Tag: Covid

Categories
Health

Marc Lewitinn, Covid Affected person, Dies at 76 After 850 Days on a Ventilator

Marc Lewitinn, Covid Patient, Dies at 76 After 850 Days on a Ventilator

None of them come close to Mr Levitinn’s streak, a combination, doctors say, of his physical and mental strength and the speed with which the medical establishment has developed protocols for long-term care for Covid.

“He had a long and difficult road,” wrote Dr. Abraham Sanders, one of his doctors at Weill Cornell, in an email. “He was a strong man and benefited from sophisticated medical care.”

Murad Albert Lewitinn was born on March 12, 1946 into a Jewish family in Cairo. (As a child, he anglicized his first name to Marco and later dropped the O.) His father, Albert Lewitinn, was a medical technician and his mother, Sarah (Amiga) Lewitinn, was a homemaker. He grew up speaking Arabic and later learned English, French and Spanish.

Egypt had a thriving Jewish community of 75,000, but after the Arab nationalist revolution in 1952 and the Suez Crisis in 1956, which pitted the country against Israel, France and Britain, they faced deteriorating conditions. The government took over the elderly Mr. Lewitinn’s business, and after a brief imprisonment, he and his family were expelled in 1958.

They settled in Baltimore, where Albert Lewitinn was hired by Johns Hopkins University to work on organ transplant technology.

As a young man, Marc lived in New York City and Los Angeles, where he briefly attended college, then in Paris, where he met Ondine Green, the sister of a childhood friend from Cairo. They married in 1968.

Categories
Health

Dr. Ounceshas ties to hydroxychloroquine corporations as he backs Covid therapy

Dr. Oz has ties to hydroxychloroquine companies as he backs Covid treatment

Republican Senate candidate from Pennsylvania, Dr. Mehmet Oz, has financial ties to at least two pharmaceutical companies that supply hydroxychloroquine, an antimalarial drug he circulated as a possible treatment for Covid-19.

Oz, a physician and veteran television host who is up against Democrat John Fetterman in the race for the Pennsylvania Senate seat, owns with his wife at least $615,000 in Thermo Fisher Scientific stock, according to its financial disclosure. Thermo Fisher Scientific’s website lists hydroxychloroquine sulfate as one of the available products. It’s unclear when Oz and his wife bought the stock or if they owned it, as Oz promoted hydroxychloroquine as a Covid treatment early in the pandemic.

Oz and his wife also own between $15,001 and $50,000 in McKesson Corporation stock, according to the disclosure. According to the FDA, the company labels and sells hydroxychloroquine sulfate. It’s also unclear when they bought McKesson stock.

Hydroxychloroquine sulfate is the anti-malarial drug commonly known as hydroxychloroquine, according to the Food and Drug Administration. Doctors across the country, helped in part by support from former President Donald Trump and conservative media figures, have been offering the drug to patients as a Covid treatment, despite its questionable effectiveness against the virus.

Oz’s financial ties to a manufacturer and distributor of the drug, and his promotion of it as a potential Covid treatment, raise questions about what he would benefit from its wider use during the pandemic. If he wins the Senate election, he could also face conflicts of interest as Congress grapples with a still-evolving coronavirus pandemic.

In a statement responding to CNBC questions about Oz’s ties with companies that manufacture or distribute hydroxychloroquine, including when he and his wife bought shares in Thermo Fisher Scientific, Oz campaign spokeswoman Brittany Yanick, does not affect the financial interests of the candidate.

“At the beginning of the pandemic, Dr. Mehmet Oz with healthcare professionals worldwide who are considering hydroxychloroquine and azithromycin as viable treatment options for critically ill COVID patients. He offered to fund the clinical trial at Columbia University,” she said.

The FDA has approved hydroxychloroquine to fight malaria but warned that it “has not been shown to be safe or effective for treating or preventing COVID-19.”

Oz took bold steps early in the pandemic to promote its use as a treatment. He urged Trump administration officials in 2020 to support a study he wanted to fund at Columbia University Medical Center on the effect of hydroxychloroquine on Covid-19 patients, according to emails obtained by the select subcommittee of the House of Representatives on the coronavirus crisis have been received and published.

Oz also has ties to a third company, which it says has divested hydroxychloroquine from its US portfolio.

Sanofi, which is headquartered in France and previously manufactured hydroxychloroquine, supported Oz’s nonprofit HealthCorps for years, according to the group’s annual disclosure reports. Between 2009 and 2018, Sanofi was listed as either a sponsor or donor in kind to the Oz-funded group, which owns aims to help teenagers with their health and well-being. In 2013, Sanofi is listed as one of the group’s “School Sponsors”. HealthCorps’ website states that a school sponsor must donate $100,000 to qualify.

Sanofi announced in April 2020 that it would donate 100 million doses of hydroxychloroquine to 50 countries around the world as studies evaluated the drug’s effectiveness in treating Covid-19.

A spokesman for Sanofi told CNBC that the company was not involved in Oz’s comments about Covid-19 or hydroxychloroquine. He explained that Sanofi divested hydroxychloroquine from its US portfolio in 2013 and was investigating the drug’s use as a potential way to fight the virus early in the Covid pandemic. After it was deemed ineffective against Covid-19, the company’s work on it was suspended.

