Operation Warp Speed Archives - Medical Design Sourcing

U.S. government withholds funding from Novavax

Although Novavax (NSDQ:NVAX) disclosed the news in a July 31 SEC filing, investors apparently didn’t react to the development until today. In mid-day trading, the stock dipped 20% to $188.18. The company’s stock had surged earlier in the week.

In the SEC filing, Novavax said the U.S. government told the company to align its analytic methods with the FDA before planning additional domestic manufacturing. Furthermore, the government told Novavax that it would withhold funding for additional manufacturing until the company had done so.

The company had landed a $1.75 billion contract as part of the U.S. government’s Operation Warp Speed program to produce a COVID-19 vaccine. The U.S. agreed to purchase 110 million doses of the vaccine after it receives emergency use authorization.

Similar to Moderna, the COVID-19 vaccine will be Novax’s first commercial product.

The New York Times report suggests that Novavax has struggled to convince the FDA th…

Former head of Operation Warp Speed leaves two more drug companies

Following allegations of sexual harassment, former head of Operation Warp Speed Moncef Slaoui has left roles at two more companies.

Yesterday, Slaoui was terminated as the chair of the Galvani board of directors, GlaxoSmithKline’s board of directors announced. The same day, Vaxcyte confirmed in an SEC filing that it had axed Slaoui as its chairman of the board. Today, Centessa Pharmaceuticals announced that he stepped down as the company’s chief scientific officer.

Get the full story at our sister site, Drug Discovery & Development.

Former head of Operation Warp Speed leaves two more drug companies

Following allegations of sexual harassment, former head of Operation Warp Speed Moncef Slaoui has left roles at two more companies.

Yesterday, Slaoui was terminated as the chair of the Galvani board of directors, GlaxoSmithKline’s board of directors announced. The same day, Vaxcyte confirmed in an SEC filing that it had axed Slaoui as its chairman of the board. Today, Centessa Pharmaceuticals announced that he stepped down as the company’s chief scientific officer.

Slaoui, who served as the head of Operation Warp Speed — the Trump administration’s program to accelerate COVID-19 vaccine development — had his termination made effective immediately by all three companies.

Termination of Slaoui follows the receipt of a letter by GlaxoSmithKline alleging against him sexual harassment and inappropriate conduct towards a GSK employee. The allegations refer to incidents that occurred several years ago when he was a GSK employee.

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Former head of Operation Warp Speed loses board seat over sexual harassment claims

GlaxoSmithKline’s board of directors announced today that it terminated Moncef Slaoui as the chair of the Galvani board of directors.

Slaoui, who served as the head of Operation Warp Speed — the Trump administration’s program to accelerate COVID-19 vaccine development — was terminated effective immediately, according to a news release from GSK, the majority shareholder of Galvani Bioelectronics.

Get the full story at our sister site, Drug Discovery & Development.

Former head of Operation Warp Speed loses board seat over sexual harassment claims

GlaxoSmithKline’s board of directors announced today that it terminated Moncef Slaoui as the chair of the Galvani board of directors.

Slaoui, who served as the head of Operation Warp Speed — the Trump administration’s program to accelerate COVID-19 vaccine development — was terminated effective immediately, according to a news release from GSK, the majority shareholder of Galvani Bioelectronics.

Termination of Slaoui follows the receipt of a letter alleging against him sexual harassment and inappropriate conduct towards a GSK employee. The allegations refer to incidents that occurred several years ago when he was a GSK employee.

Once GSK received the letter with the allegations, its board immediately initiated an investigation, bringing in a law firm to conduct it. That investigation substantiated the allegations made against Slaoui and remains ongoing.

“Dr. Slaoui’s behaviours are wholly unacceptable,” GSK wr…

7 core strategies in Biden’s battle against COVID-19

[Photo by Fusion Medical Animation on Unsplash]

Included in President Joe Biden’s sprawling strategy document for dealing with the COVID-19 pandemic are an array of plans intended to ramp up vaccination efforts.

Also included are proposals for accelerating the development of therapies such as antiviral compounds effective against SARS-CoV-2 and other coronaviruses with pandemic potential.

The “full-scale, wartime” plans have considerable relevance for the pharmaceutical and medical device industries. (More information is available on the medical-device ramifications of the plan from our sister site, Medical Design & Outsourcing.)

While the plan stands out from the prior administration’s COVID-19 response in its detail and earnestness, several portions effectively represent a continuation of existing policy. The policy, for instance, says it will end the U.S. government’s practice of stockpil…

U.S. government stockpile of COVID-19 vaccines already drained

Pfizer-BioNTech vaccine image courtesy of Wikipedia

Last week, President-elect Joe Biden vowed to release COVID-19 vaccine doses from a government stockpile.

On Jan. 13, the U.S. Department of Health and Human Services (HHS) echoed that sentiment, stating it would “no longer stockpile millions of COVID-19 vaccine doses held to ensure Americans receive their second shot,” according to a brief notice.

But federal officials had already drained vaccine reserves before the HHS vowed to open up a vaccine stockpile, according to state officials who had been expecting more doses.

Local government officials expecting vaccine supplies to roughly double starting next week are now forced to contend with the status quo.

Critics of Operation Warp Speed, a public-private partnership established by the Trump administration to support COVID-19 vaccine distribution, have been frustrated with the speed …

Biden vows to ramp up COVID-19 vaccine distribution with $1.9T stimulus package

[Joe Biden photo from Wikipedia]

President-elect Joe Biden has announced a proposal for a $1.9 trillion economic rescue package that includes $415 billion to fight the pandemic, including boosting COVID-19 vaccine deployment. Of that latter total, some $20 billion would be invested in a national vaccination program to establish community vaccination centers across the country, including mobile vaccination units in rural areas. Another $30 billion would cover supplies and personal protective equipment.

The possibility of a Senate trial in Biden’s first 100 days in office could be a roadblock for the plan.

Nevertheless, Biden aims to have 100 million COVID-19 vaccine doses administered in his first 100 days in office.

Biden’s plan also earmarks $50 billion for COVID-19 testing and would strengthen the nation’s use of genomic testing to track SARS-CoV-2 mutations.

To date, there have bee…

Moderna and NIH assessing whether COVID-19 vaccine doses can be halved

Moderna Logo (PRNewsFoto/Moderna Therapeutics)

AstraZeneca (LON:AZN) inadvertently discovered halving the first dose of its COVID-19 vaccine could boost its efficacy.

Researchers at the National Institutes of Health (NIH) and Moderna (NSDQ:MRNA) are examining vaccine data to determine whether they can halve the 100-microgram dose to vaccinate twice as many people.

Some data from Moderna’s clinical trial support that possibility, according to Moncef Slaoui, head of Operation Warp Speed.

“We know [a half dose] induces identical immune response” to the recommended dose in individuals aged 18 to 55, Slaoui said on CBS’ “Face the Nation.”

Slaoui’s comment referenced a Phase 2 clinical trial designed to test for an immune response rather than vaccine efficacy.

To date, about 4.8 million Americans have received COVID-19 vaccines. States have received an additional 13 million doses, according to the CDC.

The U.…