IFPMA. //www.bbaltong.com 国际药品制造商和协会联合会 星期四,7月8日15:00:02 +0000 en - 每小时 1 为什么我们必须消除贸易障碍以实现疫苗公平(步骤3) //www.bbaltong.com/global-health-matters/why-we-must-remove-barriers-to-trade-to-achieve-vaccine-equity-step-3/ 玛蒂娜Bilova 星期三,07年7月2021年7月14:00:01 +0000 COVID-19疫苗 贸易限制 疫苗股本 //www.bbaltong.com/?post_type=health_matters& p=13157 为了结束大流行,业界被要求从零开始生产和供应数十亿种COVID-19疫苗。这一重大任务正在逐步实现,据世界银行预测,到2021年底将有110亿剂疫苗,足以满足世界成人人口的需求。然而,贸易限制,在[& # 8230;]< / p > < p > post < rel =“nofollow”href = " //www.bbaltong.com/global-health-matters/why-we-must-remove-barriers-to-trade-to-achieve-vaccine-equity-step-3/ " >为什么我们必须消除贸易壁垒实现疫苗股本(步骤3)< / >第一次出现在< rel =“nofollow”href = " //www.bbaltong.com " > IFPMA < / >。< / p >

为了结束这一流行病,该行业的任务是从零开始制造和供应数十亿种新冠病毒-19疫苗。这项艰巨的任务即将实现,据世界银行统计,到2021年底,预计将达到110亿剂。然而,贸易限制以及其他障碍阻碍了上游和下游的供应,对实现疫苗公平提出了重大挑战。

生产

世贸组织及其成员国已经认识到并承认这一瓶颈。世界贸易组织(WTO)总干事Ngozi Okonjo-Iweala博士最近指出,仅在2021年,与用于对抗新冠病毒-19的医疗用品相关的贸易限制就增加到53项。今年还出现了对疫苗分销的贸易限制。为了解决这些问题,一些成员国提出了一份关于贸易和卫生的宣言草案。[2]

为了满足前所未有的需求,工业界已经达成了300多个制造业协议,其中220个涉及技术转让。需要熟练工人来转让技术,并对制造商进行质量和安全培训,他们的可用性也受到贸易限制的严重影响。尽管业界尽了最大努力并制定了强有力的应急计划,但这些瓶颈仍在继续干扰新冠病毒-19疫苗的生产和供应。

因此,作为我们的实现疫苗公平的五个步骤,我们呼吁各国政府取消贸易限制,以便关键供应品、疫苗和熟练工人不间断地流动,为全世界生产足够剂量的新冠肺炎疫苗,以结束这一流行病。

贸易相互依存:商品和服务

疫苗生产非常复杂,专业化并依赖于全球供应链,货物、服务和人员的快速运输。

单一疫苗的复杂性意味着需要全球供应商提供大量成分。例如强生公司,;约翰逊疫苗包含180种成分,在12个国家的67个工厂生产;辉瑞生物技术公司的疫苗需要280种成分,依赖于分布在19个国家的86家供应商,仅在三家制造厂生产;Moderna疫苗的数量与此相似。

脂质对于mRNA疫苗的提供非常重要,而在流感大流行之前,这种疫苗并不需要如此大规模。生产和储存疫苗需要不同类型的设备,如生物反应器和冰箱/冰柜。疫苗的制造、包装、储存和管理需要其他医疗用品,如小瓶、冷盒、注射器和针头。目前,六个关键投入品供应正面临或可能面临短缺:生物反应器袋、一次性组件、过滤器、细胞培养基、脂质、小瓶和塞子。

更复杂的是,没有一个生产线或生产线与另一种疫苗的生产线或生产线相同。Airfinity,一家提供疫苗生产实时信息的生命科学分析公司,已经绘制了全球83个疫苗原料药生产点的地图[2],每个都有自己的流程。

尽管存在这些挑战和复杂性,许多国家仍然对医疗产品实施贸易壁垒和关税。五分之一的国家对疫苗征收积极关税,其中8%的国家的关税等于或大于5%。取消或降低医疗产品和投入品的关税将有助于加快生产。

今天,我们面临的风险是单一成分被滞留在边境,导致整个生产过程停止。对上游供应链的限制正导致原材料短缺。其中许多重要组成部分和下游供应链上的组成部分正在影响分配,导致剂量被浪费和处置,并延长大流行时间。这是全世界都知道的nnot afford.

