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FDA將完全批準(zhǔn)新冠疫苗,會(huì)扭轉(zhuǎn)現(xiàn)狀嗎?

有證據(jù)表明,對(duì)新冠疫苗進(jìn)行完全批準(zhǔn)或?qū)⑼苿?dòng)更多民眾接種疫苗。

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美國(guó)總統(tǒng)喬?拜登于7月21日表示,他認(rèn)為美國(guó)食品與藥品管理局(Food and Drug Administration,以下簡(jiǎn)稱為FDA)最快將于今年秋季授予新冠疫苗完全批準(zhǔn)。

在俄亥俄州的一處市政大廳,拜登表示,F(xiàn)DA將很快對(duì)新冠疫苗進(jìn)行完全批準(zhǔn),而截至目前,相關(guān)疫苗獲得的僅為緊急使用授權(quán)。

拜登說(shuō):“我們召集了許多科學(xué)家,其中20多位來(lái)自一線,經(jīng)過(guò)對(duì)話之后,我預(yù)期在新學(xué)年開(kāi)始的某個(gè)時(shí)候,8月底或者9、10月初,新冠疫苗將會(huì)獲得完全批準(zhǔn)。”

有證據(jù)表明,對(duì)新冠疫苗進(jìn)行完全批準(zhǔn)或?qū)⑼苿?dòng)更多民眾接種疫苗。凱澤家族基金會(huì)(Kaiser Family Foundation)于今年6月啟動(dòng)的疫苗監(jiān)測(cè)報(bào)告發(fā)現(xiàn),31%的未接種疫苗的成年人稱,如果目前獲得緊急使用批準(zhǔn)的某款疫苗獲得完全批準(zhǔn),那么他們將更有可能前去接種疫苗。

凱澤家族基金會(huì)的高級(jí)調(diào)查分析師盧娜?洛佩斯認(rèn)為,對(duì)疫苗進(jìn)行完全批準(zhǔn)將對(duì)那些尚未接種疫苗同時(shí)表示“等等看”的民眾產(chǎn)生最強(qiáng)影響。

洛佩斯說(shuō):“疫苗安全性、研發(fā)速度及新穎性都是他們非常關(guān)心的問(wèn)題。獲得FDA完全批準(zhǔn)或?qū)⒋偈共糠稚形唇臃N且持‘觀望’態(tài)度的民眾前去接種疫苗。”

盡管有跡象表明,獲得FDA完全批準(zhǔn)或?qū)⑼苿?dòng)部分民眾前去接種新冠疫苗,但如洛佩斯所言,很多人實(shí)際并不清楚緊急授權(quán)與完全批準(zhǔn)之間的區(qū)別。根據(jù)該基金會(huì)的報(bào)告,“三分之二的成年人(包括大多數(shù)尚未接種疫苗的成年人)要么認(rèn)為美國(guó)現(xiàn)有疫苗已經(jīng)獲得FDA完全批準(zhǔn),要么不確定現(xiàn)有疫苗獲得的是完全批準(zhǔn)還是緊急使用授權(quán)?!?/p>

在2020年12月輝瑞(Pfizer)和BioNTech開(kāi)發(fā)的新冠疫苗率先獲得緊急使用授權(quán)之前,大多數(shù)美國(guó)民眾可能并不了解緊急使用授權(quán)和完全批準(zhǔn)之間的區(qū)別。此后, Moderna公司和強(qiáng)生公司(Johnson & Johnson)的新冠疫苗也都獲得了緊急使用授權(quán)。

本世紀(jì)初,為保護(hù)軍隊(duì)免受“9?11”事件后的炭疽攻擊,美國(guó)國(guó)會(huì)給予了FDA授予緊急授權(quán)的權(quán)力。豬流感(H1N1)、中東呼吸綜合征(MERS)、寨卡病毒(Zika)和埃博拉病毒(Ebola)的實(shí)驗(yàn)療法也曾經(jīng)獲得類似授權(quán)。

