banner



Home  ›  World Of Warships Says Download Speed Has Fallen To Zero UPDATED

World Of Warships Says Download Speed Has Fallen To Zero UPDATED

Written By Tuesday, March 8, 2022 Add Comment Edit

World Of Warships Says Download Speed Has Fallen To Zero

U.South. markets open up in 4 hours 44 minutes

  • S&P Futures

  • Dow Futures

  • Nasdaq Futures

  • Russell 2000 Futures

  • Rough Oil

  • Aureate

  • Silver

  • EUR/USD

  • 10-Yr Bond

  • Vix

  • GBP/USD

  • USD/JPY

  • BTC-USD

  • CMC Crypto 200

  • FTSE 100

  • Nikkei 225

Novavax'due south effort to vaccinate the earth, from zero to not quite warp speed

A stock image of a syringe with a drop of liquid coming out in front of the Novavax logo
A stock image of a syringe with a drib of liquid coming out in forepart of the Novavax logo

On a sweltering June morning, Novavax CEO and covid vaccine maker Stanley Erck stood on a stage unmasked and did something that would have been unthinkable 6 months ago: He shook hands with Maryland's governor.

Erck was with Gov. Larry Hogan to announce Novavax'due south global vaccine headquarters ― a campus expected to house laboratories and more 800 employees. Hogan called Novavax'south hereafter "bright" and marveled that more than than 71% of the land'due south adults had received at least one shot.

  • How the history of Zimbabwe played out on the country'south cricket fields

None of those was a Novavax vaccine, which is still unavailable for the American public due to delayed clinical trial results and other difficulties. Hogan, for his part, received his start vaccine dose ― made by young man biotech upstart Moderna ― in January.

"As you tin imagine, we're eager to receive our own," said John Trizzino, Novavax's chief commercial officeholder and interim master financial officer. Its two-dose covid vaccine, which showed overall 90.four% efficacy in key U.S. and Mexico trials, has notwithstanding to be authorized. "In the meantime," Trizzino said, "nosotros've had to utilise one of the existing licensed vaccines and we look forward to the booster" fabricated by Novavax.

Looking forward has kept Novavax afloat for decades ― along with its deep ties to grant makers and federal agencies. With its focus on developing vaccines, including for the SARS and MERS pandemics, Erck argues Novavax is "built for this moment." Withal, the 34-year-old startup has never brought one to market place.

  • Half of urban carbon emissions come from just 15% of cities

Novavax's quest to scale up operations underscores how difficult it can exist to launch a vaccine ― even with the formula and engineering in mitt. And then what happened? Information technology has had the financial backing of the U.Southward. government and full faith of international agencies. Everything took longer than expected: hiring necessary researchers and scientists, getting supplies and transferring its vaccine technology. It didn't move at warp speed.

America is awash with vaccine options, and Novavax does not plan to file for regulatory authorizations until late July at the primeval. The delay could have dire consequences for people across the globe awaiting a vaccine.

"We're not making aspirin," Trizzino said. "We're making a very complicated biological."

A moonshot goal

A yr earlier the covid pandemic hit, Novavax had a failed late-phase trial on a potential respiratory virus vaccine, after which it cut its workforce and sold off all its manufacturing capabilities. So, when more than $ii billion in federal and international funding landed at its doorstep, Novavax plant itself developing both "a vaccine and a visitor" in 12 months, said Dr. Gregory Glenn, president of research and development.

Novavax's proprietary secret ingredient is Matrix-M, an immune booster. Executives say the additive ― derived from Chilean soapbark copse ― works and so well that less of an antibody-producing antigen would be needed with it in a vaccine. One financial filing said Matrix-M "has the potential to be of immense value."

Equipped with its recombinant nanoparticle vaccine mixed with Matrix-M, Novavax deployed a core team of employees, dubbed "SuperNOVAs," to crisscross the globe. They assembled a manufacturing network and shared vaccine technology in India, South korea, Spain, Nippon and the Czech Commonwealth too every bit in the Usa ― about 20 contract manufacturing and test sites in all.

