌握病原体的基因序列，就可以很快研制出mRNA疫苗。研究人员利用靶向病毒的基因序列对能够对抗它的mRNA进行编程。
去年11月，美国国家过敏和传染病研究所(National Institute of Allergy and Infectious Diseases)的安东尼·福西(Anthony Fauci)和约翰·马斯科拉(John Mascola)在《自然免疫学评论》(Nature Reviews Immunology)杂志上写道：”mRNA有可能成为一个快速灵活的疫苗平台。由基因序列开始，几周内就可以生产出mRNA疫苗。”
快速发展
2010年成立以来，Moderna一直专注于mRNA的研发，在掌握了新冠病毒表面刺突蛋白序列后的两个月内，该公司制作了足够约45人使用的剂量，开始了新冠疫苗的首次人体研究。
Moderna首席执行官斯蒂芬·班塞尔(Stephane Bancel)表示，有了这样一个平台，Moderna就可以通过插入mRNA的相关片段来快速设计新药或疫苗。他把mRNA称为“生命的软件”。
今年1月25日，也就是德国首次出现新冠病例的几天前，德国BioNTech公司联合创始人乌格·撒辛(Ugur Sahin)在查阅了新冠病毒刚刚出炉的基因组解码后，在家中的电脑上描绘出了10种潜在的mRNA疫苗版本。其中一种成为目前这款新冠疫苗的基础。
他找到了辉瑞公司。辉瑞在2018年首次与BioNTech合作，研制一种基于mRNA的流感疫苗，这款疫苗目前仍在开发当中。撒辛和妻子厄兹勒姆·图雷齐(Ozlem Tureci)在2008年创办了BioNTech，两人花了25年以上的时间研究mRNA。
辉瑞疫苗研究负责人凯瑟琳·扬森(Kathrin Jansen)说，辉瑞被mRNA所吸引，因为一旦使用这项技术，任何疫苗都可以快速制造出来，并且和传统疫苗相比可能产生更强的免疫反应。
扬森指出，与其他疫苗技术相比，RNA似乎可以通过产生抗体和诱导T细胞（即识别和消除感染细胞的白细胞）产生反应，进一步激发免疫系统。
扬森说：“mRNA平台基本上是完全合成的。它是一种明确的分子，可以非常、非常迅速地制造出来，因此不需要用到任何生物，像活病毒、活细胞培养、受精鸡蛋胚胎等，这些统统都不需要。”
信使RNA是制药公司正在使用的一系列新技术之一，这些技术的出现是对人类智慧的一次千载难逢的考验。
阿斯利康(AstraZeneca PLC)和强生公司(Johnson＆Johnson)的疫苗均也基于同一种技术，使用普通感冒病毒来传递遗传指令，教导人类免疫系统进行防御。这些普通感冒病毒是经过改造的，不会引起感染。
这种疫苗技术是强生埃博拉疫苗方案的构成部分，欧洲监管机构今年已批准这一方案。强生和阿斯利康的疫苗目前正处于大规模后期临床试验阶段，结果可能在未来几周或几个月内出来。
默克公司(Merck & Co.)则采用一种较为传统的方法，利用成熟技术的疫苗，繁殖弱化的病毒以产生免疫反应。默克公司表示，与其他技术相比，他们的疫苗可以提供更为持久的保护，免遭新冠病毒侵害，但他们的研发时间要比mRNA疫苗来得更长。
尽管辉瑞和Moderna的疫苗取得了积极的早期结果，但目前还存在很多未知数，例如针对新冠病毒的明显保护能持续多久，疫苗在老年人等高危人群中起效如何等等。
Moderna和辉瑞都在等待更多和疫苗相关的安全数据。美国食品药品管理局 (Food and Drug Administration, 简称FDA)则想要搞清楚在注射疫苗后的两个月内是否会有严重的副作用出现。
mRNA疫苗还有其他一些局限性，这些局限性在其他疾病广泛使用的疫苗中并不常见。
