Tag: Asks

Categories
Health

Pfizer asks FDA to approve storing doses at greater temperatures

Pfizer to temporarily reduce Covid vaccine deliveries to Europe

A picture taken on January 15, 2021 shows a pharmacist holding a vial of undiluted Pfizer BioNTech vaccine for Covid-19 with gloved hands, which is stored at -70 ° in a super freezer at Le Mans hospital in northwestern France became country runs a vaccination campaign to fight the spread of the novel coronavirus.

Jean-Francois Monier | AFP | Getty Images

Pfizer is asking the Food and Drug Administration for permission to store its Covid-19 vaccine for two weeks at temperatures typically found in pharmaceutical freezers and refrigerators, the US drug maker said on Friday.

The vaccine, which was developed with the German drug manufacturer BioNTech, currently has to be stored in ultra-cold freezers, which, according to the FDA, are between minus 112 and minus 76 degrees Fahrenheit. Pfizer said it presented new data to the U.S. agency showing the vaccine is stable between negative 13 and 5 degrees Fahrenheit.

If the FDA grants the OK, it could simplify the logistics for distributing the vaccine in the US. Federal and state officials are trying to speed up the pace of vaccinations across the country as the virus continues to spread.

“We have continuously conducted stability studies to support the manufacture of the vaccine on a commercial scale with the aim of making the vaccine as accessible as possible to healthcare providers and people in the US and around the world,” said Albert Bourla, CEO of Pfizer a publication. “If approved, this new storage option would offer pharmacies and vaccination centers more flexibility in managing their vaccine supplies.”

Medical experts had previously warned that Pfizer’s vaccine would pose a new logistical challenge as it would have to be stored in ultra-cold temperatures. In December, US officials said they quarantined several thousand doses of the vaccine in California and Alabama after an “anomaly” in the transportation process caused the storage temperature to become too cold.

The vaccine comes in a special warming container that can be used as a temporary storage facility for up to 30 days, with dry ice refilled every five days. The vaccine can also be refrigerated for up to five days at a standard refrigerator temperature of between 36 and 46 degrees Fahrenheit, according to the company, before mixing it with a salt diluent.

In comparison, Moderna’s vaccine has to be delivered between 13 and 5 degrees Fahrenheit. It has said its vaccine will stay stable for up to 30 days at 36 to 46 degrees Fahrenheit, the temperature of a regular household or medical refrigerator. It can be stored at minus 4 degrees Fahrenheit for up to six months.

Johnson & Johnson’s Covid vaccine, expected to receive FDA emergency approval as early as this month, plans to ship its vaccine at 36 to 46 degrees Fahrenheit.

As additional stability data will be obtained, Pfizer believes that shelf life could be extended and alternative short term temperature storage could be considered.

Categories
Politics

Trump Lawyer Asks to Pause Impeachment Trial if It Runs Into Sabbath

Trump Lawyer Asks to Pause Impeachment Trial if It Runs Into Sabbath

It is unclear how the Senate leaders will comply with Mr. Schön’s request. If they rushed the process to ensure it was completed by Friday sundown, it would be by far the fastest impeachment trial of the president in history. If they put it on hold, as Mr. Schön has requested, the process could turn into a federal holiday on Monday and a holiday week for the Senate during which its members should take a break to go home to their states. If leaders instead chose to delay this further, it would support the planned measures to confirm Mr Biden’s nominations and further develop his pandemic relief law.

Mr Schön said in a telephone interview on Friday that he had not heard from the leaders about a number of issues related to the trial, including the timing and time each side would be given to present their arguments. It is expected that Mr Schumer, who negotiated these matters with Mr McConnell, will provide the details shortly before the trial begins.

Mr. Schön is part of a second group of attorneys who have represented Mr. Trump in his second impeachment trial. The first team resigned after their lawyers refused to set the former president’s preferred trial strategy – that they would defend him by reiterating his unsubstantiated claims that the election had been stolen from him.

