疾病控制和预防中心主任周二签署了一项建议，即所有6个月及以上的美国人都应接受更新的COVID booster病例和住院率上升全国各地。
就在美国美国食品药品监督管理局的第二天授权和批准新镜头。
辉瑞-BioNTech和Moderna制造的助推器是针对目前正在传播的变异体而设计的，这些变异体与XBB有关，XBB是omicron变异体的一个分支。
顾问小组提出了建议，然后由主任曼迪科恩博士批准。
FDA生物制品评估和研究中心主任彼得·马克斯(Peter Marks)博士在一份声明中说:“疫苗接种对于公共健康和持续预防新冠肺炎的严重后果(包括住院和死亡)仍然至关重要。
“公众可以放心，这些更新的疫苗符合该机构在安全性、有效性和生产质量方面的严格科学标准。我们非常鼓励那些有资格的人考虑接种疫苗，”声明继续说。
这些疫苗预计将在本周晚些时候上市，因为它们将被运送到全国各地的药店和医疗保健机构，并可能从下周开始大量供应。
在COVID booster获得批准后，拜登总统表示，“今天标志着另一个重要的里程碑”，并鼓励美国人继续保持对疫苗接种的更新。
“今天的宣布也意味着我们现在已经对所有三种主要的季节性呼吸道病毒——新冠肺炎病毒、流感病毒和呼吸道合胞病毒——进行了免疫接种。接种新冠肺炎疫苗仍然是避免住院、长期健康并发症和死亡的最重要的保护措施。我鼓励所有美国人及时接种疫苗，”拜登说。
2022年9月8日，宾夕法尼亚州Schwenksville的Skippack药房拍摄了一瓶针对BA.4和BA.5 Omicron亚变异体的Moderna新冠肺炎加强疫苗。
汉娜·贝尔/路透社
FDA目前表示，5岁及以上的儿童——无论以前是否接种过疫苗——都有资格在最后一次COVID剂量后至少两个月接受一次更新的加强剂量。
更新的助推器每个都被批准用于12岁和12岁以上的儿童，并被授权用于6个月至11岁的儿童的紧急情况。
对于那些6个月到4岁以前接种过疫苗的儿童，该机构表示，他们有资格接受一次或两次加强剂量。对于这个年龄段未接种疫苗的人，FDA说他们有资格接种三剂疫苗。
最近的数据表明，加强剂可以提供额外的保护，防止目前流行的变异，特别是防止严重疾病和死亡，特别是对那些老年人或免疫功能受损的人。
Moderna发布的数据在一项基于实验室的研究中显示，其加强剂使针对较新的亚变异BA.2.86的抗体增加了近9倍。
疫苗制造商之前的结果表明，新的加强剂还提供了针对亚变异体如5和FL.1.5.1的额外保护，这些变异体目前在美国占主导地位，估计占新病例的36%,疾控中心数据显示。
“随着主要的流行毒株继续进化，更新的疫苗将对保护这一季节的人群至关重要，”Moderna的首席执行官Stéphane Bancel在声明。“我们感谢FDA的及时审查，并鼓励打算接种流感疫苗的个人同时接种最新的新冠肺炎疫苗。”
同样，辉瑞公司董事长兼首席执行官Albert Bourla称赞了FDA的决定，并建议美国人可以在每年接种流感疫苗的同时接种疫苗。
他在一份报告中说:“我们预计本季疫苗将在未来几天上市，等待公共卫生当局的建议，这样人们就可以在每年接种流感疫苗的同一时间向医生询问接受新冠肺炎疫苗的事宜，这样既节省了时间，也有助于在呼吸道病毒处于高峰期时预防严重疾病。”声明.
CDC recommends new COVID booster for all Americans over 6 months amid rising cases, hospitalizations
The Centers for Disease Control and Prevention director signed off on the recommendation that all Americans aged 6 months and older receive the updated COVID booster on Tuesday amidrising cases and hospitalizationsacross the country.
It comes just a day after the U.S. Food and Drug Administrationauthorized and approvedthe new shot.
The boosters made by Pfizer-BioNTech and Moderna were formulated to target variants that are currently circulating, which are related to XBB – an offshoot of the omicron variant.
The advisory panel made the recommendation, which was then approved by director Dr. Mandy Cohen.
"Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement.
"The public can be assured that these updated vaccines have met the agency's rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated," the statement continued.
The shots are expected to be available later this week as they are delivered to pharmacies and health care providers across the country, with likely meaningful supply starting next week.
Following the COVID booster approval, President Biden said "today marks another important milestone" and encouraged Americans to continue to stay updated on vaccinations.
"Today’s announcement also means that we now have immunizations for all three major seasonal respiratory viruses – COVID-19, flu, and RSV. Vaccination against COVID-19 remains the most important protection in avoiding hospitalization, long-term health complications and death. I encourage all Americans to stay up-to-date on their vaccines," Biden said.
The FDA currently says children aged 5 and up -- regardless of previous vaccination --- are eligible to receive one updated booster dose at least two months after the last COVID dose.
The updated boosters are each approved for those aged 12 and older and authorized for emergency use for children between ages 6 months and 11 years.
For those aged 6 months to 4 years who have previously been vaccinated, the agency says they are eligible to receive one or two booster doses. For unvaccinated individuals in this age group, the FDA says they are eligible for three doses.
Recent data has indicated the booster could offer additional protection against currently circulating variants and especially protect against severe disease and death, particularly for those who are elderly or immune compromised.
Data published from Modernashowed its booster generated a nearly nine-fold increase in antibodies against the newer subvariant BA.2.86 in a lab-based study.
Previous results from the vaccine manufacturer indicated that the new booster also offered additional protection against the sub variants EG.5 and FL.1.5.1, which are currently dominating in the U.S. and make up an estimated 36% of new cases,CDC datashows.
"As the primary circulating strain continues to evolve, updated vaccines will be critical to protecting the population this season," said Stéphane Bancel, CEO of Moderna, in astatement. "We appreciate the FDA's timely review and encourage individuals who intend to get their flu shot to also get their updated COVID-19 vaccine at the same time."
Similarly, Albert Bourla, chairman and CEO of Pfizer, lauded the FDA's decision and suggested Americans might be able to receive the vaccine at the same time as their annual flu shot.
“We expect this season’s vaccine to be available in the coming days, pending recommendation from public health authorities, so people can ask their doctor about receiving their COVID-19 vaccine during the same appointment as their annual flu shot, saving time now and helping to prevent severe disease later when respiratory viruses are at their peak," he said in astatement.
