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Germany hopes protein-based Covid vaccine will sway sceptics
Source: The Guardian
Germany will offer its population a new protein-based Covid-19 vaccine comparable to conventional flu jabs this week, in the hope of swaying a sizeable minority that remains sceptical of the novel mRNA technology used in the most commonly used vaccines.
Unlike the novel mRNA vaccines produced by Pfizer/BioNTech and Moderna or viral vector made by AstraZeneca and Johnson & Johnson, Nuvaxovid is a protein subunit vaccine. It contains a non-infectious component on the surface of the Sars-CoV-2 virus, which induces a protective immune response when the body’s immune cells come into contact with it.
Novavax announced in June last year that its vaccine had proven more than 90% effective against symptomatic infections with the Alpha variant, in trials including nearly 30,000 volunteers in the US and Mexico.
The company says its product is similarly effective against the Delta and Omicron variants, especially after a booster shot administered six months after the second jab. Germany’s Paul Ehrlich Institute notes that the data proving the vaccine’s efficacy against more infectious variants remains limited.
Read more: https://www.theguardian.com/world/2022/feb/21/germany-hopes-nuvaxovid-protein-based-covid-vaccine-will-sway-sceptics
This was permitted for use by the EU last December, but as of yet has only been used in the Philippines and Indonesia.
12 replies
= new reply since forum marked as read
= new reply since forum marked as read
yet... 
Novavax Posts Coronavirus Vaccine Contract That Government Didn't Disclose
November 11, 2020 1:10 PM ET
Sydney Lupkin
A day after Pfizer's announcement that its COVID-19 vaccine is more than 90% effective, rival Novavax shared its $1.6 billion Operation Warp Speed contract on Tuesday. Operation Warp Speed is the Trump administration's crash program to make a vaccine available in record time. While there's been rapid progress on vaccines, the government has been slow to release details of its billions of dollars' worth of deals with manufacturers.
Notably, the Department of Health and Human Services told NPR in late August that it had "no records" of the Novavax contract in response to a public records request for it over the summer. The agency announced the deal July 7 to support development, manufacturing and the purchase of 100 million doses. Novavax released its federal contract in a quarterly financial filing with the Securities and Exchange Commission. HHS has yet to release this contract.
"We shouldn't have to be getting the details in these contracts through the companies and their SEC filings," says Ameet Sarpatwari, assistant director of Harvard Medical School's Program on Regulation, Therapeutics and Law. "They should be publicly available, and there should be input even prior to the execution of the contracts." The Novavax contract is one of several Operation Warp Speed contracts that were issued through a third party, Advanced Technology International, a fact that NPR first revealed in September.
This arrangement concerned members of Congress and advocacy groups who feared the nontraditional agreements would omit the safeguards that often come with taxpayer funding, like protections against potential future price-gouging. Novavax's contract appears to include the kind of "march-in" rights found in a typical government contract, which allow the government to take over a drug or vaccine if the manufacturer that received federal funding can't or won't make its product or sets an unreasonable price.
https://www.npr.org/sections/health-shots/2020/11/11/933864908/novavax-posts-coronavirus-vaccine-contract-that-government-didnt-disclose
November 11, 2020 1:10 PM ET
Sydney Lupkin
A day after Pfizer's announcement that its COVID-19 vaccine is more than 90% effective, rival Novavax shared its $1.6 billion Operation Warp Speed contract on Tuesday. Operation Warp Speed is the Trump administration's crash program to make a vaccine available in record time. While there's been rapid progress on vaccines, the government has been slow to release details of its billions of dollars' worth of deals with manufacturers.
Notably, the Department of Health and Human Services told NPR in late August that it had "no records" of the Novavax contract in response to a public records request for it over the summer. The agency announced the deal July 7 to support development, manufacturing and the purchase of 100 million doses. Novavax released its federal contract in a quarterly financial filing with the Securities and Exchange Commission. HHS has yet to release this contract.
"We shouldn't have to be getting the details in these contracts through the companies and their SEC filings," says Ameet Sarpatwari, assistant director of Harvard Medical School's Program on Regulation, Therapeutics and Law. "They should be publicly available, and there should be input even prior to the execution of the contracts." The Novavax contract is one of several Operation Warp Speed contracts that were issued through a third party, Advanced Technology International, a fact that NPR first revealed in September.