The spokesperson also explained that the company’s last financial contribution to HealthCorps was in 2011. The company representative later corrected himself in a follow-up email to CNBC after the publication of this story, saying that 2013 was actually the last year that Sanofi made a financial donation to HealthCorps.

Oz’s ties to companies that would benefit from wider use of hydroxychloroquine could pose problems for the Republican if he wins the Senate seat. Kedric Payne, an ethics attorney at the Campaign Legal Center, told CNBC in an email that Oz could choose to walk away from the companies if he defeated Fetterman in November.

“He could have a rude awakening if elected because ethics rules could bar him from the job. Senators cannot use their positions to promote goods or services that benefit them financially,” Payne said. “Oz could voluntarily divest the shares if elected or stop promoting anything tied to his shares.”

A spokesman for Thermo Fisher Scientific declined to comment. A McKesson representative did not respond to a request for comment prior to publication.

Since launching his campaign late last year, Oz has downplayed warnings from the FDA and other experts against the use of hydroxychloroquine as a Covid treatment. He suggested political animus against Trump endorsing the drug as a treatment and Oz in the Senate election, motivating criticism of the drug as a way to combat Covid.

“Well let me say this real quick, I really don’t know if it works or not, we haven’t been able to prove to this day if it works [hydroxychloroquine] works or not, which is a shame because we should have known by now whether a cheap 70-year-old drug used by a billion people works or not,” Oz said at a campaign event earlier this year. “But we don’t know. t which is a problem in itself. However, I mentioned it and then President Trump mentioned it in a press conference and suddenly the whole world hated hydroxychloroquine without testing it, without knowing it.”

Before launching his campaign, Oz championed hydroxychloroquine more explicitly. During an interview with Fox News in March 2020 at the height of the pandemic, Oz said that “hydroxychloroquine has a role” in fighting the virus. An on-screen graphic while Oz was being interviewed called the anti-malarial drug “promising” as a treatment option for Covid-19.

Oz also sought White House help to get the hydroxychloroquine trial going, which he wanted to fund at Columbia, where he was once vice chairman of the department of surgery. He has since said the study never got off the ground.

The Pennsylvania nominee’s communications with White House officials were released last month by the House’s select subcommittee on the coronavirus crisis. In an email dated March 2020 Deborah Birx, former Trump White House coronavirus response coordinator, told Oz he would recruit patients and pay for the hydroxychloroquine trial himself.

Also in March 2020, Oz Trump’s son-in-law and adviser Jared Kushner emailed that “we must make the completion of this study a national priority and insist on immediate enrollment,” according to correspondence obtained by the House Committee and has published. Kushner replied to Oz the same day, “What do you recommend to speed it up?”

The New York Post reports that Oz spent $8,800 on hydroxychloroquine tablets for the study at the time and offered to spend $250,000.

Oz, during his campaign for the Pennsylvania Senate seat, accused then-New York Governor Andrew Cuomo of stopping the study after effectively banning the anti-malarial drug as a Covid treatment.

Oz’s financial ties could pose a bigger problem for him if he wins the Pennsylvania race, one of a few contests to decide which party will control the Senate next year. A Real Clear Politics poll average shows Fetterman leading Oz by almost 7 percentage points.

Share ownership in Congress will come under increased scrutiny. Some lawmakers in Congress have proposed a ban on individual stock deals that would require lawmakers to invest assets in a blind trust or to divest them outright.

Business Insider has identified at least 71 lawmakers who have violated the Stop Trading on Congressional Knowledge Act, or STOCK Act. The law aims to prevent members of Congress from trading stocks using inside information gained from their work as legislators.

By and large, however, members of Congress had little impact on lucrative stock deals.

Categories
Health

CDC clears reformulated Covid pictures concentrating on omicron in time for varsity

Millions of Americans could be eligible for a new Covid refresher

Justin Sullivan | Getty Images

The Centers for Disease Control and Prevention have released reformulated Covid shots targeting the latest Omicron subvariants for the fall, allowing many people to get an extra boost in days.

The agency’s independent committee on vaccines voted 13-1 in favor of the shots on Thursday after reviewing the available safety and efficacy data in a nearly seven-hour session. CDC Director Dr. Rochelle Walensky approved the injections a few hours later, clearing the way for pharmacies to administer the injections soon.

Pfizer’s Omicron boosters were approved for ages 12+, while Moderna’s updated shots were approved for ages 18+. The eligible age groups can receive the boosters no earlier than two months after the completion of their primary series or their last booster with the old vaccinations.

Walensky said her decision followed “a thorough scientific evaluation and sound scientific discussion.”

“If you are eligible, there is no bad time to get your Covid-19 booster and I strongly encourage you to get it,” she said in a statement.

Pfizer plans to ask the Food and Drug Administration to also approve the new boosters for children ages 5 to 11 in early October, company executives told the committee Thursday.

The original vaccines are no longer used as a booster dose in people aged 12 and over as the reformulated vaccines are now online.

Public health officials expect another wave of Covid infections this fall as immunity to the legacy vaccines wanes, more contagious omicron subvariants spread and people spend more time indoors as the weather turns colder and families close gather for the holidays.

