Wednesday, October 18, 2023

FDA Finds Safety Signal for COVID-19 Vaccination Among Toddlers

A safety signal is a sign that a health condition may be caused by vaccination, but further research is required to verify a link.

A safety signal of seizures for young children following COVID-19 vaccination has been detected by the U.S. Food and Drug Administration (FDA).

Seizures/convulsions "met the statistical threshold for a signal" in children aged 2 to 4 following receipt of a Pfizer COVID-19 vaccine and children aged 2 to 5 following receipt of a Moderna COVID-19 vaccine, researchers with the FDA and three large healthcare companies said in a new preprint study.
A safety signal is a sign that a health condition may be caused by vaccination, but further research is required to verify a link.

The data came from three health claims databases run by Optum, Carelon Research, and CVS Health, supplemented with vaccination information from state and local systems. The health claims databases are part of the FDA's Biologics Effectiveness and Safety System, a drug safety monitoring system.

Researchers looked at 15 health conditions following vaccination entered in the commercial databases and compared rates among children aged 6 months old to 17 years old to background rates from 2019, 2020, or both.

Overall, 72 cases of seizures/convulsions were recorded within seven days of a shot among toddlers and other young children. Most happened within three days of a shot.

When stratifying the data by dose, the researchers found signals for dose one and dose two for Pfizer's shot in two of the three databases in children aged 2 to 4. They also found a signal following dose two of Moderna's shot in children aged two to five.

The signal for seizures/convulsions for the young children "has not been previously reported for this age group in active surveillance studies of mRNA COVID-19 vaccines," the researchers said, referring to the Pfizer and Moderna shots.

There are reports of seizures and convulsions after COVID-19 vaccination among children in the Vaccine Adverse Events Reporting System, the researchers noted. Though anybody can lodge reports with the system, most are made by health care professionals.

Another five convulsions were reported after Pfizer vaccination in Pfizer's clinical trial.

The research did not cover the bivalent COVID-19 vaccines, which were introduced for some populations in 2022 and completely replaced the old vaccines in April, or the newest versions of the vaccines that were rolled out in September.

It's not clear when the signal was first detected. The FDA and Patricia Lloyd, an FDA statistician who is the study's corresponding author, did not respond to requests for comment. Pfizer and Moderna did not return inquiries.

Caution Warranted: Researchers

The researchers said the signal "should be interpreted with caution and further investigated in a more robust epidemiological study."

That's partly because the signal disappeared when changing background rate years. The signal was detected when comparing rates with background rates from 2020. But when using background rates from 2022, which were about 2.3 times higher, a signal was not detected.

The higher number of cases in 2022 may stem from an increased incidence of respiratory infections such as influenza, the researchers posited.

The case count may have also included seizures "unrelated to vaccination," the researchers said.

Similar to previously analyzed data from the same system, the researchers also detected a signal for heart inflammation and a related condition, or myocarditis and pericarditis, for children aged 12 to 17. Because that signal has been known since 2021, researchers did not attempt to further explore it.
No other signals were detected.

Strengths of the study include the population covered by the databases being large and geographically diverse. Limitations include a lack of control of confounding factors.

Stroke Risk in Elderly

The FDA and the U.S. Centers for Disease Control and Prevention in January announced they detected a signal for ischemic stroke for people aged 65 or older following receipt of Pfizer's bivalent vaccine. Ischemic stroke is a type of stroke caused by blood clotting.

In another preprint paper published on Oct. 15, FDA researchers said they analyzed Medicare data to estimate the risk of stroke after bivalent vaccination.

They included Medicare beneficiaries aged 65 or older who received a bivalent shot or an influenza vaccine and suffered stroke, except for stroke cases deemed to have been caused by something other than a COVID-19 shot.

The primary analysis did not identify an increased risk of stroke, but stratifying the population by age showed an increased risk after Pfizer vaccination for people aged 85 or older of non-hemorrhagic stroke and for non-hemorrhagic stroke/transient ischemic attack. An increased risk was also found for Moderna recipients aged 65 to 74 for non-hemorrhagic stroke/transient ischemic attack.

No increased risk was found for hemorrhagic stroke.

For people who received a Pfizer jab with an influenza shot, an elevated risk of non-hemorrhagic stroke was detected. For people who received a Moderna jab with an influenza shot, an elevated risk of transient ischemic attack was detected.

A separate analysis of only influenza vaccination detected an increased risk of non-hemorrhagic stroke following receipt of a high-dose/adjuvanted influenza shot, and signals for different ages upon stratification.

"Our study did identify an elevated risk of stroke when the COVID-19 bivalent vaccines were administered with a concomitant high-dose/adjuvanted influenza vaccine. However, the observed effects were not consistent," the researchers, with the FDA and Acumen, said.

A similar finding was detected in a study of data from the Centers for Disease Control and Prevention's Vaccine Safety Datalink system.

The researchers said that the study's findings suggest the elevated risk of stroke in the group that received influenza and COVID-19 vaccines together "was likely driven by influenza vaccination alone rather than concomitant administration."


