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  <title>启明专栏 | ​启明创投梁颕宇：疫苗研发须加强国际合作 | Qiming Venture Partners</title>
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            <h2 class="font-medium">启明专栏 | ​启明创投梁颕宇：疫苗研发须加强国际合作</h2>
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          <span class="date-display-single">19/06/2020</span>    
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          启明创投    
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          <p><strong>编者按：</strong>文章为启明创投主管合伙人梁颕宇在《大公报》（2020年6月17日）的专栏文章。梁颕宇特别指出，加强国际合作，是疫苗研发尽快能够惠及全球的关键因素。为了加快疫苗上市，梁颕宇建议，不妨考虑采用一个公开透明的制度，只要药厂能证明疫苗达到一个最低的预防率，并清晰列明成分和有效性，即容许已证明无害的疫苗上市。</p>

<p class="rtecenter"><img alt="" src="/sites/default/files/article/%E5%90%AF%E6%98%8E%E8%A7%82%E7%82%B9%20%20%E5%90%AF%E6%98%8E%E5%88%9B%E6%8A%95%E6%A2%81%E9%A2%95%E5%AE%87%EF%BC%9A%E4%B8%AD%E5%9B%BD%E5%88%9B%E6%96%B0%E4%BC%81%E4%B8%9A%E4%BB%A5%E5%AE%9E%E5%8A%9B%E5%85%A8%E7%90%83%E6%88%98%E2%80%9C%E7%96%AB%E2%80%9D_0.jpg" style="width: 640px; height: 360px;"></p>

<section>启明创投主管合伙人梁颕宇</section>

<section>&nbsp;</section>

<section><strong>世界各国陆续解封重启经济，多地新冠肺炎确诊案例旋即反弹，证明要克服新冠肺炎病毒，始终还是要寄望疫苗。</strong>面对这个千斤重担，全球医疗卫生专家和科研人员不敢松懈，以不同技术多线发展，经过近半年时间，欧美和中国已取得较大进展；但是疫情蔓延至南美和非洲发展中国家后，由于医疗卫生系统脆弱，也没有足够研发能力，成了全球防疫一大缺口。<strong>如何实现疫苗在全球，特别是发展中国家的稳定供应和普及应用，成了一个关键课题。</strong></section>

<section>&nbsp;</section>

<section><strong>国家主席习近平5月中出席世界卫生组织大会时，率先提出“团结合作是战胜疫情最有力的武器”，呼吁加强国际抗疫合作。</strong>为了展示中国的承担，他于会上承诺将在两年内提供20亿美元国际援助支持受疫情影响的国家；承诺支持非洲，将建立30个中非对口医院合作机制，加快建设非洲疾控中心总部，协助非洲提升疾病防控能力；并承诺中国新冠肺炎疫苗研发完成并投入使用后，将作为全球公共产品，实现疫苗在发展中国家的可及性和可担负性，是一个强而有力的答案。</section>

<section>&nbsp;</section>

<section><strong>01/</strong></section>

<section><strong>授权技术提升产能</strong></section>

<section>&nbsp;</section>

<section>新冠肺炎疫苗被视为推动经济恢复运行的关键，各国政府均重本支持研发。根据世卫统计，全球目前有逾120种新冠肺炎疫苗在研发，其中约13种进入了人体试验阶段，但能够进入Ⅱ期临床的暂时只有两种：</section>

<section>&nbsp;</section>

<section><strong>一是由美国生物科技公司Moderna研发的信使核糖核酸（mRNA）疫苗；另一是由中国生物科技公司康希诺生物与军事科学院合作研发的腺病毒载体Ad5-nCoV疫苗。</strong>两者均已在国际权威医疗刊物发布Ⅰ期临床初步数据，疫苗安全性和免疫反应正面。</section>

<section>&nbsp;</section>

<section>正当全球均殷切期待疫苗通过进一步试验，可以早日面世，造福全球之时，美国上月却突然宣布退出世卫组织，并拒绝继续提供资金支持全球抗疫。这种独善其身的态度令各国开始担心，即使美国药厂成功开发出疫苗，最终可能会被美国独揽或只以高价出售，令经济条件较差的发展中国家无法受惠。欧盟即时在世卫大会上发声，强调所有国家需要“不受阻碍地及时获得”抗击疫情所需的疫苗、药品、诊断方法和其他技术，支持加强合作交流。</section>

<section>&nbsp;</section>

<section><strong>至于同样在新冠肺炎疫苗研发领跑的中国，一直抱开放态度，乐意分享研发成果，鼓励国内疫苗开发商与不同国家合作，通过资源互补和技术交流，互相补充不足，务求把疫苗开发时间缩至最短，并确保研发成功后，可第一时间在各国推出，为所有人带来希望。</strong></section>

