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FDA疫苗主管希望,新的COVID增强剂授权将影响父母为幼儿接种疫苗

2022-12-09 15:13  -ABC   - 

食品药品监督管理局疫苗主管彼得·马克斯博士说,他很清楚最近一次注射的新冠肺炎加强剂摄取量可能很低,周四早上由政府授权对于6个月以上的儿童,但他告诉美国广播公司新闻,他希望更多的接触也可能导致一些孩子在冬天到来之前获得更好的保护,防止病毒感染,因为冬天更有可能发生。

马克斯在一次采访中说,针对多种新病毒株的更新的二价加强剂可能会在下周早些时候用于最小的儿童。该年龄组是最后一个有资格获得新的助推器。

到目前为止,根据疾病控制和预防中心的数据,不到10%的5岁以下儿童接种了初始新冠肺炎疫苗——这意味着有资格接受强化免疫的儿童数量非常少。但是马克斯希望那些接种过疫苗的儿童将很快得到他们的加强剂,并且未接种疫苗的儿童将被鼓励获得他们的第一系列疫苗。

“今天行动的重点是确保那些决定利用我们拥有疫苗这一事实的父母,这种疫苗可以帮助防止新冠肺炎带来的最坏结果,如住院和死亡...可能会受益于拥有最新版本的疫苗,即二价疫苗,”马克斯说。

“希望这也是一个机会,90%没有给这个年龄段的孩子接种疫苗的父母会考虑这样做。因为根本不接种疫苗会使一个人面临新冠肺炎最糟糕的后果,”他补充道。

根据新的授权,接受Moderna疫苗的6岁以下儿童可以在第一轮注射后至少两个月获得二价加强剂。

对于接受辉瑞疫苗的5岁以下儿童,情况略有不同:儿童可以获得新授权的二价加强剂,代替辉瑞系列中针对幼儿的第三针。今后,任何接种三针辉瑞系列疫苗的儿童都将接种两针主剂,然后接种二价加强剂。

在更大的范围内,在整个疫情,最年轻年龄组的疫苗接种率一直远远低于其他群体。

即使对于年龄较大的人群,在二价疫苗上市的三个月内,加强剂量的摄入也非常低。

PHOTO: Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research within the Food and Drug Administration answers a question at a Committee hearing to discuss the on-going federal response to COVID-19, May 11, 2021, at the Capitol.

Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research within the Food and Drug Administration answers a question during a Senate Health, Education, Labor and Pensions Committee hearing to discuss the on-going federal response to C...Show moreundefined

格雷格·纳什/POOL/法新社

根据疾病预防控制中心的数据,只有不到13%的5岁以上的人接种了二价疫苗。65岁以上人群的失业率最高,约有三分之一的人被提升。

9月份,12岁以上的所有人都有资格接种二价加强剂,只要距离他们最后一次接种疫苗已有三个月。然后在10月,资格扩大到5岁以上的所有人。

现在,在12月,6个月大的婴儿也有资格。

公共卫生官员长期以来一直希望寒冷天气和流感季节的到来会给人们一种自然的推动力,让他们及时接种流感疫苗和新冠肺炎疫苗。

但马克斯承认,新冠肺炎镜头的增加并没有完全实现,他不确定这个冬季的摄取量会有多大变化——尽管他强烈建议。

“我并不完全理解为什么人们对获得二价加强剂犹豫不决。我想我是第一个承认这些疫苗并不完美的人。他们不会给你100%的保护来对抗新冠肺炎。马克斯说:“也许因为人们听说,‘嗯,我得到了增强剂,但我得到了COVID’,所以有些人对此持怀疑态度。”。

但他说,接种疫苗仍将降低感染病毒的几率,并使人们远离医院。

“即使不完美,这也是你能做到的最好的了,”马克斯说。“我将重复一些迄今为止让我受益匪浅的事情,那就是完美是好的敌人。”

Marks特别鼓励在冬季到来之前接种疫苗,他预测病例可能会增加,医院可能会因严重的RSV和流感病例而紧张。

全国各地的废水监测系统已经开始发现新冠肺炎案件的上升,马克斯称案件的上升趋势“令人不安”

