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The UK has recognized a brand new pressure of Covid-19 that’s spreading sooner. This is what they know

England’s top medical officer announced Saturday that the UK had identified a new variant of the coronavirus that “can spread faster” than previous strains of the virus, prompting Prime Minister Boris Johnson to impose new restrictions on parts of the nation to control its spread.

“We learn from this over time, but we already know enough, more than enough, to be sure that we need to act now,” Johnson said during a press conference on Saturday setting new restrictions on London and other parts of England before the Christmas holidays.

“If the virus changes its method of attack, we’ll have to change our method of defense,” said Johnson.

The UK government announced the new strain of coronavirus on Monday after cases increased in the south and east of England. According to a statement from Public Health England, just over 1,100 Covid-19 cases had been identified with the new variant by Sunday.

Now it is believed the new strain could be up to 70% more communicable than the original strain of the disease, Johnson said on Saturday, adding that it appears to be fueling the rapid spread of infections. Johnson urged residents not to travel and “stay on-site” to keep the new strain from moving around the country and abroad.

The UK reports around 24,061 new Covid-19 cases daily based on a weekly average, an increase of more than 40% from the previous week, according to a CNBC analysis of data compiled by Johns Hopkins University.

“This is early data that needs to be verified, but it is the best we have right now and we need to respond to information as we have it because it is now spreading very quickly,” said Johnson.

Professor Chris Whitty, England’s chief medical officer, said at the press conference that “viruses are constantly mutating”. Seasonal influenza mutates every year, and other new variants of the coronavirus have already been identified in countries like Spain, according to Public Health England.

What needs to be answered is whether the new strain will transmit more easily, make people sick, and whether it will change the way a person’s immune system responds to the virus if they are already infected or vaccinated, Whitty said.

So far, a body of evidence from genetic studies, frequency studies, and laboratory studies suggests that the new strain “has a significant, substantial increase in transmissibility,” Whitty said. So far, however, there is no evidence that the new strain causes a higher mortality rate.

Health officials believe the new variant first appeared in London or Kent in mid-September, and by mid-November it is believed to have caused about 28% of cases in London and other parts of south-east England, Whitty said.

Now those numbers are much higher, he said. In London last week, data suggests the new variant accounts for more than 60% of new cases, Whitty said.

“So that tells us that this new variant is not only moving fast, it also transmits better, it also becomes the dominant variant. It beats everyone else in terms of transmission,” he said.

However, there is “no evidence” that it causes more severe illness, more hospitalizations, or “more problems than the other virus,” Whitty said. While there are reasons to suspect the new variant might alter a person’s immune response to the disease, nothing suggests that it has so far, he said.

“We are currently assuming by all scientists that the vaccine response for this virus should be appropriate,” he said. “Obviously this has to be checked in the future, and we have to remain vigilant in this regard.”

The UK has alerted the World Health Organization and will continue to analyze data on the new strain.

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You’ll be able to’t sue Pfizer or Moderna for unwanted effects

If you’ve had serious side effects after taking a Covid vaccine, attorneys tell CNBC that there is basically no one to blame in a U.S. court.

The federal government has granted companies like Pfizer and Moderna liability immunity if something goes wrong with their vaccines.

“It is very rare for a blanket immunity bill to be passed,” said Rogge Dunn, a Dallas work and employment attorney. “Pharmaceutical companies are typically not afforded much liability protection by law.”

You also can’t sue the Food and Drug Administration for approving an emergency vaccine, and you can’t hold your employer accountable for making vaccination a condition of employment.

Congress created a fund specifically to cover lost wages and medical expenses for people who have been irreparably harmed by a “covered countermeasure” such as a vaccine. But it’s hard to use and rarely pays off. Lawyers say it has compensated less than 6% of claims filed over the past decade.

Immune to lawsuits

In February, the Secretary for Health and Human Services, Alex Azar, invoked the Public Preparedness and Emergency Preparedness Act. The 2005 Act empowers the HHS Secretary to provide legal protection to companies that manufacture or sell critical medical supplies such as vaccines and treatments unless the company has “willful misconduct”. The protection lasts until 2024.