The CDC and FDA hope the new boosters will provide more durable protection against infection, mild illness, and serious illness. The reformulated shots target omicron BA.5, the dominant variant of Covid, as well as the strain that emerged in China more than two years ago.

The US has so far secured 171 million doses of the new boosters from Pfizer and Moderna. More than 200 million people are entitled to the recordings, according to the CDC. dr Sara Oliver, a CDC official, told the committee Thursday there should be enough vaccine supplies to meet demand this fall.

No omicron BA.5 human data

There is no human trial data on the new BA.5 boosters, so it is unclear how they will perform in the real world. The CDC and FDA used human clinical trial data for vaccinations against the original version of Omicron, BA.1, which elicited a stronger immune response than the old vaccines.

Pfizer and Moderna originally developed Omicron boosters for BA.1, but the FDA told the companies to change gears in June and develop BA.5 shots instead after the subvariant became dominant. The decision to focus on BA.5 did not leave enough time to wait for data from human trials before a vaccine launch in the fall.

The lack of human data for the BA.5 vaccines has caused some controversy, but Dr. Peter Marks, a senior FDA official, said the agency has followed the same process it has used for years to change strains for flu vaccines. Marks said Wednesday flu vaccine strains are being changed even without human clinical data.

dr Pablo Sanchez, the only committee member who voted against the injections, called the recommendation premature and said the US should have waited for human data before proceeding with the boosters.

“There’s already a lot of hesitation with vaccines — we need the human data,” said Sanchez, a professor of pediatrics at Ohio State University. But Sanchez said he believes the new boosters are safe and he will likely receive one himself.

CNBC Health & Science

Read CNBC’s latest global health coverage:

Board member Dr. Oliver Brooks, chief medical officer at Watts HealthCare Corporation in Los Angeles, questioned why the FDA chose a BA.5 vaccine when clinical data is available for the BA.1 vaccine that vaccine manufacturers are initially developing had. Brooks eventually voted for the shots.

But dr Sarah Long, also a committee member, said there was no reason to believe the BA.5 boosters will be inferior to the old vaccines as they also contain the original Covid strain and have the potential to increase hospitalizations and deaths along the way in the future to reduce autumn and winter. Long also voted in favour.

mouse studies

FDA and CDC officials have said that the omicron BA.1 and omicron BA.5 boosters are similar enough that the immune response data of the BA.1 vaccine should give a good indication of how the BA.5 vaccine will work. Omicron BA.1 and BA.5 are according to Dr. Jacqueline Miller, who works on vaccine development at Moderna, are closely related and share a difference of four mutations.

Moderna completed enrollment in clinical trials on the BA.5 shots last week and should have results by the end of the year, Miller told the CDC committee on Thursday. Pfizer’s clinical trial is also ongoing, although the company hasn’t said when it expects results.

Health authorities also reviewed data on the BA.5 shots from mouse studies. Moderna presented data showing that the BA.5 shots increased antibodies in mice more than four-fold compared to the old shots. The mice express the same cellular protein as humans, to which the virus attaches. Pfizer’s BA.5 booster increased antibodies in mice by 2.6-fold compared to the original vaccine.

security

According to the FDA, the most common side effects from the human trials of BA.1 injections were pain, redness, swelling at the injection site, fatigue, headache, muscle pain, joint pain, chills, nausea, vomiting, and fever.

Oliver, the CDC official, told the committee that health officials do not expect a difference in the safety profile of the BA.1 and BA.5 shots because the subvariants differ by only a few mutations.

However, Oliver noted that the risk of myocarditis following a BA.5 booster dose is unknown. Young men and adolescent boys are at increased risk of myocarditis after the second dose of Pfizer and Moderna, but the risk of myocarditis from Covid infection is higher, according to the CDC.

“We know that the risk of myocarditis is unknown, but expect a risk similar to that seen after the monovalent vaccines,” Oliver said. The monovalent vaccines are the old vaccines that have been given to millions of people in the US over the last two years.

Old vaccines are losing their effectiveness

The original vaccines, which were first approved in December 2020, no longer offer any meaningful protection against infection because the virus has mutated so much in the last two years. The shots were developed against the first strain to appear in China, so they are no longer tailored to attack the expanding Omicron subvariants.

Infections, hospitalizations and deaths have all fallen dramatically since last winter’s massive Omicron outbreak, but have leveled off at stubbornly high levels this summer. Omicron BA.5 is the most contagious and immune-avoidable variant to date, and breakthrough infections have become increasingly common as a result.

The effectiveness of the old vaccines against hospitalization also decreased after omicron BA.5 became dominant. A third dose was 77% effective at preventive hospitalization four months after receiving the shot, but protection dropped to as much as 34% at 120 days, according to CDC data. A fourth dose in people aged 50 and over was 56% effective in preventing hospitalization at four months.

Deaths and hospitalizations from Covid among people aged 65 and older have increased since April, according to Heather Scobie, a CDC epidemiologist who presented data during Thursday’s meeting. The number of deaths has increased, particularly among people aged 75 and over, Scobie said.

