3月1日上午,印度總理納倫德拉·莫迪接受了他的第一劑Covaxin疫苗。這種疫苗由印度疫苗制造商巴拉特生物技術(shù)公司(Bharat Biotech)研發(fā)。莫迪總理的這一針,代表了他向印度產(chǎn)新冠疫苗抱以的重大信任。但是,科研人員普遍批評稱,該疫苗的效果未經(jīng)證實。
在接種疫苗后,莫迪公開敦促“所有符合資格的人”報名接種疫苗,包括60歲以上的印度公民,以及45歲以上且健康狀況符合標(biāo)準(zhǔn)的人。
六周前,在衛(wèi)生部門和一線員工的參與下,印度發(fā)起了世界上最大規(guī)模之一的疫苗接種運動。目前,除其他四國之外,印度接種的疫苗比任何國家都多,但仍然遠(yuǎn)低于此前定下的目標(biāo)——截至今年8月完成3億印度公民的疫苗接種工作。印度疫苗應(yīng)用程序的故障,以及公眾對巴拉特公司產(chǎn)品的排斥情緒,都延緩了疫苗的推廣工作。
與中國制造商科興和國藥控股的疫苗一樣,Covaxin使用滅活新冠病毒來誘導(dǎo)免疫反應(yīng)。巴拉特公司于去年6月啟動了Covaxin疫苗的一期和二期試驗,隨后在11月啟動了三期試驗,有近26000名志愿者參與。
但在三期療效試驗結(jié)束前,印度監(jiān)管機(jī)構(gòu)于1月3日批準(zhǔn)了巴拉特公司的申請,在印度緊急分發(fā)該疫苗。當(dāng)時,科研人員對印度監(jiān)管機(jī)構(gòu)批準(zhǔn)該疫苗的理由提出質(zhì)疑——據(jù)報道,巴拉特公司尚未完成三期臨床試驗,也未披露其疫苗對新冠病毒的有效性。
輝瑞(Pfizer)和Moderna等其他疫苗制造商已經(jīng)公布了有效性數(shù)據(jù),在預(yù)防新冠病毒感染方面,這兩家公司疫苗的有效性分別為95%和94%。但巴拉特公司的Covaxin疫苗目前還沒有這樣的數(shù)據(jù)。
印度醫(yī)學(xué)監(jiān)督機(jī)構(gòu)“全印度藥物行動網(wǎng)絡(luò)”(All India Drug Action Network)在1月3日發(fā)布的一份聲明中稱:“我們搞不懂是什么科學(xué)邏輯促使頂級專家們……批準(zhǔn)這種疫苗。批準(zhǔn)一種尚未完全結(jié)束研究的疫苗將帶來更多的麻煩,而不是答案……而且人們很可能不會恢復(fù)對科學(xué)決策機(jī)構(gòu)的信心?!?/p>
拿我在全印度醫(yī)學(xué)研究院(AIIMS)接種的第一劑新冠疫苗來說。
我們的醫(yī)生和科學(xué)家們在如此之短的時間內(nèi)加強(qiáng)了全球抗擊新冠疫情的工作,令人驚嘆。
我向所有有資格接種疫苗的人呼吁。讓我們一起使印度擺脫新冠病毒!
