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After ruining 75M J&J doses, Emergent gets FDA clearance for 25M doses

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Enlarge / The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson’s COVID-19 vaccine, in Baltimore, Maryland, on April 9, 2021.

The US Food and Drug Administration is making progress in its efforts to sort out the fiasco at Emergent BioSolutions’ Baltimore facility, which, at this point, has ruined more than 75 million doses of COVID-19 vaccines stemming from what the regulator identified as significant quality control failures.

In March, news leaked that Emergent ruined 15 million doses of Johnson & Johnson’s vaccine as well as millions more doses of AstraZeneca’s vaccine. The spoilage happened when Emergent cross-contaminated batches of the two vaccines with ingredients from the other.

Last week, the FDA told Emergent to trash about 60 million more doses of Johnson & Johnson’s vaccine due to similar contamination concerns, The New York Times reported.

But at the same time, the agency cleared 10 million doses of Johnson & Johnson’s vaccine for use—with the catch that the doses must carry a warning saying that the FDA cannot guarantee Emergent followed good manufacturing practices while making them. And on Tuesday, the FDA cleared an additional 15 million doses of Johnson & Johnson’s vaccine, bringing the total number of acceptable doses to just 25 million, according to The Wall Street Journal.

Still, more than 100 million finished doses of Johnson & Johnson’s and AstaZeneca’s vaccines are still in limbo at the facility, awaiting FDA review. All of the doses at the facility were made prior to April 16, when the FDA shut down production after an investigation found sweeping and significant quality control failures and manufacturing violations.

Some lawmakers say the issues were clear before the investigation; Emergent has a long track record of such problems, as well as trouble fulfilling contracts.

Troubled past

Still, the manufacturer was contracted during the pandemic to produce both the Johnson & Johnson’s one-dose vaccine and AstraZeneca’s vaccine, which use similar adenovirus-based vaccine platforms. Emergent had also been awarded millions of dollars in federal grants to help respond to the pandemic swiftly, including $27-million monthly “reservation” payments to keep its facility at the ready to produce large amounts of vaccine under proper manufacturing standards and practices.

But the FDA’s nine-day inspection of the Baltimore facility, which began April 12, revealed that Emergent wasn’t putting that money to good use. FDA inspectors logged a long list of problems, including unsanitary conditions, paint peeling off of the walls and floors, black and brown residue on surfaces, improperly trained staff, and numerous opportunities for vaccine products to be contaminated. For instance, inspectors witnessed Emergent employees dragging unsealed, non-decontaminated bags of medical waste across different areas of the facility. In some cases, employees tossed unsealed bags of medical waste in an elevator.

Though Emergent had already scrapped the initial 15 million contaminated vaccine doses at the time, FDA inspectors concluded that “there is no assurance that other batches have not been subject to cross contamination,” the inspectors wrote.

The FDA shut down production April 16 and has been sorting through the premade doses ever since. For the most part, Emergent’s failures have not had a significant impact on vaccination efforts in the US. All of the doses of Johnson & Johnson vaccine administered in the US were made in the Netherlands. And demand for the one-shot vaccine has slipped amid slowed vaccination rates and concern over an extremely rare but life-threatening blood-clotting condition. In fact, US regulators recently extended the expiration data on millions of doses that have gone unused. AstraZeneca’s vaccine, meanwhile, is not yet authorized for use in the US.

However, Emergent’s failures have global effects—many of the doses have been earmarked to be donated to other countries in need of vaccine supplies. The contamination problem has held up the export of potentially usable doses.

In a statement Tuesday after the FDA cleared the additional 15 million doses, Emergent said:

We welcome the approval of an additional batch of J&J vaccine made at Emergent. We remain committed to addressing the FDA’s observations in order to resume production as soon as possible and look forward to continuing our work to end this pandemic.

Federal officials stripped Emergent of its control of the Baltimore facility back in April, putting Johnson & Johnson in charge and telling AstraZeneca to find another manufacturer. Federal lawmakers, meanwhile, opened a multipronged investigation into whether Emergent used ties to the Trump administration to improperly obtain lucrative government contracts.

