What Emergency?

This past week the FDA authorized emergency use of the Pfizer and Moderna Covid vaccines for children as young as 6 months of age.

For the Pfizer vaccine, this extended the authority for those ages 6 months up to 5 years of age.

For Moderna, this now allows the vaccines for use up to 17 years of age. Previously, Moderna had only been authorized for those 18 years of age and older.

Since the authority is being given you might want to know what the emergency is?

According to the CDC, there have been 143 deaths of children ages 1-4 from Covid since January 1, 2020. 

Over that same span of almost 2-1/2 years, there have been 382 deaths from the flu and pneumonia.

Source: https://data.cdc.gov/widgets/9bhg-hcku?mobile_redirect=true

Covid deaths in this age group are barely a third of flu and pneumonia deaths and there were few cases of influenza for a good portion of the last two years.

For all children 0-17 in the United States, there have been 1,086 reported deaths from Covid since January 1, 2020 compared to 1,601 deaths from flu and pneumonia and 81,532 total deaths.

This is out of a population of almost 75 million who are under the age of 18.

Does this look like an emergency?

What is even more concerning is that the United States is the only country in the entire world that has authorized these vaccines for children this young.

No countries in Europe have done it. Sweden still has not authorized these vaccines for anyone under age 12.

Israel has not done it.

Japan has not done it.

China has not done it.

Cuba has not done it.

Joe Biden's Chief of Staff, Ron Klein, thinks this is an accomplishment?

I don't think he is making the point he thinks he is.

You may recall that when the Pfizer and Moderna vaccines were authorized initially for adults it was stated they were 95%+ effective for preventing infection from Covid based on the clinical trials.

We now know that was nowhere close to being true.

How effective are the vaccines supposed to be for children?

For children ages 2-5 the clinical trial data released by Moderna found that its vaccine was only 36.8% effective in preventing Covid. It was 50.6% effective for those 6 months to 23 months.

It has always previously been the rule that if a vaccine was not at least 50% effective it could not be authorized by the FDA for use.

I guess "the science" has changed.

Follow ups in the clinical trials also only included a mere two months. We also know that any effectiveness these vaccines have seems to drop rapidly after two months such that at six months there is little, if any, protection.

That is why we are now on what seems to be an endless call for additional booster shots.

Is it not curious that the follow up in the trials stopped at two months?

I would also suggest that all parents view this video by Dr. Claire Craig who provides a detailed review of the Pfizer trial to better understand what were the underlying results of that clinical trial. It is difficult to believe that this is "the science" and the FDA authorized the vaccine for use with children.

An important tool that is used in medicine to determine whether any health intervention is useful is the Number Needed to Treat (NNT) calculation.

This is a simple explanation of the concept.

Source: https://www.healthnewsreview.org/toolkit/tips-for-understanding-studies/number-needed-to-treat/

This is due to the fact that every medical intervention carries risks. Therefore, it is important that there are clear benefits in the intervention to justify the associated risks.

A rule of thumb is that an NNT of less than 5 is associated with a meaningful health benefit. This means that treating 5 people with a health procedure, drug, vaccine in order to prevent one adverse event provides a meaningful health benefit.

An NNT of 15 or above is almost certain to be associated with a small net benefit at most.

The higher the NNT the more certain you are that the intervention should not be undertaken. 

The risks of the intervention do not justify any potential health benefit.

What is the calculated NNT for the Covid vaccines for children?

This is a slide that was in the presentation to the FDA last week that was quickly passed over without discussion.

I guess you can understand why that was.

Credit: https://twitter.com/the_Arkivist/status/1538197968632926214/photo/1

The obvious question is why did the FDA recommend these vaccines for children when the data clearly suggests that the benefits are not justified by the risks?

It is difficult to look at the data and not conclude that the FDA, CDC and others involved in the vaccine approval process are either completely incompetent or totally co-opted by Big Pharma.

The latter is the only logical explanation.

The emergency here appears to be that Pfizer and Moderna need to sell more vaccines because vaccine uptake has fallen to almost nothing,

This is the latest CDC data on vaccine uptake.

That has led to this. 

Source: https://www.nbcnews.com/news/us-news/covid-vaccine-doses-wasted-rcna31399

“The demand has plateaued or is coming down, and that leads to open-vial wastage — especially with multidose vials,” said Ravi Anupindi, a professor of operations research and management at the University of Michigan who has studied vaccination campaigns.

“It’s a demand problem,” he added.

In addition, liability protection is only provided to Pfizer and Moderna for these vaccines going forward if they are approved for children and the CDC puts them on the childhood vaccine schedule. If this is done, liability protection extends to adults using the vaccine as well. Only vaccines that are authorized for emergency use or are approved and on the CDC's childhood vaccine schedule are given liability protection under the law.

It appears to some observers the primary reason to extend the vaccine to children is to get the Covid vaccines on the childhood vaccine schedule which will then provide Pfizer and Moderna with liability protection for both children and adults since Pfizer and Moderna now have "approved" vaccines for adults.

For example, that is the conclusion of Robert F. Kennedy, Jr. who is the Chairman of the non-profit organization, Children's Health Defense.

If that is not the case, how do you explain this decision looking at the facts above?

I always thought the first priority of any society was to protect the children.

You would like to think that still applies in the United States in 2022.

Looking at the facts above makes me wonder whether that is still true.