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A man will receive the first of two Pfizer / BioNTech Covid-19 stitches on December 8, 2020 at Guy’s Hospital in London.

Victoria Jones | AFP | Getty Images

The U.S. federal government will continue to monitor the incidence of Bell’s palsy – a partial paralysis of the face – in people receiving Pfizer’s Covid-19 vaccine after four cases were reported among subjects, even though the vaccine did not appear to cause the disease .

Dr. Sara Oliver, a staff member with the Centers for Disease Control and Prevention, said Friday on the agency’s Advisory Committee on Immunization Practices that “there is no known or expected causal link between the vaccine and Bell’s palsy”. The ACIP is developing recommendations for the use of vaccines to fight disease in the US, according to the CDC.

“Post-approval safety and efficacy studies will also be critical. Monitoring for Bell’s palsy in particular could help identify a possible causal link,” said Oliver.

U.S. officials plan to continue to monitor for side effects of the Pfizer vaccine among the health care workers and nursing homes who receive it, said Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, during a Food and Drug Administration meeting Thursday.

The officers will use an SMS system called v-safe, which is designed to provide early warning of possible side effects of the vaccines.

Bell’s palsy is a sudden freeze or weakness in a person’s facial muscles, and for most people, it’s temporary, according to the Mayo Clinic. A member of the group on Friday’s ACIP call confirmed that there were four cases of “facial paralysis” among those who received the vaccine. In one of the participants, paralysis appeared as early as three days after the dose, while in another recipient, the paralysis appeared only 48 days after inoculation.

The four cases of Bell’s palsy in vaccine recipients were considered “consistent with the expected background rate in the general population” and “there is currently no clear basis for establishing a causal link,” the FDA said in its briefing documents prior to the advisory meeting Committee on Vaccines and Related Biological Products on Thursday.

During Thursday’s meeting, FDA vaccine investigator Dr. Susan Wollersheim found that the study data showed a “numerical imbalance” in Bell’s palsy.

Wollersheim said there were four cases in the vaccine group and none in the placebo group. While the incidence of the cases was no higher than that of the general population, the FDA recommended further surveillance if the vaccine is approved for wider use.

The VRBPAC voted 17 to 4 with one abstention on Thursday to recommend the vaccine that the company developed with BioNTech for emergency approval. The FDA is expected to issue Pfizers emergency coronavirus vaccine approval at any time after the recommendation.

– CNBC’s Will Feuer contributed to this report.

Customers dine at Momofuku’s outdoor seating in the East Village as the city resumes Phase 4 of its reopening after the spread of the coronavirus was restricted in New York City on September 26, 2020.

Alexi Rosenfeld | Getty Images

Goldbelly is adding Chef David Chang’s Momofuku chain to its national delivery service as the coronavirus pandemic drives customers and restaurants to the e-commerce website in droves.

CEO Joe Ariel founded Goldbelly in 2013 when he was living in New York and couldn’t find a local restaurant that craved Nashville, Tennessee, hot chicken or Mediterranean-style biscuits. More than $ 33 million has been raised since then, and the final round in 2018 was led by Danny Meyer’s Enlightened Hospitality Investments.

Before the pandemic, Goldbelly was constantly adding restaurants to the platform. But when lockdowns were introduced in the United States, restaurants that had previously avoided delivery and take-away services had to spin.

Like DoorDash and Grubhub, Goldbelly is one of the beneficiaries of the abrupt change in behavior. This year, the number of restaurants and customers on its website has almost doubled. Companies like Shake Shack, the burger chain founded by Meyer, join their ranks. Including Momofuku, the company has nearly 700 restaurants listed on its marketplace.

“A lot of partners who were interested but a little reluctant have now made it their business to give the platform a chance and tell us they can’t believe they haven’t done it sooner,” said Ariel.

“Sauce seals” hunt according to regional demands

However, Goldbelly also has some key differences from the third-party delivery apps that work with local restaurants. It ships groceries all over the country instead of being tied to a two or three mile radius. Restaurants have the freedom to fulfill their orders during quiet periods such as the afternoon or at midnight, when the kitchen is closed to customers for take-away and delivery.

