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Emergent CEO says FDA is holding over 100 million J&J Covid vaccine doses for additional testing after botched doses

Robert Kramer, CEO of Emergent BioSolutions

Scott Mlyn | CNBC

The FDA is holding over 100 million vaccine doses of Johnson & Johnson Covid-19 for further testing after the agency found multiple security breaches at the Emergent BioSolutions facility that helped make the gunshots, said Robert Kramer, CEO of Emergent, on Wednesday to lawmakers.

The US hired J&J to run the Baltimore facility last month after learning that Emergent, a federal company that made key ingredients for J&J and AstraZeneca, contaminated the two shots. Kramer testified before House lawmakers Wednesday that the conditions at the Baltimore plant allegedly were responsible for the destruction of millions of J&J Covid-19 shots.

During the hearing before the House Select Coronavirus Crisis Subcommittee, Rep. Steve Scalise, R-La., Kramer asked how many doses of J&J vaccine are held by the Food and Drug Administration but are not contaminated.

“There are a significant number of doses that we have made. Again we are making the mass drugs,” Kramer told lawmakers. “It has been reported by a number of news outlets that there are likely over 100 million doses of the J&J vaccine we make that are now under FDA review for possible release and availability.”

Kramer later stated that the regulator requested additional testing of the cans.

“The FDA, to the best of my knowledge, evaluates the doses made for mass drug use, most of which were provided to J&J,” Kramer said. “As far as I know, there was a request for additional testing on all of these lots and doses that J&J had made available to the FDA. And they are currently being evaluated.”

J&J declined to comment on the number of doses. The FDA did not immediately respond to a request for comment.

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Business

Why Japan Is Holding Again because the World Rushes Towards Electrical Automobiles

TOKYO – Just over a decade ago, Nissan was the first automaker to offer a production car that ran on batteries only. The hatchback, the Leaf, was a huge success, at least for electric cars. More than 500,000 copies had been sold by the end of last year.

But as the road that Nissan has taken becomes ever denser, Japan’s powerful auto industry is at risk of being left behind. As governments and automakers around the world make bold pledges to transition to all-electric vehicles, Japanese automakers and regulators are hedging their bets.

Japan dominates the global market for the current generation of climate-friendly vehicles – gasoline-electric hybrids – and hopes to capitalize on its huge investment in technology for as long as possible. However, with this short-term focus, there is a risk that the country’s most important industry will miss a transformative moment, said Masato Inoue, the lead designer of the original sheet.

“When it comes to disruptions, there is always fear,” said Inoue, who retired from Nissan in 2014. But, ready or not, he added, “a big wave of electric vehicles is really coming.”

Right now it’s just a wave. Electric cars account for less than 3 percent of global sales. Many buyers shy away from higher costs, limited range and long loading times. With the exception of a few luxury models, it is not easy to make a profit from the cars.

Still, the race for an all-electric future, long spearheaded by Tesla, has accelerated and broadened this year. In January, General Motors became the first major automaker to declare that it would eliminate all tailpipe emissions from its cars by 2035. Last week, Volvo promised to outperform its bigger competitors by promising to be all electric by 2030.

Alongside traditional automakers, startups like the Chinese company Nio and titans from other industries like Apple are looking for parts of the burgeoning market.

Automakers in the US, China, Europe and South Korea are already sprinting past their Japanese competitors. Toyota didn’t bring its first battery electric vehicle to the consumer market until early 2020, and then only in China. Honda relies on GM to manufacture electric vehicles for the US market.

Last year, Japanese automobiles made up less than 5 percent of battery electric vehicles sold worldwide, according to EV-volumes.com, a company that analyzes the electric car market. That proportion was largely due to the Leaf’s continued popularity: the automobile accounted for nearly 65 percent of all Japanese battery electric vehicles sold.

The electric vehicle rush has been fueled in part by plans in China, European countries and elsewhere to either require higher sales of electric cars or ban gasoline-burning vehicles in the coming years. Scientists say the transition from gas-powered vehicles is critical to tackling climate change and reducing smog.

Those moves have created a huge potential market for all-electric vehicles that investors clearly see as the cars of tomorrow: Tesla is more valuable than the next six automakers combined, despite only having a tiny fraction of their sales.