Governments need to address and eliminate unnecessary supply chain barriers and export restrictions on both intermediate and final goods so we can get vaccines to people, curb excessive stockpiling and end this pandemic.

And where export restrictions are critical and need to be applied, they should be targeted, proportional, transparent and temporary. We echo the statement by Dr. Ngozi calling on the G20 leaders to “do more,” from donating more COVID-19 vaccines to removing trade restrictions that affect the vaccine supply chain.

Trade Interdependencies: Personnel

Given the complexity of the vaccine manufacturing process, a skilled workforce is the lifeblood of the process. If trained workers are not conducting quality checks and scientific equations, the raw materials being used will go to waste and production will have to restart.

A skilled workforce is also vital for successful technology transfer between vaccine makers. Not only are they involved in the production process, they also train the licensees to manufacture. Training for technology transfer is time intensive. It helps if the licensee can absorb the technology. For example, the Moderna facility in Switzerland (Lonza site) was unable to be up and running at an earlier date because the facility could not hire enough skilled workforce.

Needless to say, a skilled workforce is an invaluable component of the entire vaccine manufacturing process and is already stretched due to the pandemic. This workforce needs to be efficiently and effectively used. Today, the top 10 vaccine manufacturers have more than 5000 vacancies for skilled workers[3]. Prioritizing the movement of skilled workers across borders is crucial to ensure training for tech transfer takes place and large manufacturing plants have the required workforce to conduct quality and safety checks.

Vaccine Protectionism

The barriers to trade are further complicated when governments put policies in place to safeguard their own vaccine supplies for their population. These policies can lead to supplies being disposed of unused, while other countries are requesting that very supply—this needs to be revaluated. The measures also put unnecessary pressure on the supply chain,  the impact of which has been acutely felt during the pandemic, as noted by World Health Organization (WHO) and WTO.

For example, the US employed export controls under the Defense Production Act (DPA) to prevent companies from exporting vaccine doses or ingredients without federal government authorisation. This decision was misguided and led to hurdles in production, as noted above. A similar restriction was placed by India, impacting supply to COVAX.

We have also seen national legislations restrict exports of raw materials. According to Airfinity, 39% of bioreactors suppliers and 37% of lipid suppliers are headquartered in the US. Legislation like the DPA controls the export of these raw materials, which leads to production lines being held up, impacting overall supply. This issue became so dire that it led to the CEO of the Serum Institute of India appealing to the US President on Twitter to lift the embargo on raw material exports out of the US, “if we are to truly unite in beating this virus.”  Rajinder Suri, CEO of the Developing Countries Vaccine Manufacturers Network (DCVMN), stressed that the export restrictions have implications for the COVID-19 vaccine rollout across the world.

It was a welcome change in June this year when countries, including the US and EU Member States, agreed to dose sharing, and we hope that India can start exporting by October. Nevertheless, more can be done, as highlighted by WHO and WTO. Dr. Ngozi called for the G20 to donate at least two to three billion more doses to countries with high disease burdens.

Call to Action

There is growing recognition that the immediate needs of the biopharmaceutical and biotech industry to achieve vaccine equity are hampered by shortages of raw materials and restrictions on distrubution through export bans.

The WTO and its members have an important role to play to eliminate trade restrictions, to adopt policies that expedite the cross-border supply of inputs and finished vaccines, and to allow the movement of skilled workforce.

On 31 June 2021, 23 member states communicated a draft text for a Declaration on Trade and Health to be announced at the WTO Ministerial Conference in November. It includes reviewing and removing export restrictions with efforts to be made to remove or reduce tariffs.

These calls now need to become actions. Viruses ignore borders and supply chains are global. Only by removing trade restrictions and working together to streamline border processes do we stand a chance of ending the pandemic and achieving vaccine equity.

[1] Airfinity Presentation at WTO COVID-19 Vaccine Supply Chain and Regulatory Transparency Technical Symposium on 29 June 2021: 

[2] https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/Jobs/GC/251R3.pdf&Open=True

[3] https://www.wsj.com/articles/covid-19-vaccines-are-in-high-demand-but-thousands-more-workers-are-needed-to-make-them-11609764172

The post Why we must remove barriers to trade to achieve vaccine equity (Step 3) appeared first on IFPMA.

