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  • 2020年12月17日 世卫为穷国争取负担得起疫苗价格

    此外,世卫组织正与两家美国制药公司辉瑞和莫德纳商讨,能否在早期以负担得起的价格为穷国提供冠病疫苗。

    世卫组织高级顾问艾尔沃德周二说,该组织也在研究其他选项以及当前领先的疫苗。他说,世卫组织正在与辉瑞和莫德纳商讨它们的疫苗能否成为“早期推出的疫苗”的一部分。

    但他也强调:“我们还须确保它们的价格适合我们要服务的人口和要帮助的国家。”

    辉瑞与德国BioNTech合作研发了首个获得西方多国监管机构批准的冠病疫苗。莫德纳疫苗则有望很快获得批准。两款疫苗均使用最先进的技术,并已在第三期临床试验中证明是高度有效的,只是相信售价都不便宜。

    辉瑞公司总裁布尔拉已公开表明,可为低收入国家降低疫苗售价。这赢得艾尔沃德的赞许。

    艾尔沃德也说,世界卫生组织支持的“冠病疫苗全球获取机制”(COVAX)希望提供多样化的疫苗组合,并会评估“任何证明有效、安全和具有质量的产品”。

    约翰霍普金斯大学的研究人员也说,COVAX机制在确保更公平分配获批疫苗方面可发挥关键作用,但它至今仅争取到5亿剂疫苗,远低于20亿剂疫苗的目标。

  • 16/12/2020 中国复星医药FosunPharma周三宣布,明年将进口至少1亿支德国生物技术BioNTech的抗冠毒疫苗。

    目前,德国生物技术BioNTech与美国辉瑞Pfizer公司合作生产的疫苗已在英国,美国,加拿大等国家/地区获得销售许可,并开始接种。

    法新社说,中国实验室也在研制Covid-19实验性疫苗,这些疫苗已开始在国内广泛配送给冠状病毒感染高风险人群,但尚未正式获得有关当局的批准。

    复星医药周三发给香港证交所的一份声明表示,2021年,德国生物技术BioNTech将向中国提供不少于1亿支抗冠状病毒疫苗。复星医药将为5,000万剂疫苗支付2.5亿欧元的预付款。

  • Moderna Vaccine Is Highly Protective Against Covid-19, the F.D.A. Finds. The positive review most likely ensures that the Food and Drug Administration will grant emergency authorization to a second coronavirus vaccine this week for millions of Americans. Dec. 15, 2020

    WASHINGTON — The coronavirus vaccine made by Moderna is highly protective, according to new data released on Tuesday, setting the stage for its emergency authorization this week by federal regulators and the start of its distribution across the country.

    The Food and Drug Administration intends to authorize emergency use of the vaccine on Friday, people familiar with the agency’s plans said. The decision would give millions of Americans access to a second coronavirus vaccine beginning as early as Monday. The Pfizer-BioNTech vaccine, cleared last week, was the first to be authorized.

    “This is great news, as this now brings us to two products with high levels of efficacy,” said Rupali Limaye, an associate scientist at Johns Hopkins Bloomberg School of Public Health.

    The review by the F.D.A. confirms Moderna’s earlier assessment that its vaccine had an efficacy rate of 94.1 percent in a trial of 30,000 people. Side effects — including fever, headache and fatigue — were common and unpleasant, but not dangerous, the agency found.

    The F.D.A. said its analysis “supported a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an emergency use authorization.”

    The success of Moderna’s vaccine has become all the more critical to fighting the pandemic as other vaccine efforts have faltered. The hopeful news arrives at a time of record-setting numbers of coronavirus cases that are overwhelming hospitals and of an ever-increasing death toll, which reached a bleak milestone of 300,000 on Monday.

    The data release is the first step of a public review process that will include a daylong meeting on Thursday by an independent advisory panel of experts. They will hear from Moderna, F.D.A. scientists and the public before voting on whether to recommend authorization. The panel is expected to vote yes, and the F.D.A. generally follows the experts’ recommendations.

    Distribution of about six million doses could then begin next week, significantly adding to the millions of doses already being shipped by Pfizer and BioNTech. Health care workers received the first shots on Monday of that vaccine, which has an efficacy rate of 95 percent.

    Emergency authorization is not the same as full approval. It allows an experimental vaccine to be used if there is evidence that its potential benefits outweigh its risks, while more data is collected to apply for full approval.

    Barry R. Bloom, a professor of public health at Harvard, said the results from Moderna and Pfizer were “extraordinarily comparable.”

    “The good news is they both did everything they were supposed to do,” he said. Based on the data, Moderna’s vaccine may be slightly less effective in people 65 and older than Pfizer-BioNTech’s. “But it’s hard to tell,” he said.

    Compared with the Pfizer-BioNTech vaccine, Moderna’s was more likely to cause headaches, sore arms and related side effects, Dr. Bloom noted.

    The vaccine rollout is one of the most ambitious in the nation’s history, but experts are uncertain how long it will take for all 330 million Americans to be inoculated, let alone return the country’s businesses, schools and everyday routines to a new normal.

