Category: Health

Elizabeth Holmes, founder and former executive director of Theranos, arrives for a hearing in the U.S. District Court in the Federal Building of Robert F. Peckham in San Jose, California on Monday, November 4, 2019.

Yichuan Cao | NurPhoto | Getty Images

A surge in coronavirus cases in California has resulted in a four-month delay in criminal proceedings against Elizabeth Holmes, the former CEO and founder of the competitive health tech company Theranos.

In an order late Friday evening, US District Judge Edward Davila set a new hearing for the case for July 13, 2021.

“The court was vigilant to keep abreast of the nation and state impact of the COVID-19 pandemic, as well as daily life on San Francisco Bay,” the tripartite ruling reads. “Unfortunately, the court finds that the impact on our lives is grave. California is in the midst of an unprecedented increase in cases and hospitalizations.”

The judge found that California had more than 1.76 million confirmed cases of Covid-19 and 22,160 deaths as of Friday. He also indicated that the Santa Clara County hospitals where the trial would take place are nearing maximum capacity.

Davila said these terms would “affect the jury and public confidence in a personal process that is expected to take several months”.

The move comes two weeks after the judge established a reconfigured courtroom, face mask requirements for study participants, and air filtration systems to move Holmes’ trial forward.

Prosecutors say they have ample evidence that Holmes ran a multi-million dollar program to scam investors, doctors and patients about the accuracy of Theranos’ blood testing technology.

Holmes, once hailed as the next Steve Jobs, pleaded guilty to a dozen criminal offenses – expecting 20 years in prison if convicted.

“The court recognizes that continuation of the trial will cause great inconvenience to victims who wish to spend their day in court, as well as to the defendant who wants a speedy defense against the charges,” he said.

The verdict came in the wake of Holmes’ struggle to prevent prosecutors from using their personal communications with their former lawyer, David Boies, while in Theranos.

US President Donald Trump gives a speech at an Operation Warp Speed ​​Vaccine Summit on December 8, 2020 at the White House in Washington, USA.

Tom Brenner | Reuters

The Food and Drug Administration has not yet approved Moderna’s coronavirus vaccine, contrary to a tweet from President Donald Trump on Friday that said the agency had “overwhelmingly approved” it and would distribute it immediately.

The FDA did not comment on Trump’s tweet, instead referring CNBC to a statement from FDA Commissioner Dr. Stephen Hahn said Thursday evening that the agency would “work quickly towards finalizing and issuing emergency clearance” for Moderna’s vaccine.

“The agency has also notified the US Centers for Disease Control, Prevention and Operation Warp Speed ​​so that they can implement their plans for a timely distribution of the vaccine,” Hahn said in a joint statement with Dr. Peter Marks, director of the FDA Center for Biologics Evaluation and Research.

The FDA statement on Thursday “is current,” FDA spokesman Michael Felberbaum told CNBC after Trump’s tweet.

It’s possible that Trump was referring to a vote by the FDA’s Advisory Committee on Vaccines and Related Biological Products Thursday, which voted 20-0, with one member abstaining to approve Moderna’s emergency vaccine advocate. The advisory board plays a key role in approving influenza and other vaccines in the US and verifying that the vaccinations are safe for public use. While the FDA does not need to follow the advisory board’s recommendation, it often does.

The FDA is expected to approve Moderna’s vaccine as early as Friday. The US plans to ship close to 6 million cans next week pending agency approval. This was announced by General Gustave Perna, who oversees the logistics for the Operation Warp Speed ​​vaccination project, to reporters on Monday.

An influential advisory body to the Food and Drug Administration overwhelmingly endorsed Moderna’s coronavirus vaccine on Thursday. This is an important step that paves the way for the distribution of the second Covid-19 vaccine in the US next week.

The non-binding decision, approved 20-0 with one abstention from the FDA’s Advisory Committee on Vaccines and Related Biological Products, came exactly one week after the external panel of vaccines and infectious diseases approved the vaccine from Pfizer and BioNTech recommended for an emergency permit or EUA. The agency granted Pfizer EUA the next day, and the first vaccinations in the US were given on Monday.

The FDA advisory panel plays a key role in approving flu 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. The US plans to ship nearly 6 million cans next week pending the agency’s OK, General Gustave Perna, who oversees logistics for the Operation Warp Speed ​​vaccination project, told reporters on Monday.

Prior to the vote, some committee members stressed that their approval of Moderna’s vaccine was not a full FDA approval and reiterated that the agency needed to review further safety and efficacy data.