COVID-19疫苗:满足世界需求(第二步) //www.bbaltong.com/global-health-matters/covid-19-vaccines-meeting-the-worlds-need-step-2/ 玛蒂娜Bilova 星期一,6月28日05:00:59 +0000 //www.bbaltong.com/?post_type=health_matters&p=13080 提高COVID-19疫苗的产量是确保为风险最大的所有人群提供足够剂量的关键。但按照世界所需量生产COVID-19疫苗是一个巨大的挑战,原材料的短缺和贸易壁垒可能会打乱110亿剂疫苗的估计——这足以满足世界成人人口的需求[…]

href="//www.bbaltong.com/global-health-matters/covid-19-vaccines-meeting-the-worlds-need-step-2/">COVID-19疫苗:满足世界需求(步骤2)首先出现在IFPMA.

增加新冠病毒-19疫苗的生产是确保所有高危人群都有足够剂量疫苗的关键。但以全世界所需的数量生产新冠病毒-19疫苗是一个巨大的挑战,而原材料的稀缺和贸易壁垒可能会打乱到2021年底可以生产110亿剂疫苗的估计。要实现疫苗公平,疫苗生产产量必须得到优化,供应链中的瓶颈要么先发制人,要么紧急解决。

并非一成不变

扩大生产规模是一项艰巨的任务,但多亏在流感大流行的头几个月采取的措施,自首次批准新冠病毒-19疫苗以来,在过去六个月内,新冠病毒-19疫苗的产量已从零增加到30亿剂。

这需要在发达国家和发展中国家的制药和疫苗行业进行前所未有的努力和合作。好消息是,我们现在正走上大流行前全球所有疫苗生产能力翻一番以上的轨道,并在年底前实现110亿剂新冠病毒-19疫苗。

但生产需要加快并优化。目前,无论是mRNA疫苗、病毒载体疫苗还是重组蛋白疫苗,单批生产都需要90至120天。各公司正在努力尽可能缩短交付周期。例如辉瑞生物技术公司启动了“光速项目”,将其mRNA疫苗的生产时间从110天缩短到60天。

成功的合作

从一开始,该行业就知道它需要迅速扩大规模,疫苗制造商迅速开始在世界各地寻找合适的和值得信赖的合作伙伴拥有可靠的业绩记录和“最佳匹配”,确保了质量、效率和生产规模。今天,有300多个伙伴关系和合作伙伴正在与疫苗制造商一起为这一历史性的努力而努力。

迄今为止所取得的成就是前所未有的,许可协议和技术转让是扩大规模的基础。创建全球优化的供应商和生产商网络的努力正在取得成效。

我们看到来自发达国家和发展中国家的生物技术、制药公司和合同制造组织(CMO)齐聚一堂提高产能。疫苗创新者已经与数百家公司建立了联系,其中最著名的是印度泰瑟姆研究所、巴拉特生物技术公司、阿斯彭制药公司以及生物工程公司。合作是否涉及帮助从头开始生产疫苗,或为最终阶段做出贡献,例如疫苗创新者将通过转让其专有技术和技术来帮助“填充和完成”,以确保合作伙伴能够达到所需的质量水平,以及最佳的产出水平。

这种知识共享确实需要时间才能实现。例如,除了现有的制造能力,强生公司;约翰逊已与全球10多个生产合作伙伴签订多项协议,以扩大原料药、药品或包装的生产能力。其中一个合作伙伴是Aspen Pharma,Johnson&;约翰逊去年同意转让其技术。他们的共同努力将很快得到回报,首批药瓶将在未来几周内离开南非的生产线。但有时,尽管每个人都尽了最大的努力,事情还是出了差错。强生公司之一;约翰逊合作伙伴在美国的紧急生物解决方案被发现不完全符合安全性和有效性要求。这导致FDA介入并决定丢弃7500万剂。

许多人听说阿斯利康去年4月与印度血清研究所达成了许可协议,但这并不是阿斯利康参与的唯一合作。该公司最近宣布了与巴西Fiocruz的技术转让协议,它基本上建立在现有的填充物和饰面上,以允许活跃的药物生产。

自从IFPMA宣布其19日紧急改善疫苗公平性的五步计划href=”//www.bbaltong.com/resource-centre/five-steps-to-urgently-advance-covid-19-vaccine-equity/“>th五月,已经很高的合作伙伴数量已从286家进一步增加到307家。新的合作伙伴包括AGC Biologics and BioNTech or Moderna and Samsung Biologics and Thermo Fischer Scientific.

