Today the news has come out that the Food & Drug Administration has expanded the Emergency Use Authorization for the Pfizer vaccine to include children ages 12-15. The Advisory Committee on Immunization Practices (ACIP) meets on Wednesday 5/12/21 to finalize a formal recommendation. Also of note, Pfizer is expecting to receive full FDA approval for its vaccine (beyond EUA) based on its trials and the real-world data we're seeing. Both of these are great news!
HOWEVER, it is perfectly okay to have questions about this. There are plenty of questions about adults getting this vaccine, and now we are talking about children. Pfizer has enrolled younger kids aged 6 months-11 years for the next phase of its trial, and I expect we shall be seeing results of that soon. Why am I excited about this? Because these vaccines are working, and the more people that get vaccinated the more we can stop the spread of this deadly virus and feel safer in our world again.
Disclaimer: I'm not a parent. That said, I am a son, a brother, a cousin with several cousins who have children who I call my nieces/nephews/niblings, a friend to many friends with children I love, and most of all I am a physician who cares about your children and my future children. I bring my knowledge to bear in my research of these things because I care and I can be objective.
Before we get started, let's talk about what EUA actually means. It does NOT mean skipping any steps in data-gathering or review. It just allows for manufacturing of the product (vaccines, in this case) to occur while the trial is ongoing, but nothing can be distributed or administered until the review process is complete. In addition, it only requires two months (read on to see why that's okay) of follow-up data from the initial trial vs. the six months required for full FDA approval (and it only occurs in extenuating circumstances like a global pandemic). I'll link to the Unbiased Science Podcast's excellent Instagram post on this.
THE RESEARCH
In Pfizer's study of 2,260 children aged 12-15, about half of whom got the vaccine and half got a saline placebo (randomized, placebo-controlled trials are the gold standard for this research). Similar to the adult trials, the vaccine subgroup saw impressive efficacy in preventing COVID-19! Of the >1000 people in the vaccine subgroup and nearly 1000 people in the placebo subgroup that followed up (because some folks in every trial don't check in afterward or don't respond), there were ZERO cases in the vaccine subgroup vs. 16 cases in the placebo subgroup. Now, we may still see some cases after vaccination as time goes on because no vaccine is 100% effective (more on that later), but efficacy will likely remain quite high. They are still assessing for data on transmission/spread, but if it's anything like what we're seeing with adults, we will at least see a reduction, which is a big part of why it will be important to vaccinate kids.
Moderna is reporting similar results in their trial of 3,235 children in the 12-17 age group.
IS IT SAFE FOR THE KIDS?
Yes! As I mentioned above, trial participants were monitored for a full two months after dosing (you'll recall, any major effects of a vaccine show up in the first six (6) weeks, according to pediatrics/infectious disease/vaccine expert Dr. Paul Offit) and they found similar reactogenic side effects as in adults (arm pain, fevers, muscle aches, chills). Similar to the adult vaccines, we MAY also see the temporary alterations in menstrual cycles among individuals with uteruses (not reported from the trial data yet), but the key word there is temporary - though it's important to anticipate it and be able to prepare your kids for it. Like adults, mileage may vary among individuals, but there were no major adverse effects, which is a blessing.
IS THIS TOO FAST? THIS VACCINE IS SO RUSHED!
No, it isn't. Let's go back over a few facts:
The vaccine was not rushed. It underwent all the proper stages for the appropriate time, including animal testing. The only reason it did not take 10 years for this vaccine is because they eliminated bureaucracy/red tape, poured money into development (always an issue), and because volunteers signed up in droves so there was no wait for recruitment.
mRNA vaccines are not new technology. They are in the spotlight now, of course, but the first mRNA vaccine was created all the way back in 1995, and it had been in heavy research since 1961. They have created mRNA vaccines against HIV, rabies, influenza, and other viruses, but in some cases the vaccines were not as effective (very different viruses) and in others, quite frankly, there was not a global pandemic driving the efforts or need. It did take us time to get the storage capability and delivery technology right, but even that part is not new, either (h/t Unbiased Science Podcast again for their excellent primer on this subject).
Finally, despite what influencers and disinformation-mongers will say, these are not "gene therapy." They are vaccines and they work similarly to other vaccines.
KIDS ARE NOT AFFECTED BY COVID-19!
Yes, unfortunately they are. There have been 3.78 MILLION cases of COVID-19 in children (including cases of Multi-System Inflammatory Syndrome in Children (MIS-C) and Post-Acute Sequelae due to SARS-CoV-2 ("Long COVID")), and over 400 have passed away. If you want to point out how relatively small of a number that is, my next question will be to ask, similar to adult death rates, how many children dying would no longer be okay with you.
In addition, the new variant B.1.1.7 is more contagious/more easily spread among all age groups, and cases among younger adults and children are rising because of it. Children are already known to be vectors as well - even if they have milder cases, they easily spread it to the adults (including the elderly) in their lives, through no fault of their own, but which can have devastating consequences (I have seen it).
BUT KIDS HAVE DIED FROM THE COVID-19 VACCINE!
No, they haven't. If you recall, from my recent post on VAERS: Someone reported the death of a 2-year-old due to the COVID-19 vaccine on VAERS. This would be terrible if it actually happened, so they investigated. Turns out the 2-year-old was hospitalized for 17 days. It was reported that they died a week after their vaccination, but if they had been hospitalized for 17 days, they could not have gotten the vaccine a week prior to their death. AND, all the events reported occurred BEFORE the vaccine trials for either company enrolling children at that age started! Also, they reported it as an adverse event to the Moderna vaccine, and then it changed to the Pfizer vaccine.
There have been no reported deaths from the vaccine, and there has been a spotlight on these trials. As you have seen, when warnings and adverse events DO arise, we monitor them closely (see my post on blood clots - though that was a different vaccine).
WHY BOTHER WITH THESE VACCINES IF YOU CAN STILL GET IT? ISN'T THAT THE POINT OF A VACCINE?
These vaccines would not be the first to not prevent mild/asymptomatic infection (though again, we are seeing data that says those are prevented as well). The pertussis vaccine is another example - that's why we have been seeing so many pertussis outbreaks in recent years. As vaccination rates drop, that's one of the easiest to spread. The vaccinations keep spread down, and keep infections mild or asymptomatic - that is what we want. Less sick and dying people.
PEOPLE WHO WANT TO VACCINATE THEIR KIDS CAN DO SO, WHY DO I NEED TO?
Vaccinations against COVID-19 need to be as widespread as possible for the same reason we recommend widespread vaccinations against all of the other preventable disease against which we vaccinate in childhood. Not every child is able to get vaccinated due to allergies (rare with the mRNA vaccines) or immunocompromising conditions. Not every vaccine is 100% effective, meaning a rare few may not mount the same immune response and some kids (just like some adults) may still get it. But if there are a high amount of vaccinations, that curbs spread enough that hopefully we can eliminate it.
If we want to truly achieve herd immunity, we must safely include children in our vaccinations. If we want to get kids safely back into schools full-time (you know, with less remote days due to exposures and less frequent disruptions to education as so many have called for), the vaccines are the way to get there. #ThisIsOurShot
Unbiased Science Podcast Instagram Post on EUA: https://www.instagram.com/p/COf3bA0DYdP/?utm_source=ig_web_copy_link
Unbiased Science Podcast Instagram Post on mRNA: https://www.instagram.com/p/COSoEuDjO5p/?utm_source=ig_web_copy_link
