Secretary of Health and Human Services (HHS) Robert F. Kennedy Jr. put the brakes on a multi-million contract with the American biotech company Vaxart to create a new COVID-19 vaccine, Fox News Digital reported.
Kennedy on Feb. 21 issued a 90-day stop-work order on the contract until HHS determines whether it is “prudent and safe” to continue. The order came just as the next phase of the company’s clinical trial, involving 10,000 participants, was set to start on Monday.
In this phase of the trial, the company is planning to test the efficacy of its vaccine against existing mRNA vaccines, bypassing a placebo-controlled assessment.
“While it is crucial that the Department [of] Health and Human Services (HHS) support pandemic preparedness, four years of the Biden administration’s failed oversight have made it necessary to review agreements for vaccine production, including Vaxart’s,” Kennedy told Fox News Digital.
“I look forward to working with Vaxart and medical experts to ensure this work produces safe, effective, and fiscal-minded vaccine technology,” he said.
Fox News Digital reported that the trial is only paused, not terminated. HHS will decide whether to resume development of the vaccine within the next 90 days.
The development of Vaxart’s new COVID-19 vaccine was part of the Biden administration’s $4.7 billion Project NextGen initiative, launched in 2023 to develop innovative vaccines — like oral pills and nasal sprays — that are easier to administer and provide improved protection against the SARS-CoV-2 virus.
Project NextGen is the successor to the Trump administration’s “Operation Warp Speed,” launched in March 2020 to expedite the development of COVID-19 vaccines.
Similar to Operation Warp Speed, Project NextGen — with funding from the Bill & Melinda Gates Foundation and the Rockefeller Foundation — encourages public-private partnerships.
Vaxart announced in June 2024 that it had been awarded up to $453 million to fund the Phase 2b trials of its pill vaccine under a contract from the Biomedical Advanced Research and Development Authority (BARDA). BARDA operates under the Administration for Strategic Preparedness and Response (ASPR), a department of HHS.
The company was developing a COVID-19 vaccine that can be taken orally. The paused trial was designed to compare the efficacy of Vaxart’s oral vaccine to an approved mRNA vaccine.
Of the $453 million approved, $240 million had already been authorized for the preliminary study, according to Fox Digital. The company had been recently authorized to bill the remaining balance of the contract for the clinical trials, but that billing is now on hold.
Vaxart can still bill the federal government for the costs of monitoring those people who participated in earlier phases of the trial.
The company said in an email statement to The Defender that it did not know the nature of the stop work order, but was informed it would be in effect for 90 days. The spokesperson said the trial hadn’t had any impediments to date and they “remain excited” to move forward.
“We recognize and appreciate the importance of oversight, transparency, and fiscal responsibility in government-funded biomedical research, and we are committed to working collaboratively with Secretary Kennedy, HHS, BARDA and other members of President Trump’s administration as they evaluate the data supporting the 10,000-participant portion of the Phase 2b study and determine how the study should move forward,” the spokesperson said.
Children’s Health Defense (CHD) Senior Research Scientist Karl Jablonowski said taxpayers have paid more than enough to vaccine makers, who don’t have the public’s best interests in mind.
He said:
“The U.S. taxpayers have already paid for our pandemic. Big Pharma has made out like bandits. They are using the Biden administration’s $4.7 billion Project NextGen initiative funds to expand their patent portfolio — for the betterment of profit.
“They are not beholden to the 340 million Americans footing the bill, they are beholden to the 227 million publicly traded shares of their company.”
The pause comes less than two weeks after Kennedy was sworn in as HHS secretary. During the nomination process, he came under fire from mainstream media and Democratic politicians for his so-called “anti-vaccine views.”
Kennedy and the organization he founded, CHD, were vocal critics of the COVID-19 vaccine and were censored on social media for dissenting views.
The Center for Countering Digital Hate targeted him for censorship as one of the “Disinformation Dozen” who raised questions about the government’s COVID-19 vaccine narrative.
Kennedy has repeatedly said he is not “anti-vaccine,” but wants vaccines to be subjected to rigorous safety testing and pledged to investigate the childhood immunization schedule as part of his work at HHS.
In 2023, the CDC added COVID-19 vaccines to the childhood immunization schedule, even though they were shown to provide little or no benefit to children.
Biden administration was funding new nasal and oral COVID vaccines
When BARDA funded Vaxart, it also granted funding to CyanVac’s (up to $40 million) and Castlevax’s ($34 million) intranasal vaccines.
Each company’s Phase 2b trials were set to recruit 10,000 volunteers to compare the safety and efficacy of the investigational vaccine against the existing mRNA vaccines.
ASPR Assistant Secretary Dawn O’Connell said in a news release at the time that the new vaccines “may … be easier to administer through intranasal or oral delivery.” The announcement suggests the delivery methods have the “potential to improve vaccine access.”
Jablonowski said oral vaccines, like the one being developed by Vaxart, “have generally not been terribly effective in creating and sustaining an immune response,” with the exception of the oral polio vaccine. That vaccine, which is a liquid, not a pill, has been plagued with safety issues, causing polio outbreaks in many countries.
When the funding was awarded, Vaxart CEO Steven Lo celebrated it in a press release. “Vaccine delivery has relied primarily on injection for more than 150 years. This funding from BARDA will assist us in determining whether we can bring a transformational, next-generation approach to global vaccination.”
Vaxart’s pill, VXA-CoV2-1, uses an adenovirus vector to infect epithelial cells in the lower small intestine. The vaccine delivers the genetic material to create the spike protein. The company boasts that a special coating allows the oral pill to survive the low pH in the stomach.
Adenovirus vaccines reportedly cannot make you sick, and cannot replicate or be integrated into the host body’s DNA.
However, Jablonowski said, “Two adenovirus-based COVID vaccines have already been pulled from the market because they were remarkably unsafe, yet passed initial — and clearly insufficient — safety standards.”
Johnson & Johnson’s (J&J) and AstraZeneca’s COVID-19 vaccines also used adenovirus vectors.
The use of J&J’s vaccine was paused in April 2021 after reports of thrombosis with thrombocytopenia syndrome (TTS), a severe blood clotting disorder. In July 2021, the FDA warned about the risk of Guillain-Barré syndrome with the J&J vaccine, after approximately 100 cases were reported among 12.5 million vaccine recipients.
With existing doses of the J&J vaccine having expired in May 2023, the vaccine is no longer in use.
The AstraZeneca COVID-19 vaccine also caused blood clots, resulting in temporary pauses in its use in several countries. It was removed from the market in May 2024.
In addition to its COVID-19 vaccine, Vaxart is also developing oral vaccines for norovirus and bird flu, with initial trials for the norovirus vaccine beginning this year.
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This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
February 26, 2025
Posted by aletho |
Corruption | BARDA, COVID-19 Vaccine, HHS, United States, Vaxart |
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