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First task for Biden’s CDC director: Fix everything Trump broke

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Enlarge / Dr. Rochelle Walensky, President-elect Joe Biden’s pick to head the Centers for Disease Control.

Midday today, January 20, Dr. Rochelle Walensky will take over as director of the Centers for Disease Control and Prevention—and one of her top priorities will be to try to undo all the harms done to the agency by the Trump administration.

“How is it that I make sure that the people who are there—these incredible scientists, these incredible civil servants for their entire career—understand and feel the value that we should be giving them? They have been diminished. I think they’ve been muzzled, that science hasn’t been heard,” Walensky said in a brief, but wide-ranging interview with JAMA Tuesday. “This top-tier agency—world renowned—hasn’t really been appreciated over the last four years and really markedly over the last year. So, I have to fix that.”

Part of her plan to do that is unmuzzling those scientists and getting their science out to the public where it can make a difference. And that blends into the next challenge: “We obviously need to get this country out of COVID and the current pandemic crisis,” she said. And that will also entail increasing communication with the public, as well as state and local health authorities and members of Congress.

Walensky—a professor of medicine at Harvard Medical School and chief of the Infectious Disease division at Massachusetts General Hospital and Brigham and Women’s Hospital—will be new to government health work when she takes over the federal agency of over 10,000 staff today. “I will have all of the benefit of coming in from the outside and being able to look in and say ‘This feels really broken,’” she said. For any institutional knowledge she’ll need, she’ll rely on long-standing career staff, she added.

Like President-elect Biden, Walensky will immediately focus on helping smooth out and speed up the COVID-19 vaccine rollout—and reaching the administration’s goal of getting 100 million shots into arms in the first 100 days. According to CDC data as of January 19, the government has distributed more than 31 million doses, but less than 16 million have been administered.

A bit of a cushion

Picking up the pace will involve helping states set the right eligibility conditions for vaccination—conditions that aren’t so restrictive that vaccine doses end up sitting unused in refrigerators, or so loose that there are long lines outside overwhelmed vaccination sites, she said. The Biden team also aims to boost manufacturing for vaccine supplies, increase the number of people who can provide vaccines, and increase the number of places where vaccines are administered.

Addressing one of the most pressing topics in recent days, Walensky also said she and the Biden team have their eye on the concerning coronavirus variants that are popping up in various places around the world—including the US. The team is working to “dramatically” bolster surveillance efforts, including partnering with industry and academic labs, so that they can track any variants that develop in or enter the US and begin to spread.

The main things to worry about with variants are if they spread more easily, if they cause more severe disease and deaths, and if they make therapies and vaccines less effective, she noted. We’ve seen variants that seem to spread from person to person more easily. But we have yet to see evidence that variants are increasing disease and death or that they’re evading vaccines and therapies.

“I think the good news with regard to the variants is that the efficacy of the vaccines is so good and so high that we have a little bit of a cushion,” she said. Even if lab studies show vaccines aren’t quite as effective against a variant as the initial strain, “we’ll probably still end up with quite a good vaccine.” Her point has been echoed by many other experts who predict it will take years before the coronavirus evolves to completely outwit immune responses.

“I just want to remind people: almost no vaccine we have is 95 percent effective” like the COVID-19 vaccines, she added. “So, before we panic and say ‘well, should I really get the vaccine if it’s not going to work against the variant?’—It’s going to work against the variant. Will it be 95 percent? Maybe. Will it be 70 percent? Maybe. But our flu vaccines aren’t 70 percent effective every year and we still get them. So, I’m really optimistic about how these variants are going to go.”

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Biden says US will halve carbon emissions by 2030

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Getty Images | Bloomberg

President Joe Biden announced Thursday that the US would cut carbon emissions by 50 to 52 percent by 2030 compared with 2005 levels. It’s an aggressive target that aims to put the country on a path to limit warming to below 1.5˚C.

The pledge comes as Biden hosts dozens of world leaders for a virtual climate summit today. It nearly doubles the targets set by former President Barack Obama when the Paris Agreement was initially signed.

