I’m guessing the news of Pfizer’s 2-5 year old trial data has reaching your corner of the earth and if you have children this age it’s probably left you feeling pretty discouraged and overwhelmed. I’m so sorry. I wanted to quickly break down what the announcement told us and then I wanted to leave you with a few positives to take with you going forward. This is the scientific process – refine, refine, refine. And what happens when you refine? You produce something even smoother and shinier than before. Hang in there 🤍
Essentially, adults were given 30 micrograms (ug), kids 5-11 were given 10ug, and the trials for 6mo-5 were given 3ug. It is most likely that Pfizer chose a very low dose to try and minimize reactogenicity and risk associated with vaccination (even though it’s already incredibly low). Pfizer announced that the 2-5 age group did not produce a sufficient immune response at this low dose and 6mo-2 did better but not as great as we’d like to see. They are now moving forward investigating a 3rd dose (this would then be a 3-dose primary series) at this 3ug amount for 6mo-5 years. The third dose will be given at least 2 months after the second dose. They aim to submit for EUA approval with this 3-dose regimen in the first half of next year.
Now for the positives!
1. The safety profile was positive. They announced that no safety concerns were identified in either the 6mo-2 or 2-5 trials.
2. By adding a 3rd dose instead of starting over with a higher dose, the results should come in quicker! I definitely wonder if a 3rd dose at this lower amount will be sufficient but without seeing the data it is hard to say.
3. This information is being used to inform and improve the 6mo-2 group! I am certain it will also inform future mRNA vaccine trials for children. Unfortunately we have to learn somehow.
4. 3 doses in the primary series might be the key to having a stronger and more robust immune memory for variants! You hear scientists talk of the booster actually needing to be considered a 3rd dose of the primary series, so maybe children are just going to get to that conclusion sooner.
5. This is data transparency and the scientific process in action. Do we hate to see it happen here? Yes. Yes we do. But I hope it helps you see that when things don’t work, they don’t get approved.