輝瑞公司和BioNTech公司的新數(shù)據(jù)顯示,,這兩家公司生產(chǎn)的新冠疫苗在正常冷凍溫度下儲(chǔ)存兩周仍然有效,。這或?qū)⒋蟠蠼档鸵呙缭诿绹?guó)及世界各地的分發(fā)難度。
新的研究和分析還表明,,輝瑞疫苗的第一劑就能夠?qū)︻A(yù)防新冠病毒產(chǎn)生很強(qiáng)的效果,。兩名加拿大研究人員表示,第一劑注射的有效性為92.6%,,注射兩劑后的有效性則為95%,。他們表示,這些結(jié)果應(yīng)該被用于重新評(píng)估有限的疫苗供應(yīng)分配情況,。
根據(jù)輝瑞及BioNTech疫苗最初獲得的美國(guó)食品與藥品管理局(FDA)緊急使用授權(quán),,疫苗必須在零下70攝氏度儲(chǔ)存,需要使用價(jià)格高昂的專用冰箱才可以實(shí)現(xiàn)。在新冠疫情爆發(fā)之前,,這種設(shè)備很難找到,,只有專業(yè)的研究機(jī)構(gòu)才有。
對(duì)冰箱的高要求帶來(lái)了不少麻煩,,增加了成本和風(fēng)險(xiǎn),,對(duì)農(nóng)村及偏遠(yuǎn)地區(qū)而言,尤其如此,。輝瑞公司開(kāi)發(fā)了一種用干冰冷卻的運(yùn)輸箱,,可以在有限的時(shí)間內(nèi)保持低溫,但專家們對(duì)這一設(shè)備表示擔(dān)憂,,認(rèn)為使用這種低技術(shù)方法可能會(huì)使疫苗變質(zhì),。
但現(xiàn)在,兩家公司的新數(shù)據(jù)顯示,,疫苗在零下15攝氏度至零下25攝氏度之間保存至少兩周之后仍然有效,,標(biāo)準(zhǔn)的醫(yī)療冷藏庫(kù)很容易達(dá)到這個(gè)溫度范圍。
新數(shù)據(jù)已經(jīng)提交給FDA,。但在對(duì)現(xiàn)有疫苗分發(fā)辦法進(jìn)行任何更改之前,,對(duì)當(dāng)前儲(chǔ)存標(biāo)準(zhǔn)的更改(作為緊急使用授權(quán)的部分修訂)都必須得到批準(zhǔn)。
專家們一直期待輝瑞公司對(duì)更寬松的儲(chǔ)存要求提出審批申請(qǐng),。疫苗最初的極低溫儲(chǔ)存要求是壓縮研發(fā)時(shí)間,、快速趕工的結(jié)果,而后續(xù)要求的放寬,,需要在進(jìn)一步的長(zhǎng)期研究和測(cè)試之后才能夠給出。
研究人員發(fā)現(xiàn),,輝瑞和BioNTech公司的疫苗具有很強(qiáng)的保護(hù)性,,基于此,研究人員達(dá)努塔?斯科夫龍斯基和加斯頓?德?塞雷斯說(shuō):“推遲第二次接種,,直到所有疫苗接種的優(yōu)先組成員至少接種了一劑疫苗——這樣可以最大限度地減輕疫苗供應(yīng)不足帶來(lái)的影響,。”作為加速疫苗接種行動(dòng)的一部分,,這一方法早期在英國(guó)嘗試過(guò),,幫助英國(guó)成為了“首針疫苗接種率”世界排名第三位的國(guó)家。
但是,,在對(duì)疫苗分發(fā)方案做出任何變動(dòng)之前,,這些新數(shù)據(jù)還必須經(jīng)由美國(guó)監(jiān)管部門的檢視。要知道,,第二劑疫苗能夠有效地幫助身體“鞏固”免疫系統(tǒng)從第一劑疫苗“學(xué)習(xí)”到的東西,,因此,“在沒(méi)有第二劑的情況下,第一次免疫可以持續(xù)多久”,,這個(gè)不確定因素或?qū)⒊蔀楫?dāng)下的關(guān)鍵,。
一劑就生效
早在2月初就有初步證據(jù)表明,阿斯利康與牛津大學(xué)(University of Oxford)聯(lián)合研發(fā)的疫苗,,只需一劑就能夠?qū)⒉《镜膫鞑ヂ式档图s三分之二,。
