Children are people too. They have noses, mouths, lungs, and other parts of the body and can catch and spread severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) just like adults. Therefore, a big question in the United States’ current fight against the Covid-19 coronavirus pandemic is when children under the age of 12 will be able to get vaccinated.
After all, you may be fully immunized. Your significant other may be fully immunized. Your sixteen-year-old who no longer thinks you are cool may be fully immunized. But as long as you have unvaccinated people running around the house, you need to maintain other strict Covid-19 precautions. Yeah, you might have to say to your seven year old, “bruh, you’re really holding us all back. ”
This is because unvaccinated people, no matter how small, are at much, much, much higher risk of getting infected with the virus, of having serious consequences from the infection, and of infecting you and you. others with the virus than those who are fully vaccinated. And telling your unvaccinated seven-year-old to move out and find their own home is probably not an option.
According to the American Academy of Pediatrics, “As of August 19, more than 4.59 million children have tested positive for COVID-19 since the start of the pandemic. More than 180,000 cases were added last week, reaching levels from the previous winter wave of 2020-21. Recently, the Covid-19 coronavirus has spread among children apparently faster than that song “Baby Shark” in 2018, with the number of cases increasing fourfold over the past month.
It meant as much anticipation for Covid-19 vaccines for young children as it did for the movie Spider Man: Home Alone 2 Where Spider Man: Home Improvement, or whatever the name of the upcoming Marvel Spider Man movie is. So when will the Covid-19 vaccine, doo doo doo doo doo doo, be available for children under 12, in other words children?
Trials of Covid-19 vaccines for children under 12 have been underway for some time. From mid-March to the end of March 2021, Pfizer / BioNTech and Moderna announced the launch of their clinical trials. For more details on the trials, you can visit the ClinicalTrials.gov website of the United States National Library of Medicine (NLM), where you will find a web page for Moderna clinical trials that has been published for the first time on March 15 and a webpage for the Pfizer / BioNTech Clinical Trials which was first published on March 25. These two web pages list the trials being recruited and include contact information in case you want to know how to participate in these trials.
As you can see, these trials involve testing different doses of the vaccine to help determine which doses to use for each age group. Vaccine dosages are not like Nutella. More is not always better. Children under 12 may end up receiving lower recommended doses than adolescents and adults. For example, Pfizer / BioNTech’s Phase 1 clinical trials tested 10 micrograms, 20 micrograms, and 30 micrograms of their vaccine in the following three age groups: those five to 11 years old, those two to four years old, and those from 6 months to a year. The phase 1 trial evaluated the safety, tolerability and resulting antibody levels of these different doses and determined which doses would be used for phase 2/3. Phases 2/3 further assessed the safety, tolerability and antibody response in each age group for the dose level selected in phase 1 and the efficacy of the vaccine in preventing Covid-19 by compared to placebo.
The United States Food and Drug Administration (FDA) will likely want to see at least four to six months of trial data before considering emergency use authorization (EUA) for young children. The FDA isn’t going to behave the way someone would after seeing a tiger selfie on Tinder: recklessly. He will stick to the protocols already established.
Towards the end of July, the FDA asked Pfizer / BioNTech and Moderna to increase the number of children enrolled in their clinical trials. This came after the FDA added myocarditis and pericarditis to the list of possible side effects of Pfizer / BioNTech and Moderna Covid-19 mRNA vaccines, as I reported for Forbes back in June. Myocarditis is an inflammation of the heart muscles and pericarditis is an inflammation of the membranes that surround the heart. This is because “myo-” which is pronounced like the beginning of “my oh my” means “muscle”. The prefix “peri-“, which is pronounced like the beginning of “peri peri sauce” and Perry the platypus or the end of Rick Perry, means “around or around”. 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 the age of 30 may be more likely to get myocarditis or pericarditis after vaccination, keep in mind that these side effects are still very, very rare, even in young adults and adolescents. Your chances of having myocarditis or pericarditis after vaccination with Covid-19 mRNA are still much 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 children under 12 enrolled in their trials to better see what percentage might 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 have to sift through a lot more samples to find it.
So, given this increase in registrations, what is the schedule for results now? Pfizer said clinical trial results for children aged five to 11 will most likely be available in September. Assuming there is no problem with these results, expect Pfizer-BioNTech to request an EUA for this age group shortly thereafter. It will take some time for the United States Food and Drug Administration (FDA) and any outside advisers, perhaps a month, to review the EUA application and all the information available. This could mean an EUA in late fall or early winter for this age group for the Pfizer / BioNTech vaccine. The schedule for the Moderna Covid-19 vaccine, which if you recall received its initial EUA after the Pfizer / BioNTech vaccine, appears to be a bit behind the Pfizer / BioNTech schedule.
Pfizer / BioNTech Covid-19 vaccine results for 2-4 year olds could come a bit later, and results for 6 months to a year will likely come even later, possibly in October or November. Therefore, expect the EUAs for the youngest of the young to arrive even later. That means telling your nine-month-old to postpone their TED Meaning of Life talk until 2022.
Of course, these deadlines could always be further delayed. Clinical trials and the FDA process are not like heating a Hot Pocket in the microwave. Since these are complex operations, things can happen along the way. In addition, the FDA will need to be extra careful to minimize the risk of unanticipated side effects, however rare they may be. This is especially the case with various politicians, personalities, and social media accounts who behave like pseudo-scientific far-away cannons these days.
Now, if you can’t wait to get your youngest children vaccinated, your only real option right now is to see if they can be enrolled in clinical trials. It is not a good idea to find a doctor who is willing to administer the vaccine to young children “off label”. Technically, since Pfizer / BioNTech is now officially approved by the FDA for ages 16 and over, as I recently reported for Forbes, “off-label” use is possible. “Off-label” means doing something that is not on the FDA approved label accompanying the product. Doctors have the discretion to use an FDA-approved vaccine or drug in a way that goes beyond what is stated on the label. However, using a vaccine or medication in an unapproved or unauthorized manner is not the same as using hot dogs in an unapproved or unauthorized manner. For example, it is not yet clear what dose levels should be given to young children.
So for now you will have to wait for it, wait for it, wait a while after the end of September for the vaccines to be available for those under 12. It is not yet known how long after the end of September things will take. Even once vaccines are available, it will take time for young children to be fully immunized.