In Japan, however, automakers and the government are questioning some of the basic assumptions that power the electric train. They are skeptical – at least in the short to medium term – of the potential profitability and environmental superiority of electric cars.

In December, Japan announced that it would stop selling new gas-only cars by 2035. However, the government continues to view hybrids as an important technology and does not intend to follow the lead of places like the UK and California who plan to ban them. A Commerce Department official said in a recent interview. Japanese regulators announce that they will release details this year.

The opposition to the elimination of hybrids has found its strongest voice in Akio Toyoda, chairman of the Japan Automobile Manufacturers Association and president of Toyota, the world leader in hybrid car sales.

The company sets the tone for the entire Japanese auto industry. The company owns Daihatsu and in recent years has partnered with three smaller automakers – Subaru, Suzuki and Mazda – a group that makes more than half of all Japanese cars to develop electric vehicles, including hybrids. It has also heavily promoted cars that run on clean-burning hydrogen, a technology that has not yet caught on in Japan or elsewhere.

During a press conference in December in his capacity as head of the automobile association, Toyoda derided the idea of ​​replacing Japan’s hybrids with all-electric vehicles and accused the Japanese media of increasing their economic and environmental viability.

Electric cars, Toyoda emphasized, are only as clean as the electricity that drives them and the factories in which they are built. Japan, Toyota’s second largest market, plans to become carbon neutral by 2050. However, as long as it continues to rely on fossil fuels to generate electricity, the environmental benefits of vehicles will remain a mirage.

Japanese automakers are “hanging on their fingernails,” he added, and if Japan mandates a move to all-electric vehicles, which have fewer components and are easier to manufacture, it could cost millions of jobs and destroy an entire ecosystem of auto parts suppliers.

According to a report from market research company IDTechEx, sales of gasoline-electric hybrids are expected to continue to grow through 2027. It is understandable, therefore, that Japanese companies – and regulators – want to try to recoup the country’s huge investments in hybrid technology and wait to see how consumer preferences and foreign regulatory systems develop, said James Edmondson, an analyst for the company.

“For manufacturers like Toyota and Nissan, the hybrids are so productive that there is a good business model for them. It is therefore in the government’s interest to keep pushing for them,” he said.

Kota Yuzawa, an auto industry analyst at Goldman Sachs, said it wasn’t about whether Japan’s automakers could make the transition. They have world-class technology and invest significant resources in developing more of it. “But they’re waiting for the timing to be right,” he said.

“The biggest questions are: Can you make a mass market vehicle? Can you break even? ” he added.

The answer is yes, said Mr Inoue, the leaf designer who now splits his time between running a consulting firm and teaching sustainable mobility design at IAAD, a design institute in Italy.

The transition from building hybrids to building all-electric vehicles is not easy, however. The two types of cars cannot be inexpensively manufactured on the same platforms, Inoue said. “If a lot of companies don’t change now, the efficient production of electric vehicles will be quite difficult in the future.”

With a history of mass producing electric vehicles, Nissan is arguably the best positioned Japanese automaker to compete in the zero-emission car market. But the company says it has lost its lead and is now trying to catch up.

Last summer it announced its most ambitious battery-electric vehicle since the Leaf, an SUV called the Ariya. And in January, the company said it would be carbon neutral by 2050, a decision that reflected a new change in national policy late last year.

But like the other Japanese automakers, it is moving cautiously.

“For Nissan’s key markets, every brand new vehicle offering will be electrified in the early 2030s,” the company’s chief sustainability officer Joji Tagawa said in an email. “In other markets, however, we will gradually switch to electrified vehicles.”

In the meantime, the company will be heavily promoting its newer hybrid technology it calls e-Power: essentially an electric motor powered by a gas generator.

In Japan, the government’s lack of enthusiasm for zero-emission cars is likely to put automakers at a serious disadvantage, said Kazuo Yajima, a former chief engineer at Leaf who now runs Blue Sky Technology, a company that develops micro-electric vehicles.

China and the European Union have lost the hybrid technology race, Yajima said. Hence, their governments have made a strategic decision to invest in the development of electric cars, including key technologies such as batteries.

