中國向國藥集團的COVID-19疫苗授予“有條件批准”

Recently Yahoo News on-line reported the following:

China grants 'conditional approval' to Sinopharm's COVID-19 vaccine

The Associated Press

Thu., December 31, 2020, 6:11 a.m. PST

China authorized its first homegrown COVID-19 vaccine for general use Thursday, adding another shot that could see wide use in poorer countries as the virus surges back around the globe.

The Sinopharm vaccine had already been given to groups such as health care professionals and essential workers under emergency-use guidelines as part of China's program to inoculate 50 million people before the Lunar New Year holiday in February. But the go-ahead should allow it to be supplied more broadly at home and moves Beijing closer to being able to ship it abroad. It comes one day after British regulators authorized AstraZeneca's inexpensive and easy-to-handle vaccine.

Both shots have been closely watched by developing countries, many of which have been unable to secure the Pfizer and Moderna doses being snapped up by rich nations. Pakistan's science minister said Thursday that his government will buy 1.2 million doses of a Sinopharm shot, two days after its death toll topped 10,000.

The greenlight came a day after the state-owned company announced that preliminary data from last-stage trials had shown it to be 79.3 percent effective. That announcement did not detail the size of the control group, how many people were vaccinated and at what point the efficacy rate was reached after injection, and experts have cautioned that trial data needs to be shared.

Officials have said the vaccine standards were developed in "close cooperation" with the World Health Organization. Securing WHO's so-called pre-qualification could go some way toward assuring the rest of the world about the quality of Chinese vaccines, which already face a reputation problem back home. It would also open the path for the shots to be distributed in the global vaccine consortium, COVAX, and potentially in countries that don't have their own regulatory agencies.

China is eager to ship its vaccines globally, driven by a desire to repair the damage to its image caused by the pandemic that started a year ago in the central city of Wuhan.

Technically, China granted conditional approval for the vaccine, meaning that research is still ongoing, and the company will be required to submit follow-up data as well as reports of any adverse effects after the vaccine is sold on the market, Chen Shifei, the deputy commissioner of the National Medical Products Administration, told a news conference. Final proof of its effectiveness will depend on publication of more data.

Sinopharm, which has another shot under development, is one of at least five Chinese developers that are in a global race to create vaccines for the disease that has killed more than 1.8 million people. While the Pfizer and Moderna shots have been greeted with much fanfare in the West, those shots must be stored at ultra-cold or freezer temperatures, complicating distribution.

The Sinopharm vaccine, like the AstraZeneca one, could be easier for countries around the world to handle since they can be stored at normal fridge temperatures.

Both shots, as well as Russia's Sputnik, are expected to be supply much of the developing world. That means the cost will also be important. AstraZeneca is expected to cost about $2.50 a dose, while Russia has said its doses will be priced at $10 for the global market. Pfizer's vaccine costs about $20, while Moderna's is $15 to $25, based on agreements with the U.S. government.

Chinese officials declined to name a particular price and gave conflicting statements about it. One official said it would be affordable for the Chinese public, but another jumped in to clarify that it will be free. President Xi Jinping had previously vowed to donate a Chinese-made vaccine as a public good to the world.

The Sinopharm shot is already under mass production, though officials did not answer questions about current capacity. It has already been approved in the United Arab Emirates and Bahrain, and is slated for use next in Morocco.

Other countries have also been buying doses of another Chinese vaccine candidate, made by Sinovac Biotech. Turkey received shipments this week of 3 million doses, and Indonesia and Brazil have also purchased it.

Belarus and Argentina both launched mass vaccinations Wednesday using Russia's vaccine, and Guinea has begun giving it to government officials.

In addition to the emergency vaccinations already underway in China, the country plans to start vaccinating high-risk population, such as seniors as well as people with existing chronic illnesses. Officials did not say what percentage of the population they will vaccinate in China.

"This is very exciting that there is another vaccine and one that can be distributed in locations that don't have the cold chain," said Ashley St. John, an immunologist at the Duke-NUS Medical School in Singapore. "But at the same time we have to temper the excitement. We have to understand the long-term efficacy, effect on transmission and effect on severe disease."