This means that for the next four years these companies “cannot be sued in court for monetary damages” for violations related to the administration or use of products for treatment or protection against Covid.

HHS declined CNBC’s request for an interview.

Dunn believes a big reason for the unprecedented protection has to do with the accelerated timeline.

“When the government said, ‘We want you to develop this four or five times faster than normal,’ the manufacturers most likely said to the government, ‘We want you, the government, to protect us from multi-million dollar lawsuits. “” said Dunn.

It is very rare for a blanket immunity law to be passed. … Pharmaceutical companies are usually not afforded much liability protection by law.

Rogge Dunn

Dallas labor and employment attorney

The fastest vaccine ever developed was for mumps. It took four years and was approved in 1967. Pfizer’s Covid-19 vaccine was developed and approved for emergency use within eight months – a fact that has fueled public suspicion of coronavirus vaccination in the United States

About 4 in 10 Americans say they would “definitely” or “probably” not get the vaccine, according to a recent poll from the Pew Research Center. While this is lower than two months ago, it still indicates a large trust gap.

But drug manufacturers like Pfizer continue to reassure the public that no shortcuts have been taken. “This is a vaccine that has been developed without compromising,” said CEO Dr. Albert Bourla in an interview with CNBC’s “Squawk Box” on Monday. “This is a vaccine that is approved by all authorities in the world. That should say something.”

The immunity granted to pharmaceutical companies not only protects them from lawsuits. Dunn said it helps lower the cost of vaccinations.

“The government doesn’t want people to sue the companies that make the Covid vaccine, because then the manufacturers would likely charge the government a higher price per person per dose,” said Dunn.

Pfizer and Moderna have not returned CNBC’s request for comment on their legal protection.

Is anyone liable?

Remember, vaccine manufacturers are not the ones who approve their product for mass distribution. That is the job of the FDA.

Which begs the question, if you react extremely poorly to a vaccine, can you sue the US government?

Again the answer is no.

“You can’t sue the FDA for approving or rejecting a drug,” said Dorit Reiss, professor at the University of California’s Hastings College of Law. “It’s part of his sovereign immunity.”

Sovereign immunity came from the king, explains Dunn, referring to British law before the American Revolution. “You couldn’t sue the king. So America has sovereign immunity, and even every state has sovereign immunity.”

There are limited exceptions, but Dunn said he doesn’t think they are a viable legal avenue to hold the federal government responsible for a Covid vaccination violation.

Bringing workers back into a post-Covid world also brings with it an increased fear of employer liability. Lawyers across the country say their corporate clients are reaching out to them to ask if they can request employees to be vaccinated.

India Medley, Chief Nurse Officer at Howard University Hospital, receives the Covid-19 vaccine at Howard University Hospital in Washington, DC on December 15, 2020.

Nicholas Comb | AFP | Getty Images

Dunn’s customers who run businesses that serve customers in person or on-site are most interested in getting a Covid vaccine for employees.

“They see it as a selling point,” said Dunn. “It is especially important for restaurants, bars, gyms and salons. My customers in this segment of the service industry are very keen to make this a binding selling point for their customers.”

While this is in part a public relations tactic, it is legally the right of an employer to impose such a requirement.

“Requiring a vaccine is a health and safety work rule, and employers can do it,” Reiss said.

There are a few notable exceptions. If a workforce is unionized, the collective agreement may need to require negotiations with the union before a vaccine is made mandatory.

Anti-discrimination laws also offer protection. The American With Disabilities Act allows workers who do not wish to be vaccinated for medical reasons to apply for an exemption. If ingestion of the vaccine is a violation of a “righteous” religious belief, Title VII of the Civil Rights Act of 1964 would possibly provide a route sign out.

If none of these exceptions apply, employees can appeal if they suffer from debilitating side effects after a work-related Covid vaccination.

Lawyers say claims would most likely be channeled through employee compensation programs and treated as workplace injury.

“However, there are significant limits or caps on the damage an employee can claim,” Dunn said. He added that it would likely be difficult to prove.