——納倫德拉·莫迪(@narendramodi),2021年3月1日
作為回應(yīng),巴拉特公司的董事長克里希納·埃拉為印度政府的決定進(jìn)行了辯護(hù)。他在一場新聞發(fā)布會上說,該公司進(jìn)行了“誠實的臨床試驗”,在生產(chǎn)安全有效的疫苗方面,該公司也有著良好的記錄。1月4日,埃拉還承諾,巴拉特公司將在一周內(nèi)公布疫苗的有效性數(shù)據(jù)。
近兩個月后,當(dāng)Covaxin疫苗已經(jīng)在印度各地推廣時,巴拉特公司卻仍未公開Covaxin疫苗對新冠病毒有效的證據(jù)。
根據(jù)彭博社(Bloomberg)的疫苗跟蹤數(shù)據(jù),印度迄今已經(jīng)接種了1430萬劑疫苗,但尚不清楚其中有多少是Covaxin疫苗。印度政府還批準(zhǔn)了另一種名為Covishield的新型疫苗,這種疫苗最初由阿斯利康(AstraZeneca)和牛津大學(xué)(Oxford University)共同研發(fā),由印度血清研究所(Serum Institute of India)生產(chǎn)。在1月16日啟動印度疫苗接種運動后,印度政府表示,其采購了550萬劑Covaxin和1100萬劑Covishield。
巴拉特生物技術(shù)公司承諾將很快發(fā)布Covaxin疫苗的數(shù)據(jù)。
2月22日,埃拉表示,公司將在兩周內(nèi)公布Covaxin的有效性數(shù)據(jù),并將這一推遲歸咎于巴拉特公司的試驗結(jié)構(gòu)。
“我們進(jìn)展得很快,但不幸的是,我們錯過了得出有效性數(shù)據(jù)的時間點?!卑@f,“如果我們之前將試驗的二三期階段結(jié)合起來,我們將更快地獲得有效性數(shù)據(jù)?!?/p>
然而,巴拉特公司數(shù)據(jù)的缺乏,給它的推廣帶來了一些問題。
今年2月,印度中部的恰蒂斯加爾邦表示,該邦將停止使用Covaxin,直到巴拉特公司能夠證明這種疫苗是有效的。
據(jù)報道,在國際上,巴拉特公司在40多個國家提交了申請Covaxin的批準(zhǔn),但迄今為止,伊朗是唯一一個批準(zhǔn)該疫苗緊急使用的國家。
此外,巴西在上周也購買了2000萬劑Covaxin,但由于藥效數(shù)據(jù)的缺乏,一些政府官員正試圖阻止Covaxin的運輸。
雖然巴拉特公司的疫苗尚未得到驗證,但現(xiàn)在,莫迪的疫苗注射表明,Covaxin疫苗至少得到了印度最有權(quán)力的人的支持。(財富中文網(wǎng))
編譯:楊二一
3月1日上午,印度總理納倫德拉·莫迪接受了他的第一劑Covaxin疫苗。這種疫苗由印度疫苗制造商巴拉特生物技術(shù)公司(Bharat Biotech)研發(fā)。莫迪總理的這一針,代表了他向印度產(chǎn)新冠疫苗抱以的重大信任。但是,科研人員普遍批評稱,該疫苗的效果未經(jīng)證實。
在接種疫苗后,莫迪公開敦促“所有符合資格的人”報名接種疫苗,包括60歲以上的印度公民,以及45歲以上且健康狀況符合標(biāo)準(zhǔn)的人。
六周前,在衛(wèi)生部門和一線員工的參與下,印度發(fā)起了世界上最大規(guī)模之一的疫苗接種運動。目前,除其他四國之外,印度接種的疫苗比任何國家都多,但仍然遠(yuǎn)低于此前定下的目標(biāo)——截至今年8月完成3億印度公民的疫苗接種工作。印度疫苗應(yīng)用程序的故障,以及公眾對巴拉特公司產(chǎn)品的排斥情緒,都延緩了疫苗的推廣工作。
與中國制造商科興和國藥控股的疫苗一樣,Covaxin使用滅活新冠病毒來誘導(dǎo)免疫反應(yīng)。巴拉特公司于去年6月啟動了Covaxin疫苗的一期和二期試驗,隨后在11月啟動了三期試驗,有近26000名志愿者參與。
但在三期療效試驗結(jié)束前,印度監(jiān)管機(jī)構(gòu)于1月3日批準(zhǔn)了巴拉特公司的申請,在印度緊急分發(fā)該疫苗。當(dāng)時,科研人員對印度監(jiān)管機(jī)構(gòu)批準(zhǔn)該疫苗的理由提出質(zhì)疑——據(jù)報道,巴拉特公司尚未完成三期臨床試驗,也未披露其疫苗對新冠病毒的有效性。
輝瑞(Pfizer)和Moderna等其他疫苗制造商已經(jīng)公布了有效性數(shù)據(jù),在預(yù)防新冠病毒感染方面,這兩家公司疫苗的有效性分別為95%和94%。但巴拉特公司的Covaxin疫苗目前還沒有這樣的數(shù)據(jù)。
印度醫(yī)學(xué)監(jiān)督機(jī)構(gòu)“全印度藥物行動網(wǎng)絡(luò)”(All India Drug Action Network)在1月3日發(fā)布的一份聲明中稱:“我們搞不懂是什么科學(xué)邏輯促使頂級專家們……批準(zhǔn)這種疫苗。批準(zhǔn)一種尚未完全結(jié)束研究的疫苗將帶來更多的麻煩,而不是答案……而且人們很可能不會恢復(fù)對科學(xué)決策機(jī)構(gòu)的信心?!?/p>
拿我在全印度醫(yī)學(xué)研究院(AIIMS)接種的第一劑新冠疫苗來說。
我們的醫(yī)生和科學(xué)家們在如此之短的時間內(nèi)加強(qiáng)了全球抗擊新冠疫情的工作,令人驚嘆。
我向所有有資格接種疫苗的人呼吁。讓我們一起使印度擺脫新冠病毒!
