FOIA'd Contracts Show CDC Expected up to 1,000 VAERS Reports per Day for COVID Vaccines

"With up to 40% of the reports serious in nature"

Executive Summary

• In late August 2020, the CDC contracted with General Dynamics to handle VAERS reports for COVID-19 vaccines. The contract anticipated up to 1,000 reports per day, with up to 40% of them serious in nature. The value of the year-long contract was $9.45 million.

• This means that months before the EUA of any COVID vaccines, the CDC anticipated up to a 600% increase over the average annual number of VAERS reports in recent years with 8 times the rate of serious reports.

• In early March 2021, the contract was amended in order to process an estimated 115,000 backlogged reports received up to Feb. 28, with an increased capacity to 25,000 reports per week. The plan was to have the backlog cleared within 6 months.

• These cost overruns amounted to an additional $21.5 million.

• A contract to continue this work plus additional functions was signed with Eagle Health Analytics covering the period July 8, 2021 to January 7, 2022 for nearly $6 million.

• A modification was entered effective Oct. 29, 2021 for an increase in hours for VAERS support from about 16,000 hours to nearly 20,000 hours, which may have been necessitated by an increase in reporting after the booster and workplace mandates in the fall of 2021. This modification also added an additional function: assisting CDC with the V-SAFE pregnancy data processing.

• Although many of the dollar amounts involved with the contracts are redacted, it is a reasonable to estimate that the Federal government paid contractors at least $40 million dollars over 2 years to keep track of this devastation:

Introduction

An anonymous source has sent me two key contracts obtained via FOIA between the CDC and two contractors hired to assist with COVID-19 vaccine safety monitoring, including reports to the Vaccine Adverse Events Reporting System (VAERS). “Assist” is not quite the right word, since the contracts essentially outsource VAERS maintenance and reporting for COVID-19 vaccines to these companies. Both contracts are embedded at the bottom of this post.

The Initial Contract with General Dynamics

The first contract, with General Dynamics (a major weapons manufacturer), is dated August 27, 2020. It outlines a series of services the company was to provide to the CDC pursuant to the anticipated increase in VAERS reports due to the COVID-19 vaccines. Except, there were no COVID-19 vaccines close to approval on August 27, 2020. In fact, the Pfizer/BioNTech vaccine trial phase 2/3 had only started a month earlier on July 27.

I have it on good authority that already in late summer 2020, key observers were speculating that EUA would be granted based on almost no evidence whatsoever, as the EUA’s “may be effective” standard essentially demands no evidence. Still, the FDA was touting a 50% efficacy target — how could they be so confident that any of the vaccines would reach that target? And how could the CDC be so confident about the safety of these untested products? 

There is no clause in the contract giving the CDC an option to cancel or suspend the contract in the event that vaccines would not be authorized. Also, the contract stipulates that the contractor would have everything up and running within 60 days of the contract, which means by the end of October. But what if the vaccines were never approved? Or what if they were approved much later, say in February, April or June? Was the CDC just going to hand over [redacted] millions of dollars to the contractor for nothing? Or did the CDC know something about the impending approval of COVID-19 vaccines? It certainly appears that by August, 2020, the impending emergency use authorization of at least one COVID-19 vaccine was a foregone conclusion.

CDC Expected Huge Increase in VAERS Reporting

The contract states that they were expecting up to 1,000 VAERS reports to be filed per day, with up to 40% of the reports being serious in nature:

Earlier in the contract, some historical background is provided, which indicates that 5% of reports from the US were classified as serious. So why were they expecting up to 40% serious adverse events when historically it was only 5%?

Notice towards the bottom that the “US Government considers … surveillance for any licensed and new vaccines through VAERS to be a nationally critical function, and … VAERS activity to constitute essential services for which any lapse in coverage of services would unacceptable.” You have to laugh. We know that they don’t really mean a word of that, since officials are falling over each other to throw VAERS under a bus, and we know the CDC couldn’t even be bothered to follow their own standard operating procedures (SOP’s) to do the most basic pharmacovigilance of VAERS data.

According to the contract, VAERS had been receiving an annual average of 53,000 reports in recent years, so in contracting for up to 1,000 reports per day, the CDC was already anticipating that the COVID vaccines might generate nearly seven times as many reports as all other vaccines combined (a 600% increase), with a rate of serious adverse events that could be up to 8 times higher.

I have estimated in other work that at least 250 million vaccine doses are administered annually in the US. So if they were expecting the new vaccines to generate the same rate of reports per vaccine dose, that would imply administering 1.75 billion doses in a year, which is more than 8 times the US adult population. Clearly, the CDC was preparing for a much higher rate of reporting with a higher rate of serious reports for the COVID-19 vaccines.

Contract Revised Due to Explosion in VAERS Reports

But even their most dire expectations turned out to be massively underestimated, because on March 1, 2021, the contract was revised so General Dynamics could hire more workers to process an estimated backlog of 115,000 reports up to Feb. 28, 2021!

According to the updated contract it was supposed to take them 6 months to complete that work, with an additional 5,000 reports per week.

