Connect with us

Government

Covid-19 roundup: EU begins reviewing Moderna vaccine; CureVac and EU agree to 405M-dose deal

Covid-19 roundup: EU begins reviewing Moderna vaccine; CureVac and EU agree to 405M-dose deal

Published

on

A day after announcing their vaccine is highly effective at preventing Covid-19, Moderna said European regulators have begun a rolling review of the product for approval.

The news sets Moderna’s mRNA-1273 vaccine to be one of the first Covid-19 vaccines authorized on both sides of the Atlantic, with CEO Stéphane Bancel anticipating in an interview Sunday that the FDA will OK both their vaccine and the vaccine co-developed by Pfizer and BioNTech in early or mid-December. Neither company has yet submitted to the US agency.

Although the second company to release pivotal data on a vaccine, Moderna is the third to begin a rolling review at the EMA. AstraZeneca and BioNTech, both based in Europe, announced in early October that regulators have begun a rolling review of the vaccine. Moderna said they submitted documents on Oct. 14.

Designed to speed approvals, rolling reviews give the EMA an early look at certain preclinical, clinical and manufacturing data, but the agency doesn’t issue decisions until pivotal results are in. AstraZeneca is hoping to release such data before the end of the year, which would likely position them as the third Covid-19 vaccine company to do so.

It’s unclear how long the EMA may take to review a vaccine. The EMA has operated throughout the pandemic more deliberately than their American counterpart. The FDA, for example, authorized remdesivir three days after Phase III results came out and nearly two months before the EMA did.

EMA officials, though, indicated last month that they would have been willing to authorize a vaccine that’s less than 50% effective, the FDA’s bar. Both Pfizer and Moderna say their vaccines are more than 90% effective.

Bancel said Sunday he anticipated an FDA advisory hearing on their vaccine on Dec. 7th or Dec. 14, with an EUA coming a few days later. He predicted a similar timeline for Pfizer-BioNTech, with the two companies potentially sharing a single adcomm.

Jason Mast

CureVac and EU agree to 405 million dose deal

Moderna and Pfizer/BioNTech were the first companies to show pivotal data for their vaccines, but the third major mRNA company, CureVac, is looking to become the arsenal of Europe.

Already financed with a €300 million investment from the German government and a €75 million loan from the European Investment Bank, CureVac announced yesterday that they have signed an agreement to provide the EU with 405 million doses of their mRNA vaccine.

CureVac’s close operations with European officials stood in contrast to its competitors, with Moderna relying heavily on US government cash and Pfizer providing the funding and clinical and manufacturing expertise to advance BioNTech’s vaccine. The bulk of their manufacturing will occur in Europe as well, with the company announcing plans this morning to establish a European-based network of factories that can produce 300 million doses in 2021 and 2022.

CureVac did not say on what timeline they will deliver the 405 million doses to Europe.

The new deal will add to the up to 300 million doses Pfizer and BioNTech agreed to sell to the EU and the 300 million-dose deal Sanofi and GSK signed back in September. Moderna is still in discussions with the European Commission, with officials reportedly looking to negotiate the price down to below $25 per dose.

Ursula von der Leyen

“This is the fifth contract with a pharmaceutical company for our COVID-19 vaccine portfolio. And we are working on a sixth one, with Moderna,” European Commission president Ursula von der Leyen said in a statement. “We hope to finalise the contract soon.”

CureVac is still in Phase I of clinical testing. They have talked about receiving approval by the third quarter of 2021 and touted a vaccine that’s stable at refrigerator temperatures as a key advantage over other mRNA approaches.

After Moderna, Pfizer news World Health Organization cautions long road ahead

The world now has data to suggest two vaccines are highly effective against Covid-19, but WHO officials cautioned Monday that proof a vaccine works is just one small step in a long path towards ending the pandemic.

Edward Kelly

“It’s not vaccines that save people,” Edward Kelly, director of the WHO’s work on service delivery and safety, told reporters, according to The Washington Post. “It’s vaccinations that will actually save people.”

And it will take a long time to vaccinate the globe. As companies and officials have warned, doses will be in short supply for the foreseeable future; Moderna and Pfizer expect to make enough to vaccinate between 800 million and a billion people next year, but the world population numbers more than 7 billion.