——納倫德拉·莫迪(@narendramodi),2021年3月1日
作為回應(yīng),巴拉特公司的董事長克里希納·埃拉為印度政府的決定進(jìn)行了辯護(hù)。他在一場新聞發(fā)布會上說,該公司進(jìn)行了“誠實的臨床試驗”,在生產(chǎn)安全有效的疫苗方面,該公司也有著良好的記錄。1月4日,埃拉還承諾,巴拉特公司將在一周內(nèi)公布疫苗的有效性數(shù)據(jù)。
近兩個月后,當(dāng)Covaxin疫苗已經(jīng)在印度各地推廣時,巴拉特公司卻仍未公開Covaxin疫苗對新冠病毒有效的證據(jù)。
根據(jù)彭博社(Bloomberg)的疫苗跟蹤數(shù)據(jù),印度迄今已經(jīng)接種了1430萬劑疫苗,但尚不清楚其中有多少是Covaxin疫苗。印度政府還批準(zhǔn)了另一種名為Covishield的新型疫苗,這種疫苗最初由阿斯利康(AstraZeneca)和牛津大學(xué)(Oxford University)共同研發(fā),由印度血清研究所(Serum Institute of India)生產(chǎn)。在1月16日啟動印度疫苗接種運動后,印度政府表示,其采購了550萬劑Covaxin和1100萬劑Covishield。
巴拉特生物技術(shù)公司承諾將很快發(fā)布Covaxin疫苗的數(shù)據(jù)。
2月22日,埃拉表示,公司將在兩周內(nèi)公布Covaxin的有效性數(shù)據(jù),并將這一推遲歸咎于巴拉特公司的試驗結(jié)構(gòu)。
“我們進(jìn)展得很快,但不幸的是,我們錯過了得出有效性數(shù)據(jù)的時間點?!卑@f,“如果我們之前將試驗的二三期階段結(jié)合起來,我們將更快地獲得有效性數(shù)據(jù)?!?/p>
然而,巴拉特公司數(shù)據(jù)的缺乏,給它的推廣帶來了一些問題。
今年2月,印度中部的恰蒂斯加爾邦表示,該邦將停止使用Covaxin,直到巴拉特公司能夠證明這種疫苗是有效的。
據(jù)報道,在國際上,巴拉特公司在40多個國家提交了申請Covaxin的批準(zhǔn),但迄今為止,伊朗是唯一一個批準(zhǔn)該疫苗緊急使用的國家。
此外,巴西在上周也購買了2000萬劑Covaxin,但由于藥效數(shù)據(jù)的缺乏,一些政府官員正試圖阻止Covaxin的運輸。
雖然巴拉特公司的疫苗尚未得到驗證,但現(xiàn)在,莫迪的疫苗注射表明,Covaxin疫苗至少得到了印度最有權(quán)力的人的支持。(財富中文網(wǎng))
編譯:楊二一
On March 1 morning, Indian Prime Minister Narendra Modi received his first dose of Covaxin, a COVID-19 jab developed by Indian vaccine maker Bharat Biotech. His taking of the shot represents a major vote of confidence in a COVID-19 vaccine that scientists have widely criticized as unproved.