However, mandatory vaccination protocols may not be created until the FDA officially approves the vaccines and licenses Pfizer and BioNTech or Moderna for sale. This will take several months for data to show their safety and effectiveness.

“An emergency permit is not a license,” said Reiss. “There is a legal issue as to whether you can mandate an emergency observation. The language, in fact, is a bit unclear on this.”

$ 50,000 per year

The government created a way to compensate people in case something goes wrong after vaccination.

In addition to Due to legal immunity, the PREP Act introduced the Countermeasures Injury Compensation Program (CICP), which provides benefits to eligible individuals seriously injured by any of the protected companies.

The little-known government program has been around for a decade and is managed by an agency under HHS. This fund usually only deals with vaccines that you would probably never get, like the H1N1 and Anthrax vaccines.

If a case is successful for compensation from the CICP, the program allows up to $ 50,000 per year in non-reimbursed lost wages and medical expenses. There are no legal fees or other costs to compensate for pain and suffering.

It is also limited to the $ 370,376 death benefit total. This is the maximum amount a surviving family member will receive if a Covid vaccine turns out to be fatal.

However, experts who specialize in vaccination law say that it is difficult to navigate. “This state compensation program is very difficult to apply,” said Reiss. “The bar for compensation is very high.”

Also of concern to some vaccination injury attorneys is the fact that the CICP has turned down a large portion of the claims for compensation it has made since the program began 10 years ago. Of the 499 claims filed, The CICP has settled only 29 claims totaling more than $ 6 million.

People harmed by a Covid vaccine deserve to be compensated quickly and generously. The PREP law doesn’t do that.

Dorit Reiss

Professor at the University of California Hastings College of Law

David Carney, vice president of the Vaccine Bar Association, said the CICP could deny a claim for a variety of reasons. “One reason could be that the medical records do not support an allegation,” said Carney, who regularly deals with vaccination injury cases. “We have to process a lot of really complex questions … and provide a medical basis for why the injury occurred.”

Proof of injury as a direct result of the Covid vaccine could be difficult, Carney said. “It’s not that easy to say, ‘Hey, I got Covid treatment and now I have an injury.’ There is a lot of evidence there. “

There is also a strict one year law, which means that all claims must be made within 12 months of receiving the vaccine.

“People who are harmed by a Covid vaccine deserve to be compensated quickly and generously,” said Reiss. “The PREP Act doesn’t do that.”

Lawyers tell CNBC that it would make more sense to channel Covid vaccination violations through another program under the HHS called the National Vaccine Injury Compensation Program that handles applications for 16 routine vaccines instead. The program known colloquially as the “vaccination court” paid for about 70% of the petitions decided by the court from 2006 to 2018.

And since reviewing claims in 1988, the VICP has paid total compensation of approximately $ 4.4 billion. This dwarfs the approximately $ 6 million in paid services of the CICP during the life of the program.

The VICP also gives you more time to file your claim. You have three years from the date of the first symptom to claim compensation.

“The VICP provides recovery from pain and suffering, legal fees, and any medical expenses and lost wages,” said Michael Maxwell, a lawyer specialing in litigation and personal injury. “Under the CICP, it’s just lost wages and medical expenses. That’s it, unless there’s a death.”

However, the Covid-19 vaccines are not on the list of eligible vaccines.

Reiss said the best solution would be to change VICP’s rulebook to include Covid vaccines in the vaccination coverage list. “That requires a change in the law. I hope that there will be a change in the law.”

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California’s Covid Surge forces Theranos Elizabeth Holmes trial to be late

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.

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The FDA says it hasn’t accredited Moderna Covid’s vaccine regardless of Trump’s tweet

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.

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The FDA panel recommends emergency clearance

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.

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5 issues you must know earlier than the FDA panel votes on Thursday

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.

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Singapore International Minister for Covid Vaccines, world outlook for 2021

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.”

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Prisoners have been excluded from vaccination plans for 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.

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Health

HHS Secretary Azar says the general public can be given a Covid vaccine “in late February by March”.

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.”

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Health

FDA workers advocate looking for Bell’s palsy in recipients of Moderna and Pfizer vaccines

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.

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