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Missouri AG wages war on masks as state blazes with delta cases

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Enlarge / Eric Schmitt, Missouri Attorney General.

Missouri has been one of the hardest-hit states so far in these early days of a delta-fueled COVID-19 surge. Cases increased nearly 500 percent since the start of July, while vaccinations stalled. Right now, with just 41 percent of the state fully vaccinated, 112 of the state’s 114 counties have high or substantial levels of coronavirus spread. Hospitalizations are up statewide, and some facilities have already run out of ventilators and seen intensive care units hit maximum capacity. Deaths are also increasing, with more than 300 people losing their lives this month since July 1. And the proportion of COVID-19 tests coming back positive is still rising, suggesting that things will likely only get worse in the weeks to come.

By nearly every metric, this entirely preventable surge is tragic. Yet, it hasn’t stopped the Show Me State’s Republican attorney general, Eric Schmitt, from waging war on local health restrictions aimed at trying to curb transmission. On Monday, Schmitt filed a lawsuit to stop St. Louis County and St. Louis City from enforcing mask mandates for fully vaccinated people and children, which took effect that day.

The timing of the lawsuit is awkward. It partly rests on now-outdated guidance from the Centers for Disease Control and Prevention that fully vaccinated people didn’t need to wear masks in most indoor settings. “The Mask Mandates are arbitrary and capricious because they require vaccinated individuals to wear masks, despite the CDC guidance that this is not necessary,” the lawsuit claims. The rest of the lawsuit didn’t argue that masks were ineffective at curbing transmission but rather claimed that they were unnecessary for children—despite that they are largely ineligible for vaccinations—and that requiring them is “unconstitutional.” Otherwise, the lawsuit nitpicked language of the mandates, such as alleging that they didn’t define the word “dwelling.”

The CDC reversed its mask policy Tuesday, citing evidence that even fully vaccinated people are catching and spreading the hypertransmissible delta coronavirus variant—though at much lower frequencies than unvaccinated people. The agency now recommends universal masking in K-12 schools and that fully vaccinated people mask in indoor public settings when local transmission is high or substantial. Both the city and county of St. Louis have high levels of COVID-19 transmission, as defined by the CDC.

Lies and freedoms

Still, Schmitt is not backing down. Though his office did not immediately respond to a request from Ars, Schmitt took to Twitter and Fox News to blast the CDC’s update.

“People are tired of being lied to by elites & the ruling class,” Attorney General Schmitt, who is also running for US Senate, tweeted on Tuesday evening. “We were told—get vaccinated and you don’t have to wear a mask. Now the vaccinated are forced to wear masks in St. Louis. Kids forced to wear masks too. The lies go on and on.”

On Wednesday, Kansas City’s Democratic Mayor Quinton Lucas announced that he, too, would reinstate an indoor mask mandate in the city for all persons aged five and older, regardless of vaccination status. And Schmitt quickly said that he would sue to stop that mandate as well.

“To the great people of Kansas City: I will be filing a lawsuit to protect your freedoms,” Schmitt tweeted Wednesday. This mask mandate is about politics & control, not science. You are not subjects but citizens of what has been the freest country in the world & I will always fight for you.”

It’s unclear how the lawsuits will pan out, but Mayor Lucas has already noted that he intends to put up a fight of his own. A press release from his office stated:

In light of recent litigation between the State of Missouri and the City and County of St. Louis, Mayor Lucas will also introduce a resolution in the weeks ahead for City Council support of emergency actions. Mayor Lucas stands with Mayor Tishaura Jones and County Executive Sam Page in protecting Missourians from the spread of COVID-19.

In St. Louis, County Executive Page also stood behind the mask mandate. The courts will decide its fate, he said, according to the St. Louis Post-Dispatch, but “until then, the law stands.” Page argued that masks are necessary to help lower transmission as more people get vaccinated. “These cases, and this curve is shooting straight up,” he said. “And if we don’t make some decisions fast, we’re going to be in a bad spot.”

