2026-05-28 10:04:26 / 路透社
Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo Purchase Licensing Rights, opens new tab
5月28日（路透社）——在工作人员对当前流行毒株的相关数据有限性提出担忧后，美国食品药品监督管理局（FDA）的咨询小组将于周四召开会议并投票，决定2026-2027年度免疫接种 campaign 所用新冠疫苗是否应针对主流XFG变异株。
美国FDA疫苗及相关生物制品咨询委员会将按原班人马召开会议，不会出现罗伯特·F·肯尼迪 Jr. 带来的人事变动，这是卫生部长领导下一系列疫苗政策调整后程序回归正常的标志。
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自一年前上次发布推荐意见以来，疫苗监管一直处于停滞状态：一家法院叫停了疾控中心（CDC）咨询委员会取消包括新冠疫苗在内的儿童疫苗推荐的决定，理由是肯尼迪未恰当任命该委员会成员。
在会议前发布的简报文件中，FDA表示，随着各州和地方公共卫生部门的病毒学监测、测序数量及时数据共享出现下滑，评估新冠病毒的演变变得愈发困难。
美国疾控中心的新冠数据仪表盘也反映出这一缺口，由于测序提交量过低，目前无法提供每周数据。最新的更新数据已滞后一个月，显示在截至4月11日的四周内，XFG变异株占美国新冠病例的一半以上。
南佛罗里达大学公共卫生学院副教授吉尔·罗伯茨表示，测序工作减少既源于政府监测人员流失，也与学术资助缩减有关。
在2025-2026季度，FDA曾推荐新冠疫苗针对LP.8.1——JN.1毒株的一个亚变异株。
根据FDA的简报文件，尽管新冠变异株仍源自JN.1毒株，但自去年5月以来，已出现NB.1.8.1等其他亚变异株。
本月早些时候，世界卫生组织建议疫苗制造商针对单价LP.8.1变异株或当前流行的其他变异株，如XFG或NB.1.8.1。
美国已批准四款新冠疫苗上市：莫德纳的
MRNA.O
mNEXSPIKE和Spikevax，辉瑞-生物科技的
PFE.N
、
22UAy.DE
Comirnaty，其中三款为mRNA疫苗，以及诺瓦瓦克斯-赛诺菲的
NVAX.O
、
SASY.PA
蛋白疫苗，这类疫苗的生产周期更长。
本报记者克里斯蒂·桑托什班加罗尔报道；希尔皮·马朱姆达尔编辑
FDA advisers to weigh composition of COVID vaccines for 2026-2027
2026-05-28 10:04:26 / Reuters
Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo Purchase Licensing Rights, opens new tab
May 28 (Reuters) – The U.S. FDA’s advisory panel will meet and then vote on Thursday on whether COVID-19 vaccines for the 2026-2027 immunization campaign should target the dominant XFG variant, after staff members raised concerns about limited data on currently circulating strains.
The Food and Drug Administration’s Vaccine and Related Biological Products Advisory Committee will convene with no membership changes by Robert F. Kennedy Jr., a sign of procedural normalcy after a series of vaccine policy shake-ups under the health secretary.
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Since the last recommendation a year ago, vaccine regulation has been in a state of limbo after a court put a stay on decisions made by the CDC’s advisory panel to drop recommendations for childhood vaccines, including the COVID shot, saying that Kennedy had not properly appointed the panel.
In briefing documents released ahead of the meeting, the FDA said assessing the evolution of COVID-19 has become increasingly difficult as virologic surveillance, sequencing volumes and timely data sharing from state and local public health departments have declined.
The Centers for Disease Control and Prevention’s COVID dashboard reflects the gap, with weekly data currently unavailable due to low sequencing submissions. The most recent update, now a month old, showed XFG strains accounted for more than half of U.S. cases over the four weeks ended April 11.
Reduced sequencing reflects both the loss of government surveillance staff and reduced academic funding, said Jill Roberts, associate professor at the University of South Florida College of Public Health.
For the 2025-26 season, the FDA had recommended COVID shots target LP.8.1 — a subvariant of the JN.1 strain.
While COVID variants continue to be derived from the JN.1 strain, other subvariants such as NB.1.8.1 have emerged since May last year, according to the FDA’s briefing documents.
Earlier this month, the World Health Organization recommended vaccine manufacturers to target the monovalent LP.8.1 strain or other currently circulating variants such as XFG or NB.1.8.1.
Four COVID shots have been approved for use in the U.S: Moderna’s
MRNA.O
mNEXSPIKE and Spikevax, Pfizer-BioNTech’s
PFE.N
,
22UAy.DE
Comirnaty, three of which are mRNA-based vaccines, as well as Novavax-Sanofi’s
NVAX.O
,
SASY.PA
protein-based shot that takes longer to manufacture.
Reporting by Christy Santhosh in Bengaluru; Editing by Shilpi Majumdar
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