Processing an additional 5,000 reports per week for six months (24 weeks) would enable them to clear the backlog, but apparently this wasn’t enough to meet the actual demand,¹ because on March 6 contract update increased their processing capacity to 25,000 reports per week for six months. That means that in addition to clearing 115,00 backlogged reports, they were expecting up to an addition 485,000 reports in that time frame, which is about 20 times the weekly average before the rollout of the COVID-19 vaccines.

In this revision, they also specify up to 30% serious reports, instead of the initial 40%. Why the change? We can imagine at the beginning they might not have known what to expect, but here they were more than two and a half months into the vaccine rollout with many thousands of VAERS reports received. If they changed this number based on their experience, why the 30% number (which, recall, is still 6 times higher than the 5% they had been getting historically)?

If we use the MedAlerts VAERS WayBack machine to look at the VAERS release from Feb. 26, 2021, we can see that 17% of domestic reports were recorded as serious. Albert Benavides of vaersaware.com has communicated to me that due to slipshod VAERS coding, there are many, many reports that should be coded as serious based on the text but are not. So a true rate of 30% serious reports is not impossible. Whether the miscoding of serious events is deliberate or not is another question. You’d think $30 million might be enough to buy accurate processing of such a “nationally critical function,” but I guess the “good enough for government work” mindset is hard to shake.

July 2021: New Contract with Eagle Health Analytics

On July 8, 2021 the CDC contracted with Eagle Health Analytics to support the COVID VAERS reporting through January 7, 2022, with the possibility to extend through July 7, 2022. The General Dynamics contract was supposed to expire at the end of August, 2022, though there was an option to extend that as well, which likely happened. We don’t know if Eagle Health Analytics took over the VAERS work from General Dynamics or was brought in to help with their efforts. It is also not clear if the Eagle Health VAERS work was specific to COVID-19 vaccines. We do know that the initial contract also included providing support for the CDC’s CISA project related to COVID-19 vaccines, which provides consulting services to healthcare providers and local departments of health.

The Eagle Health Analytics contract does not stipulate a specific number of reports to be processed. However, the contract was revised on October 29, 2021 to increase the total number of hours for the VAERS work by 4,333 to 19,933, which is a 28% increase. So how was it that in July, 2021 — nearly 8 months after the COVID vaccines were first rolled out — the CDC did not know how much VAERS processing it was going to need? It is likely that the introduction of booster doses and employer mandates in the fall of 2021 created an increase in VAERS reports.

There is another increase in the revised contract, raising optional CLIN 0002 physician by 12,480 hours to a total of 20,800. It seems from the contract that CLIN 0002 refers to the optional VAERS support work from Jan. 8, 2022 through July 7, 2022. A rough calculation of 24 weeks (6 months) at 40 hours/week implies hiring 22 full time staff to do the work they were contracted for with respect to VAERS support for the first half of 2022, which was then extended for an additional two months in a final contract update.

Two things to keep in mind with this contract: 1) it is not clear if Eagle Health is being contracted to work specifically on COVID VAERS reports or just VAERS in general; and 2) it is not clear whether other companies were contracted to work on VAERS during this same period, though it is likely that General Dynamics continued to their work.

A final note about the contract with Eagle Health Analytics: the CDC stipulated that “the contractor shall work with the CDC VAERS team to ensure monitoring and evaluation processes are followed per established standard operating procedures (SOPs).” But we know that the contractor never did this, because the CDC VAERS team didn’t follow their own SOP.

How Much Did All of This Cost?

The amounts paid out under the contracts with General Dynamics were redacted. But according to this site, the initial amount paid was $9.45 million, with $4.4 million added in late February, and then an additional $16.3 million tacked on in early March. In March of 2022 there was an additional $5.2 million added, though it’s not clear for what since the contract had presumably expired by then. (Best guess is that General Dynamics continued some or all of its work on COVID VAERS reports with Eagle Health brought in for additional support.) Grand total? $35,425,642 of your taxpayer dollars.

The initial total amount specified (with options) under the contract with Eagle Health Analytics was $5,925,388.58 or $7,077,054.90 “with all options” (which presumably includes the extension of the VAERS work through July). This amount also includes the CISA project assistance. However, it does not include the increased hours in the Oct. 29 revision, nor the increase for the V-SAFE pregnancy registry work. However, I have not been able to find the contract in any Federal contracts database. Perhaps one of my readers will have better luck.

But based on the initial amount paid out to General Dynamics, I think it’s safe to say that CDC paid Eagle Health around $10 million for their work on VAERS alone. This is on top of other contracts for VAERS processing that may have been in effect during this time, and obviously on top of the money spent on CISA, V-Safe and all the rest.

So the next time somebody says that VAERS data is worthless, ask them why the Federal government paid contractors at least $40 million dollars over 2 years to maintain this “nationally critical function.”

[Update a few hours after publishing: the Eagle Health contract has been located (and many thanks to the person who found it). The total contract with all options and additions totaled $11.4 million, so my estimate of $10 million just for the VAERS work was probably too much. Perhaps half of that, so I have revised the above total down to $40 million.]

The Contracts

23 00099 General Dynamics Information Technology, Inc

11.1MB ∙ PDF file

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23 00099 Eagle Health Analytics, Llc

4.61MB ∙ PDF file

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1. It’s possible that the 5,000 reports per week in the March 1 contract was some kind of typo where they left out the 2, which would explain why a new contract was filed just a week later with the 25,000 number.