The Food and Drug Administration is banning the use of Red No. 3, the petroleum-based dye that gives many popular foods and drinks their recognizable, vibrant hues. Although some companies already began phasing out the additive prior to the FDA’s January 15 announcement, the synthetic ingredient is still found in over 3,000 products like fruit juice, beef jerky, sodas, and even some over-the-counter medications.

Red No. 3, chemically known as erythrosine, was first introduced into foods in 1907. Companies subsequently added it to thousands of products to boost their colors over the decades, often in snacks like ice cream and candy marketed directly to children. Some of the earliest calls for Red No. 3’s removal date back to the 1980s, when a research study indicated the synthetic could be carcinogenic in rats after ingesting it in large enough amounts. There is no definitive link between the additive and cancer in humans, but consumer advocacy groups continued to push for its prohibition.

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Source: https://www.popsci.com/health/red-3-ban/

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Over 92 million COVID-19 vaccine doses have been administered across the United States as of Monday, according to the latest data from the Centers for Disease Control and Prevention.

There are currently three vaccines approved by the CDC and the Food and Drug Administration for emergency use, which were manufactured by Pfizer and BioNTech, Moderna, and Johnson & Johnson.

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BNTX             BIONTECH SE                     257.68                     -26.53                         -9.33%
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JNJ               JOHNSON & JOHNSON       165.49                       -0.41                         -0.25%

Here’s a FOX Business roundup of the profit each company’s vaccine is expected to bring in:

Pfizer and BioNTech
Pfizer and BioNTech’s Comirnaty vaccine, the first to receive an emergency use authorization from the FDA in December after it was found to be 95% effective, currently accounts for more than 46.8 million of the total vaccine doses administered in the United States, according to the CDC.

Pfizer’s latest earnings report notes that Comirnaty profits are split 50-50 with BioNTech. The companies expect the vaccine to bring in revenues of approximately $15 billion in 2021. Pfizer and BioNTech plan to supply up to 1.3 billion doses of the vaccine worldwide by the end of 2021. The vaccine, which requires two doses, costs $39 in the United States and £28 in the EU.

Following Comirnaty’s approval, the United States agreed to pay the companies $1.95 billion upon the receipt of the first 100 million doses. The agreement also allowed the federal government to purchase an additional 50 million doses. Later that month, Pfizer, BioNTech and the federal government reached a second agreement for 100 million more doses for the same $1.95 billion price tag. Under the second agreement, the companies will deliver at least 70 million of the additional doses by June 30, with the remaining 30 million doses to be delivered no later than July 31. The government also has the option to acquire up to an additional 400 million doses.

Pfizer and BioNTech also announced an agreement in November with the European Commission for 200 million doses of the vaccine to be distributed to the European Union’s 27 member countries, with the option to request an additional 100 million doses. The European Comission made that request in December, Pfizer said.

Last month, Pfizer said the European Commission had reached a second agreement for an additional 200 million doses, 75 million of which will be supplied in the second quarter of 2021. The total number of doses to be delivered to the E.U. member states by the end of 2021 is now 500 million, with the potential to increase to 600 million based on the option granted in the new agreement.

Moderna
Moderna’s mRNA-1273 vaccine, the second to be approved for emergency use by the FDA after it was found to be 94.5% effective, accounts for more than 44.9 million of the total vaccine doses administered in the United States, according to the CDC.

The company noted in its fourth quarter earnings report that it expects $18.4 billion in anticipated product sales related to advanced purchased agreements for its vaccine. Moderna remains on track to deliver the first 100 million doses in the first quarter of 2021 and the second order of 100 million doses in May 2021. The company is aiming to build supply up to 1 billion doses in 2021, and 1.4 billion doses in 2022.

Moderna has reached an agreement with the United States for 300 million doses, with the option to purchase an additional 200 million doses. In addition, the company reached agreements with the European Union (310 million doses with option to purchase an additional 150 million doses in 2022), Japan (50 million doses), Canada (44 million doses), the Republic of Korea (40 million doses), the United Kingdom (17 million doses), Switzerland (13.5 million doses), Colombia (10 million doses), Israel (6 million doses) and Taiwan (5 million doses).

Moderna charges $30 for the required two shots in the U.S. and $36 in the E.U.

Johnson & Johnson
Johnson & Johnson’s vaccine, manufactured by its pharmaceutical subsidiary Janssen, was given an emergency use authorization by the FDA on Feb. 27 and an official stamp of approval from the CDC a day later.