Now Mr. Schön is joining a list of prominent Jews who have encountered problems in Washington because of Sabbath observance. Ivanka Trump and Jared Kushner, the daughter and son-in-law of the former president who are Orthodox Jews, said they received special permission from a rabbi to attend Mr. Trump’s opening ceremonies in 2017. They said they had at least received a similar exemption once later in Mr. Trump’s presidency to travel on the Sabbath.

During the impeachment trial of Bill Clinton in 1999, then Connecticut Senator Joseph I. Lieberman, an observant Jew, went four miles from his Georgetown apartment to Capitol Hill to serve as a juror. Because Jewish law teaches that one can break the Sabbath when it comes to “caring for human life”, Mr. Lieberman, in consultation with his rabbis, has developed his own rule that he is not allowed to engage in purely political activities on the Sabbath . but would attend the Senate meetings and vote if necessary.

However, he did not ride in a car or elevator, which is a restriction resulting from a ban on the generation of sparks and fire.

Mr Schön’s request now has to be taken into account with decades of rules for impeachment proceedings as well as the timetable, work habits and politics of the Senate. The rules state that the Senate should meet for impeachment trials Monday through Saturday and only pause on Sunday, the schedule followed during both the final trial of Mr Trump and the trial of Mr Clinton.

Categories
Politics

California asks Federal Maritime Fee to take motion on delivery delays

California asks Federal Maritime Commission to take action on shipping delays

A container ship enters the port of Los Angeles on February 1, 2021 in San Pedro, California.

Mario Tama | Getty Images

Just a week after CNBC’s two-month investigation into shipping companies’ rejection of US agricultural exports, California is urging the Federal Maritime Commission (FMC) to take immediate action. A letter to the FMC was signed by several state officials requesting immediate action to review the airlines’ export policies.

Shipping companies turned down hundreds of millions of dollars in US agricultural export containers in October and November and instead sent empty containers to China to fill with more profitable Chinese exports, according to the CNBC investigation.

In the letter received from CNBC, state officials said, “We seek your assistance in addressing the current delays and ongoing shipping problems in California ports, which are having a significant impact on the business of companies across the state. In particular, the business of our The Agriculture Sector, who is heavily dependent on the export markets is badly affected. “

California, the letter reads, is the country’s largest agricultural exporter and producer, with more than $ 21 billion in annual agricultural exports requiring and supporting an estimated 157,800 full-time jobs. These exports benefit the economy directly by generating $ 25 billion in additional economic activity.

The call for proposals letter comes after FMC announced in November an investigation into trade with key ports in California, New York, and New Jersey to determine whether airlines’ refusal to ship US exports was a violation against the Shipping Act.

The law makes it unlawful for air carriers to “improperly refuse to do business or negotiate,” “boycott or take other concerted action that will result in an improper refusal” or “engage in behavior that involves the use of intermodal services inappropriately restrict “.

The FMC declined to comment.

The World Shipping Council (WSC), whose members control approximately 90 percent of the global container fleet, and the Pacific Merchant Shipping Association (PMSA) responded to California officials and urged better communication between them compared to the involvement of the FMC.

In a two-page letter to CNBC, the two groups accused the record surge in imports from China as a catalyst for the port’s efficiency and the associated fees that importers and exporters pay.

The WSC and PMSA listed the export sales of the various farms exported from the Port of Los Angeles, saying they were “up significantly” year over year. The group then called it a “false impression that California’s agricultural exports are being excluded from access to the international supply chain”.

CNBC previously reported that while agricultural export volumes for 2020 were larger than 2019 due to the U.S. Phase One trade agreement with China, purchases fell short of targets. According to the Peterson Institute for International Economics, China imported $ 100 billion of the U.S. goods agreed under the deal – roughly 58% of the targeted $ 173.1 billion. Exports are only official once they have been transported and processed in the country of destination. However, the increase in agricultural exports pales in comparison to the increased ration of empty export containers.

CNBC launched its own review of import and export data, and concluded that the airlines rejected an estimated 177,938 containers, called TEUs (20-foot equivalents), in October and November. This was the result of an analysis of the data compiled by the Census Bureau and the ports of Los Angeles, Long Beach, California and New York and New Jersey. The total value of lost export trade from these ports is $ 632 million.