Technology transfers are complex in their nature, including the technology itself. Certain external factors play a key role in determining whether a company wishes to engage in a technology transfer within a region. These factors include a transparent and stable legal and policy framework, an innovation ecosystem backed by intellectual property incentives, high technical and regulatory standards, availability of raw materials and trade barriers, to name a few. In addition, it is crucial that the partner being selected is one that has the capacity and capability to absorb the technology, have the necessary skilled worker and the ability to scale up. A proven track record on safety and quality is undeniably a factor where no compromise should be made.

The basis of any technology transfer arrangement is trust and willingness to work together, and we have seen how transfer of know-how can be greatly accelerated.

Challenges Ahead: Shortages of Critical Supplies and Workforce

Despite the best efforts of all those involved in the scaling up of manufacturing, there are numerous challenges that could thwart vaccine production and the first year estimate of 11 billion doses. Raw materials are in short supply and scarcity of critical input supplies, such as bioreactor bags, single-use assemblies, cell culture media, filters, lipids, vials and stoppers is hampering production. A delay in the supply chain of any one of these components can set back production output by weeks if not months.

It is important to stress that these ingredients are also needed for other routine vaccines, such as hepatitis, measles, shingles and biological medicines used in the treatment of cancer. Greater visibility in the supply chain could help avert these bottlenecks.

Also key to continued production is a skilled workforce. Vaccines are complex biological products, and their production and oversight requires a complicated dance of multiple experts in manufacturing, quality, regulation, engineering, and logistics as well as trainers, lab technicians, maintenance crews, scientists, and many more. Pharmaceutical manufacturing teams are currently stretched, and additional specialized technicians are needed to ensure the smooth running of the myriad of production steps and quality checks. As Moderna experienced when Lonza was unable to start production as soon as had been hoped, due to a lack of skilled technicians needed to set up and run production lines.

The World Trade Organization (WTO) and The World Customs Organization (WCO) also have an important role to play to work with governments to eliminate trade barriers to export and to adopt policies that facilitate and expedite the cross-border supply of key raw materials, essential manufacturing materials and vaccines, along with the prioritized movement of skilled workforce needed for COVID-19 vaccine manufacturing.

Speed up Regulatory Processes

Finally, the pandemic has shown that regulatory systems can collaborate and be more agile, and this can help avoid wasting time and resources. Regulatory approvals for COVID-19 vaccines have been facilitated and accelerated, but there is a need to continue to harmonize regulatory standards across countries and speed up requirements to validate processes, approve new manufacturing sites, and avoid redundant local testing that could reduce the remaining shelf life for a vaccine.

In addition, the emergence of variants requires regulatory authorities to react quickly to approve updated vaccines. Solutions to help expedite these approvals include use of reliance, work-sharing, and recognition processes along with digitalization.

Staying Ahead

Industry continues to carry out research to ensure the wheel of innovation continues. We are hopeful that several new vaccines are likely to come to the market in the next few months. Upon regulatory approvals, Novavax remains on track to reach manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the fourth quarter of 2021.

However, addressing bottlenecks with practical steps must continue. That’s why our 5-steps plan to urgently address vaccine inequity is important. Manufacturers, governments, and non-governmental organizations must work together to take urgent steps to address vaccine inequity, with immediate action on stepping up responsible dose sharing and maximizing production without compromising quality or safety. We must remain ahead of the virus and collaboration is the only way out of the pandemic.

The post COVID-19 vaccines: Meeting the world’s need (Step #2) appeared first on IFPMA.

协调监管要求,加快疫苗供应 //www.bbaltong.com/global-health-matters/harmonization-regulatory-Requirements-to-accelerve-the-supply-of-vaccines/ 玛蒂娜Bilova 星期五,6月25日06:00:33 +0000 //www.bbaltong.com/?post_type=health_matters& p=12934

本博客最初于2021年6月25日发表在“媒体星球运动的疫苗价值”上。在过去几十年里,全球监管环境变得更加严格,要求始终如一地保证药品和疫苗的质量、安全和效力。需求的增加,监管当局尚未实现[& # 8230;]< / p > < p >的<一个rel =“nofollow”href = " //www.bbaltong.com/global-health-matters/harmonizing-regulatory-requirements-to-accelerate-the-supply-of-vaccines/ " >协调监管要求加快疫苗供应的< / >第一次出现在 IFPMA < / >。< / p >