The CDC has shifted to a more focused public health response, with a focus on protecting the most vulnerable — the elderly, those with serious illnesses and those with weakened immune systems. Though there’s no data on the real-world effectiveness of the new boosters, the US is moving quickly to introduce them in hopes they’ll protect people this fall.

Categories
World News

Kentucky Governor: State’s Covid surge is ‘dire’

Kentucky Governor: State's Covid surge is 'dire'

The Democratic governor of Kentucky on Sunday described the spike in Covid cases in the state as “bleak,” pointing out that Republican lawmakers have curtailed their ability to control the record wave of infections there.

“If I had the opportunity to do it now, we would have a masking order for you when you are in public and indoors,” Governor Andy Beshear said on NBC’s Meet the Press news program. “We know this is a proven way to slow the spread of the virus and ultimately support our health capacities.”

Kentucky recorded 4,423 new daily cases on Saturday, a seven-day average, according to a database from the New York Times. The number of deaths and hospitalizations has also increased. “Our situation is dire,” said Mr. Beshear.

The state’s Supreme Court recently ruled that a lower court cannot block attempts by lawmakers to restrict Mr Beshear’s emergency powers to deal with Covid. He had tried to enforce a comprehensive mask mandate in schools.

Mr Beshear has called a special session of the state legislatures on Tuesday to look at the crisis.

The National Guard, FEMA and nursing students have been deployed across the state to help hospitals, Mr Beshear said.

“When you’re at war, you can’t cry about what you can or can’t do,” he said. “You have to do your best every day because this is a life-and-death struggle.”

In the state, 68 percent of people over the age of 12 have received at least one dose of a Covid vaccine and 58 percent are fully vaccinated, according to a Times database. This puts Kentucky in the middle compared to the vaccination rates in other states.

“We have, I believe, across America far behind the populations who will listen to a government official and take the vaccine because of it,” said Mr Beshear. “We’re probably even past a local official, pastor, or other.”

He attributed some of the state’s vaccine reluctance to misinformation and urged individuals to speak to loved ones in addition to public information campaigns.

“People are going to have to break that Thanksgiving dinner rule,” he said. “You have to call or go to an unvaccinated person whom you love and care for. You will have to jeopardize your relationship with this person because you have never been exposed to greater risk. “

“I think it is this kind of care and the person who is willing to do this and make this sacrifice that finally reaches those who are not vaccinated.”

He added, “You could lose a friend through this conversation, but that friend could lose his life if not vaccinated.”

Categories
World News

WHO says it’s monitoring a brand new Covid variant known as ‘mu’

WHO says it is monitoring a new Covid variant called 'mu'

World Health Organization (WHO) Director General Tedros Adhanom Ghebreyesus speaks during a bilateral meeting with Swiss Interior and Health Minister Alain Berset on the sidelines of the opening of the 74th World Health Assembly at the WHO headquarters, in Geneva, Switzerland May 24, 2021.

Laurent Gillieron | Reuters

The World Health Organization is monitoring a new coronavirus variant called “mu,” which the agency says has mutations that have the potential to evade immunity provided by a previous Covid-19 infection or vaccination.

Mu — also known by scientists as B.1.621 — was added to the WHO’s list of variants “of interest” on Aug. 30, the international health organization said in its weekly Covid epidemiological report published late Tuesday.

The variant contains genetic mutations that indicate natural immunity, current vaccines or monoclonal antibody treatments may not work as well against it as they do against the original ancestral virus, the WHO said. The mu strain needs further study to confirm whether it will prove to be more contagious, more deadly or more resistant to current vaccines and treatments.

Mu “has a constellation of mutations that indicate potential properties of immune escape,” the WHO wrote in its report Tuesday.

“Preliminary data presented to the Virus Evolution Working Group show a reduction in neutralization capacity of convalescent and vaccine sera similar to that seen for the Beta variant, but this needs to be confirmed by further studies,” it added.

The agency is monitoring four variants “of concern,” including delta, which was first detected in India and is the most prevalent variant currently circulating in the U.S.; alpha, first detected in the U.K.; beta, first detected in South Africa, and gamma, first detected in Brazil. A variant of concern is generally defined as a mutated strain that’s either more contagious, more deadly or more resistant to current vaccines and treatments.

It’s also keeping a close watch on four other variants of interest — including lambda, first identified in Peru — that have caused outbreaks in multiple countries and have genetic changes that could make them more dangerous than other strains.

Delta was a variant of interest until the WHO reclassified it in early May after preliminary studies found it could spread more easily than other versions of the virus. That variant has since been blamed for a number of large outbreaks around the world, including in the United States.

The new variant, mu, was first identified in Colombia but has since been confirmed in at least 39 countries, according to the WHO. Although the global prevalence of the variant among sequenced cases has declined and is currently below 0.1%, its prevalence in Colombia and Ecuador has consistently increased, the agency warned.

The WHO said more studies are required to understand the clinical characteristics of the new variant.

“The epidemiology of the Mu variant in South America, particularly with the co-circulation of the Delta variant, will be monitored for changes,” the agency said.

Categories
Health

‘Please get vaccinated now,’ Biden urges after FDA approves Pfizer Covid photographs

'Please get vaccinated now,' Biden urges after FDA approves Pfizer Covid shots

United States President Joe Biden speaks in the East Room of the White House in Washington, DC on Wednesday, August 18, 2021.