《電訊報(bào)》(Telegraph)援引英國(guó)公共衛(wèi)生署(Public Health England,PHE)的消息稱,,這一數(shù)據(jù)將很快得到證實(shí),,而且不僅是阿斯利康公司的疫苗,輝瑞公司的兩劑疫苗中第一劑的數(shù)據(jù)也將得到證實(shí),。并且,,疫苗對(duì)病毒傳播的抵御效果似乎在所有年齡組中都適用。
在此之前,,以色列在本周發(fā)表了兩項(xiàng)研究的證據(jù),,發(fā)現(xiàn)輝瑞的新冠疫苗顯著降低了病毒的傳播。輝瑞和以色列衛(wèi)生部的聯(lián)合分析發(fā)現(xiàn),,兩劑疫苗的注射方案總體減少了89.4%的感染(包括無(wú)癥狀病例),,有癥狀病例減少了93.7%。該結(jié)果通過(guò)新冠病毒感染檢測(cè)進(jìn)行追蹤,,由以色列的一個(gè)國(guó)家級(jí)新冠病毒追蹤數(shù)據(jù)庫(kù)提供支持,。這項(xiàng)研究還有待同行評(píng)議。
此外,,以色列進(jìn)行的第二項(xiàng)研究調(diào)查了7000多名醫(yī)院?jiǎn)T工,,發(fā)現(xiàn)使用輝瑞疫苗之后,感染減少了75%,。
鑒于輝瑞,、Moderna、強(qiáng)生和阿斯利康等公司的疫苗都有很強(qiáng)的有效性,,注射其中一種疫苗仍然可能有削弱病毒的功效,,或至少可以降低病毒傳染給他人的幾率。
我們知道,,這些疫苗已經(jīng)顯著降低了新冠相關(guān)住院和死亡的風(fēng)險(xiǎn),,但是,最理想的情況是達(dá)到相當(dāng)高的“消除性免疫”水平,,完全阻止新冠病毒的社區(qū)傳播,。滾滾而來(lái)的信息表明,這些疫苗或?qū)⒂舆@一挑戰(zhàn),。(財(cái)富中文網(wǎng))
編譯:楊二一
輝瑞公司和BioNTech公司的新數(shù)據(jù)顯示,,這兩家公司生產(chǎn)的新冠疫苗在正常冷凍溫度下儲(chǔ)存兩周仍然有效,。這或?qū)⒋蟠蠼档鸵呙缭诿绹?guó)及世界各地的分發(fā)難度。
新的研究和分析還表明,,輝瑞疫苗的第一劑就能夠?qū)︻A(yù)防新冠病毒產(chǎn)生很強(qiáng)的效果,。兩名加拿大研究人員表示,第一劑注射的有效性為92.6%,,注射兩劑后的有效性則為95%,。他們表示,這些結(jié)果應(yīng)該被用于重新評(píng)估有限的疫苗供應(yīng)分配情況,。
根據(jù)輝瑞及BioNTech疫苗最初獲得的美國(guó)食品與藥品管理局(FDA)緊急使用授權(quán),,疫苗必須在零下70攝氏度儲(chǔ)存,需要使用價(jià)格高昂的專用冰箱才可以實(shí)現(xiàn),。在新冠疫情爆發(fā)之前,,這種設(shè)備很難找到,只有專業(yè)的研究機(jī)構(gòu)才有,。
對(duì)冰箱的高要求帶來(lái)了不少麻煩,,增加了成本和風(fēng)險(xiǎn),對(duì)農(nóng)村及偏遠(yuǎn)地區(qū)而言,,尤其如此,。輝瑞公司開(kāi)發(fā)了一種用干冰冷卻的運(yùn)輸箱,可以在有限的時(shí)間內(nèi)保持低溫,,但專家們對(duì)這一設(shè)備表示擔(dān)憂,,認(rèn)為使用這種低技術(shù)方法可能會(huì)使疫苗變質(zhì)。
但現(xiàn)在,,兩家公司的新數(shù)據(jù)顯示,,疫苗在零下15攝氏度至零下25攝氏度之間保存至少兩周之后仍然有效,標(biāo)準(zhǔn)的醫(yī)療冷藏庫(kù)很容易達(dá)到這個(gè)溫度范圍,。
新數(shù)據(jù)已經(jīng)提交給FDA,。但在對(duì)現(xiàn)有疫苗分發(fā)辦法進(jìn)行任何更改之前,對(duì)當(dāng)前儲(chǔ)存標(biāo)準(zhǔn)的更改(作為緊急使用授權(quán)的部分修訂)都必須得到批準(zhǔn),。
專家們一直期待輝瑞公司對(duì)更寬松的儲(chǔ)存要求提出審批申請(qǐng)。疫苗最初的極低溫儲(chǔ)存要求是壓縮研發(fā)時(shí)間,、快速趕工的結(jié)果,,而后續(xù)要求的放寬,需要在進(jìn)一步的長(zhǎng)期研究和測(cè)試之后才能夠給出,。
