Please ensure Javascript is enabled for purposes of website accessibility

Why COVID Vaccines for Younger Kids Won't Win Authorization as Soon as Expected

By Keith Speights and Brian Orelli, PhD – Aug 6, 2021 at 6:08AM

Key Points

  • Pfizer, BioNTech, and Moderna hope to win EUAs for their COVID-19 vaccines in protecting younger kids.
  • The FDA requested that the vaccine makers expand the sizes of their clinical trials.
  • While the increased number of study participants will push back EUA, it should have a minimal impact on these vaccine stocks.

Motley Fool Issues Rare “All In” Buy Alert

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

The FDA has raised the bar for vaccine makers.

Pfizer (PFE 1.29%) and BioNTech (BNTX 2.08%) hope to win Emergency Use Authorization for their COVID-19 vaccine in immunizing children below age 12. Moderna (MRNA 1.59%) is pursuing the same goal. In this Motley Fool Live video recorded on July 28, Motley Fool contributors Keith Speights and Brian Orelli discuss why these vaccines won't win authorization for younger kids as soon as expected.

10 stocks we like better than Pfizer
When our award-winning analyst team has a stock tip, it can pay to listen. After all, the newsletter they have run for over a decade, Motley Fool Stock Advisor, has tripled the market.*

They just revealed what they believe are the ten best stocks for investors to buy right now... and Pfizer wasn't one of them! That's right -- they think these 10 stocks are even better buys.

See the 10 stocks


*Stock Advisor returns as of June 7, 2021


Keith Speights: We're going to talk about some COVID-19 news. The FDA has requested that Pfizer and its partner, BioNTech, as well as Moderna, expand the size of their clinical trials before seeking Emergency Use Authorization for their COVID vaccines in younger children.

Brian, why is the FDA making this request first of all, and then secondly, how does it impact these vaccine stocks?

Brian Orelli: The FDA wants larger clinical trials for the children basically to detect rare side effects. Considering the new side effects that have cropped up with the adults and the skepticism that it's created, I think that's probably a good move.

Moderna's study includes nearly 7,000 children from six months of age to 12 years old. The Pfizer and BioNTech's study is 4,500 children of the same age. Maybe there's going to be some negotiation between the FDA and the companies on how much to increase them by, and then it's going to take a couple of months to enroll the patients and then a month for dosing and then a couple of months of follow up for the children that are five years and older, and then probably another month for authorization.

We're talking about a delay of probably close to six months, if not even more than that. It depends on how big the clinical trials have to be and how long it's going to take them to enroll the patients. Younger children under the age of five could even require -- the delay could be even longer because they're probably going to have to watch those children even longer, probably maybe as much six months after, you have to follow them for six months before they are able to apply for Emergency Use Authorization.

This is going to be quite a bit of a delay in terms of the companies, I'm not sure it's really that big of a deal. The U.S. government has already committed to purchasing the vaccines for children, so it's not going to really hurt the financials except the fact that they have to pay for the larger clinical trials.

Speights: Brian, you were saying it may push things back six months, I think I saw Moderna state that they were still hopefully looking to file for EUA in younger kids, I saw by the end of this year or early next year, I think is what they were saying. This shouldn't have any real significant impact on the company's because as you said, the U.S. has already bought more than enough vaccine doses for now.

Orelli: Yeah. Financially it's not going to hurt them. It would be good to get them into kids as quickly as possible, especially with schools opening at back up in the next couple of months.

It would've been good to get them authorized in the fall and then start to do vaccinations. But I can see how the FDA probably wants more safety data before they want to do that authorization and have it go into a large number.

Speights: Alright. They are always two sides to the coin. In this case, I'm sure there are some parents who are relieved that there will be a larger study done here that will give them more confidence when the results are obtained and give them more confidence in the EUA, assuming that it comes. On the other hand, there are parents who would love to get their younger children vaccinated sooner rather than later, so it works both ways here.

Keith Speights owns shares of Pfizer. The Motley Fool recommends Moderna Inc. The Motley Fool has a disclosure policy.

Invest Smarter with The Motley Fool

Join Nearly 1 Million Premium Members Receiving…

  • New Stock Picks Each Month
  • Detailed Analysis of Companies
  • Model Portfolios
  • Live Streaming During Market Hours
  • And Much More
Get Started Now

Stocks Mentioned

Pfizer Stock Quote
$50.13 (1.29%) $0.64
Moderna Stock Quote
$175.91 (1.59%) $2.76
BioNTech Se Stock Quote
BioNTech Se
$167.02 (2.08%) $3.41

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

Related Articles

Motley Fool Returns

Motley Fool Stock Advisor

Market-beating stocks from our award-winning analyst team.

Stock Advisor Returns
S&P 500 Returns

Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of 2002. Returns as of 12/01/2022.

Discounted offers are only available to new members. Stock Advisor list price is $199 per year.

Premium Investing Services

Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services.