<section>&nbsp;</section>

<section><strong>以研发进度名列前茅的康希诺生物为例，</strong>5月在权威医学杂志《柳叶刀》刊登其疫苗的Ⅰ期临床数据后，立即宣布与加拿大国家研究委员会（NRC）签订合作协议，推进疫苗在加拿大的Ⅰ／Ⅱ期临床试验，与国内的Ⅱ期临床同步进行；并积极寻求与其他国家合作进行Ⅲ期临床试验，以解决国内发病率低，难以找到足够参与者做试验，无法累积审批疫苗所需关键数据的困局。</section>

<section>&nbsp;</section>

<section>另外，致力研发传统灭活疫苗的北京科兴生物，亦宣布与疫情严峻，累计确诊感染案例逾80万个的巴西合作，由巴西的布坦坦研究所（Instituto Butantan）安排9000名志愿者参与其CoronaVac疫苗Ⅲ期临床，双方还同意在技术许可、市场授权和疫苗商业化方面合作，一旦试验成功，巴西合作伙伴可采用CoronaVac的技术，自行在巴西生产疫苗。</section>

<section>&nbsp;</section>

<section>上述包含技术转移的合作方式，尤其适合像巴西这些发展中国家。因为从过往经验所得，即使已找到一款有效疫苗，并获监管当局批准上市，问题只解决了一半，后续还要面对批量生产和如何配发等挑战。<strong>新冠肺炎疫苗需求庞大，不管哪一国家先开发出来，生产力也难于短时间内追上全球需求，通过与不同国家合作，授权技术和生产是即时提升生产力，避免出现供应瓶颈的上策。</strong>发展中国家则可藉本土生产有效控制成本，确保人民可以负担得起的价钱，享受到携手开发疫苗的成果。</section>

<section>&nbsp;</section>

<section>
<section><strong>02/</strong></section>

<section><strong>统一疫苗上市标准</strong></section>
</section>

<section>&nbsp;</section>

<section>看目前的发展进度，只要各国愿意加强合作，相信全球最终可有5种至10种疫苗达阵。<strong>至于第一种疫苗何时能面世，克服技术困难以外，更重要的是有效标准问题，即疫苗要达至多大的预防率，各地政府才接受并批准其面世。</strong></section>

<section>&nbsp;</section>

<section>一直以来，不同国家审批疫苗时都有不同准则，有紧有松，如何在确保疫苗安全有效和快速推出中取得平衡，是全球卫生官员要面对的选择。</section>

<section>&nbsp;</section>

<section>只是世纪疫情当前，一些疫情严峻新增病例较多的国家，无论是发达国或发展中国家，每天有数以千计患者离世，无可避免要考虑容许一些因临床试验需时，无法在短期内递交全部有效数据的疫苗，临时推出市场应急，并在后续使用中评价疫苗的效果。<strong>每个国家都要在重启经济和疫苗门槛中作出选择，监管机关和地方疾控中心可参考其他国家或地区的做法，才决定是否予以适度放宽。</strong></section>

<section>&nbsp;</section>

<section>事实上，<strong>不少现有疫苗如流感疫苗都不能保证100%有效，只能做到一定预防率；一些疫苗功能更不是预防感染，而是减低感染后反应，把病毒杀伤力降至最低，大家是否愿意接受，可直接左右疫苗面世速度。</strong>又如疫苗的有效期要多长才算有效，是否必须终生免疫，要定期注射的疫苗可否获批？</section>

<section>&nbsp;</section>

<section>或是真的有人开发出一种可100%预防感染的疫苗，但制作工艺异常高，全球只有少数企业能生产，而且产能很低，是否就完全不考虑其他预防率略低，但能够迅速投入大量生产的疫苗？</section>

<section>&nbsp;</section>

<section><strong>诸如此类的因素都需要小心衡量。</strong></section>

<section>&nbsp;</section>

<section>要达到哪一个有效率才能让疫苗过关是一个微妙平衡，不同国家可能有不同想法。<strong>各国考虑到疫情严峻，而且容易人传人，为了加快疫苗上市，亦不妨考虑采用一个公开透明的制度，只要药厂能证明疫苗达到一个最低的预防率，并清晰列明成分和有效性，即容许已证明无害的疫苗上市。</strong>这做法除了能加快疫苗上市，更重要是提供了选择，让一些条件较差、负担不起昂贵的疫苗的国家或个人，可以有较合理的选择，真正保障到他们接种疫苗的权利。</section>

<section>&nbsp;</section>

<section>全球为疫苗把关的卫生机构和人员也许可尝试讨论，<strong>一个公开透明、有选择，让接种者自行评估风险，选择接种哪一种疫苗的制度，是否是击退新冠肺炎病毒的一个最实际可行的做法。</strong></section>
    
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