Translation

中國周四批准了廣泛利用其首款國產COVID-19疫苗，隨著這種病毒在全球回升之際，增加了可以在較貧窮的國家中廣泛使用的另一種注射劑。

國藥疫苗已經按照緊急使用指南,提供給醫療保健專業人員和必要工作者等團體，作為中國計劃在2月的農曆新年假期之前給5000萬人接種疫苗的一部分。但是這一批准也應該可使它在國內更廣泛地供應，並使北京更接近能夠將其運送到國外。在這之後一天，英國監管機構批准了阿斯利康的廉價且易於處理的疫苗。

發展中國家都密切注視著這兩個疫苗注射，其中許多都無法得到被保富裕國家在搶購的輝瑞和莫德納(Pfizer and Moderna)的疫苗。巴基斯坦在其死亡人數超過10,000人後僅兩天, 它的科學部長周四表示巴基斯坦政府將購買120萬劑國藥注射疫苗。

這家國企宣布其最後階段試驗的初步數據顯示有效率為79.3％之後的第二天就得到批准。該公告並未詳細說明其對照組的規模，注射了多少疫苗, 以及有效率注射後在什麼時候達到，專家警告說，試驗數據必須共享。

官員們說，疫苗標準是與世界衛生組織“密切合作” 而制定的。確保世衛組織所謂的資格預審,可以在某種程度上向世界其他地區保證中國疫苗的質量，中國疫苗已經在國內面臨聲譽問題。這也將為在全球疫苗聯盟COVAX, 以及可能在沒有自己的監管機​​構的國家中分發疫苗提供了途徑。

中國渴望在全球範運送疫苗，希望修復因一年前在武漢市中心爆發的大流行而對其形象造成的損害。

從技術上講，該疫苗已獲得中國的有條件批准，這意味著研究仍在進行中。國家藥品管理局副局長陳時飛在新聞發布會上說, 該公司將被要求提交後續數據以及有關疫苗在市場上出售後的任何不良反應的報告。其有效性的最終證明將取決於發布更多數據。

國藥控股亦正在開發中的另一種藥物，它是至少五家中國開發商之一，它們正在全球範圍內開發針對該疾病的疫苗，該疾病已經殺死了180萬人。輝瑞和莫德納的注射劑在西方受到了廣泛的歡迎，但這些注射劑必須保存在超冷或冰櫃溫度下，這使分配變得複雜。

像阿斯利康一樣，國藥疫苗可以讓世界各地的國家更容易處理，因為它們可以在正常的冰箱溫度下保存。

預計這兩種疫苗, 以及 “俄羅斯衛星” 疫苗都將為大部分發展中國家提供注射。這意味著成本也很重要。預計阿斯利康的每劑價格約為2.50美元，俄羅斯表示，其全球市場價為10美元。根據與美國政府達成的協議，輝瑞的疫苗售價約為20美元，而莫德納疫苗則為15至25美元。

中國官員拒絕透露具體價格，並給出了矛盾的說法。一位官員說，中國公眾可以負擔得起，但另一位官員則介入澄清它將是免費的。習近平主席此前曾誓言要向世界捐贈一種中國製造的疫苗，作為一種公共物品。

國藥的注射劑已經在大批量生產中，儘管官員們沒有回答有關目前產能的問題。它已經在阿拉伯聯合酋長國和巴林得到批准，並計劃之後在摩洛哥使用。

其他國家也一直在購買由Sinovac Biotech (科興生物製品)生產的另一種中國候選疫苗的劑量。土耳其本週收到了300萬劑疫苗，印尼和巴西也購買了它。

白俄羅斯和阿根廷星期三都使用俄羅斯的疫苗開始了大規模疫苗接種，幾內亞已經開始將其提供給政府官員。

除了已經在中國進行的緊急疫苗接種之外，中國還計劃開始為高危人群提供疫苗接種，例如老年人以及患有慢性病的人群。官員們沒有透露他們將在中國接種疫苗的人口比率。

新加坡杜克-國大醫學院的免疫學家Ashley St. John阿說： “令人興奮的是，還有另一種疫苗可以在沒有低溫運輸系統的地方分發。”; “但同時我們必須平衡這興奮。我們必須了解它的長期療效，及對病毒傳播的効力和對嚴重疾病的影響。”

              So, it is good news that we have choices on the Covid-19 vaccines. It is interesting to know that Belarus and Argentina both have launched mass vaccination using Russia's vaccine. According to a recent CNN news report, even some Russian people were doubtful about the effect of the Russia's Sputnik. Also, it is interesting to note that the vaccine prices can vary a lot, depending on the manufacturing company.