"This takes fourth dimension and expertise," Trizzino said. "You just simply tin't hand over the recipe so walk away from it and expect you're going to have a high-quality product."

Novavax is contracted to course the courage of the COVAX initiative, having promised 1.ane billion doses starting this year for developing countries. And while President Joe Biden announced the U.S. would donate 500 one thousand thousand doses of the Pfizer-BioNTech vaccine abroad, Novavax is still seen as vital to urgent efforts worldwide to battle the virus and its variants.

Novavax's moonshot goal of producing two billion shots a twelvemonth increasingly looks like a pipe dream for 2021. "Information technology is very hard to accept that they will make 2 billion doses as they had originally committed. I'chiliad very skeptical," said Prashant Yadav, a health care supply chain expert and senior boyfriend at Harvard'south Center for Global Evolution.

One of Novavax's biggest challenges, Yadav said, is relying on "and then many sites" that aren't fully nether its control, while other manufacturers own their plants. The more places Novavax produces the vaccine, the more than challenging it is to make certain the vaccine and its elements are comparable in every place.

When Novavax executives announced another delay in May, the company'due south stock plummeted to $121 a share ― down 62% from a loftier of about $319 in February. As the company'southward fortunes rose last twelvemonth, Novavax executives cashed out tens of millions of dollars in common stock, according to securities filings. Last twelvemonth, after the company benefited from grants and government contracts, CEO Erck sold $ix.3 million in company shares, Glenn sold $xiv 1000000, and Trizzino sold $11.3 million.

Those pinnacle executives connected selling in 2021. Erck sold more than $22.5 one thousand thousand worth of common stock in early July.

Novavax executives use trading plans, and the sales oft announced at the same fourth dimension each month. In June, subsequently Novavax appear its long-awaited U.Southward. and Mexico clinical trial results, Glenn sold more viii,000 shares for $one.5 1000000. As a measure out of the company's spectacular rise in the pandemic, Glenn purchased ane,000 shares of stock in December 2016 for the toll tag of just $1,446.

Novavax spokesperson Amy Speak said the company has programs in place to ensure all-time practices on stock sales. "Near people, including our executives, sell stock for a wide diverseness of reasons," she said, adding that Novavax's executives have "generally sold a fraction of their overall holdings in the visitor."

Charles Duncan, a biotechnology research analyst at Cantor Fitzgerald, called Novavax a "evidence me" investment in May. "It's i affair to take a place to get in," he said. "It's some other thing to exist able to make information technology at that place and get it certified."

'Hadn't heard of Covid-19'

John Kutney, Novavax'south senior director of manufacturing, joined a BioBuzz video in December, in an endeavour to recruit urgently needed talent. Kutney described the applied science transfer equally taking a recipe and teaching it to others. With that mission, he has traveled to the Czech Commonwealth, Spain and the United Kingdom too as Texas, North Carolina and New England.

When Novavax began work on its vaccine in January 2020, "nigh of us hadn't heard of covid-nineteen and nosotros were but commencement to become aware of what was happening in China," Kutney said. Novavax adjusted its established vaccine platform to the new virus and and so had to calibration and transfer it to larger manufacturing sites, build a global supply chain and develop a regulatory strategy for emergency use.

"These steps would ordinarily take years," he said.

The central step of transferring Novavax's vaccine technology tin take three to six months, depending on the quality of the partner's team. In one case equipment and raw materials are secured, the teams commencement with minor batches ― first with a fifty-liter bioreactor, so a 200-liter and eventually a 2,000-liter bioreactor, checking to brand certain the partner operators know the process every pace of the style.

"What we're trying to do here is not easy," said Fred Shemer, Novavax's vice president of quality systems and compliance, in the video: "It'southward a challenging situation."

In March 2020, Novavax received the first $4 meg of nearly $400 meg pledged by the Coalition for Epidemic Preparedness Innovations. CEPI is a global alliance backed past the Bill and Melinda Gates Foundation, which previously supported Novavax with $89 million for a vaccine for a mutual respiratory virus.

