FDA to share data on how effective the Pfizer vaccine is for kids under 5

FDA to share data on how effective the Pfizer vaccine¹ is for kids under 5

Transcript²

NPR has learned that Pfizer and BioNtech have gathered additional data that the companies say strengthen their case for authorizing³ the COVID-19 vaccine for children younger than age five.

RACHEL MARTIN, HOST:

Parents of young kids waiting for a vaccine, it's getting closer. Today we will all find out how well the Pfizer-BioNTech COVID-19 vaccine works in children 6 months to 4 years old. NPR has learned that the companies have gathered additional data to support their request for this authorization⁴. The Food and Drug Administration is expected to release that data today.

We've got NPR health correspondent Rob Stein with us. Hey, Rob.

ROB STEIN, BYLINE⁵: Hey, Rachel.

MARTIN: I know friends of mine with young kids have felt so left out of all the celebration of the vaccines⁶. They're just living like they did in 2020 because their children haven't yet been able to be vaccinated⁸. So we're getting closer?

STEIN: Yeah. Yeah. You know, that's right. The vaccine so far had only been authorized⁹ for kids ages 5 and older. So, you know, like you said, lots of parents of those younger kids have been kind of holding their breath waiting for when they might finally be able to vaccinate⁷ their kids, too. But then Pfizer and BioNTech discovered that two shots of a low-dose version of their vaccine only seem to work in kids ages 6 months to 23 months old. It did not look like it would protect those ages 2, 3 and 4. So the company started giving kids a third shot to see if that would do the trick. The results from that third shot aren't due until next month, so everyone thought we'd have to keep waiting.

MARTIN: Yeah.

STEIN: But then last week, the FDA and the company surprised everyone. The FDA asked the companies to apply for authorization for the vaccine anyway. The idea is that parents could start vaccinating¹⁰ their kids so they'll be ready for that third shot when the data hopefully shows that it works.

MARTIN: But that seems unusual, right? They're asking for approval for a vaccine series before they know if it is actually effective.

STEIN: Yeah. Yeah. That's right. You know, it's a really unorthodox strategy - maybe unprecedented¹¹, you know, to say the least. And it's triggered a big debate about whether this is really the way to do this. So lots of people are waiting to get a better look at the evidence that companies have to, you know - about whether to go this way.

MARTIN: Yeah. So what is this additional data?

STEIN: The companies continued gathering¹² data about the kids who had just gotten the two shots, including through when the omicron variant¹³ surged and lots of kids caught the virus. Now, that's obviously bad for all the kids who got sick, but it gave the companies and the FDA a chance to get a glimpse at whether the two-dose low-dose vaccine might be protecting kids. And according to someone familiar with at least an early look at that data, it suggests the vaccine may cut the risk of getting sick from the virus by about half. Now, there are some big caveats¹⁴ about all this. One is that it's based on kids who got infected at the end of the delta¹⁵ surge and in the beginning of the omicron surge. So it's unclear how well it really works against omicron, which is what really matters, obviously, at this point. And there just may not be enough evidence to really know how strong that protection is.

MARTIN: So considering the fast track of all this, what's been the reaction?

STEIN: Yeah. It's really mixed. You know, on the one hand, some are saying, you know, this strategy makes sense because, you know, the supercontagious omicron variant is still spreading fast, and some kids are still getting really sick. We're in a pandemic. So extraordinary times call for extraordinary measures. And it looks like the vaccine is very safe. Others say, hold on a minute here. You really want parents to give their kids two shots of a vaccine that may or may not work when the omicron surge is fading fast? And this could backfire, you know, by spooking parents by taking this approach. So it's already been really hard to convince many parents to vaccinate their kids.

MARTIN: So the next thing we should look towards is this big meeting Tuesday?

STEIN: Yeah. Tuesday these outside FDA advisers¹⁶ are going to get together, and they're going to review all the data. And in anticipation¹⁷ of that, the FDA is expected to release the details of the company's data today, along with the FDA's analysis. So we should get a better look at how strong the case really is later today. And if those FDA advisers are satisfied and the agency authorizes¹⁸ the vaccine...