“This is a moral imperative, an economic imperative. A moment of peril but also a moment of extraordinary possibilities,” Biden said.

The US reduced its carbon emissions to 13 percent below 2005 levels in 2019, the most recent “normal” year for energy use. While the number represents a notable decline given that the economy grew in that time, it’s still short of where the country should be if it is to achieve either Obama’s or Biden’s goals.

The US isn’t the only country that has come up short in terms of actual reductions. The world as a whole is far from meeting the goals set forth in the Paris Agreement. We’re currently on track for 3˚C of warming by 2100, an amount that would result in catastrophic consequences for people around the globe.

Emissions targets pledged as part of the Paris Agreement aren’t binding, but they do offer roadmaps for countries to decarbonize. The agreement also encourages countries to make their pledges more ambitious over time, with the hopes that emissions will decline more rapidly as technological advancements and diplomatic pressure make significant reductions more appealing.

Other leaders used the forum to announce new commitments as well. Prime Minister Yoshihide Suga of Japan said his country would aim for a reduction of 46 percent below 2013 levels, almost double its previous commitment. Canada’s Prime Minister, Justin Trudeau, increased his country’s pledge to 40 to 45 percent below 2005 levels by 2030, a bump above the previous 30 percent commitment. The European Union and the UK didn’t update their pledges, but both have already committed to major cuts over the next nine years, with the EU targeting 55 percent and the UK shooting for 68 percent.

China’s Xi Jinping also reiterated his country’s previous commitment to halt the growth of emissions by 2030 and reach net zero by 2060. China’s carbon pollution has grown precipitously over the last 20 years, to the point where the country now produces more than twice as much as the next largest polluter, the US. India, another country with swiftly rising emissions, did not put forth any targets, nor did it add to its previous commitments. Instead, Prime Minister Narendra Modi restated his country’s promise to install 450 GW of renewable energy capacity by 2030.

Globally, carbon emissions dropped 6.4 percent last year as the world hunkered down to weather the pandemic. The US contributed the most to that decline with a 13 percent drop, and most of that happened in the transportation sector, which produces the largest share of the nation’s carbon pollution. Globally, the decline in air travel allowed the aviation sector to halve its emissions.

The Biden administration again signaled that it’s considering a “border carbon adjustment”—basically a carbon tariff. Such a tariff would apply to imports from countries where carbon regulations aren’t as stringent.

For many countries, the energy transition has become less of a burden and more of an opportunity to leapfrog laggards by developing early leads in a host of promising and increasingly affordable clean technologies, including solar, wind, and batteries. Biden appears to agree with that idea and is hoping to position the US among countries taking the lead. “The countries that take decisive action now to create the industries of the future will be the ones who reap the economic benefits of the clean energy boom that’s coming,” he said.

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Contractor that ruined 15M doses of J&J vaccine hiked price of another by 800%

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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.

Things are not looking good for Emergent BioSolutions, the contract manufacturer that ruined 15 million doses of Johnson & Johnson’s one-shot COVID-19 vaccine and millions more doses of AstraZeneca’s COVID-19 vaccine at its production facility in Baltimore.

The Food and Drug Administration on Wednesday released a searing inspection report of the facility, finding a slew of significant violations and failings.

Meanwhile, federal lawmakers have opened a multi-pronged investigation into whether Emergent used ties to the Trump administration to get billions of dollars in federal contracts despite a history of failing to complete contracts, inadequately training staff, persistent quality-control issues, and an “unjustified” 800% price increase for an anthrax vaccine.

In a letter sent to Emergent’s top executives Tuesday, Rep. Carolyn Maloney, chairwoman of the House Committee on Oversight and Reform, and Rep. James Clyburn, chairman of the Select Subcommittee on the Coronavirus Crisis, laid out the investigation, writing:

Emergent received $628 million in June 2020 to establish the primary US facility for manufacturing vaccines developed by Johnson & Johnson and AstraZeneca. Dr. Robert Kadlec, who served as Assistant Secretary for Preparedness and Response under President Trump and previously worked as a consultant for Emergent, appears to have pushed for this award despite indications that Emergent did not have the ability to reliably fulfill the contract.

