Moderna requests FDA authorization for its COVID vaccine for very young kids

Moderna requests FDA authorization¹ for its COVID vaccine² for very young kids

Transcript³

Moderna announced Thursday that the company has asked the Food and Drug Administration to authorize⁴ a low-dose version of its COVID-19 vaccine as the first vaccine for children younger than age 5.

STEVE INSKEEP, HOST:

We have news this morning from the vaccine-maker Moderna. The company has asked the FDA for emergency use authorization for its vaccine for little kids. It'd be the first COVID shot available in the U.S. for children younger than 5. NPR's Allison Aubrey is covering this story. Allison, good morning.

ALLISON AUBREY, BYLINE⁵: Good morning, Steve.

INSKEEP: OK, so how effective is this vaccine, at least according to Moderna?

AUBREY: Well, the company says two kid-sized vaccine doses spaced about a month apart led to a strong immune response, with antibody levels similar to what they've documented in adults. There were about 7,000 children in this study. Moderna says the vaccine was about 51% effective in preventing infection in babies 6 months old through 2 years and about 37% effective in kids 2 up to 6 years old. Now, this might not sound so great...

INSKEEP: No.

AUBREY: ...But much of their data was collected during the omicron wave, when there was a drop in vaccine effectiveness overall. I talked to Moderna's chief medical officer, Paul Burton, about how the company views the results.

PAUL BURTON: I think the levels of antibody that we see are very reassuring⁶. They should provide good protection. And even the vaccine effectiveness - while it's lower than we have seen, you know, with previous variants⁷, it's certainly what we see in adults, and we know that they have good protection against severe disease and hospitalizations.

AUBREY: Which is what's most important, he says. So, again, not perfect here, but the company emphasizes the strong antibody response in these young children.

INSKEEP: What do pediatricians, independent of the company, say about that?

AUBREY: You know, because the data has just been handed over to the FDA, details of the clinical trial results have really not been available. But generally speaking, pediatricians have been waiting for a vaccine for this age group. I talked to an infectious disease pediatrician in Oregon, Judy Guzman-Cottrill, about what she calls the unmet need.

JUDY GUZMAN-COTTRILL: There are still so many high-risk infants, toddlers and preschoolers with chronic⁸ conditions who are still being admitted to the hospital because of COVID. And it's frustrating⁹ to continue to see these kids with chronic lung disease and other conditions get so sick when we know that COVID vaccines¹⁰ are so incredibly effective at preventing hospitalization.

AUBREY: She says, while it is true that most kids have only mild sickness from COVID, about 20% of the kids who have been hospitalized with very serious inflammatory disease following COVID are younger than 5 years old. So she says, in her mind, there's an urgency to getting vaccines for these very young children, and pediatric groups have really echoed this message.

INSKEEP: I guess we should be frank here - some parents just aren't going to do this because some parents have not had their older kids get vaccines when they were available. But some parents, as we know very well, have been extremely anxious to get this protection for their children.

AUBREY: That's right.

INSKEEP: So what's the FDA timeline?

AUBREY: You know, the agency has a lot to review right now, Steve. Pfizer has been testing its three-dose regimen in young children because the company concluded two doses of its vaccine didn't lead to the protection they had hoped for, so the FDA will analyze¹¹ this data and now all of the Moderna data. So, you know, it's not lost on the agency that, as you just said, lots of parents and pediatricians have been waiting for this. And Dr. Paul Burton at Moderna says the agency will be very careful in its review, but it could happen pretty swiftly.

BURTON: You know, we've seen them review applications within, you know, four weeks, so it might be that by late May they would be in a position to come to a ruling.

AUBREY: But, of course, that timing¹² is up to the Food and Drug Administration, and June may be a better estimate.

INSKEEP: Allison, thanks.

AUBREY: Thank you, Steve.

INSKEEP: That's NPR's Allison Aubrey.

1 authorization   

n.授权，委任状

参考例句：

• Anglers are required to obtain prior authorization from the park keeper.垂钓者必须事先得到公园管理者的许可。
• You cannot take a day off without authorization.未经批准你不得休假。

2 vaccine   

n.牛痘苗，疫苗；adj.牛痘的，疫苗的

参考例句：

• The polio vaccine has saved millions of lives.脊髓灰质炎疫苗挽救了数以百万计的生命。
• She takes a vaccine against influenza every fall.她每年秋季接种流感疫苗。

3 transcript   

n.抄本，誊本，副本，肄业证书

参考例句：

• A transcript of the tapes was presented as evidence in court.一份录音带的文字本作为证据被呈交法庭。
• They wouldn't let me have a transcript of the interview.他们拒绝给我一份采访的文字整理稿。

4 authorize   

v.授权，委任；批准，认可

参考例句：

• He said that he needed to get his supervisor to authorize my refund.他说必须让主管人员批准我的退款。
• Only the President could authorize the use of the atomic bomb.只有总统才能授权使用原子弹。

5 byline   

n.署名；v.署名

参考例句：

• His byline was absent as well.他的署名也不见了。
• We wish to thank the author of this article which carries no byline.我们要感谢这篇文章的那位没有署名的作者。

6 reassuring   

a.使人消除恐惧和疑虑的，使人放心的

参考例句：

• He gave her a reassuring pat on the shoulder. 他轻拍了一下她的肩膀让她放心。
• With a reassuring pat on her arm, he left. 他鼓励地拍了拍她的手臂就离开了。

7 variants   

n.变体( variant的名词复数 )；变种；变型；（词等的）变体

参考例句：

• Those variants will be preserved in the'struggle for existence". 这些变异将在“生存竞争”中被保留下来。 来自辞典例句
• Like organisms, viruses have variants, generally called strains. 与其他生物一样，病毒也有变种，一般称之为株系。 来自辞典例句

8 chronic   

adj.(疾病)长期未愈的，慢性的；极坏的

参考例句：

• Famine differs from chronic malnutrition.饥荒不同于慢性营养不良。
• Chronic poisoning may lead to death from inanition.慢性中毒也可能由虚弱导致死亡。

9 frustrating   

adj.产生挫折的，使人沮丧的，令人泄气的v.使不成功( frustrate的现在分词 )；挫败；使受挫折；令人沮丧

参考例句：

• It's frustrating to have to wait so long. 要等这么长时间，真令人懊恼。
• It was a demeaning and ultimately frustrating experience. 那是一次有失颜面并且令人沮丧至极的经历。 来自《简明英汉词典》

10 vaccines   

疫苗，痘苗( vaccine的名词复数 )

参考例句：

• His team are at the forefront of scientific research into vaccines. 他的小组处于疫苗科研的最前沿。
• The vaccines were kept cool in refrigerators. 疫苗放在冰箱中冷藏。

11 analyze   

vt.分析，解析 (=analyse)

参考例句：

• We should analyze the cause and effect of this event.我们应该分析这场事变的因果。
• The teacher tried to analyze the cause of our failure.老师设法分析我们失败的原因。

12 timing   

n.时间安排，时间选择

参考例句：

• The timing of the meeting is not convenient.会议的时间安排不合适。
• The timing of our statement is very opportune.我们发表声明选择的时机很恰当。