“从我所看到的最近发生的事情来看,我认为好消息是,我们不太可能看到前几个冬天的死亡人数。令人担忧的是,我们可能会看到大量病例,”他说。

“我们也看到住院人数显著上升,而一直在下降的死亡人数又开始上升。一旦人们看到这一点,我猜测他们可能会考虑这样做,”马克斯说。“虽然我不会等待。”

New COVID booster authorization will sway parents to get young kids vaccinated, FDA vaccine chief hopes

Dr. Peter Marks, the Food and Drug Administration's vaccine chief, said he is well aware that COVID-19 booster uptake might be low for the latest shot,authorized by the government on Thursday morningfor young children over 6 months old, but he told ABC News that he's hopeful increased access may also lead to some kids getting greater protection against the virus ahead of the winter, when infections can be more likely.

The updated bivalent booster that targets multiple newer strains of the virus, will likely be available early next week for the youngest children, Marks said in an interview. That age group is the last to become eligible for the new booster.

So far, according to the Centers for Disease Control and Prevention, less than 10% of kids under 5 have gotten their initial COVID-19 vaccines -- which means there's a very small pool of children who are even eligible for boosters. But Marks hopes that those vaccinated children will soon get their boosters, and unvaccinated children will be encouraged to get their first series.

"The whole point of today's action was to ensure that those parents who have decided to take advantage of the fact that we do have a vaccine that can help prevent the worst outcomes from COVID-19, such as hospitalization and death ... could have the benefit of having the most up-to-date version of the vaccine, which is the bivalent vaccine," Marks said.

"Hopefully this is also an opportunity that the 90% of parents who have not vaccinated their children in this age range will consider doing so. Because not being vaccinated at all puts one at risk for the worst outcomes from COVID-19," he added.

Under the new authorization, children under 6 who received the Moderna vaccine can get a bivalent booster at least two months after their first series of shots.

For children under 5 who received the Pfizer vaccine, it's slightly different: Kids can get the newly authorized bivalent booster in place of the third shot in the Pfizer series for young kids. And going forward, any young child who gets the three-shot Pfizer series will get two primary shots and then the bivalent booster.

On a larger scale, vaccine uptake for the youngest age group has traditionally been far lower than other groups throughout the pandemic.

And even for older age groups, booster uptake has been very low over the three months that bivalent shots have been on the market.

According to the CDC, just under 13% of people over 5 years old have gotten a bivalent booster. The rate is highest for people over 65, for whom around one-third have been boosted.

Everyone over age 12 became eligible for bivalent boosters in September, so long as it had been three months since their last vaccine. Then in October, the eligibility expanded to everyone over age 5.

And now, in December, babies as young as 6 months old are eligible as well.

Public health officials have long hoped that the arrival of cold weather and flu season would give people a natural push to get up-to-date on both their flu vaccines and their COVID-19 boosters.

But that bump in COVID-19 shots hasn't quite materialized, Marks acknowledged, and he's not sure that uptake will budge all that much over this winter season -- despite his avid recommendations.

"I don't quite fully understand why there's significant hesitancy to get the bivalent boosters. I think I'm the first to acknowledge that these vaccines are not perfect. They're not going to give you 100% protection against COVID-19. And perhaps because people have heard, 'Well, I got the booster but I got COVID,' there's some skepticism there," Marks said.

But inoculation will still cut down on the chances of contracting the virus and keep people out of the hospital, he said.

"Even if it's not perfect -- it's the best you can do," Marks said. "I will repeat something that has done me well to date, which is perfection is the enemy of good."

Marks particularly encouraged getting vaccinated and boosted ahead of the winter season, when he predicted that cases were likely to go up and hospitals could be strained from the combination of heavy RSV and flu cases.

Already, wastewater surveillance systems across the country have begun to pick up upticks in COVID-19 cases, and Marks called the increasing slope of cases "disturbing."

"From what I can see happening over the recent past, I think the good news is, we're not likely to see the number of deaths that we've seen in previous winters. The part that is concerning is that we could see a large number of cases," he said.

"We're also seeing hospitalizations rise significantly and deaths, which had been declining, are starting to increase again. Once people see that, my guess is that will drive them to potentially consider this," Marks said. "Though I wouldn't wait for that."

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