Prioritize empty export containers

The data showing the increase in empty containers being shipped back to China corresponds to the timing of the carriers who informed agricultural exporters in mid-October that they would prioritize empty export containers over agricultural exports.

The air carriers also said they would raise prices on US agricultural exports if the goods were moved. The rise in agricultural export fees continues. Last week, ZIM Integrated Shipping Services announced agricultural exporters that they would be introducing surcharges for all cargo from the US to China and other Asian countries between $ 150 and $ 500 per container starting Feb.17.

CNBC asked ZIM for a comment.

According to the CNBC investigation, the total export container deficit for the ports of Long Beach and Los Angeles was 136,392 TEU. An estimated 41,546 TEU were denied from the ports of New York and New Jersey.

To calculate the value of the potential trade loss resulting from the rejection of agricultural exports, CNBC used the containerized agricultural export price for soybeans / oilseeds / grain in the Port of Los Angeles, which can be found on the US Census website, USA Trade Online.

The value of this export is USD 3,552 per TEU. The value of the lost trade is likely to be higher as the value of the Ag’s raw materials fluctuates widely. Soybeans are at the lower end of the commercial value spectrum.

This balance was calculated using the difference between the actual empty exports in 2020 and the share of export empty in 2019.

However, CNBC analysis shows that the pattern of the growing US export container deficit extends beyond October and November.

Based on the trade data, empty container exports began to rise as early as June for Los Angeles, July for Long Beach, and August for New York and New Jersey. From July to November a total of 297,997 TEU from the ports of Los Angeles, Long Beach as well as New York and New Jersey were denied a container deficit of USD 1.1 billion.

“The core problem is that a rapidly recovering China has revived its export economy and pays huge premiums for containers, which makes it more profitable to send them back empty than to refill them,” said Peter Friedmann, executive director of the Agriculture Transportation Coalition. “In the Port of Los Angeles, three out of four boxes returning to Asia are empty, compared to the normal rate of 50%. Food is piling up in the wrong places.”

Read the full letter:

Categories
Politics

Elizabeth Warren asks Robinhood to elucidate GameStop commerce restrictions

Elizabeth Warren asks Robinhood to explain GameStop trade restrictions

Senator Elizabeth Warren wrote to Robinhood Tuesday to explain why trading in glowing GameStop stocks was restricted after hedge funds suffered huge losses in a short period of time.

Warren, D-Mass., Noted that last week the online broker abruptly changed the trading rules for individual investors in certain stocks on its fee-free platform, while hedge funds and institutional investors on Wall Street continue to operate in GameStop, Koss , AMC, Entertainment, Express, Naked Brand Group and other companies.

“Robinhood has a responsibility to treat its investors honestly and fairly and to provide them with access to the market according to a transparent and uniform set of rules,” Warren wrote in her letter to Robinhood CEO Vladimir Tenev.

“It is deeply disturbing that the company may not do this,” wrote Warren, a member of the Senate Banking Committee.

The letter asked Robinhood to disclose what resulted in severe trading restrictions being imposed on video game retailer GameStop and the rest of the stocks, and whether its hedge fund investors or other financial services partners who had large stakes in such trading supported the decision of the App companies influenced.

Robinhood had severely restricted purchases of a handful of stocks, so in some cases customers could only buy a single stock. In addition, the margin requirements for certain stocks and options have been increased.

“The public deserves a clear account of Robinhood’s relationships with major financial corporations and the extent to which those relationships could undermine their commitments to their customers,” Warren wrote.

The Senator also wrote that she was “concerned that Robinhood included compulsory arbitration clauses in their client agreement, suggesting that investors will not have sufficient opportunity to pursue their claims and seek relief.”

In the past week, at least 18 lawsuits have been filed against Robinhood over trade restrictions.

Warren wrote that forcing these allegations into “secret arbitration denies customers a fair hearing, undermines public accountability, and hinders efforts to have a thorough and complete understanding of what happened”.

“Investors harmed by Robinhood’s trading restrictions should be able to argue their case in court rather than in closed camera proceedings too often directed against claimants,” she wrote.