Moreover, the cold chain requirements for each vaccine will limit how widely they can be distributed in less developed areas of the world. Meanwhile, wealthy countries and particularly the US have bought much of the early supply of vaccine, leaving low and middle income parts of the world waiting.

These factors, along with lingering unknowns about how long the vaccines last and the still-surging levels of virus, underscore the need to continue measures such as social distancing and testing, officials said.

“A vaccine on its own will not end the pandemic,” WHO Director-General Tedros Adhanom Ghebreyesus said.

Pfizer begins pilot program begins to distribute its vaccine

A week after reading out long-awaited interim Phase III results from their Covid-19 vaccine trial, Pfizer and BioNTech are talking distribution.

The vaccine, which Pfizer and BioNTech said is more than 90% effective at preventing symptomatic Covid-19, must be shipped in -70 degrees Celsius (-94 degrees Fahrenheit) temperatures to remain stable, then used within 5 days of being thawed. Delivery poses a major challenge, with some countries saying they can’t afford to build the distribution system required to handle the vaccine.

To test the waters, Pfizer has launched a pilot delivery program in Rhode Island, Texas, New Mexico and Tennessee, according to Reuters. The four states were chosen for their differences in size, diversity of populations, infrastructure, and urban and rural settings, the news agency reported.

“We are hopeful that results from this vaccine delivery pilot will serve as the model for other U.S. states and international governments, as they prepare to implement effective COVID-19 vaccine programs,” Pfizer said, per Reuters.

The pilot states won’t get doses earlier than other states or have special consideration, according to Pfizer. The pharma said it plans on filing for an EUA around the third week of November, once it has the necessary safety data to approach regulators.

Ding Sheng, director of the Beijing-based Global Health Drug Discovery Institute, told Bloomberg that production of Pfizer and BioNTech’s candidate is “costly” and requires cold-chain transportation. Philippines’ health secretary Francisco Duque told Reuters that the cold chain requirement is “hefty,” and that the country does “not have such facility.”

Pfizer has designed that “thermal shippers” can be stored at room temperature and keep the vaccine cold for 10 days if replenished with dry ice, which they say will

The US struck a $1.95 billion deal for 100 million doses of Pfizer and BioNTech’s vaccine, with the option to acquire another 500 million down the road. Last week, the drug makers finalized a deal with the EU for 200 million doses, with the option for 100 million more later on, though the parties didn’t disclose the cost.

Moderna said its candidate — which interim results have shown to be 94.5% effective — can be kept for months at -20 degrees Celsius (-4 Fahrenheit) and at refrigerator temperatures for up to 30 days. — Nicole DeFeudis 

Eli Lilly teams with Samsung Biologics to mass produce its Covid-19 antibody

Beleaguered by questions about how safely it can make its Covid-19 neutralizing antibody, Eli Lilly has pulled out a card they placed at the beginning of the pandemic.

Samsung Biologics disclosed yesterday that they signed an agreement back in May to mass-produce its antibody and, after delays in securing raw materials, had recently begun production, Reuters reported.

The FDA recently authorized the antibody, known as bamlanivimab, for moderate and mild cases of Covid-19 — a huge population at a time when the US is recording 100,000 cases.

Experts such as ex-FDA chief Scott Gottlieb have warned for months that the US was under-investing in the infrastructure to mass produce the monoclonal antibodies in development at Lilly, Regeneron and elsewhere.

Lilly has said they can make 1 million doses by the end of this year, with 300,000 of those earmarked for the US. But they’ve been dogged by quality control questions at one of the plants churning out the drug. Although they authorized the antibody earlier this month, the FDA stipulated that Lilly would have to hire outside consultants to test batches and confirm the quality control data.

It was not immediately clear whether the Samsung production was baked into previous dose estimates from Lilly or would add new capacity. The Big Pharma has talked about ramping up production next year as new plants came online. In September, they announced a manufacturing collaboration with Amgen.

Lilly’s Covid-19 antibody will not be the first Samsung has agreed to help mass produce. The South Korean company has also signed agreements with Vir Biotechnology to produce the neutralizing antibody they are co-developing with GlaxoSmithKline. — Jason Mast

For a look at all Endpoints News coronavirus stories, check out our special news channel.

Read More

Continue Reading

Government

Are Voters Recoiling Against Disorder?

Are Voters Recoiling Against Disorder?

