华盛顿-联邦健康官员们周三批准了一种新的新冠肺炎抗体药物，用于患有严重健康无法从疫苗接种中获得足够保护的问题或过敏患者。
一年多来，抗体药物一直是治疗新冠肺炎感染的标准疗法。但是食品药品监督管理局批准的阿斯利康抗体药物不同。这是第一个旨在长期预防新冠肺炎感染，而不是短期治疗。
可能从这种抗体药物中受益的人包括癌症患者、器官移植接受者和服用免疫抑制药物治疗类风湿性关节炎等疾病的人。健康专家估计，大约2%到3%的美国人口属于这一群体。
“这些人仍然必须在原地避难，因为他们面临严重疾病和死亡的高风险，”明尼苏达大学的大卫·波尔维尔博士在宣布之前说。“因此，接受这种治疗将使他们中的许多人恢复正常生活。”
具体来说，美国食品和药物管理局批准了一种名为Evusheld的阿斯利康药物，用于免疫系统对新冠肺炎病毒没有充分反应的12岁及以上的成人和儿童疫苗或者对注射有严重过敏反应史。监管机构表示，所需的两次抗体注射可能在六个月内有效预防新冠肺炎感染。
像类似的药物一样，阿斯利康公司提供实验室制造的人类抗体蛋白，帮助免疫系统抵御病毒和其他感染。
美国食品和药物管理局和其他健康当局强调，抗体药物不是疫苗的替代品，疫苗是最有效、最持久、最经济的病毒保护形式。抗体药物很难制造，通常每剂的成本超过1000美元，而疫苗通常每剂不到30美元。
阿斯利康的药物会有不同的用途——只是作为一种长期预防措施，用于更容易感染病毒的人群。
美国食品和药物管理局表示，在一项公司研究中，接受艾弗舍德注射的人比接受六个月以上虚拟注射的人感染风险低77%。
New COVID-19 antibody drug OK'd to protect most vulnerable
WASHINGTON -- Federal health officials on Wednesday authorized a new COVID-19 antibody drug for people with serious health problems or allergies who can’t get adequate protection from vaccination.
Antibody drugs have been a standard treatment for treating COVID-19 infections for over a year. But the AstraZeneca antibody drug cleared by the Food and Drug Administration is different. It's the first intended for long-term prevention against COVID-19 infection, rather than a short-term treatment.
People who could benefit from the antibody drug include cancer patients, organ transplant recipients and people taking immune-suppressing drugs for conditions like rheumatoid arthritis. Health experts estimate about 2% to 3% of the U.S. population falls into that group.
“These people still have to shelter in place because they’re at really high risk of severe disease and death,” said Dr. David Boulware of the University of Minnesota, ahead of the announcement. “So having this therapy will enable a lot of them to get back to their normal lives.”
Specifically, the FDA authorized the AstraZeneca drug called Evusheld for adults and children 12 and older whose immune systems haven't responded adequately to COVID-19 vaccines or have a history of severe allergic reactions to the shots. Regulators said the required two antibody injections may be effective at preventing COVID-19 infections for six months.
Like similar drugs, AstraZeneca's delivers laboratory-made versions of human antibody proteins, which help the immune system fight off viruses and other infections.
The FDA and other health authorities have stressed that antibody drugs are not a substitute for vaccines, which are the most effective, long-lasting and economical form of virus protection. Antibody drugs are tricky to manufacture and often cost more than $1,000 per dose compared with vaccines that are typically under $30 per shot.
AstraZeneca’s drug would be used differently— only as a long-term preventive measure in people who have increased vulnerability to the virus.
In a company study, people who received Evusheld had a 77% lower risk of infection than people who received a dummy shot over six months, the FDA said.