Pete Marovich | Bloomberg | Getty Images

President Joe Biden again urged more Americans to get vaccinated against Covid-19 on Monday, saying the majority of deaths and hospitalizations in the United States from the virus are unvaccinated.

“Those who have been waiting for full approval should take their chance now,” Biden said during a press conference at the White House hours after the Food and Drug Administration completed the full Covid vaccine from Pfizer and BioNTech for people aged 16 and over Had granted approval.

He said the US agency had evaluated “mountains” of clinical study data and determined “without question” that the Covid syringe was safe and highly effective.

“The overwhelming majority of people hospitalized with Covid-19, or almost all of those who have died of Covid-19, are not vaccinated, not vaccinated,” he told reporters. “If you are fully vaccinated – both vaccinations plus two weeks – your risk of developing serious Covid-19 is very, very small.”

“Please get vaccinated now,” added Biden.

According to the agency, FDA scientists evaluated “hundreds of thousands of pages” of vaccine data from 40,000 study participants before granting approval. The two-dose vaccine was found to be 91% effective in preventing Covid – slightly lower than the 95% effectiveness rate study data shown when the vaccine was approved late last year and before the Delta variant prevailed in the USA

So far, the mRNA vaccine, marketed as Comirnaty, has been on the US market under emergency approval granted by the FDA in December. Since then, more than 204 million Pfizer shots have been administered, according to the Centers for Disease Control and Prevention.

Biden’s latest plea comes because coronavirus cases are still safe nationwide, filled by the highly contagious Delta variant. The president said U.S. health officials are beginning to see signs that new cases may decline in some regions of the nation. Still, he said, cases are increasing overall, especially among the unvaccinated.

US officials believe vaccination is the best way to stave off rising cases. According to the Centers for Disease Control and Prevention, about 51% of the entire US population will be fully vaccinated against Covid as of Sunday.

The US approval is expected to spark a new wave of vaccine mandates from American companies and schools. Large companies have already told some or all of their employees that they need to get a full Covid vaccination this fall. Still, despite having legal authority to do so, health experts say some private companies and other institutions may be reluctant to request the shots before full approval.

Earlier in the day, New York City officials said they are now requiring all 148,000 public school teachers and employees to receive their Covid-19 vaccine shots this fall. They had previously said that employees could avoid the vaccines if they had regular weekly Covid tests.

During his speech, Biden urged other schools and companies to prescribe the vaccine.

“All over the world people want these vaccines here in America,” he said. “They’re free, convenient, and waiting for you. So today please go for yourself, for your loved ones, for your neighbors, for your country.”

– CNBC’s Rich Mendez and Bob Towey contributed to this report.

Categories
Health

F.D.A. Grants Full Approval to Pfizer-BioNTech Covid Vaccine

F.D.A. Grants Full Approval to Pfizer-BioNTech Covid Vaccine

The Food and Drug Administration on Monday gave Pfizer-BioNTech’s coronavirus vaccine full approval for people aged 16 and over, making it the first to go beyond emergency status in the United States.

The decision will trigger a cascade of vaccine requests from hospitals, colleges, corporations, and other organizations. Secretary of Defense Lloyd J. Austin III will send vaccination guidelines to the country’s 1.4 million active military personnel, the Pentagon said on Monday.

United Airlines recently announced that its employees must provide proof of vaccination within five weeks of regulatory approval.

Oregon has introduced a similar requirement for all government employees, as have a variety of universities in the states of Louisiana through Minnesota.

Approval comes as the nation’s fight against the pandemic has re-intensified, with the highly contagious Delta variant dramatically slowing the country’s progress in the first half of the year. The Biden administration hopes the development will motivate at least some of the roughly 85 million unvaccinated Americans eligible for syringes.

President Biden plans to commemorate this in a speech urging vaccination, which is scheduled for 1:30 p.m. Eastern time on Monday afternoon. “If you haven’t been vaccinated, now is the time,” the president said on Twitter.

“While millions of people have safely received Covid-19 vaccines, we recognize that FDA approval of a vaccine may now create additional confidence for some to get vaccinated,” said Dr. Janet Woodcock, acting FDA commissioner, in a statement. “Today’s milestone brings us one step closer to changing the course of this pandemic in the US”

Pfizer said it provided the FDA with data from 44,000 participants in clinical trials in the United States, the European Union, Turkey, South Africa and South America. The company said the data showed the vaccine 91 percent prevented infection – a slight decrease from the 95 percent effectiveness rate the data showed when the FDA decided to approve the emergency vaccine in December. Pfizer said the decrease reflects the fact that researchers had more time to capture infected individuals.

A recent survey by the Kaiser Family Foundation, which tracked public attitudes during the pandemic, found that three in ten unvaccinated people said they were more likely to be vaccinated with a fully approved vaccination.

But pollsters and other experts warned that the percentage could be exaggerated. “I think that’s a tiny number of people in real life,” said Alison Buttenheim, an associate professor of nursing at the University of Pennsylvania and an expert on vaccination hesitation.

More important, says Dr. Buttenheim, is the effect of requirements. “Mandates make things easier for people,” she said.