Authored by Michael Barone via The Epoch Times (emphasis ours),

The headlines coming out of the Super…

Published

on

Are Voters Recoiling Against Disorder?

Authored by Michael Barone via The Epoch Times (emphasis ours),

The headlines coming out of the Super Tuesday primaries have got it right. Barring cataclysmic changes, Donald Trump and Joe Biden will be the Republican and Democratic nominees for president in 2024.

(Left) President Joe Biden delivers remarks on canceling student debt at Culver City Julian Dixon Library in Culver City, Calif., on Feb. 21, 2024. (Right) Republican presidential candidate and former U.S. President Donald Trump stands on stage during a campaign event at Big League Dreams Las Vegas in Las Vegas, Nev., on Jan. 27, 2024. (Mario Tama/Getty Images; David Becker/Getty Images)

With Nikki Haley’s withdrawal, there will be no more significantly contested primaries or caucuses—the earliest both parties’ races have been over since something like the current primary-dominated system was put in place in 1972.

The primary results have spotlighted some of both nominees’ weaknesses.

Donald Trump lost high-income, high-educated constituencies, including the entire metro area—aka the Swamp. Many but by no means all Haley votes there were cast by Biden Democrats. Mr. Trump can’t afford to lose too many of the others in target states like Pennsylvania and Michigan.

Majorities and large minorities of voters in overwhelmingly Latino counties in Texas’s Rio Grande Valley and some in Houston voted against Joe Biden, and even more against Senate nominee Rep. Colin Allred (D-Texas).

Returns from Hispanic precincts in New Hampshire and Massachusetts show the same thing. Mr. Biden can’t afford to lose too many Latino votes in target states like Arizona and Georgia.

When Mr. Trump rode down that escalator in 2015, commentators assumed he’d repel Latinos. Instead, Latino voters nationally, and especially the closest eyewitnesses of Biden’s open-border policy, have been trending heavily Republican.

High-income liberal Democrats may sport lawn signs proclaiming, “In this house, we believe ... no human is illegal.” The logical consequence of that belief is an open border. But modest-income folks in border counties know that flows of illegal immigrants result in disorder, disease, and crime.

There is plenty of impatience with increased disorder in election returns below the presidential level. Consider Los Angeles County, America’s largest county, with nearly 10 million people, more people than 40 of the 50 states. It voted 71 percent for Mr. Biden in 2020.

Current returns show county District Attorney George Gascon winning only 21 percent of the vote in the nonpartisan primary. He’ll apparently face Republican Nathan Hochman, a critic of his liberal policies, in November.

Gascon, elected after the May 2020 death of counterfeit-passing suspect George Floyd in Minneapolis, is one of many county prosecutors supported by billionaire George Soros. His policies include not charging juveniles as adults, not seeking higher penalties for gang membership or use of firearms, and bringing fewer misdemeanor cases.

The predictable result has been increased car thefts, burglaries, and personal robberies. Some 120 assistant district attorneys have left the office, and there’s a backlog of 10,000 unprosecuted cases.

More than a dozen other Soros-backed and similarly liberal prosecutors have faced strong opposition or have left office.

St. Louis prosecutor Kim Gardner resigned last May amid lawsuits seeking her removal, Milwaukee’s John Chisholm retired in January, and Baltimore’s Marilyn Mosby was defeated in July 2022 and convicted of perjury in September 2023. Last November, Loudoun County, Virginia, voters (62 percent Biden) ousted liberal Buta Biberaj, who declined to prosecute a transgender student for assault, and in June 2022 voters in San Francisco (85 percent Biden) recalled famed radical Chesa Boudin.

Similarly, this Tuesday, voters in San Francisco passed ballot measures strengthening police powers and requiring treatment of drug-addicted welfare recipients.

In retrospect, it appears the Floyd video, appearing after three months of COVID-19 confinement, sparked a frenzied, even crazed reaction, especially among the highly educated and articulate. One fatal incident was seen as proof that America’s “systemic racism” was worse than ever and that police forces should be defunded and perhaps abolished.

2020 was “the year America went crazy,” I wrote in January 2021, a year in which police funding was actually cut by Democrats in New York, Los Angeles, San Francisco, Seattle, and Denver. A year in which young New York Times (NYT) staffers claimed they were endangered by the publication of Sen. Tom Cotton’s (R-Ark.) opinion article advocating calling in military forces if necessary to stop rioting, as had been done in Detroit in 1967 and Los Angeles in 1992. A craven NYT publisher even fired the editorial page editor for running the article.

