写的:
汤娅Villafana
全球连锁加盟头感染
Testing a potential new vaccine on human volunteers is a key step in the journey from laboratory to clinic, and ensuring that volunteers represent those who will need to be vaccinated is a major priority. im体育首页需要向所有需要疫苗的人证明疫苗的安全性和有效性, 不管他们年龄多大, 性, 种族与整体健康, 无论他们住在哪里.
Historically, clinical trials for vaccines were mainly carried out in North America and Europe. 然而, 20年前, when I moved to Botswana to set up HIV vaccine trials in collaboration with the US National Institutes of Health HIV Vaccine Trials Network, 让当地社区参与疫苗研究的重要性立即显现出来.
Establishing trials in the communities where vaccines are needed helps to ensure that safety and efficacy data are relevant to those vaccinated. It also helps to build understanding of the importance of vaccines and confidence in their use. 在大流行中，这一点可能更为重要，因为所有大陆的人都受到影响. 新型冠状病毒肺炎疫苗试验计划与im体育首页以前见过的任何情况都不同, 或者可能会再次发生. 希望参与的国家当然不少, im体育首页把国家包括进来，以确保全球代表性的多样化.
安全性和有效性测试
比如新药, 疫苗从小型试验发展到确定效力的大型研究. Specifically vaccines progress from Phase 1 safety studies in a small number of healthy volunteers, usually through Phase 2 safety and immunogenicity studies in a few hundred and finally to large Phase 3 trials to compare vaccine safety and efficacy against placebo or control vaccine in thousands of volunteers. Vaccine studies also test each volunteer’s immune response to the target virus or bacterium. This may mean measuring both humoral and cellular components of the immune system including neutralising antibodies and, 在某些情况下, T细胞. For SARS CoV2 we do not know what level of immune response corresponds to protection against 新型冠状病毒肺炎. This is currently being investigated in the context of vaccine efficacy for multiple vaccine candidates and very exciting for scientists as we seek to determine “correlates of protection” against disease. 许多问题仍然存在，包括多久需要注射一次, 剂量之间的间隔是最佳的, how long vaccination provides protection and can different vaccines be given together to optimise immune responses and protection.
疫苗的三期试验往往比新药的三期试验规模更大. 疫苗在健康人群中进行试验, so great attention and scrutiny is paid to monitoring adverse effects and ensuring the benefit/risk for healthy populations is appropriate. 通常情况下，尽可能多的人被录取.
用于预防导致严重疾病的呼吸道病毒, 比如新型冠状病毒肺炎, 确定疫苗是否能减少疾病的严重后果是很重要的, 比如严重的呼吸问题需要住院治疗, 重症监护室的人工通风, 或死亡. We also investigate whether the vaccine reduces less severe respiratory disease and the risk of the virus spreading from person to person.
试验志愿者的鼓舞人心的反应
在大型三期临床试验中快速得到结果, recruitment is initially carried out in countries or regions with the highest levels of the infection that a vaccine is designed to prevent, 所以它的功效可以在高危人群中进行测试.
以前为大规模艾滋病毒疫苗试验而开发的基础设施, 疟疾和拉丁美洲的其他疾病, Asia and Africa have been instrumental for recruiting volunteers at highest risk of 新型冠状病毒肺炎, 比如有色人种, 在过去12个月的疫苗试验中. 协助试招, collaborations between industry and organisations such as the 新型冠状病毒肺炎 Prevention Network (CoVPN), 由美国国家过敏和传染病研究所(NIAID), 非常重要. They have been able to leverage approaches based on the volunteering networks for HIV vaccine and prevention studies, 哪些在世界范围内被证明是成功的.
It is truly inspiring to see the commitment of community networks in spreading the word about the importance of 新型冠状病毒肺炎 vaccine trials and the value of volunteering, 并见证那些挺身而出参与的人们的慷慨.
和大多数疫苗开发一样, 新型冠状病毒肺炎疫苗试验在18-55岁的健康志愿者中开始, after initial safety and immunogenicity information was collected trials were extended to older adults who are more susceptible to disease. For AZD1222 studies, enrolment extended to those aged 55-69, followed by older adults over70.
We do not expect significant differences in clinical data from vaccine trials of people of different ages, 性 or ethnicity but it is important for all those at risk of infection to be included and for this to be investigated. Regulatory agencies and institutional review boards/ethics committees also expect trials to reflect the burden of disease in different groups of people.
将多样性扩展到现实世界的研究中
大流行期间, we have worked closely with regulators to ensure that each stage of data review is carried out as rapidly and efficiently as safely possible. 结果是, the first approval of a 新型冠状病毒肺炎 vaccine for emergency use occurred only nine months after research began – an incredible achievement. Full approval of all 新型冠状病毒肺炎 vaccines will require longer term data showing durable immune responses and reduced disease, 住院率和死亡率.
We are also collecting real world safety and efficacy data from hundreds of thousands of vaccinated individuals to confirm clinical trial findings and extend our knowledge across ever more diverse populations including those in poor health due to other diseases or old age. Novel dosing frequencies of vaccines as well as combinations of different vaccines are also being investigated.
在我参与疫苗研发20多年后, 我为我的科学家同行们所取得的成就感到无比自豪, 临床医生, 社区团体及, 当然, 志愿者本身, 让新型冠状病毒肺炎疫苗为世界各地的人们带来成果. im体育首页把不可能变成可能!
