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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.

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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.

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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.

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Stocks Mentioned

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

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