隨著有大量人群未接種疫苗的多個州感染病例和住院人數(shù)激增,美國政府計劃直接加強對新冠抗體治療藥物分配的管制。
美國衛(wèi)生及公共服務(wù)部網(wǎng)站上發(fā)布的9月13日的最新信息顯示,醫(yī)院和其他醫(yī)療提供商不能再直接向分銷商訂購單克隆抗體治療藥物。
相反,美國政府將根據(jù)新冠病例的數(shù)量和本地治療藥物的使用情況,決定向各州和領(lǐng)地運送藥物的數(shù)量。衛(wèi)生及公共服務(wù)部的信息稱,之后,各州健康部門將決定如何向醫(yī)院和其他場所分配抗體治療藥物。
該部門的網(wǎng)站顯示,德爾塔變種病毒引發(fā)的感染病例增加“導致單克隆抗體(mAb)藥物的使用量大幅增加,尤其是在疫苗接種率較低的區(qū)域?!痹摬块T稱其“致力于幫助確保國內(nèi)所有地區(qū)現(xiàn)有和未來的患者始終有這類關(guān)鍵性藥物可用。”
美國許多疫苗接種率較低的地區(qū)目前依賴抗體藥物避免患者涌入面臨壓力的醫(yī)院。這種治療藥物與新冠疫苗一樣已經(jīng)獲得美國食品與藥品管理局(Food and Drug Administration)的緊急使用授權(quán),但曾經(jīng)反對快速審查疫苗的人們卻贊同快速批準這些藥物上市。
政府公布的數(shù)據(jù)顯示,根據(jù)新分配機制,大量藥物將在本周被運送到佛羅里達州、得克薩斯州、佐治亞州和密西西比州。
到下周二,美國將把藥物分配量的18%交付給佛羅里達州,13%交付給得克薩斯州。此外,30多個州和領(lǐng)地將分別得到不足1%的供應(yīng)量。疫苗接種率較高且病例數(shù)較少的佛蒙特州將獲得0.1%的藥物。
一位發(fā)言人稱,衛(wèi)生及公共服務(wù)部做出調(diào)整的目的是“根據(jù)國內(nèi)所有地區(qū)的病例數(shù)量和藥物使用量保證[單克隆抗體藥物]的穩(wěn)定供應(yīng)?!?/p>
該發(fā)言人稱,該部門發(fā)現(xiàn),自7月中旬以來,單克隆抗體藥物的訂購量和使用量增加了20倍,有7個州的訂購量占總量的約70%。
發(fā)言人表示:“考慮到這種現(xiàn)實,我們必須保證這些救命治療藥物的供應(yīng),能夠滿足所有州和領(lǐng)地的需求,而不只是供應(yīng)部分地區(qū)?!边@位發(fā)言人還補充說,衛(wèi)生及公共服務(wù)部每周發(fā)出約15萬劑治療藥物,比8月初的平均發(fā)運量增加了50%。
但致力于治療藥物分配的倡議者戴安娜·貝倫特表示,她擔心這種調(diào)整只會讓患者更難獲得單克隆抗體藥物治療。在許多地區(qū),患者想要使用單克隆抗體藥物已經(jīng)困難重重。
她說:“這對于疫苗接種率較高的州是不公平的?!?/p>
美國政府使用聯(lián)邦模型進行抗體藥物分配,包括由再生元制藥公司(Regeneron Pharmaceuticals Inc.)和禮來公司(Eli Lilly & Co.,)在新冠疫情之初開發(fā)的藥物。但政府選擇允許醫(yī)療服務(wù)提供商直接向分銷商美源伯根公司(AmerisourceBergen Corp.)訂購藥物。
禮來的發(fā)言人指出,該制藥公司“會繼續(xù)與各國政府合作,在新冠疫情期間幫助滿足患者對治療藥物的需求。”
再生元的代表則拒絕置評。
美國疾病預(yù)防與控制中心(CDC)在上周發(fā)布的一項研究顯示,未接種疫苗的人群感染新冠病毒的風險比已經(jīng)接種疫苗的人群高約5倍,住院和死亡的風險高出10倍以上。(財富中文網(wǎng))
翻譯:劉進龍
審校:汪皓
隨著有大量人群未接種疫苗的多個州感染病例和住院人數(shù)激增,美國政府計劃直接加強對新冠抗體治療藥物分配的管制。
美國衛(wèi)生及公共服務(wù)部網(wǎng)站上發(fā)布的9月13日的最新信息顯示,醫(yī)院和其他醫(yī)療提供商不能再直接向分銷商訂購單克隆抗體治療藥物。
相反,美國政府將根據(jù)新冠病例的數(shù)量和本地治療藥物的使用情況,決定向各州和領(lǐng)地運送藥物的數(shù)量。衛(wèi)生及公共服務(wù)部的信息稱,之后,各州健康部門將決定如何向醫(yī)院和其他場所分配抗體治療藥物。
該部門的網(wǎng)站顯示,德爾塔變種病毒引發(fā)的感染病例增加“導致單克隆抗體(mAb)藥物的使用量大幅增加,尤其是在疫苗接種率較低的區(qū)域?!痹摬块T稱其“致力于幫助確保國內(nèi)所有地區(qū)現(xiàn)有和未來的患者始終有這類關(guān)鍵性藥物可用。”
美國許多疫苗接種率較低的地區(qū)目前依賴抗體藥物避免患者涌入面臨壓力的醫(yī)院。這種治療藥物與新冠疫苗一樣已經(jīng)獲得美國食品與藥品管理局(Food and Drug Administration)的緊急使用授權(quán),但曾經(jīng)反對快速審查疫苗的人們卻贊同快速批準這些藥物上市。
政府公布的數(shù)據(jù)顯示,根據(jù)新分配機制,大量藥物將在本周被運送到佛羅里達州、得克薩斯州、佐治亞州和密西西比州。
到下周二,美國將把藥物分配量的18%交付給佛羅里達州,13%交付給得克薩斯州。此外,30多個州和領(lǐng)地將分別得到不足1%的供應(yīng)量。疫苗接種率較高且病例數(shù)較少的佛蒙特州將獲得0.1%的藥物。
一位發(fā)言人稱,衛(wèi)生及公共服務(wù)部做出調(diào)整的目的是“根據(jù)國內(nèi)所有地區(qū)的病例數(shù)量和藥物使用量保證[單克隆抗體藥物]的穩(wěn)定供應(yīng)?!?/p>
該發(fā)言人稱,該部門發(fā)現(xiàn),自7月中旬以來,單克隆抗體藥物的訂購量和使用量增加了20倍,有7個州的訂購量占總量的約70%。
發(fā)言人表示:“考慮到這種現(xiàn)實,我們必須保證這些救命治療藥物的供應(yīng),能夠滿足所有州和領(lǐng)地的需求,而不只是供應(yīng)部分地區(qū)?!边@位發(fā)言人還補充說,衛(wèi)生及公共服務(wù)部每周發(fā)出約15萬劑治療藥物,比8月初的平均發(fā)運量增加了50%。
但致力于治療藥物分配的倡議者戴安娜·貝倫特表示,她擔心這種調(diào)整只會讓患者更難獲得單克隆抗體藥物治療。在許多地區(qū),患者想要使用單克隆抗體藥物已經(jīng)困難重重。
她說:“這對于疫苗接種率較高的州是不公平的。”
美國政府使用聯(lián)邦模型進行抗體藥物分配,包括由再生元制藥公司(Regeneron Pharmaceuticals Inc.)和禮來公司(Eli Lilly & Co.,)在新冠疫情之初開發(fā)的藥物。但政府選擇允許醫(yī)療服務(wù)提供商直接向分銷商美源伯根公司(AmerisourceBergen Corp.)訂購藥物。
禮來的發(fā)言人指出,該制藥公司“會繼續(xù)與各國政府合作,在新冠疫情期間幫助滿足患者對治療藥物的需求?!?/p>
再生元的代表則拒絕置評。
美國疾病預(yù)防與控制中心(CDC)在上周發(fā)布的一項研究顯示,未接種疫苗的人群感染新冠病毒的風險比已經(jīng)接種疫苗的人群高約5倍,住院和死亡的風險高出10倍以上。(財富中文網(wǎng))
翻譯:劉進龍
審校:汪皓
The U.S. government plans to more directly control where Covid-19 antibody treatments are sent amid a surge in infections and hospitalizations in states with large pockets of unvaccinated people.