Government action gives doctors more leeway to prescribe patients a third shot of the Pfizer vaccine, but federal officials strongly advised people not to seek additional vaccinations until regulators decide they are safe and effective. Pending regulatory approval, the federal government plans to offer booster syringes for adults next month.

The vaccine continues to be approved for emergency use in children ages 12-15 as Pfizer collects the data necessary for full approval. A decision on whether to approve the vaccine for children under the age of 12 could be at least several months away, and Dr. Woodcock said no child this age should get a Covid-19 vaccine due to a lack of safety data from regulators.

To date, more than 92 million Americans – 54 percent of those fully vaccinated – have received Pfizer vaccinations. Most of the others got the vaccine from Moderna.

Dr. Peter Marks, the FDA’s lead vaccine regulator, said the approval of Pfizer vaccine followed a rigorous review of hundreds of thousands of pages of data and included inspections of the factories where the vaccine is made. “The public and the medical community can rest assured that while we were swiftly approved this vaccine, it met our existing high standards for vaccines in the United States,” he said.

He said federal health officials would continue to monitor the safety of the vaccine and that the FDA would require Pfizer to assess the risks of myocarditis, an inflammation of the heart muscle, and pericarditis, an inflammation of the membrane surrounding the heart, including long-term results for the recipients. The FDA added warnings to the Pfizer-BioNTech and Moderna vaccines in June indicating a possible increased risk for these conditions after the second dose.

Although Pfizer can now market the drug under the Comiraty name, the company said only the federal government will be distributing doses in the United States.

Understand US vaccination and mask requirements

    • Vaccination rules. On August 23, the Food and Drug Administration fully approved Pfizer-BioNTech’s coronavirus vaccine for people aged 16 and over, paving the way for increased mandates in both the public and private sectors. Private companies are increasingly demanding vaccines for employees. Such mandates are legally permissible and have been confirmed in legal challenges.
    • Mask rules. The Centers for Disease Control and Prevention in July recommended that all Americans, regardless of vaccination status, wear masks in public places indoors in areas with outbreaks, reversing the guidelines offered in May. See where the CDC guidelines would apply and where states have implemented their own mask guidelines. The battle over masks is controversial in some states, with some local leaders defying state bans.
    • College and Universities. More than 400 colleges and universities require a vaccination against Covid-19. Almost all of them are in states that voted for President Biden.
    • schools. Both California and New York City have introduced vaccination mandates for educational staff. A survey published in August found that many American parents of school-age children are opposed to mandatory vaccines for students but are more likely to support masking requirements for students, teachers and staff who are not vaccinated.
    • Hospitals and medical centers. Many hospitals and large health systems require their employees to have a Covid-19 vaccine, due to increasing case numbers due to the Delta variant and persistently low vaccination rates in their communities, even within their workforce.
    • New York City. Proof of vaccination is required by workers and customers for indoor dining, gyms, performances, and other indoor situations, though enforcement doesn’t begin until September 13. Teachers and other educational workers in the city’s vast school system are required to have at least one vaccine dose by September 27, with no weekly testing option. City hospital staff must also be vaccinated or have weekly tests. Similar rules apply to employees in New York State.
    • At the federal level. The Pentagon announced that it would make coronavirus vaccinations compulsory for the country’s 1.3 million active soldiers “by mid-September at the latest. President Biden announced that all civil federal employees would need to be vaccinated against the coronavirus or undergo regular tests, social distancing, mask requirements and travel restrictions.

Health experts and state officials welcomed the development. With the delta variant driving up case numbers across the country, “full approval could not come at a more important time,” said Dr. Richard Besser, President of the Robert Wood Johnson Foundation and former acting director of the Centers for Disease Control and Prevention. He urged schools and businesses to require a vaccination before people can gather indoors.

Less than two months after the spread of the virus appeared to be contained, the US is now recording an average of around 150,000 new cases per day and more than 90,000 hospitalized Covid-19 patients. An average of around 1,000 per day die from Covid-19 – a toll that federal health experts recently dismissed as highly unlikely before the delta variant fully caught on. Many children under the age of 12 also become infected.

Vaccination rates have also risen in the past few weeks, in part because of the greater fear of the virus. Vendors were delivering approximately 837,000 shots a day, a significant increase from earlier this summer.

Some experts estimated that full consent could only convince five percent of the unvaccinated to get injected. Even if that is the case, “that is still a huge part of the people,” Dr. Thomas Dobbs, the Chief Health Officer of Mississippi, a state particularly hard hit by the Delta variant. He said the approval will help “get rid of this false claim that the vaccines are an ‘experimental’ thing”.

Dr. Marks, the vaccines agency, cited a number of other myths about the vaccines as a major stumbling block in fighting the pandemic, including false claims that the vaccinations cause infertility, promote Covid disease rather than prevent it, or have resulted in thousands of deaths. “Let me be clear. These claims are just not true,” he said.

The FDA is in the middle of a decision marathon related to coronavirus vaccines. The next important question emerging for regulators is whether or not to approve booster injections. The Biden government said last week it plans to offer third vaccinations starting September 20, for adults who received the Pfizer and Moderna vaccines eight months after their second injection. Third vaccinations are already approved for some people with immunodeficiency, but the risk-benefit ratio is different for the general population.

