We should soon know whether a coronavirus vaccine will be available to Americans in the near future. Four COVID-19 vaccine candidates are currently in late-stage clinical studies, with another expected to join the ranks by late November.
The focus for these drugmakers so far has been on determining if their experimental vaccines are safe and effective in protecting adults against SARS-CoV-2, the coronavirus that causes COVID-19. But what about vaccinations for children? There's a clear leader on this front.
Pfizer in first
AstraZeneca, Johnson & Johnson, and Moderna are only enrolling adults in the late-stage studies for their respective COVID-19 vaccine candidates. Novavax hasn't started a late-stage study in the U.S. for its investigational coronavirus vaccine, but the company's U.K. trial includes only adults between the ages of 18 and 84.
However, in September, Pfizer (NYSE:PFE) and its partner BioNTech (NASDAQ:BNTX) proposed expanding their late-stage clinical trials of coronavirus vaccine candidate BNT162b2 to include adolescents as young as 16.
This expansion didn't mention younger children, but reports surfaced a few weeks ago that Pfizer plans to enroll children as young as 12 in its late-stage U.S. clinical trials for BNT162b2. Pfizer subsequently confirmed that it received permission from the Food and Drug Administration earlier this month to enroll kids as young as 12.
Pfizer CEO Albert Bourla spoke about the decision to enroll children in the BNT162b2 study in the company's Q3 conference call this week. He said, "It was mainly because we felt very good about the safety profile, so we opened our vaccination to kids of 16 years old in beginning, then we went to 12 years old, and then we went to people who are suffering from HIV, from hepatitis B, from hepatitis C."
A controversial call
The move to include kids in the late-stage study of an experimental coronavirus vaccine stirred controversy. Experts disagree about whether or not children should be test subjects at this point.
At a recent public meeting of an FDA advisory panel discussing coronavirus vaccines, pediatric infectious disease specialist Dr. Cody Meissner stated, "If I were part of the FDA I would certainly want to be very convinced about the safety of a vaccine before I approved its use in children." He added, "The pattern of disease is very different in children, and lumping them in with adults would cause me some discomfort."
However, other experts argue that it's important to include children in coronavirus vaccine testing sooner rather than later. They're concerned that children will receive COVID-19 vaccines approved only for adults. A clinical study that includes kids is the only way to know if a coronavirus vaccine will be safe for children.
While COVID-19 doesn't impact kids as severely as adults in most cases, some children have developed serious symptoms that required hospitalization. At least 120 children have died from COVID-19 in the U.S. so far. Last year, 189 children died from the flu.
The big opportunity
Whichever side you take on the issue, there's without question a big opportunity in the pediatric market for coronavirus vaccines. There are currently around 74 million children in the U.S. aged 17 and younger. That number is projected to continue to grow each year over the next three decades.
The Centers for Disease Control and Prevention reported that 63.6% of U.S. children ages 17 and younger received a flu vaccine in the 2018-2019 flu season. If a similar percentage of kids eventually receive a COVID-19 vaccine, that's more than 47 million vaccines per year.
Most of the current leading coronavirus vaccine candidates, including Pfizer's, require two doses. At $20 per dose (close to what Pfizer and BioNTech will receive to supply 100 million doses of BNT162b2), the annual U.S. pediatric coronavirus vaccine market could approach $2 billion. Adding the pediatric markets in other countries would boost that number.
Pfizer fully recognizes the opportunity it has in providing coronavirus vaccines to kids. Like it or not, the drugmaker is pursuing that opportunity. With the big pharma stock trading at only 12.4 times expected earnings, Pfizer looks like a bargain for investors who expect the company to be a winner in the COVID-19 vaccine market.