Japanese automakers’ reluctance to take the plunge to all-electric vehicles could lead them to suffer the same fate as the country’s consumer electronics companies, which have largely become irrelevant for not staying ahead of market trends, according to Yajima.

Mr. Inoue agrees. The automotive sector is “the final battlefield” for Japanese industry, he said.

“Now Japan is winning,” he said, “but I think if we lose the opportunity to switch to electric vehicles in 10 years, we may lose.”

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Health

Biden official says docs holding again wanted doses as reserve

Close-up of the Moderna vaccine at the Park County’s Department of Health’s COVID-19 Vaccination Clinic for Seniors 80+ on January 28, 2021 in Livingston, Montana.

William Campbell | Getty Images

Some health care providers have regularly withheld doses of vaccine for Covid-19 to ensure supplies are in place when people come back to get their second shots, an official on President Joe Biden’s coronavirus response team said Monday.

Andy Slavitt, a senior advisor to Biden’s Covid Response Team who previously served in the Obama administration, said health care providers shouldn’t withhold vaccine doses. He said the practice is actually causing some vendors to cancel appointments and preventing some Americans from getting their first shots.

“We want to make it clear that we understand why health care providers did this, but that it doesn’t have to and shouldn’t,” he told reporters during a coronavirus briefing, adding that US officials are aware of supplies of Covid vaccines to states were often unpredictable during the early rollout in late December.

“We fully understand that this is a direct result of the unpredictability that many states and suppliers have had about the number of doses they would receive,” he said. “That’s one reason we announced last week that the federal government would provide a continuous three-week window for the vaccines to be shipped.”

“With this move, states and vaccine providers will use their allocation of the first doses faster to vaccinate as many people as quickly and equitably as possible because they now have the predictability,” he said, that the second shots will be on time.

Biden is trying to accelerate the pace of vaccination in the US after a slower-than-expected rollout under the administration of former President Donald Trump. The Biden government has advised states and health care providers that they no longer need to withhold the two-dose doses reserved for the second round of Pfizer and Moderna vaccinations.

Still, some states have raised concerns that the federal government will be able to maintain an adequate dose supply for the second round of firing. Pfizer and Moderna vaccines require two vaccinations three to four weeks apart, and the states vaccinate approximately 1 million people daily.

The U.S. has distributed nearly 50 million doses of vaccine, but only about 31.1 million had been administered as of 6 a.m. ET Sunday, according to the Centers for Disease Control and Prevention. As of Monday, states had 62% of their vaccine inventories managed, but officials expect that number will improve, Slavitt said.

U.S. officials also hope vaccine supplies will increase after Johnson & Johnson’s Covid-19 vaccine was approved by the Food and Drug Administration for emergency use. The FDA could give the OK this month.

The Department of Health and Human Services announced in August that it had signed a contract with Janssen, J & J’s pharmaceutical subsidiary, worth approximately $ 1 billion for 100 million doses of its vaccine. The deal gives the federal government the opportunity to order another 200 million cans, according to the announcement.

Unlike Pfizer and Moderna’s vaccines, J & J’s vaccine only requires one dose, which makes logistics easier for healthcare providers.

Dr. Anthony Fauci, the nation’s leading infectious disease expert, said Monday that making sure people who get their first dose can get their second remains a top priority for officials. CDC director Rochelle Walensky said the agency is still recommending people get their second recordings on time.

On Sunday, an epidemiologist advising Biden’s transition to the Covid-19 crisis warned of an impending wave of infections and said the US should adjust its vaccination strategy to save lives.

Dr. Michael Osterholm told NBC’s Meet the Press that the government should try to give as many first vaccine doses as possible, especially for those over 65, before there is a potential increase in cases involving mutations overseas.

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Business

What Is 13-3? Why a Debate Over the Fed Is Holding Up Stimulus Talks

When the markets collapsed in March, the Federal Reserve introduced novel programs to help keep the flow of credit to states, medium-sized businesses, and large corporations alive. Congress presented Treasury Secretary Steven Mnuchin $ 454 billion to support the effort.

Nine months later, Senate Republicans are trying to ensure the same programs cannot be restarted after Mr Mnuchin lets them end on December 31st. Aside from preventing their reincarnation under the Biden administration, Republicans are trying to fit language into a pandemic stimulus package that would limit the Fed’s future powers and potentially prevent it from lending to businesses and local authorities in future crises.

