在使用輝瑞-德國生技公司的新冠肺炎疫苗上 - 加拿大科學家終於可以看到他們的努力成果

Yahoo News a few days ago reported the following:

Canadian scientists finally get to see their work on the Pfizer-BioNTech COVID-19 vaccine put to use

Elisabetta Bianchini

Yahoo News Canada Tue., December 15, 2020, 9:21 a.m. PST

As the first doses of the Pfizer-BioNTech COVID-19 vaccine are administered across Canada Acuitas Therapeutics, the Vancouver-based company behind a key component of the vaccine, is excited about the historic moment.

“Obviously, as a Canadian company and as Canadian scientists, we were particularly pleased to see Health Canada provide the approval,” Acuitas Therapeutics president and CEO Dr. Thomas Madden told Yahoo Canada. “Everybody within Acuitas has been working all hours of the day and night since February this year.”

“They're just delighted that the work they put in has supported this early availability of vaccines and looking forward to more being available in 2021, to allow us to sort of gradually come out of this pandemic situation.”

The Pfizer-BioNTech vaccine is using Acuitas Therapeutics lipid nanoparticle (LNP) delivery system. The messenger RNA (mRNA) used in the vaccine is fragile after administration and is put in this carrier to protect it.

“[It is] using...a messenger RNA, which are the instructions to produce a protein that's found in the COVID-19 virus,” Dr. Madden, told Yahoo Canada earlier this year. “The message is administered, gets into our cells, the cells produce the COVID-19 protein, and our immune system recognizes that protein and develops an immune response, which protects us against future infections.”

Since Acuitas Therapeutics began working on helping companies develop COVID-19 vaccines, about 60 per cent of the company’s efforts went towards these developments. The Vancouver company is also working on COVID-19 vaccines with both Imperial College London and CureVac.

Could the vaccine be stored at warmer temperatures?

One of the core considerations of the Pfizer-BioNTech vaccine is the requirement to have it stored at ultra-cold temperatures, with recommended storage conditions set to -70 C. Dr. Madden stressed that there are still studies to evaluate whether there could be conditions where the vaccine can be stored at more easily achievable temperatures.

“It's simply the fact that we haven't wanted to delay making the vaccine available while studies are being conducted to demonstrate that it can be stored under other conditions...or at [-20 C],” he said. “Those studies need to be undertaken and the data then provided to the regulatory agencies, so that they can potentially approve alternate storage conditions.”

According to Pfizer, the vaccine vial can be stored for up to five days at between 2 to 8 C once thawed.

For anyone who still may have concerns about possibly receiving this vaccine, Dr. Madden stressed that no corners have been cut in the assessment process.

“The design of the clinical studies had previously been established by the regulatory agencies,” he said. “They had outlined exactly what information they wanted to receive, so that they would be able to review and assess safety and efficacy.”

In a statement, Dr. Madden also identified that there is the need for multiple companies globally to participate in the development COVID-19 vaccines.

“The more companies that are developing vaccines and sharing information on the safety and efficacy, the better it is,” a statement from the Acuitas Therapeutics president and CEO reads. “It’s important that people realize the spirit in which the biotechnology/pharmaceutical community is approaching this crucial task, and that is with innovative science and with a commitment to work together to benefit society on a global level.”

Translation

隨著輝瑞-德國生技公司(Pfizer-BioNTech) 的新冠肺炎疫苗注射首次藥在加拿大進行，作為在背後製作疫苗關鍵成分的溫哥華公司Acuitas Therapeutics對這一歷史性時刻感到興奮。

Acuitas Therapeutics總裁兼首席執行官Thomas Madden博士告訴加拿大雅虎說 “很明顯，作為一家加拿大公司和加拿大科學家，我們很高興看到加拿大衛生部提供了批准” 。又 說 “自今年2月以來，Acuitas內部的每個人都晝夜不停地工作。”

“他們感到高興的是，他們所做的工作為疫苗的早期提供提供了支持，並期待在2021年提供更多疫苗，以使我們逐漸擺脫這種大流行的狀況。”

輝瑞-德國生技公司疫苗正在使用Acuitas Therapeutics脂質納米顆粒（LNP）輸送系統。疫苗中使用的RNA（mRNA）信息傳達體在注射後成変脆弱，故放入該輸送系統對其進行保護。

Madden博士在今年早些時候告訴Yahoo Canada時說： “[正在]使用...RNA信息傳達，這是發現在COVID-19去生產病毒的蛋白質的信號指令。”; “信息號被注射，進入我們的細胞，細胞產生COVID-19蛋白，我們的免疫系統識別出該蛋白並產生免疫反應，從而保護我們免受將來的感染。”

自從Acuitas Therapeutics開始致力於幫助公司開發COVID-19疫苗以來，公司約有60％的努力用於這些開發。這家溫哥華公司還與倫敦帝國學院和CureVac合作研究COVID-19疫苗。

疫苗可以在較高溫度下保存嗎？

輝瑞-德國生技公司疫苗的核心考慮因素之一是要求將其保存在超冷溫度下，建議的存儲條件設置為-70C。Madden博士強調，仍在進行研究以評估是否可以使疫苗存放在更容易達到的溫度。

他說：“簡單的事實是，我們不希望為要進行研究表明可以在其他條件下或[-20 C]下儲存疫苗而推遲提供疫苗”;  “這些研究是需要進行的，然後將數據提供給監管機構，以便他們有可能批准替代的存儲條件。”

據輝瑞公司稱，一旦解凍，疫苗小瓶可以在2至8攝氏度之間保存最多5天。

對於任何仍可能對接種這種疫苗有疑慮的人，Madden博士強調說，在評估過程中他們沒有走捷徑。

他說：“臨床研究的設計是由監管機構以前定立的。” “他們準確地概述了他們想要接收的信息，以便他們能夠審查和評估安全性和有效性。”

Madden博士在聲明中還指出，全球需要多家公司參與開發COVID-19疫苗。

Acuitas Therapeutics總裁兼首席執行官在一份聲明中說： “越多公司開發疫苗, 並共享有關安全性和有效性的信息，效果越好” 。又說 ： “重要的是，人們必須意識到生物技術/製藥界用以邁進這一關鍵任務的精神，這就是要用創新科學與工作熱情，致力於在全球範圍內共同造福社會。”

       Acuitas Therapeutics president and CEO has expressed the spirit of the biotechnology/pharmaceutical community as about “the use of innovative science and with a commitment to work, together to benefit society on a global level”. It is an idealistic and touching professionalism among the scientists. In the 21^st century competitive world, I think national politics and economic interests may have played a even bigger role in making available the Covid-19 vaccine in such a short period of time.