And it’s the restaurants rather than Goldbelly who are responsible for making and shipping their groceries. The business model means that Goldbelly is profitable, according to Ariel.

However, restaurants also benefit from joining the e-commerce website. Ariel said some restaurants on Goldbelly are seeing higher sales volumes than their pre-pandemic dining rooms.

The crisis brought another facet to the Goldbelly experience: live cooking classes with famous chefs like Daniel Boulud. The courses are free with the purchase of the appropriate meal set.

Goldbelly uses a team of Boy Scouts, known internally as “Sauce Seals,” to search the country and social media for restaurants that are loved by their customers or offer unique local specialties. The restaurants on the platform range from nationally known establishments to mom and pop restaurants.

Goldbelly founder and CEO Joe Ariel

Source: Goldbelly

The company also works with the restaurants to determine the price that the consumer will pay. This ultimately includes the platform’s transaction fees and the high cost of shipping the groceries overnight anywhere in the country. The food can be frozen, pre-assembled, or delivered as part of a meal set for easy preparation.

A more common treatment

Ultimately, the New York bagels or Philadelphia cheesesteaks cost more than if a customer had bought them in person. However, the service is aimed at consumers who are far from the comfort foods they want to eat. And as the current crisis is limiting travel and dragging some consumers to the suburbs, they are ready to pay the premium price. The service has also been switched from being used for special occasions to something that is searched for more often.

“As the world has changed it has become much more of a weekly and monthly event,” said Ariel.

The fourth quarter is usually the busiest time of year for Goldbelly, thanks to the holidays, according to Ariel. The Thanksgiving approach means an influx of orders for cakes, side dishes, and turduckens.

“This year it’s going to be a different level because people aren’t traveling to see their families,” said Ariel.

Goldbelly customers purchase multiple items to ship to different people and create their own virtual Thanksgiving dinner through Zoom. Corporate employers want to offer their employees and customers Goldbelly’s meal sets and virtual cooking classes in place of in-person office parties.

Of course, the pandemic also brings new challenges to Goldbelly. Vaccine manufacturers are concerned about potential rollout delays due to dry ice shortages. Goldbelly’s dealers use the solid form of carbon dioxide to ship some of their items such as ice cream across the country overnight.

Goldbelly has an entire department devoted to brainstorming how to keep food frozen – or at least cold – before it gets to customers.

“It’s something we keep our eyes peeled for, but we have a few different approaches to attacking that before it becomes more of a problem,” said Ariel, adding that the majority of Goldbelly orders don’t use dry ice .

For Goldbelly and the rest of the world, a vaccine also means a return to travel, dining, and all the other opportunities that were abandoned during the pandemic. However, Ariel believes consumers will continue to order from Goldbelly as often as they do now.

“We believe having nationwide delivery of your favorite foods will continue to be a value proposition that is really exciting to many people, especially those who have experienced and made a deeper emotional connection with our brand and platform during that time.” Said Ariel.

The Food and Drug Administration has approved Pfizer and BioNTech’s coronavirus vaccine for emergency use. This is a monumental turning point in the one-time pandemic that killed nearly 300,000 Americans and devastated the US economy in less than a year.

FDA chief scientist Denise Hinton told Pfizer in a letter Friday that she approved the company’s emergency use of the vaccine.

President Donald Trump called it a “medical miracle” in a video tweet. “We delivered a safe and effective vaccine in just 9 months,” Trump said. “This is one of the greatest scientific achievements in history.”

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the decision “promises to change the course of this pandemic in the United States.” “With the science guiding our decision-making, the available safety and efficacy data to support the approval of the Pfizer-BioNTech COVID-19 vaccine because the known and potential benefits of the vaccine significantly outweigh the known and potential risks,” he said.

FDA approval for the emergency will now boost the federal government’s distribution of the potentially life-saving doses to 64 states, territories and major cities across the country. The government plans to distribute 2.9 million doses of the vaccine within 24 hours, followed by another 2.9 million doses 21 days later, for patients to receive their second shot, General Gustave Perna, who runs the logistics for the Operation Warp vaccination program Speed ​​monitored by President Donald Trump said Wednesday. Pfizer’s vaccine requires two doses three weeks apart.