The last-minute move has drawn democratic anger and threatened the fate of relief laws, which economists believe are badly needed as households and businesses stare at a dark winter pandemic. Here’s an overview of how the Fed’s lending powers work, and how the Republicans are trying to change them.

The most important and well-known job of the Fed is to set interest rates as a guide for the economy. However, the central bank was founded in 1913 to avoid banking problems and financial panic – when people get nervous about the future and rush to withdraw their money from bank accounts and sell stocks, bonds, and other investments. Congress dramatically expanded the Fed’s powers to fight panic during the Great Depression, adding Section 13-3 to the Federal Reserve Act.

The section allows the Fed to act as the lender of last resort in “unusual and urgent” circumstances – in short, when markets are not functioning normally because investors are extremely concerned. The central bank used these powers extensively during the 2008 crisis to support politically unpopular bailouts for financial companies. Congress then changed the Fed’s powers to require the blessing of the Treasury Department to introduce new emergency loan programs or to make significant changes to existing programs.

During the 2008 crisis, the Fed served primarily as the true lender of last resort – it mainly assisted the various financial markets by offering to intervene when conditions got really bad.

The emergency loan programs for 2020 were far more extensive. Last time the Fed focused on parts of Wall Street that most Americans know little about, like the commercial paper market and primary dealers. This time these measures were reintroduced, but new programs were also introduced to keep credit available in almost all parts of the economy. It has offered to buy municipal bonds, support bank loans to small and medium-sized businesses, and buy up corporate debt.

The comprehensive package was an answer to a real problem: many markets crashed in March. And the new programs generally worked. Although the terms were not particularly generous and relatively few corporations, as well as state and local borrowers, have taken advantage of these new programs, their existence gave investors confidence that the central bank would prevent a financial collapse.

Most lawmakers agreed that the Fed and the Treasury Department did a good job of reopening credit markets and protecting the economy. But Senator Patrick J. Toomey, a Republican from Pennsylvania, began asking questions this summer about when the programs would end. He said he was concerned that the Fed could push its limits and replace private lenders.

After the election, other Republicans joined Mr Toomey’s push to end the programs. Mr Mnuchin announced on Nov. 19 that he believes that Congress is earmarked for the five programs backed by the $ 454 billion Congress, which has the power to regulate lending and bond purchases on Dec. December to discontinue. and asked the Fed to return the money he had loaned to the central bank.

Economy & Economy

Updated

Apr. 18, 2020 at 12:25 am ET

The Fed made a statement that it was dissatisfied with his election but agreed to return the money.

Democrats criticized the move to limit the possibilities of the new Biden government. They began to discuss whether they could reclaim the funds and restart the programs once Mr Biden took office and his finance minister was confirmed, as Mr Mnuchin’s decision to close them and reclaim the funds was based on dubious legal grounds.

The new Republican move would cut that option off. Legislative language circulated early Friday suggested “any program or facility similar to an established program or facility” be banned with the 2020 funds. While this would allow the Fed to continue providing liquidity to Wall Street during a crisis, it could continue to seriously limit the central bank’s freedom to lend to corporations, states and local governments.

In a statement, Massachusetts Democrat Senator Elizabeth Warren called it an attempt to “sabotage President Biden and our nation’s economy.”

Mr Toomey defended his proposal to protect the Fed from politicization. For example, he said Democrats could try to make the Fed’s programs much more generous to states and local governments.

The Treasury Secretary would need the approval of the Fed to improve conditions and help beneficiary borrowers. The central bank could not readily agree, however, as it has generally approached its powers cautiously to avoid political scrutiny and maintain its status as a bipartisan institution.

Fed officials have avoided incriminating the ongoing showdown in Congress.

“I will have nothing more to say about this than what we have already said – that Secretary Mnuchin, as Treasury Secretary, wants the programs to end by December 31,” and that the Fed will return the money as requested, Richard H. Clarida, who vice chairman of the Fed said Friday on CNBC.

More generally, he added that “we believe the 13-3 facilities” were “very valuable”.

Emily Cochrane contributed to coverage from Washington.