本博客最初于2021年6月25日发表于媒体星球运动的疫苗价值

过去几十年,全球监管环境变得更加严格,要求始终如一地保证药品和疫苗的质量、安全性和有效性。

监管当局增加的要求并没有在世界各地得到同等的实施。如今,我们在档案审查、审批流程和时间表方面存在高度的异质性,每个国家都有特定的数据要求和流程,这些要求和流程往往在国家之间存在差异。因此,世界上每个国家几乎不可能同时获得药品和疫苗。遗憾的是,尽管疫苗被广泛认为是退出COVID-19大流行的最重要工具,但全球各地的监管要求尚未统一和简化,以加快获取。

它突出了该系统的一些弱点,更确切地说,是在生产和控制的法规管理方面。例如,验证、批准和认可新的生产设施的过程仍然不够灵活,这是扩大疫苗生产的一个关键步骤。

 width=Harmonizing regulatory requirements to accelerate the supply of vaccines appeared first on IFPMA.

剂量分享是实现疫苗公平的关键紧急步骤:它需要得到支持才能取得成功(第1步) //www.bbaltong.com/global-health-matters/dose-sharing-is-a-critical-urgent-step-towards-vaccine-equity-it-needs-support-to-be-successful/ 玛蒂娜Bilova 6月24日星期四07:00:58 +0000 //www.bbaltong.com/?post_type=health_matters&p=13088 一些能够获得足够剂量为本国人口接种疫苗的国家迄今已承诺在2021年和2022年向低收入和中等收入国家提供10亿剂疫苗。现在我们需要确保这些承诺实现和疫苗达到[& # 8230;]< / p > < p >的<一个rel =“nofollow”href = " //www.bbaltong.com/global-health-matters/dose-sharing-is-a-critical-urgent-step-towards-vaccine-equity-it-needs-support-to-be-successful/ " >剂量分享是一个关键紧急一步疫苗股权:if IFPMA.

.if IFPMA.

.if IFPMA.

解决疫苗公平问题的生物制药五步计划的第一步

到目前为止,许多能够为本国人口接种足够剂量疫苗的国家已承诺在2021年和2022年为中低收入(LMIC)国家提供10亿剂疫苗。我们现在需要确保这些承诺得以实现和实现疫苗到达最需要它们的人手中

好消息是,可用剂量越来越多。不仅仅是因为全球生物制药行业有望在2021年底前生产110亿剂疫苗。如果公平分享,这就足以为全世界大部分成年人接种疫苗。

为了确保这些疫苗能够送达需要疫苗的人,政府间的合作,需要行业和其他利益相关者规划疫苗的有序分发——以这样的方式进行分发,即各国尽快获得首批共享剂量,而不是在2021年底一次性获得所有剂量。

疫苗推广的后勤工作非常复杂。别忘了,这是前所未有的规模。向城市和偏远地区的数十亿人提供疫苗的复杂性是多方面的,所有这些都与疫苗保质期的滴答声背道而驰。

规划

确保剂量共享兑现其公平承诺的关键远远超出了承诺。这是关于拥有所有必要的信息,以了解需要由谁和何时做什么。一旦明确指定剂量何时可用以及在何处产生最大影响,整个链条上的专家就可以迅速采取行动。

我们需要以可靠和可预测的方式提供剂量。我们需要跟踪进展,以解决瓶颈问题并从中吸取教训。我们需要齐心协力。

五步计划

我们知道需要在五个方面采取行动,以推进新冠肺炎疫苗公平性:

  1. 加强剂量共享
  2. 推动进一步创新。

这些步骤是相互依存的:为了使剂量共享获得成功,我们需要同时在所有步骤上取得进展。

那么我们现在在哪里,我们知道些什么?有一个好消息是,一些重要的公告已经发布。

七国集团国家已承诺向较贫穷国家提供10亿剂,主要是通过COVAX,其中一半以上的剂量将于2021年交付。法国已经开始交付。美国还宣布捐赠5亿剂辉瑞生物技术公司(Pfizer BioNTech)疫苗,该疫苗由辉瑞生物技术公司(Pfizer BioNTech)以非盈利价格提供。此外,在最近举行的G20全球卫生峰会上,疫苗制造商承诺在2021年和2022年向中低收入国家提供35亿剂新冠病毒-19疫苗,成本或折扣价为新冠病毒和其他既定机制,除了早些时候承诺的8亿剂之外。

我们还需要深入了解这些承诺将以多快的速度兑现,以及能够以多快的速度推广这些药物,并将其投入到武器中。根据最新预测它们应该很快开始大量提供,然后在这一年中以相对均衡的速度进行[1]。但我们知道,由于我们知道技术问题、监管流程、交付限制可能会对供应计划产生影响,因此预测将继续发展。