A Robinhood spokeswoman did not immediately respond to a request for comment on Warren’s letter.

Warren’s letter came the same day Robinhood said it would allow customers to purchase up to 100 GameStop shares while lifting restrictions on AMC and Koss and lifting restrictions on BlackBerry and Genius Brand.

GameStop shares rose 400% last week and rose more than 1,600% through January as a group of investors on Reddit’s WallStreetBets discussion group hyped the stock.

The massive surge in the share price, in turn, put brief pressure on hedge funds who had bet that GameStop’s share price would fall, so these funds had to buy shares to cover the losses on their positions. These purchases, in turn, added upward pressure on the share price and further exacerbated hedge fund losses.

Short sellers lost nearly $ 20 billion in GameStop positions last month due to the shortage.

Short sellers bet on a stock by borrowing stocks and then selling them. A short seller hopes that the price of the stocks will then fall so that the short seller can pocket the price difference when they later buy stocks to replace those they borrow.

However, when prices go up, a short seller must buy stocks to replace the borrowed stocks at a higher price than they initially sold. This situation results in a loss for the short seller.

Many individual traders and politicians on both sides of the aisle have criticized Robinhood’s decision to restrict purchases of certain stocks like GameStop that are at the center of the controversy.

Tenev, the CEO of Robinhood, told CNBC last week that his company capped 13 stocks on Wednesday as a risk management decision to protect the company and its investors.

Tenev said the decision was based in part on the Securities and Exchange Commission’s net capital rules and clearinghouse deposit requirements that brokers must adhere to.

Last week’s high trading volume put pressure on online brokers like Robinhood, which clients have to pay in cash when they close a position.

The brokers also needed additional cash to provide their clearing facility with additional capital and to protect trading partners from excessive losses.

GameStop stock prices fell Tuesday, falling 51% to about $ 110 per share from noon.

This sharp drop follows a drop of more than 30% during Monday’s regular market session.

GameStop’s share price closed at $ 325 per share on Friday.

If GameStop closes at its current level, the two-day loss would be roughly 66%.

Categories
Business

Moderna asks FDA to authorize 5 further doses per Covid vaccine vial to hurry distribution, supply tells CNBC

Moderna asks FDA to authorize 5 additional doses per Covid vaccine vial to speed distribution, source tells CNBC

A health care worker holds a vial of the Moderna COVID-19 vaccine at a pop-up vaccination station operated by SOMOS Community Care during the coronavirus disease (COVID-19) pandemic in New York on January 29, 2021 .

Facebook Facebook Logo Log in to Facebook to connect with Mike Segar Reuters

Moderna has asked the U.S. Food and Drug Administration for permission to fill their Covid-19 vaccine bottles with up to five additional doses to help clear a manufacturing bottleneck, according to a person familiar with the matter.

The change would allow Moderna to fill 15 cans into vials of the same size, now cleared for 10, which eases the pressure on the manufacturing process known as filling / finishing, said the person who refused to named because the application is not public yet.

The availability of Covid-19 vaccines has caused frustration since their approval in the US in mid-December. While the pace of administration has increased to an average of more than 1 million a day, the limited supply has hampered states’ ability to operate mass vaccination centers. By Friday, the US had distributed 49.2 million doses and 27.9 million had been given, according to the Centers for Disease Control and Prevention.

“We have problems making these mRNA vaccines,” said Dr. Paul Offit, director of the Vaccine Education Center and a physician at Philadelphia Children’s Hospital. “We have up to 1.2 million doses a day when we need 3 million doses a day.”

The FDA declined to comment and asked questions to the company. Moderna did not immediately respond to a request for comment.

The move from Moderna came after Pfizer requested and received a change in emergency approval from the FDA to specify that the Covid-19 vaccine bottles contain six doses instead of five after pharmacists determined that it had a bonus dose the correct syringes could be extracted. Pfizer then said it would ship fewer vials to the US, but the same number of doses specified in its contracts.

Moderna vials have also been found to contain a bonus dose, but a policy change is being sought to add volume to the vials.

