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疫苗运输条件太高,辉瑞正在努力“贴近现实”

David Z. Morris
2020-12-02

辉瑞称,改进后的疫苗可以在普通的冰箱温度中储存。

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辉瑞11月初宣布的新冠病毒候选疫苗附加了一个重要的条件:疫苗必须储存在零下70摄氏度的超低温环境中。该条件可能会延迟其在农村地区和发展中国家的配送,而且意味着疫苗必须存放在价值高达2万美元的专业冷冻柜中,但这类冷冻柜在医疗研究机构之外十分少见。

然而,这个问题可能只是临时的。专家们说,疫苗的低温存储要求可能会变得不再那么苛刻,因为届时人们会对疫苗在较高温度环境下的表现有更多的了解。

约翰斯·霍普金斯大学的医疗物流专家戴廷龙称,如果辉瑞最终调整了其疫苗的存储要求,也没有什么可以大惊小怪的。他说,有鉴于当前的存储要求,“他们会更加谨慎。”

美国国家过敏症和传染病研究所疫苗研究中心(Vaccine Research Center at the National Institute of Allergy and Infectious Diseases)的副主任巴尼·格拉汉姆说:“你只能在已经被证实和记录的存储环境下使用[某种]疫苗。”疫苗开发的早期研究通常在更加谨慎的环境下进行,但格拉汉姆称,随后的测试可能会展现疫苗在各种环境下的耐受度。

Moderna的候选疫苗也遇到了同样的问题,该公司使用类似于辉瑞的技术来引发病毒免疫。就在今年8月,业界曾经预计Moderna会申请疫苗批准,并采用类似于辉瑞的存储标准。

然而在11月16日,也就是公司宣布其大规模临床试验结果的同一天,Moderna称其候选疫苗在零下20摄氏度的标准冷冻柜中能够存储高达6个月的时间,在2至8摄氏度的普通冰箱中可以存储高达30天的时间。

不过,辉瑞拒绝对调整其当前候选疫苗存储要求的可能性进行置评。

戴廷龙称,调整存储要求会大大降低将辉瑞疫苗运输至远离科研医院人群的难度。美国疾控中心(CDC)在其当前的“疫苗手册”上并不建议当地疫苗经理购买专业冷冻柜。

为了帮助运送疫苗,辉瑞研制了一个运输箱,在不开箱的情况下,箱内零下70摄氏度的温度最多能够维持10天。如果定期补充干冰,最多可以维持30天。

然而,使用运输箱存在风险。戴廷龙说:“每一次补充干冰都会为犯错创造机会。”

辉瑞存储条件的任何调整都不大可能对有望于2021年年初开始的第一波疫苗分发带来影响。当然,前提是疫苗的运送得到联邦政府的批准。

然而,辉瑞确实承认,自己正在研发具有更好耐受度的“冻干”疫苗。公司称,这种疫苗能够在普通的冰箱温度中储存,或将于2022年面世。美国食品与药品管理局(Food and Drug Administration)在辉瑞开展额外的临床试验后必将批准新版本的疫苗。

凯瑟家族基金会(Kaiser Family Foundation)的全球健康政策副主任约书亚·米查德表示,辉瑞还可以重新研发其疫苗核心外围的脂质保护层。Moderna称,其特殊脂质外壳技术是其疫苗拥有较高耐受度的关键。

如今,辉瑞的疫苗存储要求并不是很严重的问题,因为包括阿斯利康公司在内的那些易于存储的候选疫苗都还在等待获批。这些耐受度更好的疫苗可以被运送至那些缺乏安全存储辉瑞疫苗所需设备的地区。

然而戴称,这个挑战所面临的前所未有的规模——尽快给全球几乎所有人口接种疫苗——意味着短期内需要大量的疫苗。问题在于,耐受度更高的疫苗是否会像辉瑞的疫苗那样很快面世,这样的话也就更容易保护那些位于偏僻角落的病患。 (财富中文网)

译者:冯丰

审校:夏林

辉瑞11月初宣布的新冠病毒候选疫苗附加了一个重要的条件:疫苗必须储存在零下70摄氏度的超低温环境中。该条件可能会延迟其在农村地区和发展中国家的配送,而且意味着疫苗必须存放在价值高达2万美元的专业冷冻柜中,但这类冷冻柜在医疗研究机构之外十分少见。

然而,这个问题可能只是临时的。专家们说,疫苗的低温存储要求可能会变得不再那么苛刻,因为届时人们会对疫苗在较高温度环境下的表现有更多的了解。

约翰斯·霍普金斯大学的医疗物流专家戴廷龙称,如果辉瑞最终调整了其疫苗的存储要求,也没有什么可以大惊小怪的。他说,有鉴于当前的存储要求,“他们会更加谨慎。”

美国国家过敏症和传染病研究所疫苗研究中心(Vaccine Research Center at the National Institute of Allergy and Infectious Diseases)的副主任巴尼·格拉汉姆说:“你只能在已经被证实和记录的存储环境下使用[某种]疫苗。”疫苗开发的早期研究通常在更加谨慎的环境下进行,但格拉汉姆称,随后的测试可能会展现疫苗在各种环境下的耐受度。

Moderna的候选疫苗也遇到了同样的问题,该公司使用类似于辉瑞的技术来引发病毒免疫。就在今年8月,业界曾经预计Moderna会申请疫苗批准,并采用类似于辉瑞的存储标准。