CEPI's investment jump-started Novavax'south technology transfer to plants across Europe and Asia. It helped Novavax partner with SK bioscience in South Korea and paid for ramping up production at Praha Vaccines, which Novavax eventually bought, in the Czech Republic. Information technology likewise supported scaling up production of Matrix-M at facilities in Sweden and Denmark.

Operation Warp Speed awarded $ane.half dozen billion in July 2020 to Novavax so information technology would produce 100 million doses ― one of the largest awards from the Trump assistants'south vaccine incubator. It was "kind of a stunning number for usa," Trizzino said. In December, officials bumped the total to $1.74 billion with no changes to the previous contract. Novavax also has a $60 million contract with the Department of Defense for 10 million doses.

Paul Mango, a former senior official at the Department of Health and Human being Services, said information technology wasn't a "large concern" for the Trump assistants that Novavax had no successful vaccine. After all, that was likewise true for Moderna, which went on to launch its wildly successful mRNA vaccine.

Performance Warp Speed's personnel resources and financial back up would help carry the day. "We thought we could do it," Mango said.

At the time, Trump officials invested in several vaccine platforms to hedge bets because it wasn't known what would work, if any. "We didn't want to put all our eggs in mRNA," he said. "Nosotros didn't want to put all our eggs in viral vector," the platform used by Johnson & Johnson and AstraZeneca. Novavax's engineering science uses a more established process with a baculovirus grown inside insect cells in a bioreactor.

"It was very important to have that assortment of technologies," Mango said. "We had to pick the ones that had the best early results and the ones we thought could go through clinical trials before the spring of 2021."

Novavax scientists have spent years collaborating with officials at federal agencies such every bit the National Institutes of Wellness, National Institute of Standards and Technology, and Walter Reed National Armed services Middle ― sometimes hiring from their ranks. In 2011, Novavax signed a $179 meg contract to develop a seasonal and pandemic influenza vaccine with BARDA, the Biomedical Avant-garde Inquiry and Development Authority.

As concerns well-nigh covid-19 rose, Novavax and BARDA began another negotiation, just Operation Warp Speed officials "stepped over the top," Trizzino said. They asked Novavax what information technology would take to ramp up big-scale manufacturing, run a 30,000-subject clinical trial and the follow-on trials, and produce millions of doses.

"They said, 'Practise all these things in parallel paths. You don't worry nigh the funding risk. Yous do the work and we'll pay for those activities,'" Trizzino recalled.

Troubles in Texas

Information technology was a tall order. Novavax had worked with Emergent BioSolutions and signed a contract for manufacturing in early 2020, but BARDA pushed Novavax to partner instead with Fujifilm Diosynth Biotechnologies and its plants in North Carolina, Texas and the U.K.

In retrospect, Trizzino said, Novavax "dodged a bullet." Production bug at Emergent's Baltimore plant led to contamination or suspected contagion of millions of Johnson & Johnson and AstraZeneca doses, and in June federal regulators declared 60 million J&J doses unusable, The New York Times first reported.

Fujifilm'south Texas site, like Emergent's constitute in Baltimore, was ready in the backwash of the 2009 H1N1 pandemic to better prepare federal officials for the next one. It received $265 1000000 last July to quickly boost manufacturing capacity, according to a federal contract.

The site began production in January but had to slow the cadence of its manufacturing lines for "troubleshooting" during Novavax's engineering transfer process, Fujifilm spokesperson Christine Jackman said. The plant is producing the Novavax vaccine and another undisclosed covid vaccine.

Trizzino said Fujifilm's site in North Carolina was upwardly and running quickly, simply Texas didn't have as much experience and then "information technology's taken us a bit longer to ramp that upwardly." A March inspection by the Food and Drug Administration found overcrowded and unorganized storage areas, a failure to consistently follow cleaning procedures and questions almost why there was a backlog of batches, according to documents obtained past KHN in response to a public records request. The backup formed because bulk drug substance was being made faster than the facility could review produced batches, Fujifilm's Jackman said.