800% drain

But the investigation stretches back much farther than the start of the pandemic—through years of questionable federal contracts.

In 1998, Emergent (then called BioPort) bought the license to an anthrax vaccine. The vaccine, BioThrax, was approved by the FDA in 1970 but remains the only FDA-approved vaccine for anthrax. As such, Emergent is the sole supplier of anthrax vaccine for the federal government’s Strategic National Stockpile (SNS). When Emergent bought the vaccine in 1998, a dose went for about $3.35. By 2010, the price was up to $28 a dose. Now, the price is over $30, and average wholesale prices are even higher, reaching $90 per dose, the lawmakers note.

“Emergent has raised the government purchasing price of the anthrax vaccine by 800% since acquiring the drug in 1998,” the lawmakers write in their letter. “As a result, through most of the last decade, nearly half of the SNS’s budget has been spent purchasing Emergent’s anthrax vaccine. These spiraling costs contributed to shortages of critical supplies, including ventilators, reusable respirator masks, and other personal protective equipment, which severely impacted the government’s ability to respond to the coronavirus crisis.”

This drain on the SNS budget was particularly apparent during the pandemic—which Robert Kadlec, the former Emergent consultant, himself acknowledged.

Kadlec was nominated in 2017 by President Trump to lead the Office of the Assistant Secretary for Preparedness and Response (ASPR). Following his confirmation, Emergent received millions of dollars in federal contracts from ASPR, including contracts for the SNS that were awarded without competitive bidding, the lawmakers note in their letter.

In 2020—just before the pandemic hit the US—Kadlec’s office awarded Emergent around $3 billion in long-term contracts for anthrax and other bioterrorism threats. According to the lawmakers, Kadlec later suggested this was a bad move, saying: “If I could spend less on anthrax replenishment, I could buy more N95s. I could buy more ventilators. I could buy more of other things that quite frankly I didn’t have the money to buy.”

Failures and an inspection

Aside from the skyrocketing prices, the lawmakers suggest Emergent didn’t even deserve the contracts in the first place. In 2012, the Department of Health and Human Services awarded Emergent a $163 million contract to renovate its (currently troubled) Baltimore manufacturing plant. The idea was for the plant to become a manufacturing hub for rapidly producing vaccine in the event of an infectious disease outbreak or bioterror attack. Part of the contract stipulated that Emergent would be required to do a test run, producing 50 million doses of a pandemic influenza vaccine in the span of four months, and obtain manufacturing approval from the FDA by June 2020.

Emergent failed to meet those requirements.

Reading the FDA’s inspection report of Emergent’s Baltimore facility, it’s clear why. During the nine-day inspection, which ended April 20, FDA inspectors logged a long list of problems at the facility.

First on the list is that Emergent failed to thoroughly investigate how the millions of Johnson & Johnson and AstraZeneca doses became contaminated. The agency concluded that, without a thorough review of what happened, it’s possible that other finished batches of vaccine may also be ruined. “There is no assurance that other batches have not been subject to cross contamination,” the inspectors wrote.

The FDA inspectors went on to note unsanitary conditions, paint peeling off of the walls and floors, residue on equipment, improperly trained staff, and numerous opportunities for vaccine products to be contaminated.

The potential for cross contamination—spread of viral ingredients back and forth between Johnson & Johnson’s vaccine and AstraZeneca’s vaccine—appeared rampant at the facility. Inspectors witnessed Emergent employees dragging unsealed, non-decontaminated bags of medical waste across different manufacturing areas. In some cases, employees tossed bags of medical waste, unsealed, into a service elevator. Emergent did not have proper written procedures for how to decontaminate waste, the inspection report notes. Security footage also caught employees moving from different areas of the facility without following proper procedures for donning and removing protective gowns.

At the request of the FDA, vaccine production at the Baltimore facility has been halted since April 16.

In a statement Wednesday, Emergent said that the FDA’s findings “provide direction on the necessary steps to improve operations.” The company went on:

The FDA’s feedback will help us continue to improve and strengthen the supply chain for Johnson & Johnson’s COVID-19 vaccine. While we are never satisfied to see shortcomings in our manufacturing facilities or process, they are correctable and we will take swift action to remedy them.