“I don’t want people to interpret this as an approved vaccine,” said Dr. Cody Meissner, voting committee member and infectious disease expert at Tufts University School of Medicine. The confirmation is “based on the evidence available, but that is limited”.

An EEA means that the FDA will allow some people to receive the vaccine as the agency continues to analyze data. This is not the same as a full approval, which requires more data and can typically take several months longer. Moderna only submitted security data for two months. The agency typically takes six months for full approval. The committee recommended emergency approval of the vaccine for people aged 18 and over.

Member Dr. Michael Kurilla, an infectious disease expert at the National Institutes of Health, was the only member who disagreed with the vote. He said he had decided to abstain because he was “uncomfortable” in advocating the vaccine for anyone over the age of 18.

“In the midst of a pandemic and with limited vaccine supplies, a blanket statement for anyone aged 18 and over is just too broad,” Kurilla said. “I am not convinced by all of these age groups that the benefits actually outweigh the risks.”

The initial doses will be limited as production increases. Officials predict it will be months before everyone in the US who wants to be vaccinated is vaccinated. The Centers for Disease Control and Prevention has provided states with an outline recommending that priority be given to healthcare workers and nursing homes. However, states may distribute the vaccine at their own discretion.

Moderna’s vaccine uses messenger RNA or mRNA technology. It’s a new approach to vaccines that uses genetic material to trigger an immune response. Late-stage clinical trial data shows the Covid vaccine is more than 94% effective at preventing, safe, and appears to ward off serious illness. For maximum effectiveness, the vaccine requires two doses four weeks apart.

The FDA has announced that it will approve a Covid-19 vaccine that is safe and at least 50% effective. In comparison, the flu vaccine generally reduces the risk of developing influenza by 40% to 60% compared to people who were not vaccinated, according to the CDC.

FDA officials on Tuesday endorsed Moderna’s vaccine, saying in documents that the clinical trial results and safety data “are in line with recommendations in FDA guidelines on approving the emergency use of vaccines to prevent COVID-19.”

The FDA said 13 deaths were reported in the study as of December 3, including six in the vaccine group. Two deaths in the vaccine group were people over 75 with pre-existing medical conditions, the agency said. One case was a 72-year-old vaccine recipient with Crohn’s disease and short bowel syndrome who was hospitalized for thrombocytopenia and acute kidney failure.

Fatigue, headaches, and muscle aches are the most common side effects of Moderna’s vaccine, along with some rare symptoms such as persistent nausea or vomiting and facial swelling, which the FDA says are likely caused by the gunfire. Some side effects were tough to shake, although most were resolved within a week, the FDA said.

During the meeting on Thursday, medical experts also asked the agency about allergic reactions after two cases occurred among Alaskan health workers who took Pfizers’ vaccine. Doran Fink, deputy director of the FDA’s vaccines and related product applications division, said the agency will investigate the cases further.

“As we continue to examine and evaluate the data, we will consider whether additional recommendations need to be made,” he said. “Right now we don’t have enough data to make a definitive recommendation one way or another.”

There is little data on the safety of the vaccine in pregnant women and children. Thirteen pregnancies were reported in Moderna’s study as of December 2, six in the vaccine group, according to the FDA. The company is tracking all women who became pregnant after receiving the vaccine or were pregnant when they were vaccinated but didn’t know it, according to the agency.

Dr. David Martin, vice president of drug safety at Moderna, told the committee Thursday that the company would set up a “pregnancy registry” to track the performance of its vaccine in pregnant women.

“Regarding the safety of vaccine exposure during pregnancy, a development and reproduction study was completed in December 2020 with no adverse results,” Martin told the committee. “Given the limited human exposure to date in the Phase 3 trial, we will establish a pregnancy registry that includes a cohort recruited from the general population.”

While not necessarily a side effect, the FDA recommends monitoring people receiving Pfizer’s or Moderna’s vaccination shots for possible cases of Bell’s palsy, which leads to sudden freezing or weakness of facial muscles. The agency also found a higher prevalence of lymphadenopathy, a disease that can cause swollen or enlarged lymph nodes, in the vaccine group compared to the placebo groups in Pfizer and Moderna studies.

According to Moderna, the vaccine will stay stable for up to 30 days at 36 to 46 degrees Fahrenheit, the temperature of a normal household or medical refrigerator. It can be stored at minus 4 degrees Fahrenheit for up to six months. In comparison, Pfizer’s vaccine requires a storage temperature of minus 94 degrees Fahrenheit.