FDA inspectors called Fujifilm'due south operations "sub optimal quality," according to an April response memo written by Gerry Farrell, Fujifilm's chief operating officeholder for the facility. He said the criticism resonated and promised a thorough review with fixes completed in April and May.

Novavax and Fujifilm work closely to ensure all batches are reviewed and inspected by both companies' quality control teams, said Speak, the Novavax spokesperson. The number of doses produced in Texas to engagement have not met projections. However, responding to federal inspections in Texas has non delayed Novavax'due south vaccine evolution because Fujifilm's Due north Carolina plant is the master supplier of vaccine doses for the initial federal blessing, Speak said.

Novavax's manufacturing procedure is complicated because the vaccine is made in steps in different places. One plant makes the poly peptide antigen, and another makes the adjuvant. Then the two components go to a final fill-and-finish facility where they are combined into 10-dose vials.

Its Matrix-M relies on quillaja excerpt from soapbark trees. The extract is likewise an additive in root beer and Slurpees. Novavax warned investors in its Dec 2020 financial filings that an inability to secure enough of the extract could delay production and prevent it from meeting "obligations under our diverse collaborations and supply agreements." Still, Trizzino said that supply is "non an obstacle to total number of doses."

Supply shortages accept plagued the industry. For Novavax, those supplies included 2,000-liter bioreactor bags, used to civilisation cells; depth filters for the purification process; and the growth media, which is used to feed the cells.

Not having raw materials forced Novavax to trim the number of test batches that manufacturing lines could run. It has also taken longer to create quality control tests, known as assays, to ensure that vaccines are consistent and establish a standard quality for all subsequent batches. Those delays slowed the company'south ability to properly train operators, Trizzino said.

Novavax is working to achieve "a level of comfort that nosotros're able to produce these batches and then get to full capacity," Trizzino said. Novavax is working to consummate the final phases of validating those tests.

Too tardily?

At the headquarters result, Glenn acknowledged that Novavax is late to the game. But the global demand is still enormous, he stressed.

"We know that 2 billion people worldwide have received at to the lowest degree one shot," he said, "simply there are 6 billion people that demand to exist inoculated."

The company is working to bear witness its vaccine will exist useful even afterwards the pandemic is contained. With its Matrix-M adjuvant, Novavax is testing a combined flu and covid vaccine, which is showing strong results in ferrets and hamsters. Novavax is also focused on booster shots.

Novavax joined mix-and-match trials this jump in the U.Chiliad. to test whether its vaccine works when paired with Moderna, Pfizer or AstraZeneca's vaccines. Glenn said the results, and so far, have been promising that "we're going to be able to use our vaccine after other licensed vaccines."

First, though, "the world has to collectively, as one, really stymie this global pandemic," said Dr. Dawd Siraj, a University of Wisconsin professor specializing in infectious diseases.

Siraj said Novavax's delays shouldn't cast doubt on the quality of the vaccine itself, given the positive trial results information technology has reported globally.

The shot is a "very good vaccine," he said, that could help turn the tide in developing countries unable to support their own vaccine development.

"Let us never miss the most of import point here," Siraj added. "Anyone who is getting a vaccine that is canonical, the chances of dying, the chances of requiring ICU care, the chances of requiring a ventilator and high-flow oxygen, they well-nigh disappear."

KHN (Kaiser Wellness News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Assay and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health problems to the nation.

Sign up for the Quartz Daily Brief, our free daily newsletter with the world's most important and interesting news.

More stories from Quartz:

  • The face of global luxury brands in China is at the heart of a #MeToo storm

  • All the athletes who have dropped out of the Tokyo Olympics (and then far)

DOWNLOAD HERE

Posted by: barrowsquichaved1942.blogspot.com

0 Response to "World Of Warships Says Download Speed Has Fallen To Zero UPDATED"

Post a Comment

Subscribe to: Post Comments (Atom)

Iklan Atas Artikel

Iklan Tengah Artikel 1

Iklan Tengah Artikel 2

Iklan Bawah Artikel