Federal health officials said that both Pfizer-BioNTech and Moderna’s vaccines, which are based on similar technology, lose effectiveness over time. That trend is converging with the advent of the particularly dangerous Delta variant, making those who completed their vaccinations earlier in the year increasingly more susceptible to infection.

Some health experts have challenged the decision to recommend booster vaccinations as premature, as the data showed the vaccines withstand serious illness and hospitalization, including the Delta variant. Boosters would only be justified if the vaccines didn’t prevent hospital stays with Covid-19, some of these experts said.

Regulators are still examining Moderna’s application for full approval of its vaccine. This decision can take several weeks. Johnson & Johnson is expected to file for full approval shortly.

Helene Cooper contributed to the reporting.

Categories
Health

Florida, Texas open Covid antibody remedy facilities as delta surge overwhelms hospitals

Florida, Texas open Covid antibody treatment centers as delta surge overwhelms hospitals

Florida Governor Ron DeSantis holds a press conference to announce the opening of a monoclonal antibody treatment center to help recover COVID-19 patients at Camping World Stadium in Orlando.

Paul Hennessy | LightRakete | Getty Images

Florida and Texas are opening free monoclonal antibody centers to treat a surge in Covid-19 patients in both states in the hopes that early intervention will help keep people out of hospitals and save more lives – even if they do The governors of both states are fighting local officials with mask and vaccination regulations.

Texas is building nine antibody infusion centers, Governor Greg Abbott announced on Friday, while Florida opened its fifth site on Wednesday. With the delta variant spike, coronavirus patients were occupied by more than 46% of Texas intensive care beds and more than half of Florida intensive care units as of Thursday, compared with 27% nationwide, according to the Department of Health and Social Affairs.

“What takes you to the hospital is the inflammation. People get inflammation in their lungs,” said Dr. Arturo Casadevall, Chair of Molecular Microbiology and Immunology at the Bloomberg School of Public Health at Johns Hopkins University, told CNBC in an interview. “So what these antibodies do is, if you give them to a patient early, they neutralize the virus.”

Abbott has firsthand experience of the treatment. His office announced Tuesday that he was receiving monoclonal antibody treatment from Regeneron after testing positive for Covid despite being fully vaccinated.

Although monoclonal antibodies like Regeneron and GlaxoSmithKline treatments are one of the few proven ways to fight the virus and reduce hospital stays, they were rarely used during the pandemic because they are awkward to administer. Monoclonal antibody treatments must be injected directly into the vein via an IV infusion, which requires time and dedicated medical staff, often using the same equipment reserved for chemotherapy patients.

The Food and Drug Administration issued emergency clearances to Regeneron’s treatment in November, saying it reduced hospital admissions for Covid “in patients at high risk for disease progression within 28 days of treatment.” GlaxoSmithKline just received emergency approval for its treatment with Vir Biotechnology in May and said it has reduced hospital stays and deaths in high-risk patients by about 85%.

The FDA approved both companies’ treatments for use in patients 12 years of age and older.

“Many patients who are examined by their doctors and referred for a monoclonal antibody infusion are less likely to be hospitalized,” said Teresa Farfan, spokeswoman for the Texas Division of Emergency Management, in an email to CNBC . “This will help ensure that resources are available in the hospitals to treat those with the most severe cases of the virus.”

Treatment centers couldn’t get there early enough as the Delta variant is driving cases to record highs in Florida. The state, which publishes its cases once a week on Fridays, last reported a record seven-day average of nearly 21,700 new infections, 12.6% more than a week ago, according to a CNBC analysis of data compiled by Hopkins.

Texas has been moving closer and closer to its record highs of more than 23,000 average cases per day in January in recent weeks, reporting a seven-day average of just over 15,400 new infections on Thursday, up from a seven-day average of around 3,000 a last month.

“Let me be very clear on this – both monoclonal and vaccines save lives,” said Christina Pushaw, spokeswoman for Florida Governor Ron DeSantis, in an email to CNBC. “They certainly aren’t mutually exclusive.”

More than 34% of the 50,706 registered inpatients in Florida have the coronavirus, as does over a quarter of the 51,337 registered inpatients in Texas, as measured Thursday. Abbott called 2,500 medical workers from across the country last week to help fight the virus and urged hospitals to build capacity by postponing election procedures.

A box and vial of the Regeneron monoclonal antibody can be seen at a new COVID-19 treatment site opened by Florida Governor Ron DeSantis at Camping World Stadium in Orlando following a press conference.

Paul Hennessy | LightRakete | Getty Images

While both Abbott and DeSantis have urged residents to get vaccinated, they still strictly oppose mask or vaccination regulations, saying it violates personal freedoms. Republican governors have banned local governments and school districts from requiring face-covering. Abbott has threatened $ 1,000 fines for those who fail to comply, and DeSantis said it will withhold pay from educators who prescribe masks.

With many children returning to classrooms this fall, local officials are pushing back. Several school districts in both states have defied their governors’ orders and restored their mask mandates, with appeals courts in Dallas and San Antonio issuing injunctions last week to circumvent the ban.