The federal government announced last week it would buy another 100 million doses of Moderna’s vaccine. The US reached an agreement with Moderna in August to purchase 100 million cans for about $ 1.5 billion. Moderna said it charged some customers $ 32 to $ 37 per dose for its vaccine at lower “pandemic prices” this month. The company said it was under discussion for larger volume agreements that will have a lower price.

– CNBC’s Noah Higgins-Dunn contributed to this report.

A key Food and Drug Administration advisory body is due to vote Thursday on whether to recommend Moderna’s emergency approval of Moderna’s Cova-19 vaccine to pave the way for a second preventative treatment to be distributed in the US

The non-binding decision of the FDA’s Advisory Committee on Vaccines and Related Biological Products is due exactly one week after the external group of vaccines and infectious disease experts overwhelmingly voted to recommend Pfizer-BioNTech’s emergency vaccine approval. The FDA approved this vaccine a day later.

A positive vote from the committee will likely pave the way for the FDA to approve Moderna’s emergency vaccine. The committee 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 committee’s recommendation, it often does.

It is about the potentially life-saving doses needed to end the pandemic that killed more than 300,000 Americans in less than a year. Public health officials say the US will likely need more than one vaccine as starting doses will be limited. Approximately 75% of the US population must be vaccinated to achieve herd immunity that protects enough people so that the virus cannot spread and be contained, US officials say.

Here’s what you can expect:

1.) When do you vote?

According to a draft agenda, the meeting should take place from 9 a.m. to 5:15 p.m. The vote usually takes place towards the end.

Prior to voting, medical experts will evaluate Moderna clinical trial data and provide their opinion on the vaccine, including whether the benefits outweigh the risks for an emergency approval. Moderna is asking the FDA to approve the use of the vaccine in people 18 years and older. Pfizer’s has been approved for use in people aged 16 and over. The low data in younger teenagers was a sticking point for the few advisory board members who last week voted against approving the Pfizer vaccine.

2.) What happens next?

The FDA will decide whether to clear Moderna’s vaccine for emergency use. In Pfizer’s case, the agency’s final decision came a day after the meeting.

Such approval means that the FDA will allow some people to receive the vaccine as the agency continues to analyze data. This is not the same as a full approval, which requires more data and can typically take months longer. Moderna only submitted security data for two months. The agency typically takes six months for full approval.

3.) When will I get the vaccine?

The US plans to ship close to 6 million doses of Moderna’s vaccine once the FDA clears the EUA. This was announced by General Gustave Perna, who oversees the logistics for the Operation Warp Speed ​​vaccination project, to reporters on Monday. Medical supply company McKesson will package the cans and distribute them to 3,285 locations across the country, he said.

The initial doses will be limited as production increases. Officials predict it will be months before everyone in the US who wants to be vaccinated is vaccinated. The Centers for Disease Control and Prevention has provided states with an outline recommending that priority be given to healthcare workers and nursing homes. However, states may distribute the vaccine at their own discretion.

Moncef Slaoui, who heads the White House’s Operation Warp Speed, said Monday officials expect 20 million Americans to get their first shot of Modernas or Pfizer’s vaccine this month. He added that by the end of February, 100 million “gun vaccine shots” will be administered between the first dose and the booster shots. By the end of March, around 100 million Americans could be fully vaccinated, nearly a third of the population, he said.

4.) Should I get the vaccine if I have Covid?

The FDA has stated that patients with Covid-19 may still be at risk of re-infection and could benefit from the vaccine. Researchers are still trying to determine how long immunity lasts after being infected with the virus. An Oxford study suggests that protection lasts at least six months.

Little data is available on the safety of the vaccine in pregnant women and children, according to documents released Tuesday by the FDA. Although children and younger teenagers are not considered for Moderna emergency clearance, pregnant women are likely to be included.

Pregnant women were not excluded from Pfizer’s emergency clearance last week, leaving patients to consult their doctor. It is likely that the FDA will do the same for Moderna’s vaccine.

Thirteen pregnancies were reported in Moderna’s study as of December 2, six in the vaccine group, the FDA said. The company is tracking all women who became pregnant after receiving the vaccine or were pregnant when they were vaccinated but didn’t know it, according to the agency.

5.) What are the side effects?

Fatigue, headaches, and muscle aches are the most common side effects of Moderna’s vaccine, along with some rare symptoms such as persistent nausea or vomiting and facial swelling, which the FDA says are likely caused by the gunfire. Some side effects were tough to shake, although most were resolved within a week, the FDA said.