然而在11月16日,也就是公司宣布其大规模临床试验结果的同一天,Moderna称其候选疫苗在零下20摄氏度的标准冷冻柜中能够存储高达6个月的时间,在2至8摄氏度的普通冰箱中可以存储高达30天的时间。

不过,辉瑞拒绝对调整其当前候选疫苗存储要求的可能性进行置评。

戴廷龙称,调整存储要求会大大降低将辉瑞疫苗运输至远离科研医院人群的难度。美国疾控中心(CDC)在其当前的“疫苗手册”上并不建议当地疫苗经理购买专业冷冻柜。

为了帮助运送疫苗,辉瑞研制了一个运输箱,在不开箱的情况下,箱内零下70摄氏度的温度最多能够维持10天。如果定期补充干冰,最多可以维持30天。

然而,使用运输箱存在风险。戴廷龙说:“每一次补充干冰都会为犯错创造机会。”

辉瑞存储条件的任何调整都不大可能对有望于2021年年初开始的第一波疫苗分发带来影响。当然,前提是疫苗的运送得到联邦政府的批准。

然而,辉瑞确实承认,自己正在研发具有更好耐受度的“冻干”疫苗。公司称,这种疫苗能够在普通的冰箱温度中储存,或将于2022年面世。美国食品与药品管理局(Food and Drug Administration)在辉瑞开展额外的临床试验后必将批准新版本的疫苗。

凯瑟家族基金会(Kaiser Family Foundation)的全球健康政策副主任约书亚·米查德表示,辉瑞还可以重新研发其疫苗核心外围的脂质保护层。Moderna称,其特殊脂质外壳技术是其疫苗拥有较高耐受度的关键。

如今,辉瑞的疫苗存储要求并不是很严重的问题,因为包括阿斯利康公司在内的那些易于存储的候选疫苗都还在等待获批。这些耐受度更好的疫苗可以被运送至那些缺乏安全存储辉瑞疫苗所需设备的地区。

然而戴称,这个挑战所面临的前所未有的规模——尽快给全球几乎所有人口接种疫苗——意味着短期内需要大量的疫苗。问题在于,耐受度更高的疫苗是否会像辉瑞的疫苗那样很快面世,这样的话也就更容易保护那些位于偏僻角落的病患。 (财富中文网)

译者:冯丰

审校:夏林

Pfizer’s coronavirus vaccine candidate, announced earlier November, comes with a major complication that could delay its distribution in rural areas and developing countries: It must be stored at the ultra-cold temperature of -70°C. That means the vaccine must be kept in specialized freezers that cost as much as $20,000 each and are rare outside of medical research facilities.

But that problem may just be temporary. Experts say that the vaccine's cold storage requirements may become less stringent as more is learned about how the vaccine reacts to warmer temperatures.

Tinglong Dai, a medical logistics specialist at Johns Hopkins University, says he wouldn’t be surprised if Pfizer eventually revises the storage requirements for its vaccine. With the current storage requirements, Dai says, “they’re being more cautious.”

“You can only use [a] vaccine at storage conditions that have been proven and documented,” said Barney Graham, Deputy Director of the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases. Early research during a vaccine's development is often done under more cautious conditions, but according to Graham, later testing can demonstrate a vaccine's durability under a wider range of conditions.

This dynamic has already played out with a vaccine candidate from Moderna, which uses similar technology to Pfizer’s to trigger viral immunity. As recently as August, Moderna was expected to seek approval of its vaccine with storage standards similar to Pfizer’s.

But on November 16, the same day it announced promising large-scale trial results, Moderna revealed that its vaccine candidate was effective for up to six months when stored at standard freezer temperatures of -20° C, and for up to 30 days at standard refrigerator temperatures of 2-8° C.

Pfizer declined to comment about the possibility of revising storage requirements for its current vaccine candidate.

Changing storage requirements, according to Dai, would make it far easier to deliver Pfizer's vaccine to populations further from research hospitals. In its current “vaccine playbook”, the CDC advises against local vaccine managers buying specialized freezers.

To help with distributing its vaccine, Pfizer has developed a shipping container that can maintain the required -70° C for up to 10 days unopened. With regular refills of dry ice, it can maintain that temperature for up to 30 days.

But using shipping containers for storage is risky. “Every time you put new dry ice in is an opportunity for mistakes,” says Dai.

Any change to Pfizer’s storage requirements is unlikely to impact the first wave of vaccine distribution, which may start by early 2021. That's only if the federal government approves the vaccine for distribution.

Pfizer did confirm, however, that it's working on a more durable version of the vaccine that is "lyophilized," or freeze-dried. That vaccine, the company said, would be able to be kept at normal refrigerator temperatures and may be ready by 2022. The Food and Drug Administration would have to approve the updated vaccine following additional trials.

Joshua Michaud, associate director for Global Health Policy at the Kaiser Family Foundation, says Pfizer could also reformulate the protective layer of fatty lipids around the core of its vaccine. Moderna says its specific lipid shell technology is key to its vaccine’s greater durability.

The Pfizer vaccine’s storage requirements are slightly less of a problem now considering that easier-to-store candidates, including AstraZeneca’s, are in the approval pipeline. Those more durable vaccines could be distributed in areas that lack the equipment necessary to safely store Pfizer's.

But according to Dai, the unprecedented scale of the challenge – immunizing essentially the entire global population as quickly as possible – means every vaccine will be needed in the short term. The question is whether sturdier vaccines will be available as soon as Pfizer’s, making it easier to protect far-flung patients.

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