MARTIN: Yeah.

STEIN: ...An independent CDC committee will then vote whether or not to recommend it.

MARTIN: Rob Stein, we appreciate it.

STEIN: You bet.

1 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。

2 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。

3 authorizing   

授权，批准，委托( authorize的现在分词 )

参考例句：

• Letters of Marque: Take letters from a warning friendly power authorizing privateering. 私掠许可证：从某一个国家获得合法抢劫的证书。
• Formal phavee completion does not include authorizing the subsequent phavee. 阶段的正式完成不包括核准随后的阶段。

4 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。

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 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。

7 vaccinate   

vt.给…接种疫苗；种牛痘

参考例句：

• Local health officials then can plan the best times to vaccinate people.这样，当地的卫生官员就可以安排最佳时间给人们接种疫苗。
• Doctors vaccinate us so that we do not catch smallpox.医生给我们打预防针使我们不会得天花。

8 vaccinated   

[医]已接种的，种痘的，接种过疫菌的

参考例句：

• I was vaccinated against tetanus. 我接种了破伤风疫苗。
• Were you vaccinated against smallpox as a child? 你小时候打过天花疫苗吗？

9 authorized   

a.委任的，许可的

参考例句：

• An administrative order is valid if authorized by a statute.如果一个行政命令得到一个法规的认可那么这个命令就是有效的。

10 vaccinating   

给…接种疫苗( vaccinate的现在分词 )； 注射疫苗，接种疫苗

参考例句：

• At first blush, vaccinating the wolves against rabies seems a simple solution. 乍一看来，为狼群注射防狂犬病疫苗是一种简单的办法。
• Also vaccinating children against misers (measles) has saved many lives. 还有，给儿童进行疫苗接种防止麻疹也挽救了许多生命。

11 unprecedented   

adj.无前例的，新奇的

参考例句：

• The air crash caused an unprecedented number of deaths.这次空难的死亡人数是空前的。
• A flood of this sort is really unprecedented.这样大的洪水真是十年九不遇。

12 gathering   

n.集会，聚会，聚集

参考例句：

• He called on Mr. White to speak at the gathering.他请怀特先生在集会上讲话。
• He is on the wing gathering material for his novels.他正忙于为他的小说收集资料。

13 variant   

adj.不同的，变异的；n.变体，异体

参考例句：

• We give professional suggestions according to variant tanning stages for each customer.我们针对每位顾客不同的日晒阶段，提供强度适合的晒黑建议。
• In a variant of this approach,the tests are data- driven.这个方法的一个变种，是数据驱动的测试。

14 caveats   

警告

参考例句：

• I would offer a caveat for those who want to join me in the dual calling. 为防止发生误解，我想对那些想要步我后尘的人提出警告。 来自辞典例句
• As I have written before, that's quite a caveat. 正如我以前所写，那确实是个警告。 来自互联网

15 delta   

n.（流的）角洲

参考例句：

• He has been to the delta of the Nile.他曾去过尼罗河三角洲。
• The Nile divides at its mouth and forms a delta.尼罗河在河口分岔，形成了一个三角洲。

16 advisers   

顾问，劝告者( adviser的名词复数 )； （指导大学新生学科问题等的）指导教授

参考例句：

• a member of the President's favoured circle of advisers 总统宠爱的顾问班子中的一员
• She withdrew to confer with her advisers before announcing a decision. 她先去请教顾问然后再宣布决定。

17 anticipation   

n.预期，预料，期望

参考例句：

• We waited at the station in anticipation of her arrival.我们在车站等着，期待她的到来。
• The animals grew restless as if in anticipation of an earthquake.各种动物都变得焦躁不安，像是感到了地震即将发生。

18 authorizes   

授权，批准，委托( authorize的名词复数 )

参考例句：

• The dictionary authorizes the two spellings 'traveler' and 'traveller'. 字典裁定traveler和traveller两种拼法都对。
• The dictionary authorizes the two spellings "honor" and "honour.". 字典裁定 honor 及 honour 两种拼法均可。