随着我们努力实现全球疫苗公平,所有这些发展,希望还有更多的发展,都是令人鼓舞的。但道路上可能会有坎坷,因为我们都在做一些以前从未做过的事情。

加速推广

剂量共享仍然是一项极为复杂的全球事业,风险极高。制造商需要与全球数百家合作伙伴合作,加快生产速度,并在满足所有监管和法律要求的同时快速发货。他们必须像激光一样关注供应链,以确保所有疫苗批次的质量和安全。政府需要为疫苗进入本国铺平道路,同时保护本国公民。监管机构需要确保安全、问责和流程。

如果捐赠剂量要送达目标人群,政府、行业和其他利益相关者需要合作解决这些复杂且相互关联的挑战。

解决部署差距。

一旦捐赠剂量,如果他们想要接触到有风险的人群,相关组织和计划需要确保为治理提供资金和支持ments to enhance their vaccine distribution capacities. The timeline of deliveries should also be informed by the countries’ absorption capabilities. All countries face challenges rolling out massive vaccination campaigns, but LMICs particularly will face an intense pressure over the coming months. So knowledge sharing is vital as those countries that have successfully implemented inoculation programmes have critical know-how and technical support to give.

And the clock is ticking. The more time lost getting the logistics sorted, the greater the risk of doses going to waste. According to WHO AFRO, twenty-three African countries have used less than half of the doses they have received so far. About 1.25 million AstraZeneca doses in 18 countries must be used by the end of August to avoid expiration.

Unfortunately, we see countries having to juggle logistics around thousands of municipalities and local authorities to store and then be ready to administer their doses before they expire. This is why it is important to ensure that the donated doses are spread out over time, on a continued, rolling basis.

It is critical to build capacity to effectively store, distribute, and administer vaccines. And while doses are donated, the rest of the process needs to be budgeted to cover the costs of:

  • Developing national vaccination plans;
  • Establishing regulatory vaccine approval and vaccine safety systems;
  • Building vaccine distribution infrastructure on the ground, including cold chain capacities;
  • Training of staff involved in deployment and delivery of vaccines;
  • Strengthen data collection, reporting and tracking systems;
  • Addressing hesitancy issues by planning public health campaigns to generate trust and demand for COVID-19 vaccines.

Each of these challenges is a pressing problem in itself. Vaccinating the world against a virulent and deadly disease is a colossal global challenge. Yet the 5-steps plan to advance vaccine equity provides a robust framework to help bring the pandemic under control.

[1] COVAX Global Supply Forecast 

The post Dose sharing is a critical urgent step towards vaccine equity: it needs support to be successful (Step #1) appeared first on IFPMA.

COVID-19与前进道路:经验教训为全球合作的未来指明方向 //www.bbaltong.com/global-health-matters/covid-19-and-the-path-forward-learnings-inform-future-of-global-collaboration/ 玛蒂娜Bilova 星期三,23日6月2021 18:00:48 +0000 //www.bbaltong.com/?post_type=health_matters&p=13014 鉴于最近的2021年七国集团峰会(G7 Summit 2021), 2019冠状病毒病(COVID-19)大流行是可以理解的主要讨论焦点,我被提醒,我们的行业在这场健康和经济危机中发挥着关键作用。这种流行病,也不曾见过的像在100年,花费了太多的生活[& # 8230;]< / p > < p > post < rel =“nofollow”href = " //www.bbaltong.com/global-health-matters/covid-19-and-the-path-forward-learnings-inform-future-of-global-collaboration/ " > COVID-19前进道路:在IFPMA.

. IFPMA.

. IFPMA

考虑到最近的2021年七国集团峰会,可以理解,新冠病毒-19大流行是讨论的重点,我被提醒我们的行业在这场健康和经济危机中发挥着关键作用。这种流行病已经100多年没有出现过了,已经夺去了太多人的生命,使更多人处于危险之中。

然而,医疗创新的希望每天都带来希望。许多疫苗和治疗方法已经被批准用于世界各地的卫生系统,更多的疫苗和治疗方法正在开发中,包括抗体治疗,来自矿山、百时美施贵宝等公司。随着各国开始重新开放,大流行前的生活出现了曙光。尽管如此,新冠病毒-19及其变种仍然影响着许多人,特别是中低收入国家的人。