研究人員發(fā)現(xiàn),,輝瑞和BioNTech公司的疫苗具有很強(qiáng)的保護(hù)性,基于此,,研究人員達(dá)努塔?斯科夫龍斯基和加斯頓?德?塞雷斯說(shuō):“推遲第二次接種,,直到所有疫苗接種的優(yōu)先組成員至少接種了一劑疫苗——這樣可以最大限度地減輕疫苗供應(yīng)不足帶來(lái)的影響。”作為加速疫苗接種行動(dòng)的一部分,,這一方法早期在英國(guó)嘗試過(guò),,幫助英國(guó)成為了“首針疫苗接種率”世界排名第三位的國(guó)家。
但是,,在對(duì)疫苗分發(fā)方案做出任何變動(dòng)之前,,這些新數(shù)據(jù)還必須經(jīng)由美國(guó)監(jiān)管部門的檢視。要知道,,第二劑疫苗能夠有效地幫助身體“鞏固”免疫系統(tǒng)從第一劑疫苗“學(xué)習(xí)”到的東西,,因此,“在沒(méi)有第二劑的情況下,,第一次免疫可以持續(xù)多久”,,這個(gè)不確定因素或?qū)⒊蔀楫?dāng)下的關(guān)鍵。
一劑就生效
早在2月初就有初步證據(jù)表明,,阿斯利康與牛津大學(xué)(University of Oxford)聯(lián)合研發(fā)的疫苗,,只需一劑就能夠?qū)⒉《镜膫鞑ヂ式档图s三分之二。
《電訊報(bào)》(Telegraph)援引英國(guó)公共衛(wèi)生署(Public Health England,,PHE)的消息稱,,這一數(shù)據(jù)將很快得到證實(shí),而且不僅是阿斯利康公司的疫苗,,輝瑞公司的兩劑疫苗中第一劑的數(shù)據(jù)也將得到證實(shí),。并且,疫苗對(duì)病毒傳播的抵御效果似乎在所有年齡組中都適用,。
在此之前,,以色列在本周發(fā)表了兩項(xiàng)研究的證據(jù),發(fā)現(xiàn)輝瑞的新冠疫苗顯著降低了病毒的傳播,。輝瑞和以色列衛(wèi)生部的聯(lián)合分析發(fā)現(xiàn),,兩劑疫苗的注射方案總體減少了89.4%的感染(包括無(wú)癥狀病例),有癥狀病例減少了93.7%,。該結(jié)果通過(guò)新冠病毒感染檢測(cè)進(jìn)行追蹤,,由以色列的一個(gè)國(guó)家級(jí)新冠病毒追蹤數(shù)據(jù)庫(kù)提供支持。這項(xiàng)研究還有待同行評(píng)議,。
此外,,以色列進(jìn)行的第二項(xiàng)研究調(diào)查了7000多名醫(yī)院?jiǎn)T工,發(fā)現(xiàn)使用輝瑞疫苗之后,,感染減少了75%,。
鑒于輝瑞、Moderna,、強(qiáng)生和阿斯利康等公司的疫苗都有很強(qiáng)的有效性,,注射其中一種疫苗仍然可能有削弱病毒的功效,,或至少可以降低病毒傳染給他人的幾率。
我們知道,,這些疫苗已經(jīng)顯著降低了新冠相關(guān)住院和死亡的風(fēng)險(xiǎn),,但是,最理想的情況是達(dá)到相當(dāng)高的“消除性免疫”水平,,完全阻止新冠病毒的社區(qū)傳播,。滾滾而來(lái)的信息表明,這些疫苗或?qū)⒂舆@一挑戰(zhàn),。(財(cái)富中文網(wǎng))
編譯:楊二一
New data from Pfizer and BioNTech shows that the COVID-19 vaccine produced by the two firms remains effective when stored at normal freezer temperatures for two weeks, potentially greatly easing vaccine distribution in the U.S. and around the world.