According to an analysis by the FDA, the Janssen vaccine was about 67% effective in preventing moderate to severe cases within 14 days after dosing and 66% effective against severe to critical cases after 28 days. In addition, the vaccine was approximately 77% effective in preventing severe or critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing severe or critical COVID-19 occurring at least 28 days after vaccination.

The company is currently working to deliver its initial supply of 3.9 million vaccine doses to state health departments, pharmacies, federally qualified health centers and community vaccination centers across the country. Johnson & Johnson expects to deliver enough single-shot vaccines by the end of March to vaccinate more than 20 million Americans, and 100 million single-shot vaccines by June. Unlike the other two available vaccines, the Janssen vaccine requires a single dose.

The company is on track to produce 1 billion doses for global distribution by the end of 2021, which would generate up to $10 billion. In August, Johnson & Johnson reached a more than $1 billion agreement with the United States for 100 million doses of its vaccine, with the option to purchase an additional 200 million doses, for $10 per shot. In addition, Johnson & Johnson reached an agreement with the E.U. for up to 400 million doses.

According to Johns Hopkins University, the United States has surpassed 29 million COVID-19 cases since the pandemic began in March 2020, with over 525,000 related deaths.

Source: https://www.foxbusiness.com/money/heres-how-much-money-pfizer-moderna-and-johnson-johnson-could-make-from-covid-vaccines

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The Food and Drug Administration on Friday approved requests by COVID-19 vaccine makers Moderna and Pfizer to expand the administration of their booster shots to all U.S. adults.

In a release announcing the news, biotechnology company Moderna said the FDA extended the emergency use authorization of a booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level to all adults aged 18 and older.

The booster can be used in all individuals 18 years and older who have completed a primary vaccination with any other authorized or approved COVID-19 vaccine.

“This emergency use authorization comes at a critical time as we enter the winter months and face increasing COVID-19 case counts and hospitalizations across the country,” Moderna CEO Stéphane Bancel said in a statement. “We thank the FDA for their review, and are confident in the robust clinical evidence that a 50 µg booster dose of mRNA-1273 induces a strong immune response against COVID-19.”

Pfizer, which partnered with BioNTech on the vaccine, said its booster dose is to be administered at least six months after completion of the primary series and is the same dosage strength as the doses in the primary series.

“With boosters, more adults will now have the opportunity to help preserve a high-level of protection against this disease,” Pfizer CEO Albert Bourla said in a statement. “We are grateful to the FDA for their rigorous review, and the action taken today that we hope will help accelerate our path out of this pandemic.”

“Today’s FDA decision is supported by clinical data showing robust immune responses following a booster dose of our vaccine, exceeding what has been seen even after the completion of the highly-effective two-dose primary schedule,” BioNTech CEO Ugur Sahin said. “These data suggest a booster dose of our vaccine has the potential to maintain a high-level of protection against tested variants, including Delta.”

Later Friday, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet to discuss a potential recommendation for the rollout of COVID-19 boosters to the U.S.

CDC data shows that more than 32 million Americans have already received a booster dose.

Source: https://www.foxbusiness.com/lifestyle/moderna-pfizer-covid-boosters-approved

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Researchers found that protection against any COVID-19 infection declined for all vaccine types, with overall vaccine protection declining from 87.9% in February to 48.1% by October 2021.

The decline was greatest for the Janssen (Johnson & Johnson) vaccine, with protection against infection declining from 86.4% in March to 13.1% in September
Declines for PfizerBioNTech were from 86.9% to 43.3%
Declines for Moderna were 89.2% to 58%.

While most previous studies have focused on the PfizerBioNTech or Moderna vaccines, the Science study is the first to compare protection declines across the three main vaccine types, and the first to show the comparably dramatic decline in effectiveness for the Janssen vaccine. Declines were assessed over the period February 1, 2021 to October 1, 2021, reflecting the emergence and dominance of the Delta variant in the U.S. Patterns of breakthrough infection over time were consistent by age, despite rolling vaccine eligibility, implicating the Delta variant as the primary determinant of infection.

Importantly, vaccination of any type was protective against death among individuals who did become infected. The relative benefit of vaccination for protection against death was greater for persons under 65 but was also very strong for persons over 65.

The study showed that the risk of death from COVID infection was highest in unvaccinated Veterans, regardless of age and comorbidities. While some breakthrough infections resulted in death, vaccination remained protective against death in those who became infected during the Delta surge.

For those under 65 years old, vaccines overall were 81.7% effective against death.