虽然我们还有更多的工作要做,以确保全世界的患者都能获得疫苗和治疗,但我对我们创新的进展和我们的交付速度感到鼓舞,这是无与伦比的,全球生物制药界成员、医疗专业人员、政府和卫生系统之间的快速合作。我希望我们的进步意味着这种流行病的影响将很快在全球每个角落消退。

我还被提醒了国际制药制造商联合会等组织的重要性;关联(IFPMA),感谢他们召集世界上最好的生物制药创新者和领导者,就如何应对重大健康问题(从新冠病毒-19到癌症)提供信息并促进全球思维,推动紧急行动。过去一年的经验教训将有助于我们在寻求解决世界各地患者的疾病和状况时,为紧密合作和医疗创新的下一章提供信息。

例如,IFPMA在领导多方利益相关者防治新冠病毒19和支持中低收入国家(LMICs)解决非传染性疾病(NCD)方面取得了成功:

  • 作为href=”https://www.who.int/publications/m/item/access-to-covid-19-tools-(act)-加速器“>act加速器,其中新冠病毒-19疫苗全球接入设施(COVAX)是研发的关键支柱和驱动力,我们已经学会了如何汇集所需的专业知识,以加速将制造业和供应链扩大到前所未有的水平。
  • Via加速访问,24家生物制药公司的独特跨行业合作,包括百时美施贵宝,我们在减少预防障碍方面取得了成果,通过加强并与全民医疗覆盖目标和优先事项。

这些努力是我们如何应对全球药物滥用的复杂性的绝佳例子发现、开发和交付,并与政府、非政府组织和其他关键利益相关者在整个行业内合作,以找到解决方案。

展望未来,IFPMA和生物制药行业正在解决一系列关键领域,包括:

  • Health systems’ efficiency and sustainability, working to strengthen patient access to healthcare and medicines globally as the economic fallout of COVID-19 continues.
  • Advocating for the drivers of innovation for all medicines, including intellectual property protections, which are essential for continued biopharmaceutical innovation necessary to address current and future unmet medical and health needs.
  • These issues require smart thinking, multi-disciplinary collaboration, a global mindset and local expertise.

    I am proud to represent Bristol Myers Squibb as Council Chair of the IFPMA as I believe it is an essential platform for our industry to work together and speak with one unified voice. Through meaningful partnerships and collaboration with other stakeholders, we can better promote the discovery and development of innovative medicines for patients worldwide and tackle access barriers to healthcare in pursuit of global health equity. Together we do more for patients and society.

    [1] IFPMA COVID-19 Information Hub

    The post COVID-19 and the Path Forward: Learnings Inform Future of Global Collaboration appeared first on IFPMA.

    确保在创纪录的时间内交付疫苗 //www.bbaltong.com/global-health-matters/ensuring-the-delivery-of-vaccines-in-record-time/ 玛蒂娜Bilova 星期三,6月16日06:00:43 +0000 新冠肺炎 全球疫苗生产 //www.bbaltong.com/?post_type=health_matters&p=12973

    这篇文章最初发表于《Down to Earth》(2021年6月16-30日版)。原材料短缺和贸易壁垒可能会削弱到2021年底生产100亿疫苗的希望。疫苗创新者公司开始研究如何建立制造业和供应链生产[& # 8230;]< / p > < p > post < rel =“nofollow”href = " //www.bbaltong.com/global-health-matters/ensuring-the-delivery-of-vaccines-in-record-time/ " >确保疫苗的交付记录时间< / >第一次出现在< rel =“nofollow”href = " //www.bbaltong.com " > IFPMA < / >。< / p >

    此oped最初发布于脚踏实地(2021年6月16-30日版)。

    原材料短缺和贸易壁垒可能会削弱到2021年底生产100亿种疫苗的希望,疫苗创新者公司开始研究一旦获得批准,他们将如何建立生产和供应链生产候选疫苗。世界能够在几个月内生产数十亿种新冠病毒-19疫苗的原因之一,事实上,生产和供应团队与实验室中的科学家并行工作,但他们还不知道他们的疫苗是否能到达终点线——这是以前从未如此大规模地完成的事情。