New research and analysis also shows that the first dose of the Pfizer vaccine is highly effective at preventing COVID-19. Two Canadian researchers claim the first dose shows 92.6% efficacy, compared with 95% efficacy after both doses. The researchers say these results should be used to reassess how limited vaccine supply is distributed.
Under the Pfizer/BioNTech vaccine’s initial FDA Emergency Use Authorization, the vaccine had to be stored at –70°C, a temperature that required expensive and specialized freezers to achieve. Before the pandemic, that equipment was hard to find save for freezers housed in research facilities.
That created added headaches, costs, and risks—particularly for rural or remote vaccination facilities. Pfizer developed a shipping box cooled by dry ice that could maintain the temperatures for a limited time. But experts have expressed concern about potential spoilage of doses stored using this low-tech method.
But new data from the companies shows that the vaccine retains its effectiveness for at least two weeks when stored at temperatures of between –15°C and –25°C, easily achieved by standard medical storage freezers.
The new data has been submitted to the FDA, but changes to current storage standards must be approved as part of a revised Emergency Use Authorization before any changes are made to distribution methods on the ground.
Experts have been expecting Pfizer to pursue approval for less stringent storage requirements. The initial ultracold requirements were the product of a compressed development timeline, with further long-term research and testing needed before they could be loosened.
Based on their findings on the very high protectiveness of the Pfizer/BioNTech vaccine, researchers Danuta Skowronski and Gaston De Serres say that “the benefits derived from a scarce supply of vaccine could be maximized by deferring second doses until all priority group members are offered at least one dose.” This approach was tried early in the U.K. as part of efforts to speed vaccinations, helping it achieve the third-highest national first-dose vaccination rate in the world.
But this new data must also make its way through U.S. regulatory channels before any changes are made to vaccine distribution. One looming uncertainty is how long the first-dose immunity lasts without the second dose, which effectively helps reinforce what a recipient’s immune system learns from the first dose.
There was already preliminary evidence in early February that the AstraZeneca vaccine, created in conjunction with the University of Oxford, cut transmission rates for the virus by about two-thirds with just a single dose.
That data will soon be confirmed, reports the Telegraph, citing sources from Public Health England (PHE), not just for the AstraZeneca vaccine but for a single dose of the two-dose Pfizer vaccine as well. And that protection against transmission appears consistent across all age groups.
This adds to evidence from two Israeli studies published this week, finding that Pfizer’s COVID vaccine significantly reduces the virus’s transmission. The joint analysis between Pfizer and Israel’s health ministry found that a two-dose regimen of the shot reduced infections by 89.4% overall (including asymptomatic cases) and 93.7% in symptomatic cases. Results were tracked via testing for COVID infections, fueled by a national COVID-tracking database in Israel. The study has yet to be peer-reviewed.
The second study examined more than 7,000 hospital staff and found about a 75% reduction in infections with Pfizer’s vaccine.
Given the high efficacy rates of the Pfizer, Moderna, J&J, and AstraZeneca vaccines, getting some kind of shot would still weaken the virus and at the very least lower the chances of spreading it to others.
We already know that these vaccines significantly reduce the risk of COVID-related hospitalization and deaths for those who may go on to contract it. But the ideal would be to achieve a significant level of “sterilizing immunity,” the kind that can stop widespread community spread of the coronavirus. And the information rolling in suggests this class of vaccines may meet that challenge.