This arrangement concerned members of Congress and advocacy groups who feared the nontraditional agreements would omit the safeguards that often come with taxpayer funding, like protections against potential future price-gouging. Novavax's contract appears to include the kind of "march-in" rights found in a typical government contract, which allow the government to take over a drug or vaccine if the manufacturer that received federal funding can't or won't make its product or sets an unreasonable price.
https://www.npr.org/sections/health-shots/2020/11/11/933864908/novavax-posts-coronavirus-vaccine-contract-that-government-didnt-disclose
And then you have this (and ugh I hate to link to Politco but this is an update from last fall) -
‘Bereft’: How Operation Warp Speed’s decisions left the world waiting for a vaccine
By ERIN BANCO, ADAM CANCRYN and SARAH OWERMOHLE
10/29/2021 06:30 AM EDT
Updated: 10/29/2021 11:06 AM EDT
In a series of meetings in the fall of 2020, Trump administration officials convened to decide whether a pharmaceutical company they had helped fund and support would be able to deliver what it had promised — Covid-19 vaccine doses for the U.S. and the world. More than 500,000 people worldwide had died from the virus and the administration was under increasing pressure to find a suitable source of inoculation — and quickly. But one of its top vaccine candidates, Maryland-based Novavax, was reporting data that indicated the company was struggling to find a way to consistently manufacture a high-quality shot. And it did not yet have tests that could determine the levels of purity within each tranche. “It was a total mess,” one person with direct knowledge of Novavax’s production process said of the situation, expressing a view that at least two other people who attended the meetings shared. This account is based on the recollections of those people, along with five current and former senior officials, four of whom requested anonymity to disclose internal deliberations. The U.S. had bet big on Novavax.
In July 2020, the Trump administration announced it would invest $1.6 billion over time to help the company build up its manufacturing and deliver 100 million doses by the end of 2020 — more than any other investment in a Covid-19 vaccine maker up to that time. Unlike the other vaccines commissioned by the federal government, such as new messenger RNA technology used by Pfizer and Moderna, officials believed the Novavax shot could help not only the U.S., but the farthest reaches of the world. The vaccine did not require freezer storage and thus would be easier to ship to countries in Africa, the Middle East and Asia. But the quality and manufacturing problems Novavax faced appeared to be significant. A select group of officials working with the Trump administration's Operation Warp Speed on scaling U.S. manufacturing pressed the leader of their team, Moncef Slaoui, to reconsider whether to support the company. They wanted the administration to focus instead on helping to build capacity at other companies that had more experience.
But Slaoui, along with other Covid-19 vaccine officials, was adamant Novavax would deliver. Slaoui, the former scientific director of Covid-19 vaccine development efforts at Operation Warp Speed, confirmed his steadfast support for Novavax in an interview with POLITICO. "The reason we selected Novavax is because it had accumulated significant experience in ... making a recombinant protein vaccine against a virus that has a lot of similarities to Covid-19 virus,” Slaoui said, referring to the company’s ongoing efforts to develop a flu vaccine. “We knew that recombinant protein was going to be less fast than the other technologies because you have to make the protein in the appropriate structure. And it's very complex to do.” Operation Warp Speed officials believed that the mRNA vaccines being produced by Pfizer and Moderna could come more quickly, providing protection to U.S. citizens in controlled settings where the need for freezers could be accommodated, and then Novavax could provide an easier-to-handle vaccine to export to other countries.
With that in mind, Operation Warp Speed continued to fund and support Novavax's manufacturing over the next six months with the encouragement of top Trump officials from multiple agencies — despite clear warnings that the company had yet to solve core problems, according to five of the people who spoke to POLITICO for this story, including two former officials. Novavax during that same period pursued deals with multiple countries and international organizations, including the Serum Institute of India and the World Health Organization, to begin distributing its vaccine across the world by the end of 2021. Novavax has pledged 1.35 billion doses to the world, along with the 100 million it promised the U.S. Yet in the year since then, it's failed to successfully deliver a single dose — leaving the world's neediest countries in limbo as it tries to convince regulators it can consistently produce a high-quality shot.The delays have posed a serious challenge to American and international officials’ plans to vaccinate the world. With at least five billion doses still needed to meet global demand, the Biden administration has sought new ways to plug the gap in the coming year.