While not necessarily a side effect, the FDA recommends monitoring people receiving Pfizer or Moderna vaccinations for possible cases of Bell’s palsy, which leads to sudden freezing or weakness of facial muscles. The agency also found a higher prevalence of lymphadenopathy, a disease that can cause swollen or enlarged lymph nodes, in the vaccine group compared to the placebo groups in Pfizer and Moderna studies.

Dr. Peter Marks, director of the FDA’s Center for the Evaluation and Research of Biologics, said in an interview with JAMA on Monday that once the vaccines have been administered, the agency can easily and quickly access data on Bell palsy cases.

Dr. Paul Offit, a voting member of the advisory board, agreed that Bell’s paralysis in the launch of the vaccine is worth monitoring. He voted last week to recommend Pfizer’s vaccine. “I’m not rejecting this yet,” he said in an interview with CNBC.

CNBC’s Will Feuer and Noah Higgins-Dunn contributed to this report.

SINGAPORE – The introduction of Covid-19 vaccines in Singapore will help the economy recover – but not bring it back to what it was before the pandemic, the country’s foreign minister Vivian Balakrishnan said Thursday.

“I think we should be talking about a new normal. So yes there will be a rebound in 2021. The question is to what extent that rebound will happen. But it will be a fallacy, it will be very dangerous to assume that we there are.” I’ll be back to work as usual, “Balakrishnan told CNBC’s Squawk Box Asia.

“We all need to focus on economic restructuring,” he said, explaining that technologies like artificial intelligence and robotics will transform jobs and economies around the world.

Singapore expects the first shipment of Pfon and BioNTech coronavirus vaccine this month, Prime Minister Lee Hsien Loong announced on Monday. The government has allocated more than $ 1 billion Singapore dollars ($ 752.9 million) to purchase various Covid vaccines and plans to have enough shots for everyone in the country by the third quarter of 2021, Lee said.

So yes, there will be a recovery in 2021. The question is to what extent this recovery will occur. But it will be a fallacy, it will be very dangerous to assume that we will work as usual again.

Vivian Balakrishnan

Singapore’s Foreign Minister

The Prime Minister also said the vaccines will be free for all long-term residents regardless of nationality. Admission will be voluntary, and government ministers will be vaccinated early to show that the vaccines are safe, Lee added.

Balakrishnan told CNBC that the government has decided to make Covid vaccines free so “cost is not a factor in people’s decision-making” about whether to fire the shots. Singapore has no target for the percentage of the population to be vaccinated, he added.

“We don’t have a specific destination at this point,” he said. “So let’s see how it goes, personally I would hope we have a slow, gradual, and progressive start to this program.”

Green shoots in 2021

Singapore, an open and trade-dependent economy, has been hit hard by global uncertainties resulting from the pandemic and decreased activity during a partial lockdown to contain Covid-19.

In addition to the pandemic, the uncertainties that weighed on the global economic outlook last year also include the intensification of tensions between the US and China, the US presidential elections and the future relationship between the UK and the European Union after leaving the bloc in January.

Balakrishnan was optimistic as he discussed the outlook for the external environment in 2021.

The minister said he hoped the future government of Biden would take an “open, consultative, moderative and more collegial approach” to foreign policy. He is also confident that the US could solve its domestic political problems to play a leading role on the world stage and in Southeast Asia.

Britain could also focus on Southeast Asia and the wider Asian region, said the minister. The UK signed a trade deal with Singapore last week after signing an agreement with Japan in October as it adapted to its exit from the EU.

“My point is that these are green shoots,” said Balakrishnan. “Provided nothing unusual happens in the next few months, we can look forward with optimism to a world that is slowly but surely recovering from Covid.”

A protester waves a “Black Lives Matter” flag across the street during the demonstration. Representatives from various organizations, including Free the People Roc and HALT (Humane Alternatives to Long-Term), traveled to Elmira correctional facility from across the state to protest the conditions inmates were exposed to during the Covid-19 pandemic. Elmira, NY State Prison has seen a rash of coronavirus cases.

Kit MacAvoy | SOPA pictures | LightRocket via Getty Images

LONDON – As the US and UK roll out national immunization programs to curb the spread of the coronavirus, health experts and advocates alike are concerned about the remarkable lack of prison populations in immunization schedules.

The U.S. Centers for Disease Control and Prevention has not yet made decisions about prisoners regarding access to vaccines, although it is believed that prison staff could be included in the second phase of the allocation.

