食品药品监督管理局的负责人周四表示，无论辉瑞何时提交其五岁以下儿童的数据，该机构都将继续审查Moderna的儿童疫苗数据，这对一些父母来说将是一个好消息，他们担心等待一起批准疫苗会推迟时间表。
FDA正在考虑审查Moderna针对6岁以下儿童的数据，该数据已于周四提交紧急使用授权，以及辉瑞的数据，预计将在未来几周内提交，以便可以并排比较疫苗。
但周四，FDA专员罗伯特·卡里夫告诉记者，FDA不会“搁置”Moderna的申请，等待辉瑞的批准。
“与我交谈过的大多数专家都会说，如果能把它们放在一起考虑，那就太理想了。但如果他们不同时进来，那么就不会阻止Moderna的申请，只是让它同时进来，”Califf周四在国会山的听证会后告诉记者，这些评论后来被FDA发言人证实给ABC新闻。
一名高级政府官员也向ABC新闻证实，只要Moderna疫苗符合标准，FDA将“尽快”批准该疫苗。
这位官员表示，不会有任何延误，申请将“根据其是非曲直”进行判断。
Moderna是两针疫苗，不同于辉瑞的疫苗，后者是三针疫苗。辉瑞公司尚未完成数据收集，但一些人预计它会更有效，因为加强注射，或第三次注射，已显示出促进成年人的免疫反应。
与此同时，Moderna的疫苗数据已经准备好接受审查，尽管该公司将在一周左右的时间里继续为其应用提交更多数据。
Moderna的试验发现，注射产生了强烈的免疫反应，没有明显的风险。该公司表示，疫苗产生的抗体反应大致相当于成人的抗体反应。
与此同时，专家们质疑抗感染的低功效数字。在omicron激增期间，两剂疫苗对6个月至2岁儿童的新冠肺炎感染(包括无症状和轻度感染)的有效性约为51%，对2岁至6岁儿童的有效性为37%。
但Moderna的首席医疗官保罗·伯顿(Paul Burton)博士为疫苗的抗感染功效进行了辩护，他认为奥米克隆导致了更多的突破性感染，但注射疫苗产生的抗体反应在年轻人中甚至比18-24岁的人更强。
“我认为妈妈、爸爸、看护者、医生和护士应该对这个结果感到放心，”伯顿告诉美国广播公司新闻。
“我们在这里看到的抗体水平很高，我们可以将其转化为我们在成人身上看到的，在成人身上我们得到了很好的保护，免受严重疾病和住院治疗，”他说。
Moderna还在研究所有年龄组的第三次注射，包括一种变异特异性疫苗，可以更有效地针对一些新的病毒株。
目前还不清楚FDA单独推进Moderna的决定是否会对五岁以下儿童接种疫苗的时间表产生重大影响。
虽然Moderna希望其疫苗能在一个月内获得批准，这是疫情期间疫苗批准的通常时间表，但该公司仍需在未来几周内向FDA提交更多数据，以完成提交。
FDA已经表示，Moderna的申请需要一些时间来筛选，因为它还必须审查该公司关于17岁以下儿童疫苗的数据，这些数据尚未获得授权。
伯顿说，尽管如此，美国食品和药物管理局应该有进行审查所需的大部分材料。
FDA预计将在明天发布更多关于FDA独立顾问会议时间的信息，他们将公开审查和讨论这些数据，以启动这一进程。
辉瑞公司首席执行官Anthony Bourla表示，他预计该公司将在“未来几周内”向FDA提交数据，并可能在6月获得授权。
FDA will review Moderna's data on vaccine for young kids without waiting for Pfizer
The head of the Food and Drug Administration on Thursday said the agency would move along to review Moderna’s data for its kid vaccine regardless of when Pfizer submits its data on kids under five, a move that will be welcome news to some parents who were upset that waiting to authorize the vaccines together would delay the timeline.
The FDA was considering reviewing the Moderna data for kids under six, which was submitted for an emergency use authorization on Thursday, alongside Pfizer’s data, which is expected to be submitted in the next few weeks, so that the vaccines could be compared side-by-side.
But on Thursday, FDA Commissioner Robert Califf told reporters the FDA would not "hold up" the Moderna application to wait for Pfizer.
"Most of the experts that I’ve talked with would say it would be ideal if they could be considered together. But if they don’t come in at the same time, then there’s not going to be a hold up on the Moderna application, just to make it come in at the same time," Califf told reporters Thursday after a hearing on Capitol Hill, in comments that were later confirmed by an FDA spokesperson to ABC News.
A senior administration official also confirmed to ABC News the FDA would act "as expeditiously as possible" to authorize the Moderna vaccine, so long as it meets its standards.
The official said there would be no delay and the application would be judged "on its merits."
Dado Ruvic/Reuters
FILE PHOTO: A vial labelled with the Moderna coronavirus disease (COVID-19) vaccine is...
Moderna, which is a two-shot vaccine, is different from Pfizer’s vaccine, which is a three-shot vaccine. Pfizer hasn’t finished gathering its data yet, but some expect it to be more effective because booster shots, or third shots, have shown to boost immune response in adults.
In the meantime, Moderna's vaccine data is ready for review, though the company will continue to submit more data for its applications over the week or so.
Moderna’s trial found that the shots generated a strong immune response with no significant risks. The vaccine generated an antibody response roughly equivalent to the antibody response seen in adults, the company said.
At the same time, experts have questioned the low efficacy numbers against infection. During the omicron surge, two doses of the vaccine were roughly 51% effective against COVID-19 infection, including asymptomatic and mild infections, for children 6 months to 2 years old, and 37% effective among kids 2 years to 6 years old.
But Moderna’s Chief Medical Officer, Dr. Paul Burton, defended the vaccine’s efficacy against infection, arguing that omicron led to more breakthrough infections, but that the shot produced an antibody response that was even stronger in the young kids than it was in the 18-24-year-olds.
“I think moms and dads and caregivers, doctors and nurses should be reassured by this result,” Burton told ABC News.
“The antibody levels that we saw here were high, and we can translate that to what we see in adults where we get really good protection against severe disease and hospitalization,” he said.
Moderna is also studying third shots across all age groups, including for a variant-specific vaccine that could more effectively target some of the newer strains of the virus.
It's not clear if the FDA's decision to move ahead separately on Moderna will significantly affect the timeline for kids under five getting vaccinated.
While Moderna hopes its vaccine will be authorized within a month, which is the usual timeline for vaccine authorization during the pandemic, the company still has to submit more data to the FDA in the coming weeks to complete its submission.
The FDA has signaled that the Moderna submission will take some time to sift through because it has to also review the company’s data on its vaccines for kids up to age 17, which haven’t been authorized yet.
Burton said that the FDA should have the bulk of what it needs to do the review, though.
The FDA is expected to put out more information tomorrow on the timing of its meeting of FDA independent advisors, who will publicly review and discuss the data to kick off the process.
Pfizer’s CEO Anthony Bourla has said that he expected the company to submit data to the FDA in the “coming weeks,” and that it could be authorized in June.