Collapsing Demand for Pfizer products leads to price RISES

On Thursday, Oct. 12, the Director of the Centers for Disease Control and Prevention (CDC) perhaps, inadvertently shared the current state of COVID-19 vaccine demand, which appears fairly abysmal. Mandy Cohen mentioned at a mobile clinic situated in an elderly community center in California late last week in California that to date, since the vaccine was recommended Sept. 12 by her agency, 7 million doses of the monovalent COVID-19 booster targeting XBB.1.5 have been administered. This represents 2.1% of the total population. For comparison purposes, ultimately about 56.4 million people across the USA opted for the bivalent booster made available last September, representing about 17% of the nation’s population. Pfizer recently predicted the rate of vaccination with the new monovalent vaccine would hit 24%. Director Cohen’s reference to the total number vaccinated was first picked up by the San Jose Mercury News, then later other media such as Reuters and CNN.

Various news agencies attempted to spin the weak turnout for the inoculation noted by some of the right-leaning media such as The Blaze, Glen Beck’s media outlet. For example, CNN positioned the vaccinated figure in a positive light given the “rocky rollout.” COVID-19 has surged somewhat, and based on CDC data, by Sept. 30, approximately 11% of all COVID-19 tests making their way to the national public health agency evidenced a positive for the virus. In this latest surge, 1.6% of all emergency department visits are associated with COVID-19.

Not surprisingly, the weak demand impacts the COVID-19 vaccine manufacturers’ revenue and profit forecasts. With a deceptively innocuous title, Pfizer issued somewhat of a bombshell report on Friday, October 13, titled “Pfizer Amends U.S. Government Paxlovid Supply Agreement and Updates Full-Year 2023 Guidance.”

Among other things, Albert Bourla disclosed in a video the updated Pfizer—U.S. government arrangement. By January 2024, Paxlovid will be available via commercial payers, not just the U.S. government via the emergency use authorization. In what clearly hints at mounting pressure on the Pfizer chief, he noted the parties agreed to a Paxlovid stockpile for the U.S. government until 2028, “at no cost to the taxpayer.” This stockpile will include 1 million courses.

The dropping demand for COVID-19-related products impacts the company’s full 2023 guidance. Some key notable points:

Paxlovid revenues are estimated to decline by approximately $7 billion ($4.2 billion of this part of the non-cash revenue revealed for the return of the approximately 7.9 million treatment courses of EUA labeled U.S. government inventor)

COVID-19 vaccine Comirnaty revenues decline by $2 billion
A $5.5 billion non-cash charge in 2023 in Q3 due to inventory write-offs caused by lower-than-expected demand for the company’s COVID-19 products.

While Pfizer’s other pharmaceutical products appear to likely meet full-year expectations (6% to 8% growth), the company is cutting $3.5 billion, including $1 billion this year and $2.5 billion in 2024. The company holds its analyst and investor call today at 8 AM EDT.

How will Pfizer attempt to overcome this COVID crisis? Much like the large pharmaceutical companies did during the last couple of decades, by raising vaccine prices. In fact, TrialSite reported in March 2021, at the height of the pandemic that Pfizer informed investors the company would find ways to monetize the pandemic products---meaning extract as much money out of them as possible.

At the time Frank D’Amelio, Pfizer’s Chief Financial Officer called pricing at $19.50 “pandemic pricing.” He shared candidly with investors, “[There’s] significant opportunity for those margins to improve once we get beyond the pandemic environment that we’re in.”

That’s happening now as the company’s Comirnaty list price skyrocketed to $120 to $130 per dose covered last month by AP. While mainstream media avoids coverage of the price surge in any material way, that’s likely due to the reality that pharmaceutical advertising represents a sizable portion of overall ad revenue for media companies.

But some media have become more critical, such as the Washington Post. In a piece authored by Jenna Portnoy, a chief operating officer at a Maryland-based hospital shared that the price of the jab has risen to $150 in some cases. Jenna Vallejo told the reporter, “That’s ridiculous.” Meanwhile, the company is pricing what the market will bear, and even though technically under federal law the jabs should still be covered by public or private payers, the company and its fulfillment chain will likely try to squeeze as much out of consumers as possible.

What did Pfizer’s disclosure do to the stock price? At 3:30 PM on Thursday, Oct. 12, the company’s stock price equaled $33.10. While Pfizer is a huge company with blockbuster and innovative niche medicine, the company’s stock is in trouble. And as the reality of how the company behaved during the pandemic comes to light, likely investors may see more troubles with this stock.

To put it all in perspective, the company’s stock was priced at 59.48, an all-time high on December 13, 2021, at the height of the pandemic. But aside from the temporary surge, Pfizer equity has been on a cascading slide downward since then. It’s the artificial nature of the pandemic surge in revenues that likely helped spook investors, along with other disturbing behavior such as how the company abused its position in contracting during the crisis. As of today, Oct. 16, 2023, Pfizer’s price is $32.11.

TrialSite reported that Pfizer recently sought out unorthodox financing, inking a deal with Blackstone, a private equity group investing in drug development.

Meanwhile, TrialSite has predicted that Moderna faces real trouble when the market rejects their Spikevax COVID-19 vaccine—the only revenue-generating product.

Presently priced at $98.30 per share, Moderna’s slide throughout 2023 is apparent upon instant gaze of their chart. By Sept. 6, 2021, again right in the middle of the pandemic, Moderna’s stock hit an all-time high of $449.38. It’s been all downhill since then, currently priced at 98.30.




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