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I Was the Architect of Operation Warp Speed. I Have a Message for All Americans.
New York TimesAmong the many debatable issues around Covid-19 is one unassailable fact: The coronavirus is nonpartisan. It makes no judgment about one’s political leanings. The vaccines that were developed to fight this virus have no political bias, either.
And yet the reluctance and even refusal of many Americans — including many of my fellow conservatives and Republicans — to get a Covid-19 vaccine is a frustrating irony for those of us who worked to expedite these vaccines. While the vaccines have had doubts cast upon them by politicians throughout their production and rollout, whether a person lives in a red or a blue state has no bearing on the vaccines’ efficacy. They work incredibly well, and more than 160 million fully vaccinated Americans are proof.
Whether such skepticism is rooted in political misgivings, conspiracy theories or lack of accurate and timely information, there are still millions of Americans unwilling to take the simplest of steps to end this pandemic. That makes it incumbent upon all leaders and health experts to be honest about how safe and effective the vaccines are and urge vaccination.
I know the vaccines’ features intimately because as secretary of Health and Human Services, I oversaw their development, testing, approval and distribution from April of 2020 until January of this year. After leaving office, I watched with pride as vaccination rates rose through the early months of the year, and then with dismay as the daily number of vaccinations declined.
And yet the reluctance and even refusal of many Americans — including many of my fellow conservatives and Republicans — to get a Covid-19 vaccine is a frustrating irony for those of us who worked to expedite these vaccines. While the vaccines have had doubts cast upon them by politicians throughout their production and rollout, whether a person lives in a red or a blue state has no bearing on the vaccines’ efficacy. They work incredibly well, and more than 160 million fully vaccinated Americans are proof.
Whether such skepticism is rooted in political misgivings, conspiracy theories or lack of accurate and timely information, there are still millions of Americans unwilling to take the simplest of steps to end this pandemic. That makes it incumbent upon all leaders and health experts to be honest about how safe and effective the vaccines are and urge vaccination.
I know the vaccines’ features intimately because as secretary of Health and Human Services, I oversaw their development, testing, approval and distribution from April of 2020 until January of this year. After leaving office, I watched with pride as vaccination rates rose through the early months of the year, and then with dismay as the daily number of vaccinations declined.
Just my opinion, but I don't think the audience for this op-ed reads the Times....
30 replies
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= new reply since forum marked as read
contingent with receiving EUA approval - https://www.npr.org/sections/health-shots/2020/11/24/938591815/pfizers-coronavirus-vaccine-supply-contract-excludes-many-taxpayer-protections
Pfizer's Coronavirus Vaccine Supply Contract Excludes Many Taxpayer Protections
November 24, 2020 4:46 PM ET
When the Department of Health and Human Services released Pfizer's $1.95 billion coronavirus vaccine contract with Operation Warp Speed last Wednesday, the agreement revealed that the Trump administration didn't include government rights to intellectual property typically found in federal contracts. The drugmaker has downplayed its involvement in Operation Warp Speed, the Trump administration's more than $10 billion program to make a coronavirus vaccine available in record time.
Although Pfizer didn't receive government funding this spring toward research and development of the vaccine, it nevertheless received one of the largest Operation Warp Speed supply contracts to date on July 21. Pfizer is working on the vaccine with BioNTech, a German company. They announced results of final efficacy analysis last Wednesday, revealing that the vaccine is 95% effective. The company announced that it submitted its request for emergency use authorization on Friday.
That nearly $2 billion contract will pay for 100 million doses of the Pfizer vaccine at a price of $19.50 per dose if the vaccine is OK'd by the Food and Drug Administration. The government also has the option to buy up to 500 million more doses. The other Operation Warp Speed agreements pay for vaccines regardless of FDA approval or authorization.