如果某些疾病病情嚴(yán)重且可能危及生命,但又尚無(wú)獲得批準(zhǔn)的治療方案,那么FDA就可以通過(guò)授予緊急使用授權(quán)的方式批準(zhǔn)有關(guān)方面使用未經(jīng)批準(zhǔn)的醫(yī)療產(chǎn)品來(lái)診斷、治療和預(yù)防這些疾病。

但這并不意味著新冠疫苗并未經(jīng)過(guò)嚴(yán)格測(cè)試。數(shù)以萬(wàn)計(jì)的受試者參與了按照FDA標(biāo)準(zhǔn)開(kāi)展的嚴(yán)格臨床試驗(yàn),協(xié)助證明了疫苗的有效性。緊急使用授權(quán)只是加快了生產(chǎn)和行政審批流程。

輝瑞和Moderna分別已經(jīng)于今年5月初和6月初遞交了疫苗完全批準(zhǔn)申請(qǐng)。強(qiáng)生公司尚未提出申請(qǐng),但預(yù)計(jì)也將很快啟動(dòng)相關(guān)工作。相較緊急授權(quán),在決定是否授予FDA完全批準(zhǔn)時(shí),監(jiān)管機(jī)構(gòu)將對(duì)更多數(shù)據(jù)進(jìn)行更長(zhǎng)時(shí)間的審查,同時(shí)還將審查生產(chǎn)和質(zhì)量控制流程。

據(jù)《科學(xué)》雜志(Science Magazine)報(bào)道,7月16日,F(xiàn)DA已經(jīng)接受了輝瑞的完全批準(zhǔn)申請(qǐng),并將其列為“優(yōu)先審查項(xiàng)目”。如此一來(lái),從理論上說(shuō),相較于通常所需的10個(gè)月的審批時(shí)間,該申請(qǐng)或?qū)⒏斓玫脚鷾?zhǔn)。目前,F(xiàn)DA尚未正式接受Moderna的申請(qǐng)。

目前,12歲以下兒童還不能接種疫苗。在同一場(chǎng)市政廳演講中,拜登指出,他期望這些兒童也能夠盡快獲得在緊急狀況下接種疫苗的資格。不過(guò)FDA已經(jīng)表示,這種情況在冬季到來(lái)前不會(huì)發(fā)生。(財(cái)富中文網(wǎng))

譯者:梁宇

審校:夏林

美國(guó)總統(tǒng)喬?拜登于7月21日表示,他認(rèn)為美國(guó)食品與藥品管理局(Food and Drug Administration,以下簡(jiǎn)稱為FDA)最快將于今年秋季授予新冠疫苗完全批準(zhǔn)。

在俄亥俄州的一處市政大廳,拜登表示,F(xiàn)DA將很快對(duì)新冠疫苗進(jìn)行完全批準(zhǔn),而截至目前,相關(guān)疫苗獲得的僅為緊急使用授權(quán)。

拜登說(shuō):“我們召集了許多科學(xué)家,其中20多位來(lái)自一線,經(jīng)過(guò)對(duì)話之后,我預(yù)期在新學(xué)年開(kāi)始的某個(gè)時(shí)候,8月底或者9、10月初,新冠疫苗將會(huì)獲得完全批準(zhǔn)。”

有證據(jù)表明,對(duì)新冠疫苗進(jìn)行完全批準(zhǔn)或?qū)⑼苿?dòng)更多民眾接種疫苗。凱澤家族基金會(huì)(Kaiser Family Foundation)于今年6月啟動(dòng)的疫苗監(jiān)測(cè)報(bào)告發(fā)現(xiàn),31%的未接種疫苗的成年人稱,如果目前獲得緊急使用批準(zhǔn)的某款疫苗獲得完全批準(zhǔn),那么他們將更有可能前去接種疫苗。