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Trump EPA sidelined its own scientists when rewriting fuel economy rules

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Enlarge / Former EPA Administrator Scott Pruitt.

The Trump administration effectively muffled scientific staffers at the Environmental Protection Agency when it rewrote automobile pollution rules, the agency’s watchdog said.

When drafting fuel economy and greenhouse gas pollution rules for cars and light trucks, former EPA Administrator Scott Pruitt decided to cede various EPA duties to the National Highway Transportation Safety Administration in what is typically a collaborative process, the independent inspector general said in a report released yesterday. Though Pruitt signed the final report for the EPA, he allowed NHTSA staff to write a significant portion of the rules and to complete all modeling and analysis for both agencies.

The NHTSA’s modeling efforts did not use the EPA’s established tools that had been created to evaluate greenhouse gas emissions standards. Instead, the NHTSA hacked its own Corporate Average Fuel Economy models and sent EPA experts the results late in the process. “Technical personnel were unable to fully collaborate on rule development,” the report said.

The EPA and the NHTSA have collaborated on fuel economy and emissions standards since 2010 in an effort to streamline and harmonize regulations for automakers. In rules written during the Obama administration, the EPA and NHTSA called for 5 percent annual increases in fuel economy. After Trump was elected, though, automakers wrote to his transition team to request that the annual increases be frozen. The Trump administration obliged, reviewing the rule and issuing a new one calling for 1.5 percent increases in fuel economy. The reason for the reduction, the Trump administration said, was that it would help keep auto prices lower, allowing consumers to buy newer, safer vehicles. Not everyone was convinced by that logic.

That the final rule included such a rationale is not surprising in light of the inspector general’s report. When making fuel economy rules, the Energy Policy and Conservation Act directs the NHTSA to consider four different variables—“technological feasibility, economic practicability, the effect of other government standards on fuel economy, and the need of the nation to conserve energy,” the report points out. None of those includes pollution or its effects.

The EPA, on the other hand, is the only agency that the Clean Air Act allows to regulate greenhouse gas emissions from new vehicles.

Career EPA staff, who are not political appointees, reportedly felt shut out of the process, a drastic departure from the previous four times they worked with the NHTSA to jointly issue pollution and fuel economy rules.

The inspector general’s report also noted that the EPA skipped major milestones in its rule-making process. According to the report, the agency “did not document who decided to skip these milestones and why.”

New EPA Administrator Michael Regan said he would be reviewing the Trump-era fuel economy standards and will release a revised rule by the end of July. The new rules could effectively phase out fossil fuel vehicles.

Stifling science

This latest report isn’t the only one to find fault with the way the Trump administration went about writing or rewriting environmental regulations. EPA political appointees also ordered career staff to scale back efforts to monitor ethylene oxide pollution in the Chicago area. The flammable gas is used to sterilize medical equipment, but it’s also a proven carcinogen.

Chicago EPA staff, barred from an official effort to document ethylene oxide pollution, installed air pollution-monitoring equipment outside an agency warehouse that abutted a large sterilization plant owned by Sterigenics, a major emitter of ethylene oxide. The scientists discovered that pollution from the plant was at such high levels that it significantly increased the cancer risk in the surrounding neighborhood by orders of magnitude, according to a report by the Chicago Tribune. The company couldn’t get the plant’s pollution under control and ultimately closed the site after significant opposition from the community.

The EPA is also undertaking a broader review of decisions in which the agency’s scientific integrity may have been compromised. Regan asked employees to bring “items of concern” to scientific integrity officials or the inspector general, who would investigate accordingly.

Trump administration officials at the Centers for Disease Control and Prevention are also under fire for their meddling in scientific affairs. Earlier this month, documents released to the public showed political appointees pushing for changes in how the CDC framed reports about COVID-19 and the agency’s Morbidity and Mortality Weekly Reports. The alterations helped frame the CDC’s reporting on the pandemic in terms that hewed more closely to then-President Trump’s rosy outlook.

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