When Will Covid-19 Vaccines Be Available For Kids Under 12 Years Old – Forbes

Covid-19 vaccines are not yet authorized for kids under the age of 12, so schools will have to relay ... [+] on other Covid-19 precautions for now. (Photo by Paul Hennessy/NurPhoto via Getty Images)

Kids are people too. They have noses, mouths, lungs, and other body parts and can catch and spread the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) just like adults can. Therefore, one big question in the U.S.s current struggle against the Covid-19 coronavirus pandemic is when kids under 12 years of age will be able to get vaccinated.

After all, you may be fully vaccinated. Your significant other may be fully vaccinated. Your sixteen-year-old who no longer thinks that you are cool may be fully vaccinated. But as long as youve got unvaccinated people running around the house, youve got to maintain other stringent Covid-19 precautions. Yes, you may have to tell your seven-year-old, bruh, you are really holding all of us back.

Thats because unvaccinated people, no matter how small they may be, remain at much, much, much higher risk of getting infected with the virus, suffering bad consequences from infection, and infecting you and others with the virus than those who are fully vaccinated. And its probably not an option to tell your unvaccinated seven-year-old to move out and get a place of his or her own.

According to the American Academy of Pediatrics, as of August 19, over 4.59 million children have tested positive for COVID-19 since the onset of the pandemic. Over 180,000 cases were added the past week, reaching levels of the previous winter surge of 2020-21. Recently, the Covid-19 coronavirus has been spreading among kids seemingly faster than that Baby Shark song did in 2018 with a four-fold increase in cases over the past month.

That has meant as much anticipation for the Covid-19 vaccines for younger kids as there has been for the movie Spider Man:Home Alone 2 or Spider Man:Home Improvement, or whatever the next Marvel Spider Man movie is called. So when will the Covid-19 vaccine, doo doo doo doo doo doo, be available for those under 12 years of age, otherwise known as kids?

There's no evidence that Covid-19 vaccines will turn your kids into rabbits. (Photo by Michael ... [+] Loccisano/Getty Images)

Trials of the Covid-19 vaccines for kids younger than 12 have been underway for a little while. In mid-to-late March 2021, both Pfizer/BioNTech and Moderna announced launches of their clinical trials. For details on the trials, you can go to the U.S. National Library of Medicine (NLM) ClinicalTrials.gov website, where youll find a web page for the Moderna clinical trials that was first posted on March 15 and a web page for the Pfizer/BioNTech clinical trials that was first posted on March 25. Both of these web pages list the trials as still recruiting and include contact information in case youd like to ask about how to participate in these trials.

As you can see, these trials involve testing different dosages of the vaccines to help determine what dosages should be used for each age group. Vaccine dosages are not like Nutella. More is not always better. Children under 12 years of age may end up getting lower recommended dosages than adolescents and adults. For example, the Pfizer/BioNTech Phase 1 clinical trials tested 10 micrograms, 20 micrograms and 30 micrograms of their vaccine in the following three age groups: those from five to 11 years of age, those from two to four years of age, and those from 6 months of age to one year of age. The Phase 1 trial evaluated the safety, tolerability, and the resulting antibody levels of these different dosages and determined what doses would be used for the Phase 2/3. Phase 2/3 have been further evaluating the safety, tolerability, and antibody response in each age group for the dose level selected from Phase 1 and the efficacy of the vaccine in preventing Covid-19 when compared to placebo.

The U.S. Food and Drug Administration (FDA) will likely want to see at least four-to-six months of data from the trials before considering a emergency use authorization (EUA) for younger children. The FDA is not going to behave like someone would after seeing a Tiger selfie on Tinder: rashly. It will stick to protocols that have already been established.

