Pfizer Requests EUA for 5-11-Year-Olds At A Glance:
- Pfizer submits data for EUA approval to the FDA.
- An October 26th meeting is set to review data by the FDA advisory board.
- COVID not showing significant risk to children.
- Many parents still hesitant to vaccinate young children for COVID.
Pfizer submitted its formal request to the FDA for EUA (Emergency Use Authorization) of its vaccine in 5- to 11-year-olds this morning. The two-dose regimen is one-third the strength of the adult version also used in 12- to 15-year-olds. Last month, Pfizer stated in a press release that the two-dose series was “safe and well tolerated” in this new age group.1 The FDA’s expert panel is set to meet on October 26th to discuss the data.
Questions Regarding Pfizer’s Study
The study for this age group was done as a bridging study. There wasn’t an actual count in the number of COVID cases the vaccine prevented nor in clinical data of severity of cases since there were too few cases to report among both vaccinated and unvaccinated children. The data used was collected through blood samples indicating a similar level of neutralizing antibodies considered effective in older age groups.
While several people are hopeful there is enough data to justify an EUA approval, some are concerned the emergency authorization requires companies to submit only two months of safety data on trial participants, versus six months required for full licensure.2
At the end of July, the FDA had asked both Pfizer and Moderna to increase their study numbers to 3,000 children.3 However, in all of the data, only 2,268 kids were reported on.1 Some are concerned this study will not be large enough to catch the dangerous possible side effects such as myocarditis and pericarditis shown in the adolescent and young adult population.
Is There a Demand for a Vaccine for Children?
While case numbers have increased among children in recent weeks, the severity of cases as well as fatalities in children hasn’t kept up with that trend.4 COVID-19 still doesn’t hold the same harm as many other factors facing children.
With this in mind, some are wondering how necessary vaccines are in this young population and whether parents will be racing to have their children vaccinated.
The KFF COVID-19 Vaccine Monitor (conducted September 13-22, with the bulk of interviews concluding before Pfizer’s announcement) finds that about a third of parents (34%) say they will vaccinate their 5-11 year old child “right away” once a vaccine is authorized for their age group. About a third of parents (32%) say they will “wait and see” how the vaccine is working before having their 5-11 year old vaccinated. Notably, the share who say they definitely won’t get their 5-11 year old vaccinated remains steady at one in four (24%).
Parents continue to be more cautious about getting their younger children vaccinated with about one in four (23%) saying they will get their child under the age of 5 vaccinated right away once a vaccine is available for that age group and about a third (35%) saying they will definitely not get their child under 5 vaccinated for COVID-19.5
Hold the Phone — Doc’s Thoughts:
From the beginning we’ve talked about how important it is to focus on the health of the host, not the virus. When children are healthy, and their immune response is supported, they are able to continue to become healthier and build a more robust immune response to serve them throughout their life!
Think about the timing of this potential roll out. When you read the news, you hear articles of parents just waiting desperately to have their kids vaccinated. Kids who are waiting to see friends and family, kids who are anxious to get back to life as normal. It seems more likely the frenzy is building among parents to push for this vaccine for the kids versus having it driven by clinical data. We don’t see the number of deadly cases in kids who aren’t vaccinated. We don’t see the numbers of kids who are suffering from COVID because they are unvaccinated. We don’t see cases reduced because of the vaccine! Why? Because there were too few cases to count any reduction in the trials! This bridging study was based on blood samples, not clinical results! Those antibody responses haven’t stopped breakthrough cases and have shown significant signs of waning. And this is the science we are reviewing to justify the need for this vaccine? I can’t help but wonder what “safe and well tolerated” means. That doesn’t sound very scientific to me in terms of clinical data.
Let’s look at what else is happening with this strategic timing. Watch the news for a bit. People are going to start raising concerns about “cold and flu” season. If you’ve been around The Wellness Way for any period of time, you’ll know we don’t subscribe to that fear tactic. The reality is that it’s a high-sugar, high-stress, low vitamin D, low fresh air season. What if instead of subjecting kids to these vaccines that aren’t proven for them, and certainly don’t have enough science to show they are safe, we actually do something to help them with their health and build their immune responses? We associate “getting back to normal” with falling into unhealthy patterns because of the upcoming holidays and colder weather. We need to make healthy normal again!
When considering the risk/benefit ratio of any sort of healthcare option, this vaccine doesn’t line up. There isn’t a need for an emergency product. Kids aren’t at risk of serious COVID illness. But how many kids are at risk for vaccine injuries? In this case, the study isn’t broad enough to tell. But looking at what we know to be true for those who have had the vaccine, we can assume the risk/benefit ratio doesn’t line up with the demand we seem to be seeing for this vaccine to be rushed to approval.
What does line up is how the push for vaccine mandates are already lining up for school age children. California’s governor, Gavin Newsom, has already stated it would be required as soon as it has FDA approval. And once it’s on the childhood vaccine schedule, all legal liability is waived.
Focus on your child’s health. If you need help, reach out to a Wellness Way clinic. We know how to test your child’s immune response and how to help you make the best decisions to help them and you stay healthy for a lifetime, not just until antibodies wane.
1Pfizer: Press Release PFIZER AND BIONTECH ANNOUNCE POSITIVE TOPLINE RESULTS FROM PIVOTAL TRIAL OF COVID-19 VACCINE IN CHILDREN 5 TO 11 YEARS
2Reuters: U.S. could authorize Pfizer COVID-19 shot for kids age 5-11 in October -sources
3CNBC: Moderna says it plans to expand Covid vaccine trial for kids 5 to 11, will seek FDA OK as early as year-end
4Cleaveland Clinic: The Delta Variant and Children: How Concerned Should Parents Be?
5KFF.org: KFF COVID-19 Vaccine Monitor: Vaccination Trends Among Children And COVID-19 In Schools