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A global index to track the health of tropical rainforests

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We’ve known for decades that tropical rainforests are special. They’re nearly unrivaled in biodiversity, and research has shown that they absorb more carbon dioxide than any other ecosystem. A recent study showed that the tropics sequester four times as much carbon dioxide as temperate and boreal ecosystems combined—and several studies have estimated that all terrestrial ecosystems combined sequester as much as 30 percent of the total carbon dioxide in the atmosphere each year.

We’ve also known for decades that these ecosystems are at risk of vanishing. As much as 20 percent of tropical rainforests have been cleared in the last 30 years, with an additional 10 percent lost to degradation. Beyond these direct threats, forests worldwide, and especially rainforests, are experiencing severe losses due to climate change—notably higher temperatures and drought.

Until now, there haven’t been means to systematically keep tabs on the health of these critical ecosystems. But a collaboration of nearly 50 institutions has recently developed a comprehensive index to measure the health and vulnerability of all tropical rainforests around the world. The result is a potential warning system that allows scientists and policymakers to monitor and prioritize which forests are at the highest risk of irreversible damage and loss.

“Rainforests regulate the Earth’s climate; if they cannot function well—the patterns of climate will change almost everywhere on Earth,” says lead author Sassan Saatchi of the Jet Propulsion Laboratory at the California Institute of Technology and the Institute of Environment and Sustainability at the University of California, Los Angeles. “If we lose the ability of the tropical forests to function normally, for example absorb the carbon from the atmosphere, it may mean that all of the efforts we’re doing in terms of climate change mitigation may become moot.”

Preventing tipping points

This new tropical forest vulnerability index (TFVI) combines close to a dozen data sets spanning up to 37 years of measurements (1982–2018). Past efforts have focused on limited regions or have largely relied on fieldwork, but the TFVI brings together a wide range of available measurements and models of rainforest stresses and responses.

Stress measurements included climate data about temperature, the dryness of the air (vapor pressure deficit), and the amount of water entering and leaving each system (the water balance). Responses included tree cover, carbon storage, above-ground biomass, productivity, and evapotranspiration—the amount of water that each system exchanges with the atmosphere during photosynthesis. Available measurements also included an existing biodiversity index and the temperature of the land surface or, in forests, the temperature of the tree and leaf surfaces. In addition, models and satellite data were calibrated with ground readings as much as possible.

When combined, these measurements give a historical record of the overall health and functioning of rainforests around the world over the past several decades. From this, it’s possible to see how much stress different forests have survived in the past and to flag current and future stress readings that are far outside of past variations. The researchers suggest that too many stresses may create feedback loops that lead to tipping points, beyond which a forest will no longer recover, and the damage will become irreversible. Such tipping points can be rapid and cause mass tree deaths, or they can trigger relatively gradual transitions to a different ecosystem type, like a savanna.

Global rainforest health check

Based on current measurements, the index shows that forests in the Amazon are particularly vulnerable, while African forests in the Congo Basin are more resilient. The authors suspect this may be due to less development in the Congo Basin, as well as a history of more frequent droughts there. Forests in Asia are particularly threatened by land use and forest fragmentation.

The intention of the index is to help the early identification of forests that are in the most need of additional protections, as well as to provide specific guidance on exactly which stress factors the forests are experiencing. While some interventions, like slowing climate change, may require longer-term solutions, others—like forest fragmentation—could be managed with restoration projects.

The authors were also careful to include measures of uncertainty throughout the index, and the code for the index is freely accessible so that anyone can use it and, hopefully, improve upon it as well. Every month, the index is updated with the latest data, and the team expects to launch an online version in the next year.

“This index is not the ultimate answer. One of the biggest caveats is that, as much as we know about the ecosystem, we are always surprised how the ecosystem works, and it can still become vulnerable to something that we don’t know about, or it may become resilient to something that we thought it has been vulnerable to,” says Saatchi. “But this is a work in progress, and the more knowledge we gain in terms of the function of these ecosystems, the better we can predict which direction they’ll go. The index will help us to continuously take the pulse of global rainforests as their health is changing.”