The Texas Supreme Court on Sunday blocked the injunctions, sided with Abbott and prevented school districts from issuing their own guidelines. Local officials say they plan to continue fighting Abbott in court, and President Joe Biden on Wednesday directed the education secretary to intervene “to protect our children.”

“This includes using all of its regulators and, if necessary, taking legal action against governors who try to block and intimidate local school officials and educators,” said Biden.

Dr. Bruce Farber, chief of infectious diseases at Northwell Health in New York, said states that don’t allow schools to prescribe masks are at great risk this fall.

“These states are gambling as I see it,” he said in an interview. “By not allowing masking and preventing masking and leaving it to the parents, (they) are really playing with fire.”

Categories
Health

U.S. increasing Covid vaccine manufacturing to donate extra doses to world

U.S. expanding Covid vaccine manufacturing to donate more doses to world

The United States is expanding manufacturing of Covid-19 vaccines to donate more doses to countries that don’t have as much access to the lifesaving shots.

“We are now working on greatly expanding the capacity to allow us to donate hundreds and hundreds of millions of doses to the low- and middle-income countries,” Dr. Anthony Fauci, medical advisor to President Joe Biden, said in an interview Thursday on CNBC’s “Closing Bell.”

Scientists around the world, including officials at the World Health Organization, have condemned wealthy nations for administering booster shots to fully vaccinated people while millions in other countries cannot get the vaccine.

Dr. Mike Ryan, director of the WHO’s health emergencies program, said wealthy nations that decide to give booster doses are “handing out extra life jackets” to those who already have one while letting other people drown.

Fauci said the U.S. has given more than 120 million doses to 80 countries and has donated $4 billion in resources to the COVAX vaccine-sharing initiative, which is coordinated by Gavi, the Vaccine Alliance; the Coalition for Epidemic Preparedness Innovations and the WHO.

“We are doing both,” Fauci said of distributing booster shots and helping other countries. “We’re very sensitive to the needs of the developing world who need vaccine doses, but we believe we can do both.”

Worries about the delta variant continue to be on the minds of many Americans as health systems in states with high infection rates struggle to keep up with the demand for hospital beds. A continued acceleration of cases could be avoided in the U.S. if more people get vaccinated, Fauci said.

“There’s a lot we can do about it,” Fauci said, noting that 90 million people in the U.S. are eligible for vaccines but still haven’t gotten the shots. “We want to vaccinate the unvaccinated to the highest extent that we possibly can.”

He said it’s hard to know when the current delta outbreak will peak.

“It’s very difficult to predict. We’ve seen in the U.K. that after several weeks of a high acceleration, it’s turned around,” Fauci said.

Once delta infections begin to slow down, Covid could become an endemic disease that remains in the population at low levels, like the flu, though Covid is much deadlier. Fauci said he doubts that Covid — unlike the flu, which requires annual shots — will need recurrent boosters to maintain high levels of protection.

“I don’t think that’s going to be the case. I think this third shot will take us a long way,” Fauci said.

Correction: This article has been updated to reflect that the COVAX vaccine-sharing initiative is coordinated by Gavi, the Vaccine Alliance; the Coalition for Epidemic Preparedness Innovations and the WHO.

Categories
Health

FDA approval for Pfizer Covid vaccine might come Monday, report says

FDA approval for Pfizer Covid vaccine could come Monday, report says

Empty Pfizer COVID-19 vaccine vials will be delivered on Jan.

Paul Hennessy | NurPhoto | Getty Images

The Food and Drug Administration is working on the approval of the Pfizer-BioNTech Covid-19 vaccine on Monday, the New York Times reported, citing sources.

The review process could go beyond that date, the Times said, as paperwork and negotiations with the company continue.

The move would make it the first Covid vaccine to move from emergency approval to full FDA approval.

The FDA declined to comment on the Times report to CNBC.

White House senior medical advisor Dr. Anthony Fauci, told the Associated Press on Aug. 8 that he hoped vaccines would get full approval “within the month of August,” adding that full approval would lead to more companies and schools requiring vaccines.

U.S. companies have tightened vaccination regulations for employees as Covid cases have increased across the country in recent weeks, and some cited full FDA approval as part of the decision-making process.

Full approval could also help convince people who are reluctant to get vaccinated until the FDA has fully approved the vaccination.

According to CDC data on Friday, more than 203 million doses of the Pfizer BioNTech vaccine have been administered nationwide, fully vaccinating more than 91 million people in the United States.

Pfizer and BioNTech began applying for their biologics license for the two-dose vaccine in May after receiving emergency clearance from the FDA in December. The FDA sets a six month target for approval of high priority drugs.

If formally approved, Pfizer and BioNTech’s vaccine would remain available in the market after the pandemic ended and the companies could promote the vaccine directly to consumers. Pharmaceutical manufacturers with an EUA are banned from promoting their vaccines, CNBC previously reported.

The companies announced on Aug. 16 that they had initiated the approval process for a booster dose for fully vaccinated individuals after submitting clinical trial data to the FDA.

Top health officials from agencies like the Centers for Disease Control and Prevention, the White House and the FDA said in a statement Wednesday that the effectiveness of mRNA vaccines declines over time, especially in those with compromised immune systems. They said the US would start distributing booster shots to the public in September.

Read the full New York Times report here.