Joe Biden Nominates New NIH Director

Joe Biden on Monday announced his intention to nominate Dr. Monica Bertagnolli as Director of the National Institutes of Health (NIH).

“Dr. Bertagnolli is a world-renowned surgical oncologist, cancer researcher, educator, and physician-leader who has the vision and leadership needed to deliver on NIH’s mission to seek fundamental knowledge and promote human health,” a White House press release stated.

“Dr. Bertagnolli has spent her career pioneering scientific discovery and pushing the boundaries of what is possible to improve cancer prevention and treatment for patients, and ensuring that patients in every community have access to quality care,” Joe Biden said in a statement.

“Dr. Bertagnolli is currently Director of the National Cancer Institute (NCI), the first woman to serve as NCI Director,” the statement added.

“She previously served as the Richard E. Wilson Professor of Surgery in the field of surgical oncology at Harvard Medical School, a surgeon at Brigham and Women’s Hospital, and a member of the Gastrointestinal Cancer Treatment and Sarcoma Centers at Dana-Farber Cancer Institute.”

President Biden is set to name a cancer surgeon, and a cancer patient, to be the next head of the National Institutes of Health. Dr. Monica Bertagnolli, who Biden will nominate today, would be only the second woman to lead the NIH on a permanent basis. https://t.co/uJW1KUGsDS

— The New York Times (@nytimes) May 15, 2023

If confirmed, Dr. Monica Bertagnolli would be the second woman to serve as permanent director.https://t.co/eFYqdZCO95 pic.twitter.com/QAm8k2cRhE

— Forbes (@Forbes) May 15, 2023

From The White House:

Throughout her career, Dr. Bertagnolli has been at the forefront of clinical and research oncology and championed collaborative initiatives to transform the data infrastructure for clinical cancer research. She served as group chair of the Alliance for Clinical Trials in Oncology, a National Clinical Trials Network member organization, and was the Chief Executive Officer of Alliance Foundation Trials, LLC, a not-for-profit corporation that conducts international cancer clinical trials and focuses on the inclusion of rural communities in clinical studies.

Dr. Bertagnolli is a member of the National Academy of Medicine, a past president and chair of the board of directors of the American Society of Clinical Oncology, and has served on the board of directors of the American Cancer Society and the Prevent Cancer Foundation.

The daughter of first-generation Italian and French Basque immigrants, Dr. Bertagnolli grew up on a ranch in southwestern Wyoming. She graduated from Princeton University with a Bachelor of Science in Engineering degree and attended medical school at the University of Utah. She trained in surgery at Brigham and Women’s Hospital and was a research fellow in tumor immunology at the Dana-Farber Cancer Institute.

Bertagnolli will take control of the corrupt federal agency that owns patent rights to one of the experimental COVID-19 shots.

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Moderna previously announced that it reached a patent license agreement with the U.S. government over the experimental COVID-19 shot.

During an earnings call, CFO Jamey Mock said Moderna “entered into a nonexclusive patent license agreement with the National Institute of Allergy and Infectious Diseases, an institute or center of the NIH, to license certain patent rights concerning stabilizing prefusion coronavirus spike proteins and the resulting stabilized proteins for the use in COVID-19 vaccine products or 2P technology.”

“Pursuant to the agreement, we have agreed to pay low single digit royalties on future net sales of our COVID-19 vaccines.”

“A key driver of the increase in cost of sales as a percent of product sales was a catch up royalty payment to the National Institutes of Health or NIH of $400 million, representing 8% of product sales in the fourth quarter,” Mock added.

CCO Arpa Garay said the company expects “commercial market volumes to be approximately 100 million doses in 2023, and Moderna’s commercial organization is prepared for the transition to a commercial endemic market.”

CBS News Staff Digital Reporter Tin Alexander shared transcripts on Twitter from the earnings call for investors.

At earnings call today, @moderna_tx's Jamey Mock disclosed that the company paid

"a catch up royalty payment to the @NIH of $400 million, representing 8% of product sales in the fourth quarter"https://t.co/pEI9KtCsHe https://t.co/P3Q03PoI1j pic.twitter.com/j9qV28bkii

— Alexander Tin (@Alexander_Tin) February 23, 2023

@moderna_tx's Arpa Garay said they are "ready for the transition to a commercial endemic market"

"In the U.S., we expect commercial market volumes to be approximately 100 million doses in 2023"https://t.co/pEI9KtCsHe pic.twitter.com/3kuMrV6ixn

— Alexander Tin (@Alexander_Tin) February 23, 2023

Moderna stated:

Fourth Quarter and Full Year 2022 Financial Results

Revenue: Total revenue for the fourth quarter of 2022 was $5.1 billion, compared to $7.2 billion in the same period in 2021, mainly due to a decrease in sales of the Company’s COVID-19 vaccines. Product sales for the fourth quarter of 2022 were $4.9 billion, a decrease of 30% compared to the same period in 2021, primarily driven by lower sales volume, compared to overall higher demand in the prior year and the related manufacturing ramp up in the fourth quarter of 2021.

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Cost of Sales: Cost of sales was $1.9 billion, or 39% of product sales, for the fourth quarter of 2022, including third-party royalties of $604 million, of which $400 million related to a catch-up payment to the National Institute of Allergy and Infectious Diseases (NIAID) for a new royalty-bearing license agreement executed in December. The agreement provides for low single-digit royalties on future COVID-19 vaccine sales. Cost of sales, as a percentage of product sales, increased by 25 percentage points, from 14% in the same period in 2021. The increase was driven by increased royalties, a charge of $297 million for inventory write-downs related to COVID-19 products that have exceeded or are expected to exceed their approved shelf-lives prior to being used, a loss on firm purchase commitments and related cancellation charges of $281 million, and an expense for unutilized manufacturing capacity and related contract manufacturing organization charges of $376 million. These charges, other than royalties, are driven by costs associated with surplus production capacity, overall lower demand and a shift to our most recent Omicron-targeting COVID-19 bivalent booster, mRNA-1273.222

It’s an egregious conflict of interest between Big Pharma and the U.S. federal government.

Federal government employees share profits with pharmaceutical companies on products developed with taxpayer dollars.

NEW: Moderna entered a patent license agreement with the U.S. government that includes a $400 million catch-up payment and royalties on future sales of COVID-19 vaccines.

Isn't this a conflict of interest? pic.twitter.com/0OdNBYfwN3

— KanekoaTheGreat (@KanekoaTheGreat) February 23, 2023

The Epoch Times reported:

The Epoch Times has filed a Freedom of Information Act request for the agreement.

NIAID was headed for decades by Dr. Anthony Fauci, who retired around the end of 2022.

The disclosure means the government was paid shortly before telling a court that it, not Moderna, should face a lawsuit over patent infringement.

NIH Says Wrongly Left Off Patent

U.S. government researchers were wrongly left off of a patent filing for a key sequence that’s part of the vaccine, according to government officials.

NIH scientists were working with Moderna for four years on vaccines for diseases before the pandemic started. After COVID-19 emerged, the NIH and Moderna collaborated to develop the COVID-19 vaccine, both parties have said.