Much more: https://www.politico.com/news/2021/10/29/warp-speed-waiting-novavax-vaccine-517503
By ERIN BANCO, ADAM CANCRYN and SARAH OWERMOHLE
10/29/2021 06:30 AM EDT
Updated: 10/29/2021 11:06 AM EDT
In a series of meetings in the fall of 2020, Trump administration officials convened to decide whether a pharmaceutical company they had helped fund and support would be able to deliver what it had promised — Covid-19 vaccine doses for the U.S. and the world. More than 500,000 people worldwide had died from the virus and the administration was under increasing pressure to find a suitable source of inoculation — and quickly. But one of its top vaccine candidates, Maryland-based Novavax, was reporting data that indicated the company was struggling to find a way to consistently manufacture a high-quality shot. And it did not yet have tests that could determine the levels of purity within each tranche. “It was a total mess,” one person with direct knowledge of Novavax’s production process said of the situation, expressing a view that at least two other people who attended the meetings shared. This account is based on the recollections of those people, along with five current and former senior officials, four of whom requested anonymity to disclose internal deliberations. The U.S. had bet big on Novavax.
In July 2020, the Trump administration announced it would invest $1.6 billion over time to help the company build up its manufacturing and deliver 100 million doses by the end of 2020 — more than any other investment in a Covid-19 vaccine maker up to that time. Unlike the other vaccines commissioned by the federal government, such as new messenger RNA technology used by Pfizer and Moderna, officials believed the Novavax shot could help not only the U.S., but the farthest reaches of the world. The vaccine did not require freezer storage and thus would be easier to ship to countries in Africa, the Middle East and Asia. But the quality and manufacturing problems Novavax faced appeared to be significant. A select group of officials working with the Trump administration's Operation Warp Speed on scaling U.S. manufacturing pressed the leader of their team, Moncef Slaoui, to reconsider whether to support the company. They wanted the administration to focus instead on helping to build capacity at other companies that had more experience.
But Slaoui, along with other Covid-19 vaccine officials, was adamant Novavax would deliver. Slaoui, the former scientific director of Covid-19 vaccine development efforts at Operation Warp Speed, confirmed his steadfast support for Novavax in an interview with POLITICO. "The reason we selected Novavax is because it had accumulated significant experience in ... making a recombinant protein vaccine against a virus that has a lot of similarities to Covid-19 virus,” Slaoui said, referring to the company’s ongoing efforts to develop a flu vaccine. “We knew that recombinant protein was going to be less fast than the other technologies because you have to make the protein in the appropriate structure. And it's very complex to do.” Operation Warp Speed officials believed that the mRNA vaccines being produced by Pfizer and Moderna could come more quickly, providing protection to U.S. citizens in controlled settings where the need for freezers could be accommodated, and then Novavax could provide an easier-to-handle vaccine to export to other countries.
With that in mind, Operation Warp Speed continued to fund and support Novavax's manufacturing over the next six months with the encouragement of top Trump officials from multiple agencies — despite clear warnings that the company had yet to solve core problems, according to five of the people who spoke to POLITICO for this story, including two former officials. Novavax during that same period pursued deals with multiple countries and international organizations, including the Serum Institute of India and the World Health Organization, to begin distributing its vaccine across the world by the end of 2021. Novavax has pledged 1.35 billion doses to the world, along with the 100 million it promised the U.S. Yet in the year since then, it's failed to successfully deliver a single dose — leaving the world's neediest countries in limbo as it tries to convince regulators it can consistently produce a high-quality shot.The delays have posed a serious challenge to American and international officials’ plans to vaccinate the world. With at least five billion doses still needed to meet global demand, the Biden administration has sought new ways to plug the gap in the coming year.
Much more: https://www.politico.com/news/2021/10/29/warp-speed-waiting-novavax-vaccine-517503