Evidence of visible and tangible discontent with increasing violence and its consequences—barren and locked shelves in Manhattan chain drugstores, skyrocketing carjackings in Washington, D.C.—is as unmistakable in polls and election results as it is in daily life in large metropolitan areas. Maybe 2024 will turn out to be the year even liberal America stopped acting crazy.

Chaos and disorder work against incumbents, as they did in 1968 when Democrats saw their party’s popular vote fall from 61 percent to 43 percent.

Views expressed in this article are opinions of the author and do not necessarily reflect the views of The Epoch Times or ZeroHedge.

Tyler Durden Sat, 03/09/2024 - 23:20

Read More

Continue Reading

Government

Veterans Affairs Kept COVID-19 Vaccine Mandate In Place Without Evidence

Veterans Affairs Kept COVID-19 Vaccine Mandate In Place Without Evidence

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

The…

Published

on

Veterans Affairs Kept COVID-19 Vaccine Mandate In Place Without Evidence

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

The U.S. Department of Veterans Affairs (VA) reviewed no data when deciding in 2023 to keep its COVID-19 vaccine mandate in place.

Doses of a COVID-19 vaccine in Washington in a file image. (Jacquelyn Martin/Pool/AFP via Getty Images)

VA Secretary Denis McDonough said on May 1, 2023, that the end of many other federal mandates “will not impact current policies at the Department of Veterans Affairs.”

He said the mandate was remaining for VA health care personnel “to ensure the safety of veterans and our colleagues.”

Mr. McDonough did not cite any studies or other data. A VA spokesperson declined to provide any data that was reviewed when deciding not to rescind the mandate. The Epoch Times submitted a Freedom of Information Act for “all documents outlining which data was relied upon when establishing the mandate when deciding to keep the mandate in place.”

The agency searched for such data and did not find any.

The VA does not even attempt to justify its policies with science, because it can’t,” Leslie Manookian, president and founder of the Health Freedom Defense Fund, told The Epoch Times.

“The VA just trusts that the process and cost of challenging its unfounded policies is so onerous, most people are dissuaded from even trying,” she added.

The VA’s mandate remains in place to this day.

The VA’s website claims that vaccines “help protect you from getting severe illness” and “offer good protection against most COVID-19 variants,” pointing in part to observational data from the U.S. Centers for Disease Control and Prevention (CDC) that estimate the vaccines provide poor protection against symptomatic infection and transient shielding against hospitalization.

There have also been increasing concerns among outside scientists about confirmed side effects like heart inflammation—the VA hid a safety signal it detected for the inflammation—and possible side effects such as tinnitus, which shift the benefit-risk calculus.

President Joe Biden imposed a slate of COVID-19 vaccine mandates in 2021. The VA was the first federal agency to implement a mandate.

President Biden rescinded the mandates in May 2023, citing a drop in COVID-19 cases and hospitalizations. His administration maintains the choice to require vaccines was the right one and saved lives.

“Our administration’s vaccination requirements helped ensure the safety of workers in critical workforces including those in the healthcare and education sectors, protecting themselves and the populations they serve, and strengthening their ability to provide services without disruptions to operations,” the White House said.

Some experts said requiring vaccination meant many younger people were forced to get a vaccine despite the risks potentially outweighing the benefits, leaving fewer doses for older adults.

By mandating the vaccines to younger people and those with natural immunity from having had COVID, older people in the U.S. and other countries did not have access to them, and many people might have died because of that,” Martin Kulldorff, a professor of medicine on leave from Harvard Medical School, told The Epoch Times previously.

The VA was one of just a handful of agencies to keep its mandate in place following the removal of many federal mandates.

“At this time, the vaccine requirement will remain in effect for VA health care personnel, including VA psychologists, pharmacists, social workers, nursing assistants, physical therapists, respiratory therapists, peer specialists, medical support assistants, engineers, housekeepers, and other clinical, administrative, and infrastructure support employees,” Mr. McDonough wrote to VA employees at the time.