The vaccine couldn’t come at a more crucial time. Hospitals in the U.S. already have higher numbers of Covid patients than ever before, and the country’s outbreak is poised to break even grimmer records. According to a CNBC analysis of the Johns Hopkins University data, the US reported 3,124 new Covid-19 deaths on Wednesday, the pandemic’s deadliest one-day record to date. The director of the Centers for Disease Control and Prevention, Dr. Robert Redfield, warned earlier this month that the next few months of the pandemic would be “some of the most difficult in the history of this country’s public health.”

Initial doses of the Pfizer vaccine will be limited as production begins. Officials predict it will be months before everyone in the US who wants to be vaccinated is vaccinated. Pfizer has announced that it will ship 50 million doses of vaccine this year, enough to vaccinate 25 million people. The vaccine is expected to be distributed in phases where the most critical U.S. workers and vulnerable people receive it first. The CDC has given states an outline recommending that priority be given to health workers and nursing homes first. However, states may distribute the vaccine at their own discretion.

An emergency permit, or EEA, is not the same as a full permit, which can typically take months. Pfizer has only submitted safety data for two months, but it typically takes the agency six months for full approval. The vaccine has been approved for people aged 16 and over.

On Friday, FDA Commissioner Stephen Hahn said the agency was “working fast” to clear the vaccine in case of emergency. Shortly after Hahn testified, Trump, who has repeatedly said he had urged the FDA to move faster in the vaccine development process, told the agency in a tweet: “Get the dam vaccines out NOW.”

The FDA’s announcement comes after a key agency advisory body voted 17 to 4, with one abstention, to recommend the vaccine for emergency approval on Thursday. The Advisory Committee on Vaccines and Related Biological Products plays a key role in approving influenza and other vaccines in the United States and verifying that the vaccines are safe for public use. While the FDA does not need to follow the advisory board’s recommendation, it often does.

FDA approval marks a record breaking time frame for a process that typically takes about a decade. The fastest vaccine development to date against mumps took more than four years and was licensed in 1967. Pfizer and BioNTech announced plans to develop a coronavirus vaccine in March and filed an emergency clearance application with the FDA in November. Health authorities in Canada, the UK and Bahrain have approved Pfizer’s vaccine for most adults.

Pfizer’s vaccine uses messenger RNA or mRNA technology. It’s a new approach to vaccines that uses genetic material to trigger an immune response. Moderna, another front runner in the Covid vaccine race, also uses mRNA technology. Late-stage clinical trial data shows Pfizer’s vaccine is 95% effective against Covid, safe, and appears to ward off serious illness. For maximum effectiveness, the vaccine requires two doses about 21 days apart.

Pfizer’s vaccine requires a storage temperature of minus 94 degrees Fahrenheit, which poses potential logistical challenges for rural areas and inner cities that may not have good health infrastructure. For comparison: According to Moderna, the vaccine can be stored for up to six months at minus 4 degrees Fahrenheit.

FedEx and United Parcel Service on Thursday expressed confidence in their networks to distribute the vaccines across the country in a Senate hearing and outlined plans to monitor the location and temperatures of the shipments.

The Federal Aviation Administration asked the airports late Friday to ensure that they have adequate staff when the vaccines arrive. In a statement hours before the vaccine was approved, the FAA said airports should consider providing areas for trucks for vaccines to be picked up on arrival. The agency has announced that flights with cans and related supplies will be given priority.

U.S. officials plan to continue to monitor for side effects of the Pfizer vaccine among the health care workers and nursing homes who receive it, said Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, during the agency’s meeting on Thursday. The officers will use an SMS system called v-safe, which is designed to provide early warning of possible side effects of the vaccine.