Meanwhile, the Pfizer contract has the narrowest protections for taxpayers of any Operation Warp Speed contract released so far, drug policy and intellectual property experts tell NPR. It excludes almost all intellectual property rights, forgoing leverage to use if the company engages in price gouging down the road. It may also set a dangerous precedent for future government contracts, they say. Pfizer didn't respond to repeated requests for comment for this story.
(snip)
November 24, 2020 4:46 PM ET
When the Department of Health and Human Services released Pfizer's $1.95 billion coronavirus vaccine contract with Operation Warp Speed last Wednesday, the agreement revealed that the Trump administration didn't include government rights to intellectual property typically found in federal contracts. The drugmaker has downplayed its involvement in Operation Warp Speed, the Trump administration's more than $10 billion program to make a coronavirus vaccine available in record time.
Although Pfizer didn't receive government funding this spring toward research and development of the vaccine, it nevertheless received one of the largest Operation Warp Speed supply contracts to date on July 21. Pfizer is working on the vaccine with BioNTech, a German company. They announced results of final efficacy analysis last Wednesday, revealing that the vaccine is 95% effective. The company announced that it submitted its request for emergency use authorization on Friday.
That nearly $2 billion contract will pay for 100 million doses of the Pfizer vaccine at a price of $19.50 per dose if the vaccine is OK'd by the Food and Drug Administration. The government also has the option to buy up to 500 million more doses. The other Operation Warp Speed agreements pay for vaccines regardless of FDA approval or authorization.
Meanwhile, the Pfizer contract has the narrowest protections for taxpayers of any Operation Warp Speed contract released so far, drug policy and intellectual property experts tell NPR. It excludes almost all intellectual property rights, forgoing leverage to use if the company engages in price gouging down the road. It may also set a dangerous precedent for future government contracts, they say. Pfizer didn't respond to repeated requests for comment for this story.
(snip)
But then one could quote Seinfeld - "Not that there's anything wrong with that".
Regarding Sanofi-GSK -
Sanofi and GSK land $2.1 billion deal with U.S. for Covid-19 vaccine development and 100 million doses
By Matthew Herper July 31, 2020
The U.S. government’s Operation Warp Speed effort will provide up to $2.1 billion to Sanofi and GlaxoSmithKline to fund development and manufacturing of the companies’ experimental Covid-19 vaccine, the companies announced Friday. As part of the agreement, the companies will provide the U.S. with 100 million doses of the vaccine, which will begin human trials in September. As with other vaccines in development, the Sanofi-GSK vaccine, if effective, may require two doses.
The U.S. will have the option to procure up to 500 million doses; the companies say they are gearing up to be able to make 1 billion doses annually. The Sanofi-GSK vaccine is starting trials behind vaccines of other companies with whom Operation Warp Speed is working, including Moderna — which began a pivotal Phase 3 study aimed at proving its vaccine’s efficacy on Monday — AstraZeneca, Johnson & Johnson, and Novavax.
However, it is the only vaccine of the group based on technologies used in approved vaccines: the platform behind Sanofi’s Flublok flu shot, and a compound made by GSK, called an adjuvant, that is used to make vaccines more potent.
“The portfolio of vaccines being assembled for Operation Warp Speed increases the odds that we will have at least one safe, effective vaccine as soon as the end of this year,” Health and Human Services Secretary Alex Azar said in a statement released by the companies. “Today’s investment supports the Sanofi and GSK adjuvanted product all the way through clinical trials and manufacturing, with the potential to bring hundreds of millions of safe and effective doses to the American people.”
https://www.statnews.com/2020/07/31/operation-warp-speed-sanofi-gsk-covid19-vaccine/
By Matthew Herper July 31, 2020
The U.S. government’s Operation Warp Speed effort will provide up to $2.1 billion to Sanofi and GlaxoSmithKline to fund development and manufacturing of the companies’ experimental Covid-19 vaccine, the companies announced Friday. As part of the agreement, the companies will provide the U.S. with 100 million doses of the vaccine, which will begin human trials in September. As with other vaccines in development, the Sanofi-GSK vaccine, if effective, may require two doses.