Science Advances, 2021. DOI: 10.1126/sciadv.abe9829

K.E.D. Coan is a freelance journalist covering climate and environment stories at Ars Technica. She has a PhD in chemistry and chemical biology.

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Rocket Lab not yet close to profitability, proxy statement reveals

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Enlarge / Peter Beck, founder of Rocket Lab, is seen as essential to Rocket Lab’s success.

Rocket Lab

Running a rocket launch company is an expensive proposition. You need hundreds of employees, lots of expensive machines and tooling, plenty of hardware, and at least one launch site. To make matters worse, for a purely commercial launch firm like Rocket Lab, you typically only get paid when you deliver someone’s satellite into orbit.

So it is perhaps no surprise that the US-based company, which launches from New Zealand and has about 600 employees, has been losing a lot of money. According to a new proxy statement, Rocket Lab experienced net losses of $30 million and $55 million in 2019 and 2020, respectively. Given the company’s financial position, an independent auditor, according to the proxy statement, “expressed substantial doubt” about Rocket Lab’s “ability to continue as a going concern.”

These are the kinds of details we rarely see in the often financially opaque launch business, but as part of the process of converting into a publicly traded Special Purpose Acquisition Company, Rocket Lab had to make extensive financial disclosures. The full 712-page document can be downloaded here.

Rocket Lab reported revenue of $48 million in 2019 and $35 million in 2020. The decrease last year was due, in part, to the COVID-19 pandemic, the company said. It has contracts for 15 additional Electron launches for this year and beyond, valued at $127 million in launch and space systems revenue.

As of March 31 of this year, Rocket Lab has $34.2 million of cash and cash equivalents on hand. In addition to this, the company said it has access to both a $35 million revolving line of credit and a $100 million secured loan with Hercules Capital that is not repayable until June 2024. Rocket Lab acknowledged that there may be a fairly long pathway to profitability.

“We expect to continue to incur net losses for the next several years and we may not achieve or maintain profitability in the future,” the proxy statement says. “We believe there is a significant market opportunity for our business, and we intend to invest aggressively to capitalize on this opportunity.”

These financial losses may not cool the ardor of investors in Vector Acquisition Corporation, which is seeking to merge with Rocket Lab later this summer. Shareholders in Vector are due to vote on the proposed merger at a meeting on August 20. This merger will provide Rocket Lab with about $500 million in cash.

One reason investors will probably still be interested in Rocket Lab is that, unlike a lot of the space companies that have recently gone the SPAC route to become publicly traded, the launch company has solid revenue, demonstrated hardware, and a path toward growing its business.

Rocket Lab is already working to expand beyond small launch, including building its own satellites, performing satellite servicing in orbit, and building a medium-lift rocket called Neutron with a reusable first stage. In the proxy statement, Rocket Lab noted that Neutron has lift capacity of up to 8 metric tons to low-Earth orbit, 2 tons to the Moon, and 1.5 tons to Mars and Venus. Its first launch may occur as early as 2024.

Neutron, the company said, “will enable significantly higher revenue per launch with its capability to deploy larger spacecraft and greater numbers of spacecraft per launch as compared to our Electron launch vehicle, and will also be capable of supporting crewed flight and cargo resupply to the International Space Station.”

In terms of risks, the company cited the unexpected but potential loss of Peter Beck as its leader. Fiery, charismatic, and demanding of his employees, Beck has relentlessly promoted the Rocket Lab brand publicly and been a key driver of its technological innovation, the company said.

“We are highly dependent on the services of Peter Beck, our President, Chief Executive Officer and Chairman,” the proxy statement said. “Mr. Beck is the source of many, if not most, of the ideas and execution driving our company. If Mr. Beck were to discontinue his service to us due to death, disability or any other reason, we would be significantly disadvantaged.”

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