In the UK, the Joint Vaccination and Immunization Committee has stated that the top priority of the Covid-19 vaccination program should be to prevent death and help maintain health and welfare systems.

The Committee’s guidelines do not specifically mention prisons, but assume that allocation plans will be applied in a manner similar to those used in detention.

Both countries have been administering the first vaccinations with the Pfizer BioNTech vaccine outside of trial conditions in the past few days, raising hopes that mass adoption of safe and effective vaccines could end the pandemic soon.

With coronavirus cases and related deaths continuing to surge, experts are questioning the ethics of how governments plan to distribute the first vaccines.

“We face a major dilemma here,” said DeAnna Hoskins, president and CEO of JustLeadershipUSA, a national judiciary reform organization trying to cut the US prison population in half.

Speaking at a webinar at Chatham House earlier this month, Hoskins said people incarcerated are “still fewer than people … and that’s how we react when we talk about vaccine access.”

Covid hotspots

Health officials have for years warned of the dangers of epidemics for detainees, arguing that people are unable to maintain a safe physical distance in correctional facilities due to their confinement in small common areas.

The pandemic has turned America’s prisons and prisons into Covid hotspots. People in prison are almost four times more likely to become infected than people in the general population – and twice as likely to die, a study by the National Commission on COVID-19 and Criminal Justice found.

The CDC’s Advisory Committee on Vaccination Practices has recommended health care providers, residents and long-term care facility workers to receive the vaccine in “Phase 1a” of the distribution plans. It is said that police officers and correction officers, among others, will be included in “Phase 1b”.

In addition to the American Medical Association and others, the National Commission on COVID-19 and Criminal Justice has called for prisoners to be vaccinated in the early stages of allocation along with other key criminal justice staff.

If the biggest trouble spots for Covid are prisons, doesn’t it make sense to vaccinate everyone from guards to prisoners?

Ashish Prashar

Judicial Reform Lawyer

“From my point of view and the information we have, we need to consider where prisoners fit in in relation to their risk in relation to other high-risk groups,” said Dr. Seena Fazel, a psychiatrist at Oxford University, in a report from The Lancet Medical Journal last week. “At first glance, prisoners would be at high risk for several reasons.”

Fazel said prisoners were at high risk of contracting the coronavirus due to the underlying chronic medical conditions, age and the environment. He cited a systematic review of prison settings by his team that identified correctional facilities as high risk for infectious disease transmission with significant challenges in managing outbreaks.

“Our research suggests that people in prison should be among the first groups to receive a COVID-19 vaccine to protect themselves from infection and prevent the disease from spreading further,” he said.

A view of a new emergency care facility being built to treat COVID-19 infected inmates at San Quentin State Prison on July 8th, 2020 in San Quentin, California.

Justin Sullivan | Getty Images News | Getty Images

The CDC has recommended vaccinating those at an increased risk of infection and mortality for the coronavirus early. However, federal officials say correctional staff should be given priority access to a vaccine, but have not yet spoken out in favor of prisoners being given the same allocation.

The agency referred CNBC inquiries to the US Bureau of Prisons, which did not immediately respond to a request for comment.

Arthur Caplan, a professor of bioethics at New York University’s Grossman School of Medicine, said in The Lancet’s report that he disagreed with plans to vaccinate prison staff only.

“If you are at risk and older or sick, you should just get vaccinated. If you are in a state where you cannot isolate yourself, you should get vaccinated. I see no reason to distinguish them.”

Racial differences

“If the biggest trouble spots for Covid are prisons, doesn’t it make sense to vaccinate everyone from guards to prisoners?” said Ashish Prashar, a judicial reform attorney and senior director of global communications for Publicis.

Speaking at the webinar at Chatham House on December 4th, Prashar said, “All the guards, all health workers, everyone going to jail and out of jail are spreading it to society. Wouldn’t you start on? stop? And take care of these people first? “

A nurse holds a sign during a protest by the nurses at Rikers Island Prison about the conditions and threat of the coronavirus on May 7, 2020 in New York City.

Giles Clarke | Getty Images News | Getty Images

The mass imprisonment in the US does not affect all communities equally, as African Americans are disproportionately incarcerated.

In addition to racial disparities within the U.S. criminal justice system, an updated CDC report earlier this month found that Hispanics and Black Americans, age-adjusted, were nearly three times more likely to die of complications from the coronavirus than white Americans.