凱澤家族基金會(huì)的高級(jí)調(diào)查分析師盧娜?洛佩斯認(rèn)為,對(duì)疫苗進(jìn)行完全批準(zhǔn)將對(duì)那些尚未接種疫苗同時(shí)表示“等等看”的民眾產(chǎn)生最強(qiáng)影響。

洛佩斯說(shuō):“疫苗安全性、研發(fā)速度及新穎性都是他們非常關(guān)心的問(wèn)題。獲得FDA完全批準(zhǔn)或?qū)⒋偈共糠稚形唇臃N且持‘觀望’態(tài)度的民眾前去接種疫苗?!?/p>

盡管有跡象表明,獲得FDA完全批準(zhǔn)或?qū)⑼苿?dòng)部分民眾前去接種新冠疫苗,但如洛佩斯所言,很多人實(shí)際并不清楚緊急授權(quán)與完全批準(zhǔn)之間的區(qū)別。根據(jù)該基金會(huì)的報(bào)告,“三分之二的成年人(包括大多數(shù)尚未接種疫苗的成年人)要么認(rèn)為美國(guó)現(xiàn)有疫苗已經(jīng)獲得FDA完全批準(zhǔn),要么不確定現(xiàn)有疫苗獲得的是完全批準(zhǔn)還是緊急使用授權(quán)?!?/p>

在2020年12月輝瑞(Pfizer)和BioNTech開(kāi)發(fā)的新冠疫苗率先獲得緊急使用授權(quán)之前,大多數(shù)美國(guó)民眾可能并不了解緊急使用授權(quán)和完全批準(zhǔn)之間的區(qū)別。此后, Moderna公司和強(qiáng)生公司(Johnson & Johnson)的新冠疫苗也都獲得了緊急使用授權(quán)。

本世紀(jì)初,為保護(hù)軍隊(duì)免受“9?11”事件后的炭疽攻擊,美國(guó)國(guó)會(huì)給予了FDA授予緊急授權(quán)的權(quán)力。豬流感(H1N1)、中東呼吸綜合征(MERS)、寨卡病毒(Zika)和埃博拉病毒(Ebola)的實(shí)驗(yàn)療法也曾經(jīng)獲得類似授權(quán)。

如果某些疾病病情嚴(yán)重且可能危及生命,但又尚無(wú)獲得批準(zhǔn)的治療方案,那么FDA就可以通過(guò)授予緊急使用授權(quán)的方式批準(zhǔn)有關(guān)方面使用未經(jīng)批準(zhǔn)的醫(yī)療產(chǎn)品來(lái)診斷、治療和預(yù)防這些疾病。

但這并不意味著新冠疫苗并未經(jīng)過(guò)嚴(yán)格測(cè)試。數(shù)以萬(wàn)計(jì)的受試者參與了按照FDA標(biāo)準(zhǔn)開(kāi)展的嚴(yán)格臨床試驗(yàn),協(xié)助證明了疫苗的有效性。緊急使用授權(quán)只是加快了生產(chǎn)和行政審批流程。

輝瑞和Moderna分別已經(jīng)于今年5月初和6月初遞交了疫苗完全批準(zhǔn)申請(qǐng)。強(qiáng)生公司尚未提出申請(qǐng),但預(yù)計(jì)也將很快啟動(dòng)相關(guān)工作。相較緊急授權(quán),在決定是否授予FDA完全批準(zhǔn)時(shí),監(jiān)管機(jī)構(gòu)將對(duì)更多數(shù)據(jù)進(jìn)行更長(zhǎng)時(shí)間的審查,同時(shí)還將審查生產(chǎn)和質(zhì)量控制流程。

據(jù)《科學(xué)》雜志(Science Magazine)報(bào)道,7月16日,F(xiàn)DA已經(jīng)接受了輝瑞的完全批準(zhǔn)申請(qǐng),并將其列為“優(yōu)先審查項(xiàng)目”。如此一來(lái),從理論上說(shuō),相較于通常所需的10個(gè)月的審批時(shí)間,該申請(qǐng)或?qū)⒏斓玫脚鷾?zhǔn)。目前,F(xiàn)DA尚未正式接受Moderna的申請(qǐng)。

