美國總統喬?拜登于7月21日表示,他認為美國食品與藥品管理局(Food and Drug Administration,以下簡稱為FDA)最快將于今年秋季授予新冠疫苗完全批準。
在俄亥俄州的一處市政大廳,拜登表示,FDA將很快對新冠疫苗進行完全批準,而截至目前,相關疫苗獲得的僅為緊急使用授權。
拜登說:“我們召集了許多科學家,其中20多位來自一線,經過對話之后,我預期在新學年開始的某個時候,8月底或者9、10月初,新冠疫苗將會獲得完全批準?!?/p>
有證據表明,對新冠疫苗進行完全批準或將推動更多民眾接種疫苗。凱澤家族基金會(Kaiser Family Foundation)于今年6月啟動的疫苗監測報告發現,31%的未接種疫苗的成年人稱,如果目前獲得緊急使用批準的某款疫苗獲得完全批準,那么他們將更有可能前去接種疫苗。
凱澤家族基金會的高級調查分析師盧娜?洛佩斯認為,對疫苗進行完全批準將對那些尚未接種疫苗同時表示“等等看”的民眾產生最強影響。
洛佩斯說:“疫苗安全性、研發速度及新穎性都是他們非常關心的問題。獲得FDA完全批準或將促使部分尚未接種且持‘觀望’態度的民眾前去接種疫苗。”
盡管有跡象表明,獲得FDA完全批準或將推動部分民眾前去接種新冠疫苗,但如洛佩斯所言,很多人實際并不清楚緊急授權與完全批準之間的區別。根據該基金會的報告,“三分之二的成年人(包括大多數尚未接種疫苗的成年人)要么認為美國現有疫苗已經獲得FDA完全批準,要么不確定現有疫苗獲得的是完全批準還是緊急使用授權。”
在2020年12月輝瑞(Pfizer)和BioNTech開發的新冠疫苗率先獲得緊急使用授權之前,大多數美國民眾可能并不了解緊急使用授權和完全批準之間的區別。此后, Moderna公司和強生公司(Johnson & Johnson)的新冠疫苗也都獲得了緊急使用授權。
本世紀初,為保護軍隊免受“9?11”事件后的炭疽攻擊,美國國會給予了FDA授予緊急授權的權力。豬流感(H1N1)、中東呼吸綜合征(MERS)、寨卡病毒(Zika)和埃博拉病毒(Ebola)的實驗療法也曾經獲得類似授權。
如果某些疾病病情嚴重且可能危及生命,但又尚無獲得批準的治療方案,那么FDA就可以通過授予緊急使用授權的方式批準有關方面使用未經批準的醫療產品來診斷、治療和預防這些疾病。
但這并不意味著新冠疫苗并未經過嚴格測試。數以萬計的受試者參與了按照FDA標準開展的嚴格臨床試驗,協助證明了疫苗的有效性。緊急使用授權只是加快了生產和行政審批流程。
輝瑞和Moderna分別已經于今年5月初和6月初遞交了疫苗完全批準申請。強生公司尚未提出申請,但預計也將很快啟動相關工作。相較緊急授權,在決定是否授予FDA完全批準時,監管機構將對更多數據進行更長時間的審查,同時還將審查生產和質量控制流程。
據《科學》雜志(Science Magazine)報道,7月16日,FDA已經接受了輝瑞的完全批準申請,并將其列為“優先審查項目”。如此一來,從理論上說,相較于通常所需的10個月的審批時間,該申請或將更快得到批準。目前,FDA尚未正式接受Moderna的申請。
目前,12歲以下兒童還不能接種疫苗。在同一場市政廳演講中,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FDA已經表示,這種情況在冬季到來前不會發生。(財富中文網)
譯者:梁宇
審校:夏林
美國總統喬?拜登于7月21日表示,他認為美國食品與藥品管理局(Food and Drug Administration,以下簡稱為FDA)最快將于今年秋季授予新冠疫苗完全批準。
在俄亥俄州的一處市政大廳,拜登表示,FDA將很快對新冠疫苗進行完全批準,而截至目前,相關疫苗獲得的僅為緊急使用授權。
拜登說:“我們召集了許多科學家,其中20多位來自一線,經過對話之后,我預期在新學年開始的某個時候,8月底或者9、10月初,新冠疫苗將會獲得完全批準。”
有證據表明,對新冠疫苗進行完全批準或將推動更多民眾接種疫苗。凱澤家族基金會(Kaiser Family Foundation)于今年6月啟動的疫苗監測報告發現,31%的未接種疫苗的成年人稱,如果目前獲得緊急使用批準的某款疫苗獲得完全批準,那么他們將更有可能前去接種疫苗。
凱澤家族基金會的高級調查分析師盧娜?洛佩斯認為,對疫苗進行完全批準將對那些尚未接種疫苗同時表示“等等看”的民眾產生最強影響。
洛佩斯說:“疫苗安全性、研發速度及新穎性都是他們非常關心的問題。獲得FDA完全批準或將促使部分尚未接種且持‘觀望’態度的民眾前去接種疫苗。”
盡管有跡象表明,獲得FDA完全批準或將推動部分民眾前去接種新冠疫苗,但如洛佩斯所言,很多人實際并不清楚緊急授權與完全批準之間的區別。根據該基金會的報告,“三分之二的成年人(包括大多數尚未接種疫苗的成年人)要么認為美國現有疫苗已經獲得FDA完全批準,要么不確定現有疫苗獲得的是完全批準還是緊急使用授權。”
在2020年12月輝瑞(Pfizer)和BioNTech開發的新冠疫苗率先獲得緊急使用授權之前,大多數美國民眾可能并不了解緊急使用授權和完全批準之間的區別。此后, Moderna公司和強生公司(Johnson & Johnson)的新冠疫苗也都獲得了緊急使用授權。
本世紀初,為保護軍隊免受“9?11”事件后的炭疽攻擊,美國國會給予了FDA授予緊急授權的權力。豬流感(H1N1)、中東呼吸綜合征(MERS)、寨卡病毒(Zika)和埃博拉病毒(Ebola)的實驗療法也曾經獲得類似授權。
如果某些疾病病情嚴重且可能危及生命,但又尚無獲得批準的治療方案,那么FDA就可以通過授予緊急使用授權的方式批準有關方面使用未經批準的醫療產品來診斷、治療和預防這些疾病。
但這并不意味著新冠疫苗并未經過嚴格測試。數以萬計的受試者參與了按照FDA標準開展的嚴格臨床試驗,協助證明了疫苗的有效性。緊急使用授權只是加快了生產和行政審批流程。
輝瑞和Moderna分別已經于今年5月初和6月初遞交了疫苗完全批準申請。強生公司尚未提出申請,但預計也將很快啟動相關工作。相較緊急授權,在決定是否授予FDA完全批準時,監管機構將對更多數據進行更長時間的審查,同時還將審查生產和質量控制流程。
據《科學》雜志(Science Magazine)報道,7月16日,FDA已經接受了輝瑞的完全批準申請,并將其列為“優先審查項目”。如此一來,從理論上說,相較于通常所需的10個月的審批時間,該申請或將更快得到批準。目前,FDA尚未正式接受Moderna的申請。
目前,12歲以下兒童還不能接種疫苗。在同一場市政廳演講中,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FDA已經表示,這種情況在冬季到來前不會發生。(財富中文網)
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.