The bottleneck is not the vials themselves, but the manufacturing capacity to fill the vials. The manufacturing filling / finishing process must be performed under aseptic conditions to ensure contamination does not occur and the capacity is high.

Companies have begun to form manufacturing partnerships that focus on this step in the process to increase production. Novartis announced on Friday that it has signed an initial vial fill agreement for BioNTech, Pfizer’s partner in Europe, for the Covid-19 vaccine.

“We expect this to be the first in a series of such agreements,” said Steffen Lang, head of technical operations at Novartis.

Categories
Health

New York Gov. Cuomo asks to purchase immediately from Pfizer

New York Gov. Cuomo asks to buy directly from Pfizer

New York Governor Andrew Cuomo speaks out on Coronavirus Disease (COVID-19) on November 15, 2020 at Riverside Church in Manhattan, New York City, United States.

Andrew Kelly | Reuters

New York Governor Andrew Cuomo asked Pfizer CEO Albert Bourla Monday about the option of purchasing Covid-19 vaccine doses direct from the company. However, a statement from the company said the Department of Health and Human Services must first approve such a model.

The request comes after an alarmingly slow start to national vaccine rollout, with the country falling millions of injections short of original Trump administration projections. By January 15, the US had distributed more than 31 million doses and administered just over 12 million. Health officials had hoped to inject 20 million Americans by the end of 2020.

Cuomo, a Democrat, accused the Trump administration of not sending enough doses of vaccine to his state. This week, he said, New York would receive 250,000 doses – 50,000 fewer than the week before.

In his letter to Bourla, Cuomo suggested that Pfizer should be able to sell directly to his state, bypassing federal agencies, as Pfizer “is not bound by any commitments Moderna made under Operation Warp Speed” .

“The company’s decision to end Operation Warp Speed, which is being redesigned by the Biden Administration, puts it in a unique position that could help save lives here in New York,” Cuomo wrote.

Pfizer said the model would first need to be approved for emergency drug use under the Food and Drug Administration’s approval.

The company said in a statement it was “open to working with HHS on a distribution model that would get as many Americans as possible access to our vaccine as quickly as possible. However, before we could sell directly to state governments, HHS would need to approve it . ” this proposal is based on the EEA granted to Pfizer by the FDA. “

Representatives from HHS did not immediately respond to a request for comment.

Subscribe to CNBC on YouTube.

WATCH: How Coronavirus Vaccine Works, and Why Americans Should Trust It

Categories
Health

Some States Balk After C.D.C. Asks for Private Knowledge of These Vaccinated

Some States Balk After C.D.C. Asks for Personal Data of Those Vaccinated

“This is a new activity for us because we don’t typically report this level of detail to the federal government at this frequency,” Doug Schultz, a spokesman for the Minnesota Department of Health, said in an email. He added, “We will not provide a name, zip code, race, ethnicity or address.”

Tracking vaccinations, including collecting personal information, is not a new practice, and experts say this is especially important with a vaccine that requires two doses. But in the United States, it was a purely state effort. A push two decades ago to develop a federal registry that imploded after an uproar over patient privacy and the use of the data.

“The general philosophy in this country is that states manage public health. Therefore, the concept that we keep track of identified information at the federal level is important,” said Dr. Shaun J. Grannis, professor of medical informatics at Indiana University, who advised the CDC on data collection.

“We are 50 different states with a patchwork of regulations and different perspectives on privacy and security,” added Dr. Grannis added. “And I think people will ask the question: what does the CDC do that we cannot do regionally?”

However, the state registers differ in terms of sophistication and quality. Speaking at Monday’s briefing, Colonel RJ Mikesh of the Army, the information technology director for Operation Warp Speed, said the data collection was part of an “all America approach” to vaccine distribution.

And some experts say that amid a pandemic that has already cost nearly 284,000 lives in the US, privacy must give way to the public good and that vaccinating all Americans is a monumental task that requires federal intervention.

“We’re in a pandemic,” said Dr. Carlos del Rio, an infectious disease expert at Emory University in Atlanta. “Privacy has its role, but it can’t be what drives decision-making when you’re trying to do a monumental task like vaccinating millions of Americans with one vaccine that requires two doses.”