疫苗的储存温度必须为零下，一些卫生部门和医院因此需要竞相寻找特制冰柜。辉瑞制造了一个特殊容器，让疫苗在分销过程中保持低温，并且建立了自己的分销供应链。
为了产生正确的免疫反应，这款疫苗需要注射两剂，中间间隔三到四周，因此需要对接受注射的人进行追踪，确保他们完成两剂疫苗的注射。
全新的认识
从几十年前开始，在遗传学快速发展的推动下，人们开始努力通过利用mRNA来对抗疾病。
20多年前，免疫学家德鲁·魏斯曼(Drew Weissman)和分子生物学家卡塔琳·卡里科(Katalin Kariko)就开始在宾夕法尼亚大学(University of Pennsylvania)实验室里开展mRNA研究。
魏斯曼说，他不仅被RNA引发产生抗病蛋白的潜力所吸引，也对其潜在的安全性问题很感兴趣。
魏斯曼说：“如果它没有融合到基因组中去，就不会发生不良基因变异的情况。”他指出，与此相反的是，本世纪初法国的一项研究显示，一种不同类型的基于基因的疗法会让免疫系统紊乱的病人患上白血病类疾病。
从上世纪七十年代末起，卡里科就已经在她的家乡匈牙利从事mRNA研究。她说，她的同辈们都不敢相信她在这方面的工作已经超过了三十年。
她工作的第一个研究所是在匈牙利的塞格德，当时正是铁幕时期，研究所经费不足，她不得不经常在当地的屠宰场从牛脑中提取生物材料。
“这项技术之前一直没有机会得到证明，现在却在证明自己，”卡里科说。
当研究人员开始在动物身上测试mRNA的时候，问题出现了。在动物身上注射mRNA会引发免疫反应，进而引发炎症。在测试过程中，剂量过高会导致老鼠死亡。
魏斯曼和卡里科开始通过修改mRNA来克服炎症问题。
他们发现，通过改变RNA的一个构件核苷，可以使注射到体内的RNA避开会引发炎症的免疫反应，同时还能让RNA进入人体细胞，传递指令，开始制造所需要的蛋白质。
魏斯曼和卡里科为他们的研究成果申请了专利，宾夕法尼亚大学后来通过中介公司等方式将这项技术授权给了Moderna和BioNTech。2014年，卡里科加入BioNTech，担任高级副总裁。
Moderna花费了几年时间磨练自己的技术。其中遇到的一个大障碍是要找到合适的外壳，把mRNA带向它们在人体细胞中的目标，而不会在途中遭到人体自然产生的的破坏。
Moderna把他们的mRNA包裹在一个由被称作“脂质纳米颗粒”的脂质物质制成的保护膜中，并于2015年开始将mRNA用于人体试验。
Moderna几年前也开始与美国国立卫生研究院(National Institutes of Health)的研究人员合作，制造预防一些传染病的针剂。这一合作为两个团队从1月份开始迅速合作研发新冠疫苗铺平了道路。
纽约大学朗格尼健康中心(NYU Langone Health)疫苗中心主任马克·穆里根(Mark Mulligan)说，mRNA疫苗的早期成功，让我们对未来用于其他疫苗靶标的技术感到鼓舞。
Moderna正在就几种其他预防性的mRNA疫苗进行人体测试，包括一种针对巨细胞病毒的疫苗。巨细胞病毒是一种常见的病毒，若母亲在怀孕期间感染这种病毒，会给婴儿带来健康问题。在早期研究中，这款疫苗的总体安全性良好，并能诱导出理想的免疫反应。测试仍在继续当中。
Moderna还在和默克公司一同测试一种基于mRNA的治疗性疫苗，看它是否可以用来治疗癌症。这种治疗方法根据每个患者肿瘤细胞中的不同突变量身定制。Moderna本月表示，一项小规模早期阶段的研究显示，当这种疫苗和默克公司的癌症药物Keytruda配合在一起注射的时候，在部分头颈癌症患者身上有起效的希望。
BioNTech也在继续推进用于癌症治疗的mRNA疫苗，包括乳腺、皮肤和胰腺肿瘤等等。该公司有几款癌症疫苗正处于开发阶段，包括一款正在进行中期测试的皮肤癌疫苗。