“Half a million people haven’t been convicted of a crime, but we’ve taken their liberty away,” said Celia Ouellette, founder and executive director of the Responsible Business Initiative for Justice, a nonprofit group that advocates greater security about criminal justice systems and security Imprisonment. Her comments related to those in the US who have not been convicted of a crime but are being held in prisons.

“So there is a moral obligation to treat these people just like the surrounding community – or possibly better because they do not have the same access as the surrounding communities.”

“We need to stop thinking of inmate populations as a category of people and see them as people, as we do in the jail and jail community,” Ouellette said at the webinar at Chatham House.

Minister of Health and Human Services Alex Azar told The News with Shepard Smith that most Americans can expect to get the coronavirus vaccine by late February.

“I think by the end of February, end of March of course, depending on the decisions of our governors, but I think we will have enough offers to reach the general public for the administration – at your CVS, Walgreens, Kroegers – by the end of February by March, “said Azar.

However, Azar added that the public vaccination schedule could be even earlier if the AstraZeneca and Johnson & Johnson vaccine gets approved soon. The country’s foremost infectious disease official, Dr. Anthony Fauci predicted that Covid-19 vaccines should be widely available to most Americans by April.

Regeneron and Eli Lilly’s antibody drugs were supposed to be a bridge to a vaccine, but Moncef Slaoui, chief scientist for Operation Warp Speed, said only 5-20% of antibody drugs already shipped to states are in use. Slaoui attributed this to the challenge of administering drugs via IV within a few days of diagnosis, before people could feel sick. CNBC’s Meg Tirrell added that Slaoui said the antibodies could cut hospital admissions in half, and he hopes these challenges can be overcome. Azar repeated Slaoui’s statements when it came to the excess of monoclonal antibodies.

“It [the antibodies] can drastically reduce the risk of hospitalization at a time when our hospitals are overcrowded with people with Covid, “said Azar.” If you have comorbidities … if you are at risk of hospital admission you should start this product as soon as possible. ”

The record number of hospital stays is currently growing daily with more than 110,000 Covid patients in hospitals. Covid cases, deaths and hospital stays hit record highs today, according to the Covid Tracking Project. Hospitals in 18 states are full or almost full. More than 300,000 Americans have died from the coronavirus pandemic since February, and now more than one American is dying every minute.

Azar told host Shepard Smith that in order to gain control of the virus, Americans “must act responsibly, wash our hands, watch our distance, wear our face covers when we can’t watch our distance, and stay out of crowded indoor spaces.” ” “”

Smith pointed out that many in the White House do not follow the rules Azar has listed. Azar said he went to a Christmas party at the White House Tuesday night and there were military aides and doormen telling people to put their masks back on if they weren’t actively eating or drinking.

“People were told to wear masks at these events,” said Azar. “Our advice is the same in any setting. Wear your mask when you can’t keep your distance.”

Joel Saget | AFP | Getty Images

U.S. Food and Drug Administration officials recommend monitoring people receiving Pfizer or Moderna’s Covid-19 vaccine shots for possible cases of Bell’s palsy with half of your face hanging.

A 54-page employee report released Tuesday said that more than 30,000 clinical trial participants among Modernas reported four cases of Bell’s palsy. Three of the participants who had Bell’s palsy also received the vaccine instead of a placebo shot. The Pfizer study also reported four cases of Bell’s palsy from around 43,000 participants. All four Bell palsy cases in Pfizer’s study received the vaccine rather than the placebo.

Staff advocating Moderna’s emergency use of the coronavirus vaccine said there was insufficient data to link the cases directly to the recordings, but that warranted an in-depth review in the future. Two of the cases of Bell’s palsy in Moderna’s vaccine group have since “resolved”, while one was still ongoing at the time of the report, FDA officials said.

According to the Mayo Clinic, Bell’s palsy causes a sudden freezing or weakness of a person’s facial muscles, which is temporary for most people. The exact cause isn’t known, but it’s thought to result from either a viral infection or swelling and inflammation of the nerve that controls the muscles on one side of your face, the Mayo Clinic said.

“The information currently available is insufficient to establish a causal link with the vaccine,” the agency wrote.

The FDA’s Advisory Panel on Vaccines and Related Biological Products meets Thursday to review Moderna’s vaccine. Pfizer approved the vaccine a week ago before the FDA gave formal approval to start distribution on Friday. Health care workers at locations across the United States lined up to receive some of the first injections of Pfizer’s vaccine on Monday.