After getting the vaccine, Modi publicly urged "all those who are eligible" to sign up for jabs, which as of Monday includes Indians over age 60 and those over 45 with qualifying preexisting health conditions.
After launching one of the world's largest vaccination campaigns six weeks ago with health care and frontline workers, India has administered more jabs than all but four countries, but it remains far behind its goal of inoculating 300 million Indian citizens by August. Glitches in India's vaccine app, as well as reluctance to get vaccinated with Bharat Biotech's product, have slowed the rollout.
Like vaccines from Chinese makers Sinovac and Sinopharm, Covaxin uses an inactivated, or killed-off, form of COVID-19 to induce an immune response. Bharat Biotech launched Phase I and II trials for Covaxin in June, followed by a Phase III trial in November with nearly 26,000 volunteers.
But before the Phase III efficacy trials concluded, Indian regulators on Jan. 3 approved Bharat Biotech’s application to distribute the vaccine on an emergency basis in India. At the time, scientists raised questions about why Indian regulators had given the vaccine the green light since Bharat Biotech reportedly had not completed Phase III clinical trials and had not disclosed how effective its vaccine was against COVID-19.
Whereas other vaccine makers like Pfizer and Moderna have published efficacy data—their regimens are 95% and 94% effective, respectively, in preventing COVID-19 infections—no such number is available for Bharat Biotech's Covaxin jab yet.
“We are baffled to understand what scientific logic has motivated the top experts…to approve this vaccine,” the All India Drug Action Network, a medical watchdog in India, said in a statement on Jan. 3. “The decision to approve an incompletely studied vaccine will raise more questions than answers…and likely will not restore faith in scientific decision making bodies.”
Took my first dose of the COVID-19 vaccine at AIIMS.
Remarkable how our doctors and scientists have worked in quick time to strengthen the global fight against COVID-19.
I appeal to all those who are eligible to take the vaccine. Together, let us make India COVID-19 free! pic.twitter.com/5z5cvAoMrv
— Narendra Modi (@narendramodi) March 1, 2021
In response, Bharat Biotech chairman Krishna Ella defended the Indian government’s decision, saying in a press conference that the company had carried out "honest clinical trials" and had a strong track record of making safe and effective vaccines. On Jan. 4, Ella also promised that Bharat Biotech would publish efficacy data on the vaccine within a week.
Nearly two months later, Bharat Biotech has still not publicly established that Covaxin is effective against COVID-19 even as the vaccine has been rolled out across India.
According to Bloomberg's vaccine tracker, India has administered 14.3 million vaccine doses so far, but it is unclear how many of the doses are Covaxin jabs. India's government has also approved another COVID-19 vaccine called Covishield, a vaccine that was originally developed by AstraZeneca and Oxford University but produced by the Serum Institute of India. In the wake of launching India's vaccination campaign on Jan. 16, India's government said it procured 5.5 million Covaxin doses and 11 million Covishield doses.
Bharat Biotech has pledged to release Covaxin data soon.
On Feb. 22, Ella said that his firm would publish Covaxin efficacy data within two weeks and attributed the delay to the structure of Bharat Biotech's trials.
"We moved so fast, but unfortunately we missed the efficacy time point," Ella said. "Had we done the phase 2/3 [trials] combined, we would have captured efficacy faster."
Bharat Biotech's lack of data, however, is creating problems in its rollout.
In February, the central Indian state of Chhattisgarh said that it would stop administering Covaxin until Bharat Biotech could prove the vaccine was effective.
Internationally, Bharat Biotech is reportedly in the process of filing for approval of Covaxin in over 40 countries, but so far Iran is the lone foreign country to authorize the company's application for emergency approval.
Brazil also reportedly purchased 20 million Covaxin doses last week, but some government officials are seeking to block the shipment because of Bharat Biotech's lack of efficacy data.
Now, even as Bharat Biotech's vaccine remains unproved, Modi's vaccine jab signals that the company at least has the support of India's most powerful man.