    Last summer, the U.S. government signed deals with Moderna and Pfizer to acquire 200 million doses in the first quarter of 2021. Because both vaccines require two doses, those contracts guaranteed enough doses for 100 million people. The government announced last week that it had purchased another 100 million doses from Moderna for the second quarter, increasing the number to 150 million who can be vaccinated.

    Both vaccines will be provided free of charge.

    Because Moderna’s vaccine requires less extreme cold storage than the Pfizer-BioNTech product, it will be easier to ship, store and handle.

    “Moderna is the one that I would take out to rural areas and community health centers and private doctors’ offices,” Dr. Bloom said, adding that hospitals would be better equipped to deal with the Pfizer-BioNTech vaccine.

  • A day after vaccination, these early recipients felt little more than a sore arm.16 DEC 2020

    The swamped intensive care units and emergency departments at many American hospitals have little flexibility these days for employees to be out sick. So it came as a relief that some of the hundreds of frontline health care workers who received their first dose of the coronavirus vaccine Monday were able to return to work the next day with just a bit of soreness at the injection site.

    In interviews Tuesday, six vaccinated frontline workers said they had no significant side effects.

    Fernando Pires, a 60-year-old maintenance worker who cleans rooms in the emergency department at Rhode Island Hospital in Providence, said he was not feeling anything other than a lot of pain in his arm. It was a small annoyance, he said, considering the peace of mind the vaccine gave him after months of coming to work despite being at risk himself, as someone with diabetes and asthma.

    When his boss called him to ask if he wanted to be in the first round of vaccine recipients, Mr. Pires said, “I didn’t even think twice.”

    At Ohio State University’s Wexner Medical Center, Dr. Mercy Dickson, a 35-year-old emergency medicine resident, said she was feeling good, even after working night shifts before and after receiving the vaccine.

    “I have a little bit of soreness on my right arm where I got the shot,” she said. “But otherwise, I feel as I felt before.”

    After months spent alongside Covid-19 patients who struggled to breathe, were isolated from family members, and died from the virus, Dr. Dickson said the vaccine was a first step for her toward healing. And as a Black doctor, she said, she especially hopes it will make a dent in the disproportionately deadly toll the virus has taken on Black Americans.

    “Hopefully, someone sees me — someone who looks like them — and is encouraged to get their own vaccine, and we are able to change positively the trajectory of people’s lives and minimize the suffering and pain that families have to go through,” she said.

    Luciana Thornton, a pharmacist at Ascension Via Christi St. Francis in Wichita, Kan., said she was surprised by how good she felt the day after receiving her shot, given what she had read about the vaccine’s potential side effects.

    “Some people have fever or chills, and I have had none of that,” she said. “A lot of people I’ve talked to feel pretty good. Some people have had headaches. I feel a lot better than I expected to.”

  • The F.D.A. is likely to approve emergency use of the Moderna vaccine this week.16 DEC 2020

    The coronavirus vaccine made by Moderna is highly protective for adults and prevents severe cases of Covid-19, according to data released on Tuesday by the U.S. Food and Drug Administration.

    Based on the encouraging findings, the agency intends to grant emergency authorization for use of the vaccine on Friday, people familiar with the F.D.A.’s plans said. The decision would give millions of Americans access to a second coronavirus vaccine beginning as early as next week.

    The review by the F.D.A. confirms Moderna’s earlier assessment that its vaccine had an efficacy rate of 94.1 percent in a trial of 30,000 people. Side effects, including fever, headache and fatigue, were unpleasant but not dangerous, the agency found.

    The success of Moderna’s vaccine has become all the more crucial to fighting the pandemic as other vaccine efforts have faltered. The hopeful news arrives at a time of record-breaking numbers of new coronavirus cases in the United States, which are overwhelming hospitals, and of an ever-increasing total death toll, which reached a bleak milestone of 300,000 on Monday.

    The data release is the first step of a public review process that will include a daylong meeting on Thursday by an independent advisory panel of experts. They will hear from Moderna, F.D.A. scientists and the public before voting on whether to recommend authorization. The panel is expected to vote in favor, and the F.D.A. generally follows the experts’ recommendations.

    Distribution of about six million doses could then begin next week, significantly adding to the millions of doses already being shipped by Pfizer and BioNTech, the companies that developed the first coronavirus vaccine given emergency clearance last Friday. Health care workers received the first shots on Monday of the Pfizer-BioNTech vaccine, which has an efficacy rate of 95 percent.

    The rollout of vaccines has been highly anticipated, and is one of the most ambitious immunization campaigns ever conducted in the United States.

    The federal government signed deals last summer with Moderna and Pfizer to deliver a total of 200 million doses in the first quarter of 2021. Because both vaccines require two doses, those contracts guaranteed enough shots for 100 million people.

    Last week, the U.S. government announced that it had purchased another 100 million doses from Moderna for the second quarter, increasing the number of Americans who could be vaccinated to 150 million. But that still leaves the question of how and when the roughly 180 million other Americans will be covered.