目前,12歲以下兒童還不能接種疫苗。在同一場(chǎng)市政廳演講中,拜登指出,他期望這些兒童也能夠盡快獲得在緊急狀況下接種疫苗的資格。不過(guò)FDA已經(jīng)表示,這種情況在冬季到來(lái)前不會(huì)發(fā)生。(財(cái)富中文網(wǎng))

譯者:梁宇

審校:夏林

President Joe Biden said on July 21 he thinks the Food and Drug Administration will give full approval for vaccines as soon as this fall.

At a town hall in Ohio, Biden said the FDA would soon fully approve COVID-19 vaccines, which up to now have only been authorized for emergency use.

“My expectation talking to the group of scientists we put together, over 20 of them plus others in the field, is that sometime maybe in the beginning of the school year, at the end of August, beginning of September, October, they’ll get a final approval,” Biden said.

There is some evidence that full approval for Covid vaccines could push more people to get vaccinated. A vaccine monitoring report by the Kaiser Family Foundation from June found that 31% of unvaccinated adults said they would be more likely to get the vaccine if one of the shots that is currently authorized for emergency use received full approval.

Full approval would have the strongest effect on people that are unvaccinated and said they would "wait and see" before getting the vaccine, said Kaiser Family Foundation Senior Survey Analyst Lunna Lopes.

"One of the big concerns they have is the safety of vaccine, and how quickly it was developed, and just the newness of vaccine," Lopes said. "Full FDA approval could kind of nudge some of those people who are currently unvaccinated and in that 'wait and see' group towards getting the vaccine."

Despite indications that full FDA approval may push some people to get a Covid vaccine, Lopes said there is still confusion about the difference between emergency authorization and full FDA approval. According to the foundation's report, "two-thirds of adults (including a large majority of unvaccinated adults) either believe the vaccines currently available in the U.S. already have full approval from the FDA or are unsure whether they have full approval or are authorized for emergency use."

The difference between emergency use authorization and full approval is something most Americans were likely unfamiliar with until the first emergency use authorization for coronavirus was granted to the Pfizer-BioNTech COVID-19 vaccine in December 2020. Since then, both the Moderna and Johnson & Johnson (Janssen) vaccine have also received emergency approval.

The power to give emergency authorization was granted to the FDA by Congress in the early 2000s with one of the intention of protecting the military against anthrax attacks post-911. Similar authorizations have been issued to experimental therapies for swine flu (H1N1), Middle East Respiratory Syndrome (MERS), Zika, and Ebola.

Under emergency use authorization, the FDA can allow the use of unapproved medical products to diagnose, treat, and prevent serious and life-threatening diseases for which there are no approved alternatives.

Yet, this authorization doesn’t imply that vaccines aren’t rigorously tested. Tens of thousands of study participants have helped prove the effectiveness of vaccines in strict clinical trials that follow FDA standards. Emergency use authorization simply speeds up manufacturing and administrative processes.

Pfizer applied for full approval for its vaccine in early May and Moderna in early June. Johnson & Johnson has yet to apply, but is expected to do so soon. To determine FDA approval, the regulatory agency will review much more data over a longer period of time than it did for the emergency use authorizations. It will also review manufacturing and quality control.

On July 16, the FDA accepted Pfizer's application for full approval and labeled it “under priority review," according to Science Magazine. This means that the application will theoretically be approved faster than the typical 10 months it would usually take. The FDA has not formally accepted Moderna's application.

At the same town hall Wednesday, Biden said he expects children younger than 12, who can’t currently get the vaccine, to be eligible soon on an emergency basis, although the FDA has said it doesn't expect that to happen until the winter.

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