Hospitals and other care providers will no longer be able to directly order monoclonal antibody therapies from distributors, according to a Sept. 13 update posted on the Department of Health and Human Services website.
Instead, the U.S. government will determine what quantity of the drugs to ship to each state and territory based on Covid-19 case numbers and use of the treatments locally. State health departments will then determine how to distribute the antibody therapies to hospitals and other sites, according to the HHS update.
A rise in infections from the Delta variant “has caused a substantial surge in the utilization of monoclonal antibody (mAb) drugs, particularly in areas of the country with low vaccination rates,” HHS said on its website. The agency said it is “committed to helping ensure consistent availability of these critical drugs for current and future patients in all geographic areas of the country.”
Many parts of the country with low vaccination rates are relying on antibody therapies to try to keep patients out of strained hospitals. The treatments were cleared by the Food and Drug Administration under the same emergency authorization process used to review Covid-19 vaccines, but have been embraced by people who balked at the rapid review of the shots.
Under the new distribution mechanism, the largest shipments will be sent to Florida, Texas, Georgia, and Mississippi this week, according to data provided in the government announcement.
The U.S. will deliver 18% of its allocation of therapies through next Tuesday to Florida, and 13% to Texas. Meanwhile, more than 30 states and territories will each respectively receive less than 1% of the supply. Vermont, where vaccination rates are high and cases are low, will be allocated less than 0.1%.
HHS made the shift “to allow for a more consistent supply of [monoclonal antibodies] that is responsive to cases and utilization in all geographic areas of the country,” a spokesperson said.
The agency has seen a twenty-fold increase in ordering and use of monoclonal antibodies since mid-July, and seven states accounted for about 70% of ordering, the spokesperson said.
“Given this reality, we must work to ensure our supply of these life-saving therapies remains available for all states and territories, not just some,” the spokesperson said. The spokesperson added that HHS is now shipping about 150,000 doses of the therapies each week, a 50% increase from average shipments in early August.
But Diana Berrent, an advocate who has worked on distributing the therapies, said she is concerned that the change will only make it harder for patients to find monoclonal antibodies, an already-difficult process in many parts of the country.
“It’s penalizing states that have high vaccinations,” Berrent said.
The federal model was used to distribute antibody therapies, including ones made by Regeneron Pharmaceuticals Inc. and Eli Lilly & Co., earlier in the pandemic. But the government shifted to allow care providers to order the treatments directly from distributor AmerisourceBergen Corp.
A spokeswoman for Eli Lilly said the drugmaker “continues to work with governments globally to help address the therapeutic needs of patients during the Covid-19 pandemic.”
Representatives for Regeneron declined a request for comment.
Unvaccinated people have about five times higher risk of contracting Covid and more than 10 times the risk of getting hospitalized and risk of dying, according to a CDC study released last week.