This also includes VA volunteers and contractors. Effectively, this means that any Veterans Health Administration (VHA) employee, volunteer, or contractor who works in VHA facilities, visits VHA facilities, or provides direct care to those we serve will still be subject to the vaccine requirement at this time,” he said. “We continue to monitor and discuss this requirement, and we will provide more information about the vaccination requirements for VA health care employees soon. As always, we will process requests for vaccination exceptions in accordance with applicable laws, regulations, and policies.”

The version of the shots cleared in the fall of 2022, and available through the fall of 2023, did not have any clinical trial data supporting them.

A new version was approved in the fall of 2023 because there were indications that the shots not only offered temporary protection but also that the level of protection was lower than what was observed during earlier stages of the pandemic.

Ms. Manookian, whose group has challenged several of the federal mandates, said that the mandate “illustrates the dangers of the administrative state and how these federal agencies have become a law unto themselves.”

Tyler Durden Sat, 03/09/2024 - 22:10

Read More

Continue Reading

Government

Low Iron Levels In Blood Could Trigger Long COVID: Study

Low Iron Levels In Blood Could Trigger Long COVID: Study

Authored by Amie Dahnke via The Epoch Times (emphasis ours),

People with inadequate…

Published

on

Low Iron Levels In Blood Could Trigger Long COVID: Study

Authored by Amie Dahnke via The Epoch Times (emphasis ours),

People with inadequate iron levels in their blood due to a COVID-19 infection could be at greater risk of long COVID.

(Shutterstock)

A new study indicates that problems with iron levels in the bloodstream likely trigger chronic inflammation and other conditions associated with the post-COVID phenomenon. The findings, published on March 1 in Nature Immunology, could offer new ways to treat or prevent the condition.

Long COVID Patients Have Low Iron Levels

Researchers at the University of Cambridge pinpointed low iron as a potential link to long-COVID symptoms thanks to a study they initiated shortly after the start of the pandemic. They recruited people who tested positive for the virus to provide blood samples for analysis over a year, which allowed the researchers to look for post-infection changes in the blood. The researchers looked at 214 samples and found that 45 percent of patients reported symptoms of long COVID that lasted between three and 10 months.

In analyzing the blood samples, the research team noticed that people experiencing long COVID had low iron levels, contributing to anemia and low red blood cell production, just two weeks after they were diagnosed with COVID-19. This was true for patients regardless of age, sex, or the initial severity of their infection.

According to one of the study co-authors, the removal of iron from the bloodstream is a natural process and defense mechanism of the body.

But it can jeopardize a person’s recovery.

When the body has an infection, it responds by removing iron from the bloodstream. This protects us from potentially lethal bacteria that capture the iron in the bloodstream and grow rapidly. It’s an evolutionary response that redistributes iron in the body, and the blood plasma becomes an iron desert,” University of Oxford professor Hal Drakesmith said in a press release. “However, if this goes on for a long time, there is less iron for red blood cells, so oxygen is transported less efficiently affecting metabolism and energy production, and for white blood cells, which need iron to work properly. The protective mechanism ends up becoming a problem.”

The research team believes that consistently low iron levels could explain why individuals with long COVID continue to experience fatigue and difficulty exercising. As such, the researchers suggested iron supplementation to help regulate and prevent the often debilitating symptoms associated with long COVID.

It isn’t necessarily the case that individuals don’t have enough iron in their body, it’s just that it’s trapped in the wrong place,” Aimee Hanson, a postdoctoral researcher at the University of Cambridge who worked on the study, said in the press release. “What we need is a way to remobilize the iron and pull it back into the bloodstream, where it becomes more useful to the red blood cells.”

The research team pointed out that iron supplementation isn’t always straightforward. Achieving the right level of iron varies from person to person. Too much iron can cause stomach issues, ranging from constipation, nausea, and abdominal pain to gastritis and gastric lesions.

1 in 5 Still Affected by Long COVID

COVID-19 has affected nearly 40 percent of Americans, with one in five of those still suffering from symptoms of long COVID, according to the U.S. Centers for Disease Control and Prevention (CDC). Long COVID is marked by health issues that continue at least four weeks after an individual was initially diagnosed with COVID-19. Symptoms can last for days, weeks, months, or years and may include fatigue, cough or chest pain, headache, brain fog, depression or anxiety, digestive issues, and joint or muscle pain.

Tyler Durden Sat, 03/09/2024 - 12:50

Read More

Continue Reading

Trending