The U.S. will have the option to procure up to 500 million doses; the companies say they are gearing up to be able to make 1 billion doses annually. The Sanofi-GSK vaccine is starting trials behind vaccines of other companies with whom Operation Warp Speed is working, including Moderna — which began a pivotal Phase 3 study aimed at proving its vaccine’s efficacy on Monday — AstraZeneca, Johnson & Johnson, and Novavax.
However, it is the only vaccine of the group based on technologies used in approved vaccines: the platform behind Sanofi’s Flublok flu shot, and a compound made by GSK, called an adjuvant, that is used to make vaccines more potent.
“The portfolio of vaccines being assembled for Operation Warp Speed increases the odds that we will have at least one safe, effective vaccine as soon as the end of this year,” Health and Human Services Secretary Alex Azar said in a statement released by the companies. “Today’s investment supports the Sanofi and GSK adjuvanted product all the way through clinical trials and manufacturing, with the potential to bring hundreds of millions of safe and effective doses to the American people.”
https://www.statnews.com/2020/07/31/operation-warp-speed-sanofi-gsk-covid19-vaccine/
However their initial entity was failing in clinical trials and they basically had to start over with another candidate and that one is currently undergoing a rolling review in the EU -
July 20, 2021 1:13 PM EDT Last Updated 14 days ago
Healthcare & Pharmaceuticals
EU begins real-time review of Sanofi-GSK COVID-19 vaccine
Reuters
July 20 (Reuters) - Europe's drug regulator said on Tuesday it had started a real-time review of the COVID-19 vaccine developed by French drugmaker Sanofi (SASY.PA) and Britain's GlaxoSmithKline (GSK.L), the fifth shot currently under such a review. The decision to start the "rolling review" of the vaccine, Vidprevtyn, was based on preliminary results from lab studies and early stage clinical trials in adults, the European Medicines Agency (EMA) said.
Late-stage global trials for the protein-based coronavirus vaccine candidate began in May. Sanofi and GSK hope to get approvals by the end of 2021 after early-stage results showed the vaccine produces a robust immune response.
"EMA will assess the compliance of Vidprevtyn with the usual EU standards for effectiveness, safety and quality," the regulator said, without giving details on data it had received so far and an expected timeline for approval.
EMA's rolling reviews are aimed at speeding up the approval process by allowing researchers to submit findings in real time before final trial data is available.
https://www.reuters.com/business/healthcare-pharmaceuticals/eu-begins-real-time-review-sanofi-gsk-covid-19-vaccine-2021-07-20/
Healthcare & Pharmaceuticals
EU begins real-time review of Sanofi-GSK COVID-19 vaccine
Reuters
July 20 (Reuters) - Europe's drug regulator said on Tuesday it had started a real-time review of the COVID-19 vaccine developed by French drugmaker Sanofi (SASY.PA) and Britain's GlaxoSmithKline (GSK.L), the fifth shot currently under such a review. The decision to start the "rolling review" of the vaccine, Vidprevtyn, was based on preliminary results from lab studies and early stage clinical trials in adults, the European Medicines Agency (EMA) said.
Late-stage global trials for the protein-based coronavirus vaccine candidate began in May. Sanofi and GSK hope to get approvals by the end of 2021 after early-stage results showed the vaccine produces a robust immune response.
"EMA will assess the compliance of Vidprevtyn with the usual EU standards for effectiveness, safety and quality," the regulator said, without giving details on data it had received so far and an expected timeline for approval.
EMA's rolling reviews are aimed at speeding up the approval process by allowing researchers to submit findings in real time before final trial data is available.
https://www.reuters.com/business/healthcare-pharmaceuticals/eu-begins-real-time-review-sanofi-gsk-covid-19-vaccine-2021-07-20/
In the meantime, they are assisting Pfizer, Janssen (J&J), and Moderna with manufacturing those vaccines -
(as a note, the above was to piggy-back onto your post
)