Near the end of July, the FDA did ask both Pfizer/BioNTech and Moderna to increase the number of kids enrolled in their clinical trials. This came after the FDA had added myocarditis and pericarditis to the list of possible side effects from the Pfizer/BioNTech and Moderna Covid-19 mRNA vaccines, as I reported for Forbes back in June. Myocarditis is inflammation of the heart muscles, and pericarditis is inflammation of the membranes that surround the heart. Thats because myo- which is pronounced like the beginning of my oh my stands for muscle. The prefix peri-, which is pronounced like the beginning of peri peri sauce and Perry the Platypus or the end of Rick Perry, meansaround or about. The middle part card, which is pronounced like card or the beginning of Cardi B, means heart. And, finally -itis, which is pronounced like I piss but with a t instead of a p, means inflammation.

Although those under 30 years of age may be more likely to suffer myocarditis or pericarditis after vaccination, keep in mind that these side effects are still very, very rare even among younger adults and adolescents. Your chances of having myocarditis or pericarditis after Covid-19 mRNA vaccination are still a lot lower than the risk of experiencing such problems from Covid-19 itself.

In fact, these side effects are so rare that the FDA wanted Pfizer/BioNTech and Moderna to increase the number of kids under 12 enrolled in their trials to better see what percentage may end up developing these two types of inflammation. After all, when something is quite rare, like a set of pancakes that look like Shia LaBeouf, you need to sift through a whole lot more samples to find it.

So given this increase in enrollment, what is now the timeline for results? Pfizer has said that clinical trial results for kids from five to 11 years of age most likely will be available sometime in September. Assuming that there no issues with those results, expect Pfizer-BioNTech to apply for an EUA for that age group shortly thereafter. It will take the U.S. Food and Drug Administration (FDA) and any external advisors some time, perhaps a month, to review the EUA application and all available information. That could mean a late Fall or early Winter EUA for this age group for the Pfizer/BioNTech vaccine. The timeline for the Moderna Covid-19 vaccine, which if youll recall received its initial EUA after the Pfizer/BioNTech vaccine, seems to be lagging the Pfizer/BioNTech timeline a bit.

The Pfizer/BioNTech Covid-19 vaccine results for 2 to 4 years olds could arrive a little bit later, and results for the 6 month to one year olds will probably arrive even later, perhaps in October or November. Therefore, expect the EUAs for the younger of the young to come even later. That means telling your nine month old to postpone his or her TED Talk on the meaning of life until 2022.

Of course, these timelines could always be further delayed. Clinical trials and the FDA process arent like microwaving a Hot Pocket. Since they are complex operations, things can happen along the way. Moreover, the FDA will want to be extra careful to minimize the chances of unanticipated side effects, no matter how rare they may be. This is especially the case with various politicians, personalities, and social media accounts behaving like pseudoscience fart cannons these days.

The Pfizer/BioNTech Covid-19 vaccine already has Emergency Use Authorization (EUA) for those 12 ... [+] years and older and approval for those 16 years and older. Here Sadie Sindland, age 14, gives a thumbs up after being inoculated by Nurse Karen Pagliaro in Hartford, Connecticut on May 13, 2021. (Photo by JOSEPH PREZIOSO/AFP via Getty Images)

Now if you cant wait to get your younger kids vaccinated, your only real option right now is to check whether they can be enrolled in the clinical trials. Its not a good idea to find a doctor who is willing to give the vaccine to younger kids off label. Technically, since the Pfizer/BioNTech is now officially approved by the FDA for those 16 years and older, as I recently reported for Forbes, off label use is possible. Off label means doing something thats not on the FDA-approved label accompanying the product. Doctors do have the discretion of using an FDA-approved vaccine or medication in manners beyond whats indicated on the label. However, using a vaccine or medication in an unapproved or unauthorized way is not the same as using hot dogs in an unapproved or unauthorized way. For example, its not clear yet what dose levels should be given to younger children.

So for now, youll have to wait for it, wait for it, wait for some time after September ends for the vaccines to be available for those younger than 12 years of age. Its not yet clear how long after the end of September things will take. Even after the vaccines do become available, it will take time to get younger kids fully vaccinated.

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When Will Covid-19 Vaccines Be Available For Kids Under 12 Years Old - Forbes