Why Pfizer's COVID Vaccine For Kids Under 5 Being Postponed Is A Good Thing
The FDA recently encouraged Pfizer to submit data from their phase 1/2/3 vaccine clinical trial so a rolling approval process of their 3 mcg 2 dose series for kids 6 months up through 4 years could begin while waiting on results from a 3rd dose. Ultimately, that is now the path for Pfizer to gain EUA (emergency use authorization) approval so their vaccine can be rolled out.
Unfortunately, Pfizer postponed delivering data to the FDA today because their vaccine in kids 6 months up through 4 years didn’t make the grade in clinical trials as new findings emerged, and end points weren’t met. As a result, FDA delayed the advisory meeting that would have began the EUA appraisal. All and all, this hasty approval process has been brought on by pressure from the White House administration and doesn’t come without consequence.
Now that the table’s been set, in this publication you will learn 2 key elements:
Pfizer’s poor vaccine clinical trail results which stopped them from applying for EUA through the FDA today
The problems caused by the White House administration putting pressure on the FDA to pump out approvals for COVID vaccines
Poor clinical trial results
Below is the most up to date data from Pfizer’s phase 1/2/3 clinical trial. All information will be listed as bullet points:
Originally clinical trial included 4,500 total children, aged 6 months to under 12 years
Participants from USA, Finland, Poland & Spain
Total of (n=4,500) children derived from 90 clinical sites
3 age groups were given the treatment: 6 months- 2 years, 2 years - under 5 years, and 5 years- 12 years
Ages 6 months - 5 years received 2 smaller 3 mcg doses 21 days apart
Ages 5-12 received 2 larger 10 mcg doses 21 days apart
Results so far: Vaccine didn’t meet the low bar of non-inferiority on antibody titers for those aged 2-5 (in other words, antibody levels conferred from vaccination were arguably too low to generate protection)
To gain approval of dose 1 & 2, a 3rd dose will also need to prove efficacious in this study because the antibody response from dose 1 & 2 was insufficient
PROBLEMS:
First, the vaccine failed to meet non-inferiority on antibody titers for those aged 2-5. Said differently, the two 3 mcg doses given 21 days apart produced weak levels of antibodies and therefore conferred only suboptimal protection against COVID-19 (see FIG.1 📸).
FIG. 1 📸
Second, new data surfaced during the trial that hadn’t been factored into the final the analysis of the data. Pfizer wasn’t specific as to what kind of data so it could be anything. To be specific, there could be new safety signals, changes in immunity figures, etc (see FIG. 2 📸).
FIG. 2 📸
White House pressure for booster approval is causing major problems
To begin, some history. Pfizer first announced they would be producing booster doses during the mid-month of April of 2021. This was met with great scrutiny at first from the administration at the White House and public health officials.
Soon after Pfizer’s booster announcement, they submitted a request for EUA through the FDA. Trailing that was a meeting between the pharma giant and White House health officials to push their case on boosters.
Moving on, before FDA approval, the President gave a speech on August 18th announcing a booster rollout on the following month beginning the week of September 20th 2021.
Now that you’ve had a history lesson on the rollout of boosters, you need to understand the problems that arose from the White House administration pushing them on the public prematurely. Re-read the image immediately above to set the stage.
As you can see, the picture shows the White House made assurances to Americans in August that boosters would be ready for them by September. Now, as you could imagine, such a premature announcement put huge stress on the FDA to approve the vaccine in a very short period of time. Such a shameful form of coercion by the White House finally lead to the approval of boosters, but not before a catastrophic event occurred at the FDA.
You see, 2 senior vaccine officials resigned over pressure to approve those boosters. Their names, Dr’s Marian Gruber & Philip Krause. Soon after, they released an op-ed explaining the unethical pressure put on them by the FDA and WH administration to approve boosters. That’s not all though.
As the data came trickling in, Paul Offit, an FDA vaccine advisory committee member and co-creator of the rotavirus vaccine, made a public statement that boosters for most healthy kids wouldn’t be necessary. That opinion was contrary to his colleagues at the FDA. Furthermore, he wrote in an open article that he advised his son against boosting. The point is, a man who works for the FDA and created a vaccine advised against the COVID booster for healthy kids because he felt the risks outweighed the benefits. So why is all this problematic?
First, such a strong push for COVID vaccines in those 6 months- 4 shifts the effort away from vaccinating people who need it most. That is bad because inoculating a population that doesn’t necessarily require it (health kids) is a waste of necessary resources, time, and money. Please understand, young kids handle the virus fine and experience substantially less severe disease. Be that as it may, vaccination efforts could be put towards boosting those at greatest risk for severe disease from COVID-19 like immunocompromised individuals, those with serious comorbidities, and those over 65. The truth is, for the previously mentioned category of people, the benefits of vaccination tend outweigh the harms. However, vaccinating and boosting kids 6 months through 4 years delivers no benefit against severe disease, there’s just no data to show that. Finally, prioritizing those at lowest risk eats up resources for those who need them most.
Second, new data for natural immunity is strong. That said, it needs to be considered along with vaccination. To give you an example, previous infection conferred on average more robust, and longer lasting immunity than vaccination. At this point, people are either vaccinated or have been naturally infected whether they realize it or not. In other words, most of the population has immunity at this point and if not, a non-boosted brush with Omicron yields a 91% reduced risk of death and 74% reduced risk of hospitalization compared to Delta. On the whole, not considering natural immunity and instead focusing on vaccinating + boosting kids 6 months through 4 who will not benefit isn’t science.
Third, White House pressure to approve vaccination + boosters for all age groups, even kids 6 months up through 4 years resulted in loss of trust in public health officials. To begin, the FDA has been cutting corners. Just so it’s clear, granting Pfizer a rolling approval for their vaccine on the results of 2 doses while waiting on the results of 3 is pseudoscience. That means the FDA would be given the go ahead on a vaccine for kids without all safety, and efficacy data. That is inappropriate. Regrettably, the public sees this behavior and trust erodes. Should I even regurgitate the salient fact the vaccine didn’t elicit protective antibody titers in 2 doses for those aged 2-5 in Pfizer’s vaccine trial for kids 6 months - 4 years? Flashback to August 2021, what should be explored is the White House administration’s announcement that a booster would be approved by the FDA no later than the week of September 20th 2021. That is inappropriate because it usually takes months if not years for the FDA to approve a vaccine. Biden’s administration leveraged the hope of Americans in a time of crisis against the FDA to strong arm a vaccine approval. Sadly, that weakened the FDA’s credibility to the public- even their own employees. Hence, the resignation of 2 senior vaccine officials at the agency, then a disapproval on boosters from Paul Offit.
So why is it good that Pfizer’s vaccine approval was postponed? Answer- if they were given the green light now considering the terrible results from their clinical trial and White House coercion, public trust in the FDA would go from low to non-existent. Nevertheless, do you feel trust in public health officials can be rebuilt?
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