MEDICC Review.
MEDICC Rev. 2022 Jan 31;24(1):9-13. doi: 10.37757/MR2022.V24.N1.11.
As 2021 drew to a close, Cuba struggled to contain the highly transmissible omicron variant of SARS-CoV-2, braced for a new wave of infections and kept a close eye on other variants of concern popping up around the world-a common experience to countries everywhere as we head into the second year of the pandemic. In Cuba, however, there is one marked difference making all the difference: by early January, 87% of the population was fully vaccinated using a three-dose schedule of vaccines developed and produced on the island.[1] This massive vaccination campaign is complemented by a rapid booster rollout-also using Cuban vaccines-that began in December 2021 and was ongoing as we finalized this issue. The island nation was able to achieve the third highest COVID-19 vaccination rate in the world[2] after decades of scientific investment, research, discovery and innovation; regulatory oversight and compliance; professional training; and increased production capacity. But a vaccine is only as effective as the health system charged with administering it-in a safe and timely manner, to as many people as possible. Here too, Cuba has decades of experience, including a national pediatric immunization program where 98% of children under 5 are immunized against 13 diseases,[3] an annual polio vaccination campaign (both launched in 1962 and uninterrupted since) and campaigns to contain epidemics such as H1N1. When the first COVID-19 cases were detected on the island in March 2020, Cuba harnessed this vaccine experience, making a hard tack towards developing its own vaccines. Two of the main protagonists in the country's biotechnology development, the Finlay Vaccine Institute (IFV) and the Genetic Engineering and Biotechnology Center (CIGB), both with several groundbreaking preventive and therapeutic vaccines in their portfolios, led the search for a vaccine. Today, Cuba has three vaccines authorized for emergency use-Soberana 02 and Soberana Plus developed by IFV, and Abdala, developed by CIGB. Schedules with these vaccines have demonstrated more than 90% efficacy in clinical trials,[4] and after regulatory approval for emergency use, became the backbone of Cuban COVID-19 vaccination efforts. A fourth vaccine, Mambisa (CIGB), administered nasally, and a fifth, Soberana 01 (IFV) are still in clinical trials. For this installment in MEDICC Review's series spotlighting leading women of Cuban science, we sat down with Dr Verena Muzio, Director of Clinical Research at CIGB. A pioneer of Cuba's biotechnology sector, she is an immunologist with a doctorate in biological sciences. Her professional trajectory began researching the genetically engineered hepatitis B surface antigen that led to the development of Cuba's recombinant hepatitis B vaccine in 1989. The same technological platform used in this vaccine was used to develop CIGB's Abdala vaccine against SARS-CoV-2-part of the reason Cuba was able to secure a vaccine so quickly. A phase 3 clinical trial determined a 92.28% efficacy rate for Abdala, with results to appear in forthcoming publications.
2021 年末,古巴努力控制高传染性的 SARS-CoV-2 奥密克戎变体,为新一波感染做好准备,并密切关注世界各地出现的其他令人关注的变体——这是我们进入大流行第二年世界各地各国的共同经历。然而,在古巴,有一个明显的区别:到 1 月初,87%的人口使用三剂在岛上开发和生产的疫苗完全接种疫苗。[1] 这项大规模疫苗接种运动得到了快速加强针的补充——同样使用古巴疫苗——于 2021 年 12 月开始,并在我们完成本问题时仍在进行。这个岛国在经过几十年的科学投资、研究、发现和创新;监管监督和合规性;专业培训;以及提高生产能力之后,实现了世界上第三高的 COVID-19 疫苗接种率。[2] 但是,疫苗的有效性取决于负责以安全和及时的方式为尽可能多的人接种疫苗的卫生系统。在这方面,古巴也有几十年的经验,包括全国儿科免疫规划,该规划使 98%的 5 岁以下儿童能够预防 13 种疾病,[3] 每年开展脊髓灰质炎疫苗接种运动(均于 1962 年启动,此后从未中断)以及开展 H1N1 等传染病的防治运动。2020 年 3 月在岛上首次发现 COVID-19 病例时,古巴利用了这种疫苗经验,朝着开发自己的疫苗迈出了艰难的一步。在该国生物技术发展中的两个主要参与者,Finlay 疫苗研究所(IFV)和基因工程和生物技术中心(CIGB),都在其产品组合中拥有几种具有开创性的预防和治疗疫苗,引领了寻找疫苗的努力。今天,古巴有三种紧急使用授权的疫苗——IFV 开发的 Soberana 02 和 Soberana Plus,以及 CIGB 开发的 Abdala。这些疫苗的时间表在临床试验中显示出超过 90%的疗效,[4] 并在获得紧急使用批准后,成为古巴 COVID-19 疫苗接种工作的骨干。第四种疫苗 Mambisa(CIGB)经鼻给药,第五种疫苗 Soberana 01(IFV)仍在临床试验中。在 MEDICC Review 系列中以古巴科学领域的杰出女性为特色的这一期中,我们采访了 CIGB 临床研究主任 Verena Muzio 博士。她是古巴生物技术领域的先驱,是一位免疫学博士,拥有生物科学学位。她的职业生涯始于研究基因工程乙型肝炎表面抗原,这导致 1989 年开发出古巴重组乙型肝炎疫苗。用于开发古巴重组乙型肝炎疫苗的同一技术平台用于开发 CIGB 针对 SARS-CoV-2 的 Abdala 疫苗——这也是古巴能够如此迅速获得疫苗的部分原因。一项 3 期临床试验确定了 Abdala 的 92.28%疗效,结果将出现在即将出版的出版物中。