我國首個單針接種新冠疫苗獲批上市
中國日報網(wǎng) 2021-03-01 11:15
2月25日,由中國工程院院士、軍事科學(xué)院軍事醫(yī)學(xué)研究院研究員陳薇領(lǐng)銜的團(tuán)隊研發(fā)的我國重組新冠病毒疫苗(腺病毒載體新冠疫苗),獲國家藥品監(jiān)督管理局附條件批準(zhǔn)(conditional market approval)上市注冊申請。
The vaccine, called Ad5-nCoV, has an efficacy rate of 65.7 percent at preventing symptomatic cases and is 90.9 percent effective in preventing severe disease with a single injection, according to interim analysis of late-stage human trials released in February.
今年2月發(fā)布的三期人體試驗中期結(jié)果顯示,這款名為Ad5-nCoV的疫苗單針接種后,對抗輕癥的有效性為65.7%,對重癥的有效性為90.9%。
【知識點】
疫情發(fā)生以來,國務(wù)院聯(lián)防聯(lián)控機(jī)制科研攻關(guān)組專門設(shè)立疫苗研發(fā)專班,按照滅活疫苗(inactivated vaccines)、重組蛋白疫苗(recombinant protein vaccines)、腺病毒載體疫苗(adenovirus vector vaccines)、減毒流感病毒載體活疫苗(vaccines using attenuated influenza virus as vectors)、核酸疫苗(nucleic acid vaccines)5條技術(shù)路線共布局12項研發(fā)任務(wù)。
中國疫苗行業(yè)協(xié)會會長封多佳介紹,重組新冠腺病毒載體疫苗和我們熟知的新冠滅活疫苗在原理、制備方法等方面都不相同,但最終的免疫效果是一樣的。腺病毒載體疫苗(adenovirus vector vaccines)本質(zhì)上是核酸疫苗的一種,就是將病毒的核酸片段裝到經(jīng)過安全處理的腺病毒(genetically modified adenovirus)身上,再注射到人體內(nèi),這樣可以最大限度地發(fā)揮病毒核酸的抗原活性,激發(fā)身體的免疫作用(induce an immune response)。滅活疫苗(inactivated vaccines)則是將病毒殺死,消除致病性,保留免疫性,同樣是為了激發(fā)身體的免疫作用。
Targeting people aged above 18, the vaccine can be transported and stored at a temperature ranging from 2 to 8 degrees Celsius.
該疫苗接種對象為18歲以上人群,可在2至8攝氏度間運輸和存儲。
腺病毒載體疫苗單針保護(hù)期至少6個月
陳薇院士接受央視采訪時表示:
Data shows a single dose should provide protection for six months, and there is no need to take an additional shot during the six-month period.
數(shù)據(jù)顯示,單針接種產(chǎn)生的保護(hù)期為6個月,6個月內(nèi)無需再接種。
We also created booster shots for inoculation after six months, and with a single booster, we can increase the immune response by 10 to 20 times. Based on available data, we estimate two shots can provide protection for two years.
我們也做了6個月以后的加強(qiáng)針,再打一針,免疫反應(yīng)可以有10倍、20倍的增高。根據(jù)數(shù)據(jù),我們推測在兩針之后,達(dá)到兩年的免疫持久性。
年產(chǎn)能可達(dá)5億劑
陳薇院士表示:
China is capable of producing 500 million doses of the vaccine annually, which can cover 500 million people.
我國年產(chǎn)能可達(dá)到5億劑,相當(dāng)于是5億人的接種。
寧愿備而不用,不能用而不備
In regards to the vaccine's efficacy against mutated strains of SARS-CoV-2, the virus responsible for COVID-19, Chen said they are keeping a close eye on the situation and have begun developing vaccines for these new variants. "We may not need these vaccines, but we cannot be caught unprepared."
至于該疫苗對變異毒株的有效性,陳薇表示,他們團(tuán)隊在密切關(guān)注相關(guān)情況,且早已啟動針對變異株的疫苗研發(fā),這個疫苗不一定用得上,但寧愿備而不用,不能用而不備。
【相關(guān)詞匯】
藥品和疫苗研發(fā) drug and vaccine development
隨機(jī)試驗 random trial
雙盲試驗 double-blind trial
安慰劑對照試驗 placebo-controlled trial
免疫系統(tǒng) immune system
毒性試驗 toxicology test
有效性和安全性研究 safety and efficacy research
參考來源:央視新聞、新華網(wǎng)、中國日報
(中國日報網(wǎng)英語點津 Helen)