Paul Offit, a voting member of the FDA’s Advisory Committee on Vaccines and Related Biological Products, agreed that the condition should be monitored when the vaccine is introduced. He voted last week to recommend Pfizer’s vaccine.

“I’m not rejecting this yet,” he said in an interview with CNBC.

When Merck submitted its data from its rotavirus vaccine study, there were five cases of Kawasaki disease but none in the placebo group. That was “statistically significant” and prompted Merck to change its label to record the cases.

While there was a small imbalance in cases in the vaccine group compared to placebo, the FDA said it was not sure whether the drug contributed to the paralysis “because the number of cases was small and no more than expected in the general population.”

“There were no other notable patterns or numerical imbalances between treatment groups for any particular category of adverse event, including other neurological, neuro-inflammatory and thrombotic events, that would suggest a causal relationship with Moderna’s COVID-19 vaccine,” wrote FDA- Staff in the documents.

The FDA guidelines for Moderna vaccine released Tuesday were similar to recommendations for Pfizer’s vaccine last week. Officials from the U.S. Centers for Disease Control and Prevention said Pfizer’s vaccine didn’t appear to be causing the disease.

– CNBC’s Berkeley Lovelace Jr. contributed to this report.

This is a developing story. Please try again later.

Healthcare workers in the United States were given Covid-19 vaccinations Monday, the first Americans to do so outside of a clinical trial.

However, it will be a few more months before the average person can go to their local drug or grocery store and get the vaccine. In interviews with CNBC, Walgreens and CVS Health officials said they are expected to begin recording for the general public in the spring.

“In the next few months we expect that we will be able to [it in] Our business is similar to flu season, “said Rina Shah, group vice president of pharmacies at Walgreens, on CNBC’s The Exchange on Monday. She said it would be” hopefully in the spring. “

For now, Shah said, it is important that healthcare workers and long-term care workers have priority as supply remains limited.

“As more vaccines become available, access to this vaccine will continue to grow,” she said.

Chris Cox, CVS senior vice president, hopes the company can drop the vaccine in their drugstores “somewhere in April-May”.

Two prominent public health officials – Dr. White House Coronavirus Advisor Anthony Fauci and Dr. Ashish Jha, dean of Brown University School of Public Health – said Monday they expect healthy Americans who do not qualify for a vaccine job or health status because of their health to get the vaccine in late March or April. Fauci made the comments in an interview with Hallie Jackson of NBC News, and Jha shared the same schedule in an interview with ABC’s “The View.”

Nearly 20 drug stores and grocery stores – including Walgreens and CVS – partnered with the U.S. Department of Health in mid-November to support the delivery of Covid-19 vaccines. The two drugstore chains will also play a central role in the early stages of vaccine introduction. They have made agreements with the federal government to vaccinate residents and employees of tens of thousands of nursing homes and other long-term care facilities across the country.

Costco also expects to start offering Covid-19 vaccinations to the general public in its pharmacies starting this spring, CEO Craig Jelinek said on CNBC’s “Closing Bell” on Monday.

Rite Aid, Kroger, Publix and HEB – some of the other retailers involved in the vaccination effort – said they are still waiting to hear when they will get vaccination doses and can offer the shots to Americans.

Walmart is preparing its 5,000+ stores for the vaccines, although it wasn’t known when they might arrive. In a post on the company’s website, Chief Medical Officer Dr. Tom Van Gilder, the big box retailer, is adding freezing capacity and getting dry ice for its pharmacies. He said it is also developing a process that will help people keep track of their first and second vaccine doses and train the staff who may receive them.

CVS ‘Cox said in an interview with CNBC last week that when vaccines become available to the general public, people will need to make appointments with CVS to get their recordings.

“If someone makes an appointment, we will immediately inform them that it is a two-shot vaccine and we will get them to schedule them wherever they go like a round-trip ticket.” schedule both doses at the same time, “said Cox, who also serves as the company’s liaison with Operation Warp Speed, the Trump administration’s vaccine development program.

Pfizer and BioNTech’s two-dose vaccine is the only one to have received emergency approval from the Food and Drug Administration. By the spring, however, the health authorities expect vaccines from several manufacturers to be available. Moderna’s vaccine could get the go-ahead from the FDA later this week. It also requires two doses.

Cox said the vaccine the customer receives depends on what is in stock in the store.

Here are the top news, trends, and analysis investors need to get their trading day started:

1. Dow will open higher when Pfizer vaccine is introduced

Traders work on the trading floor of the New York Stock Exchange.