    他们的努力显而易见。到本月底,疫苗生产四大巨头(中国、欧盟、美国和印度)将生产30亿剂新冠病毒-19疫苗。到2021年底,估计将有100多亿剂疫苗离开生产线。

    作为生产准备的一部分,今天300次合作中的第一次很早就开始了。今天,合作正在世界许多地方进行:美国、中国、欧盟和印度,还有南非、印度、巴西、阿根廷、马来西亚、土耳其、泰国、埃及、墨西哥、印尼、伊朗。建立和运行合作需要时间;约翰逊于去年11月同意合作完成疫苗的灌装和成品过程,将疫苗装入小瓶。阿斯彭计划在6月底让小瓶离开生产线。

    另一个早期关注事项是检查原材料和所需设备的供应,以及寻找和培训员工,以确保顺利运行和必要的质量检查。这些数字足以说明问题。辉瑞生物技术mRNA疫苗需要280种成分,涉及19个不同国家的86家供应商;这些材料需要到达三个不同的生产工厂,疫苗将经过一个涉及50000个生产步骤的生产过程;以及至少70次质量检查。现在将其乘以已批准的疫苗数量。

    合作生产疫苗并不容易。我们已经看到,即使是经验丰富的合作伙伴也会遇到困难;J疫苗扔掉了数百万剂,因为它们没有达到必要的质量控制。

    我们从今年3月开始警告说,一些关键原材料供应不足。生物反应器巨型塑料袋的延迟交付可能会使生产推迟数周,推迟数百万急需的疫苗的交付。在其他情况下,很难找到监督生产、检查过程质量和安全所需的熟练技术人员。此外,贸易壁垒阻碍了这些商品的流通,疫苗本身。我们都记得血清研究所的Adar Poonawalla发自内心的推特:呼吁@POTUS取消对美国出口原材料的禁运,以便提高疫苗产量。

    我们一直深感关切的是,尽管我们做出了努力,目前,新冠病毒-19疫苗并没有平等地普及到全世界所有的重点人群。我们已经制定了五个迫切需要解决的步骤。我们呼吁分享剂量。我们承诺通过提供任何未承诺的剂量予以支持。我们在几天内以行动支持我们的言论,3,主要疫苗制造商在5月的G20健康峰会上承诺增加50亿剂疫苗。

    我们承诺继续努力优化生产。对于关键投入品供应,如生物反应器袋、一次性使用组件、细胞培养基、过滤器、脂质和小瓶等,供应形势依然严峻;塞子。疫苗创新者当然会继续与其供应商密切合作,以尽可能避免中断。但如果供应商的库存可能因任何原因尚未被利用,我们相信,COVAX供应链和制造业工作队能够立即关注建立自愿伙伴关系,以提高制造业投入供应的可视性,并促进建立全球贸易流程,实现原材料、疫苗成分和疫苗的自由流动,和分析试剂。

    在过去的18个月中,我们学到了很多,我们肯定会学到更多,因为我们希望达到目标产量,以满足世界的需求。对于创新型生物制药公司work is far from over.  We have our work cut out for us.  We continue to prioritize the development of new COVID-19 vaccines, including vaccines effective against new variants, looking for new formulations for easier and longer storage.   For this work to continue, we urge governments to guarantee unhindered access to pathogens of any COVID-19 variants to support the development of new vaccine and treatments.  If this does not run smoothly, it will impact booster development and it will hamper the WHO’s ability to respond to the next seasonal influenza viruses.   In the last couple of days, we have joined the G7 future pandemic preparedness partnership to achieve a moon-shot target of 100 days to develop a vaccine in the case of a future pandemic.  Cutting down from the already historic 326 days to bring a first COVID-19 vaccine.

    The post Ensuring the delivery of vaccines in record time appeared first on IFPMA.

    抗生素研究导致初创企业破产(Taggesspigel) //www.bbaltong.com/global-health-matters/antibiotic-research-leads-start-ups-to-ruin/ 玛蒂娜Bilova Tue, 15 june 2021 15:00:01 +0000 AMR //www.bbaltong.com/?post_type=health_matters&p=12989

    2021年6月15日在Taggesspigel发表的原创文章。最重要的是,由病毒引发的Covid -19大流行可能进一步助长细菌耐药性的发展:医院里的许多Covid -19患者被给予了不必要的抗生素。七国集团的卫生部长们警告说,大流行病正在蔓延。并推动[& # 8230;]< / p > < p > post < rel =“nofollow”href = " //www.bbaltong.com/global-health-matters/antibiotic-research-leads-start-ups-to-ruin/ " >抗生素研究导致初创企业毁灭(Taggesspigel) < / >第一次出现在< rel =“nofollow”href = " //www.bbaltong.com " > IFPMA < / >。< / p >

    原始