During the meeting, FDA vaccine reviewer Dr. Susan Wollersheim found that the study data showed a “numerical imbalance” in Bell’s palsy, a condition that causes temporary weakness or paralysis of the muscles in the face. She said there were four cases in the vaccine group and none in the placebo group. Although the frequency of the cases was inconsistent with the general population, the FDA recommended further monitoring once the vaccine becomes more widely distributed.

Read the full letter from the FDA below:

Klaus Fedfelt | Getty Images

The coronavirus has marginalized thousands of businesses, but there may be a glimmer of hope for businesses struggling with cash.

Businesses affected by the pandemic and lockdowns in the community now need money. One of the best ways to do this is to take advantage of very favorable rule changes in the treatment of net operating losses in the CARES Act.

A company suffers NOL when its tax deductions exceed its income in a given year. In general, taxpayers can lower their taxes by using that loss to offset income in a future year.

The CARES Act goes one step further and allows abused businesses to convert this year’s red ink into a tax refund on previous years’ income.

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A legal provision allows companies to carry back losses from 2018, 2019 and 2020 for five years.

“There are whole areas of US business where companies are making significant losses [the NOL rule changes] Give them access to cash that can help them survive, “said Doug Bekker, CPA and partner at BDO USA’s National Treasury.

“We anticipate many NOL withdrawal claims in 2021 and expect many early filings to get their money back quickly,” he said.

According to the CARES Act, losses from 2018 can be used to offset income as early as 2013. Losses made this year can be deducted from 2015 taxable income.

The IRS has also promised to send refund checks to business owners and businesses within 90 days of application if they follow a quick refund process. Individuals must submit Form 1045 while C companies must submit Form 1139.

“This is the best part of the CARES Act,” said CPA Robert Tobey, tax partner at Grassi & Co. in New York and a member of the tax committee for individuals and the self-employed at the American Institute of CPAs.

“Cash flow is the biggest concern facing businesses right now. How often does the government offer to return taxes you have already paid?” he said.

Cash for C-Corps

Gary Burchell | Getty Images

The deal is especially good for C companies – generally larger companies that are taxed as separate entities from their owners.

The Law on Tax Cuts and Jobs, passed in late 2017, lowered the tax rate for C-Corps from 35% to 21%.

Companies that can trace losses back to years prior to 2017 may receive a larger profit.

“For larger companies like airlines, hotels or restaurant franchises that have made money from higher taxes these years, this is one way to get through this period,” said Ryan Losi, CPA and executive vice president at Piascik in Glen Allen, Virginia.

Small businesses, smaller savings

Thomas Barwick | DigitalVision | Getty Images

The tax arbitrage benefit is less dramatic for small business owners, who are generally structured as pass-through businesses such as S-Companies and LLCs. In this case, the income from the business “flows” into the owner’s personal tax return.

The Tax Cut and Employment Act lowered the highest marginal tax rate for individuals from 39.6% to 37%, a cut far less drastic than the C-Corps tax rate cut.

However, the potential cash inflow from loss carryforwards can help keep pass-throughs in business.

“In my experience, most business owners need the money now,” Losi said. “If you lose money this year, you can get up to 40 cents on the dollar for those losses.”

First, talk to a tax advisor

The NOL carryover option isn’t necessarily for everyone. If a taxpayer has been out of business or has had little taxable income in those earlier years, getting a small refund may not be worth it.

It will also reopen your tax file for the years you suffer losses, which can increase the risk of previous returns being scrutinized. “You’re opening a closed year,” said Tobey. “There is a risk associated with the reward.”

Taxpayers can make an irrevocable choice to forego the loss carryforwards and use losses in the 2018-2020 period to offset future revenue. Under the CARES Act, these losses can be carried forward indefinitely.

The more complicated your tax situation, the more difficult the decision becomes, said Bekker.

Another factor to consider is whether states are complying with the new federal regulations and allowing taxpayers to also reimburse previously paid state taxes.

“You may want to help, but you are in difficult situations yourself,” said Losi.

Entrepreneurs need to work with their tax professionals to see if this year’s misery has a silver lining.

“This is the year you put every expense and bad news on your 2020 tax return,” said Tobey. “Cash is king now and this is a great place to find it.”