NYSE

Dow futures indicated a gain of more than 200 points on Monday’s opening when Pfizer and BioNTech’s Covid-19 vaccine is rolled out in an emergency. First Monday vaccinations in the US are cumulative coronavirus deaths in America near 300,000, with the 7-day average of deaths being more than 2,400.

A non-partisan $ 908 billion proposal is expected to be split in two to reach an agreement on new economic incentives for Covid-19, according to a Reuters report. The first move would be a $ 748 billion package that includes small business money, an increase in federal unemployment benefits, and vaccine distribution. The second move would cover some of the key sticking points like corporate liability protection and $ 160 billion for state and local governments. According to Reuters, the packages could be released on Monday.

Economic uncertainty kept stocks in check last week as the Dow Jones Industrial Average, S&P 500 and Nasdaq all broke profit streaks for several weeks. President Donald Trump signed a week-long extension of state funds on Friday to avoid a partial federal shutdown and free up more time for economic talks.

2. Vaccine doses are shipped to the USA

Cardboard boxes containing the Pfizer-BioNTech COVID-19 vaccine are being prepared for shipment at the Pfizer Global Supply Kalamazoo manufacturing facility in Portage, Michigan, USA, on December 13, 2020.

Morry Gash | Reuters

The first of many freezer-packaged vials of Pfizer’s vaccine will be shipped to the US after the FDA granted emergency clearance on Friday, triggering government plans to distribute 2.9 million doses within 24 hours, followed by more 2.9 million doses 21 days later for patients to get their second shot. A key CDC panel unanimously voted on Saturday to recommend the vaccine for anyone ages 16 and older, and the agency’s director was quick to sign it. Pfizer plans to ship 50 million cans this year.

This creative image, captured in a studio in Paris on November 16, 2020, showing a syringe and vaccine bottle with the logo of a US biotech company Moderna reproduced, illustrates the announcement of an experimental vaccine against Covid-19 from Moderna, which is nearly complete would be 95% effective, a second important step forward in ending the Covid-19 pandemic.

Joel Saget | AFP | Getty Images

FDA Commissioner Dr. Stephen Hahn said Sunday that the agency will release its data on Moderna’s Covid-19 vaccine this week before Thursday’s advisory panel meeting to vote on whether to recommend it for an emergency. “I will not anticipate this discussion or our assessment of the data,” Hahn said during an interview on CNN’s State of the Union. “My sincere hope is that we will go forward and do this quickly.” Moderna said it is on track to produce 20 million cans by the end of the year.

3. Voters officially elect Biden as president

U.S. President-elect Joe Biden announces another round of candidates and candidates to his administration while U.S. Vice President-elect Kamala Harris listens during a press conference on December 11, 2020 at his interim headquarters in Wilmington, Delaware.

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The presidential election will meet on Monday to officially elect Joe Biden as the nation’s next president. The results will be summarized in a joint congressional session on January 6th, chaired by Vice President Mike Pence. There is no reason to expect defects this year. Voters’ votes attracted more attention than usual in 2020 because Trump refused to allow the election and continued to raise unsubstantiated allegations of fraud. Biden plans to address the nation Monday night after the voters vote.

4. The White House recognizes reports of cyberattacks

Annette Riedl | Picture Alliance | Getty Images

The Trump administration confirmed reports that a foreign government-backed group carried out a cyber attack on the finance department and part of the trade department. The Washington Post linked the hack, which occurred over the weekend, to a group that worked for the Russian Foreign Intelligence Service. The latest revelation comes less than a month after Trump fired Christopher Krebs, the country’s leading cybersecurity officer, and accused him of making “highly inaccurate” statements about the security of the 2020 presidential election. Russia has denied the allegations.

5. Google’s YouTube, Gmail and Drive are suffering from an outage

The Gmail email application appears on a portable device on December 6, 2017 in this photo illustration. (Photo by Jaap Arriens / NurPhoto via Getty Images)

NurPhoto | NurPhoto | Getty Images

Alphabet’s Google appears to be suffering from a global outage that took several services, including YouTube, Gmail, and Google Drive, offline. Several people on social media reported issues with the platforms, with Gmail, YouTube, and Google Drive displaying error messages without further explanation. Google wasn’t immediately available for comment when contacted by CNBC.

– Reuters and The Associated Press contributed to this report. Follow all developments on Wall Street in real time with CNBC Pro’s live market blog. Find out about the latest pandemics on our coronavirus blog.