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Why The FDA Isn't The Battleground For Pfizer's, Moderna's Pediatric Covid Shots

Updated: Jul 26, 2022

Investor's Business Daily 06/02/2022

The youngest Americans soon could be inoculated against Covid, but whether the uptake will be enough to stoke vaccine stocks Pfizer (PFE) and Moderna (MRNA) remains to be seen.

Pfizer recently said its three-dose Covid vaccine is 80.3% effective in children 6 months to under 5 years old. The company studied its BioNTech (BNTX)-partnered vaccine in nearly 1,700 children. Meanwhile, Pfizer's chief vaccines rival, Moderna, says its shot was effective in 37%-51% for children younger than age 6.

Nielsen Hobbs, executive editor of Informa Pharma Intelligence, says the benefits and risks of the two-dose approach will be on display at a Food and Drug Administration advisory committee meeting next month. The outside advisors will examine data from both companies' Covid vaccine studies.

He noted Pfizer's two-dose attempt flopped in February, prompting the company to pivot quickly to a three-dose approach, using 3 micrograms each time. But Moderna swung for the fences early on with a two-jab vaccine that uses 25 micrograms.

"But whether that (Moderna's vaccine) also produced more adverse events will be an important question for regulators," he said in an email to Investor's Business Daily.

Vaccine Stocks On Display At FDA Meeting

The FDA's advisors will meet June 14-15 to discuss the pediatric vaccines. Their vote isn't binding, but the agency often follows the experts' suggestion. From there, it will be up to the Centers for Disease Control and Prevention to decide whether to recommend the shots.

Dr. Rashid Chotani expects both shots to gain FDA authorization. But uptake is a different matter.

Chotani, an epidemiologist/infectious disease specialist with HealthCentral — a website covering health issues — expects more than 20% of parents will get their babies and toddlers vaccinated immediately. Another 40% will take a "wait-and-see" approach. The remainder won't get their children vaccinated.

The IBD/TIPP Poll tackled this question in May. Of respondents with a child or grandchild in this age group, just 56% said they were comfortable with vaccinating a child against Covid. Four in 10 were not comfortable with the idea. The remaining 4% were unsure.

In fact, uptake has continued to trickle down recently. The phenomenon has been reflected in vaccine stocks. Even Pfizer — a diversified medical giant — has seen shares decline nearly 10% this year. Shares of Moderna and BioNTech have plummeted a respective 48% and 40%.

"We all want to be done with the pandemic, but unfortunately we are not done," Chotani said in an email. "The U.S. is experiencing another surge in Covid-19 cases with an estimate of 100,000 people getting the disease daily. These numbers will continue to rise, and we are far from the anticipated fall surge."

Spotty Use Of Vaccines In Young Children

Today, the only vaccine allowed for children in the U.S. is Pfizer's. Dean Fanelli, an attorney specializing in biopharma products with Cooley LLC, estimates just 10% of around 30 million children ages 5-11 in the U.S. have received both shots. He expects uptake to be similarly disjointed for the youngest children.

"Mentally, a lot of people are trying to move past Covid," he told IBD. "We're not going to see a huge spike in people getting their kids vaccinated."

Vaccine stock analysts expect Pfizer's and Moderna's sales to peak this year, and say BioNTech's sales touched their high point in 2021.

Several factors contribute to the spotty use of Covid vaccines in children.

First, children tend to have to less severe outcomes from the respiratory illness.

Second, tweaking the adult vaccines for smaller children's bodies has proved to be a challenge. Pfizer's adult vaccine is two 30-microgram doses. In children age 5-11, it's 10 micrograms. The pediatric vaccine is 3 micrograms. Moderna's adult vaccine is 100 micrograms. Its booster is 50 micrograms. And the pediatric shot uses two 25-microgram jabs.

"We tend to think of children as little adults," Fanelli said. "But their biology is different, especially for respiratory diseases. It doesn't match up as well with adults. And it's tough to guess at the dosage. Playing around with the dosage is what delayed everything."

Vaccine Stocks: Is Three Shots A Tough Sell?

Third, compliance tends to be poor. The CDC says nearly 78% of the country has received at least one Covid shot, while only 67% are considered fully vaccinated.

That means a large group of people received just one messenger RNA vaccine — from Pfizer or Moderna — but didn't get a second. Less than half of eligible people, roughly 47%, have received a booster shot from any of the vaccine stocks.

Dr. Soumi Eachempati, co-founder of Cleared4, acknowledges the struggles in giving shots to children. Cleared4 is a platform that tracks Covid testing and vaccine use. He notes young children already have frequent checkups. It's possible those Covid shots could be squeezed into the already packed vaccine schedule. He expects parents to prefer the Pfizer shot.

"I think parents would prefer the higher (effectiveness)," he said in an interview. "And it probably won't be an extra trip."

It's important to note there haven't been any head-to-head studies to compare the two shots.

Side Effects Will Be A Key Question

It will also be key to watch side effects, another factor that can impact vaccine stocks.

Notably, cases of heart and tissue inflammation — officially known as myocarditis and pericarditis — haven't appeared in the youngest recipients of messenger RNA shots, Eachempati said. But it's possible the third Pfizer dose could result in more local effects, like fever, headache or rashes.

Pfizer and Moderna haven't published an exhaustive list of side effects, though those will likely be noted at the FDA advisory committee meeting. But in many people, each subsequent dose generates a greater number of side effects, he said.

"I'm predicting the third shot will probably have the most local effects," he said. "Pfizer probably had to look at that very carefully. That may be Moderna's side effect advantage. It might have less side effects than the three-dose Pfizer vaccine."

Chotani, the epidemiologist and infectious disease expert, offered a different take. Pfizer's smaller dose could lead to fewer side effects. Both are safe and effective, though Moderna's does have the edge when it comes to convenience, he said.

Will Vaccine Stocks Gain Steam?

Still, both Chotani and Eachempati expect both vaccines to gain authorization in June and be ready to launch in July, though that might not be enough to reinvigorate the vaccine stocks.

"Pfizer and Moderna are far ahead of the game internationally with the mRNA vaccines," Eachempati said. "The others haven't risen to the occasion in terms of manufacturing and ability to produce (studies) in the way these two behemoths have. I think they will probably become the major vendors for children as well."
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