Protection against death was greatest for the Pfizer vaccine, at 84.3%.
Moderna was the next most effective, at 81.5%.
Janssen was 73% effective.
For those 65 and over, overall vaccine effectiveness against death was 71.6%.

Moderna was 75.5% effective.
Pfizer was 70.1% effective.
Janssen was 52.2% effective.

“Our study gives researchers, policy makers and others a strong basis for comparing the long-term effectiveness of COVID vaccines, and a lens for making informed decisions around primary vaccination, booster shots, and other multiple layers of protection, including masking mandates, social distancing, testing and other public health interventions to reduce chance of spread,” said Dr. Barbara Cohn of PHI, the lead author of the study. “For example, the CDC recommendation for boosters for all Janssen recipients over 18 is supported by our results. And, given the declines in vaccine protection and the dominance of the more infective Delta variant, we urge swift action to promote primary vaccination, boosters and to also encourage masking, social distancing and other layers of protection against infection. This is supported by our finding that breakthrough infections are not benign, but also by the strong evidence that vaccination still protects against death even for persons with breakthrough infections, compared to persons who become infected and are not vaccinated.”

The FDA authorized Pfizer boosters for some groups in September and Moderna and Janssen boosters in October, and the CDC has made similar recommendations, including supporting a “mix and match” approach that allows people to choose any of the three vaccine boosters regardless of which they were given initially.

Source: https://medicalxpress.com/news/2021-11-decline-effectiveness-moderna-pfizer-janssen.html

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U.S. Marines step off in the early morning during an operation to push out Taliban fighters on July 18, 2009 in Herati, Afghanistan. | Joe Raedle/Getty Images

President Joe Biden said he has not ruled out requiring all U.S. troops to get the coronavirus vaccine after the shots win final clearance from federal regulators, but cautioned that such a decision would be a “tough call.”

“I don’t know. I’m going to leave that to the military,” Biden told NBC News’ Craig Melvin in an interview that aired Friday, in response to a question on whether he would mandate the vaccine for U.S. service members once it is fully approved by the Food and Drug Administration.

The post ‘A tough call’: Biden considering mandatory Covid vaccines for U.S. troops first appeared on Garner Ted Armstrong Evangelistic Association.

“New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!” the president wrote in a tweet that tagged his hand-picked FDA commissioner, Stephen Hahn.

Trump, who is battling a coronavirus infection himself, commented hours after the FDA issued strict new requirements for Covid-19 vaccine applications, including a review by a panel of experts and two months of safety data. The guidelines are intended to reassure the American public any vaccine is safe and effective, amid accusations that the Trump administration’s response to the virus has been tainted by politics.

The FDA did not immediately respond to a request for comment.

Trump, whose re-election hinges on how the public views his Covid-19 response, has repeatedly suggested a vaccine could be ready by Election Day on Nov. 3 or even sooner, a faster timeline than laid out by public-health experts and drug manufacturers.

The president first criticized the FDA’s plan to issue tough standards for vaccine authorization late last month, calling the proposed rules a “political move.”

Source: https://www.bnnbloomberg.ca/trump-says-fda-pulled-political-hit-job-with-vaccine-rules-1.1504639

The post Trump Says FDA Pulled ‘Political Hit Job’ With Vaccine Rules first appeared on Garner Ted Armstrong Evangelistic Association.

The FDA has authorized the first diagnostic test with a home collection option for COVID-19, the disease caused by coronavirus.

In a statement released Tuesday, the FDA said that it had reissued an Emergency Use Authorization for LabCorp to COVID-19 RT-PCR Test to permit testing of samples that were self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit.

“Throughout this pandemic we have been facilitating test development to ensure patients access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options,” said FDA Commissioner Dr. Stephen Hahn.

CORONAVIRUS OUTBREAK LEADS TO NASAL SWABS BEING 3D-PRINTED

Coronavirus testing is in the spotlight as America fights to contain the outbreak. Data compiled by the CDC indicate that, since the start of April, up to 140,000 coronavirus tests a day have been conducted in the U.S.

“This reissued EUA for LabCorp’s molecular test permits testing of a sample collected from the patient’s nose using a designated self-collection kit that contains nasal swabs and saline,” explained the FDA, in its statement. “Once patients self-swab to collect their nasal sample, they mail their sample, in an insulated package, to a LabCorp lab for testing.”

CLICK HERE FOR COMPLETE  CORONAVIRUS COVERAGE

Note: See Coronavirus Interactive Map here.

As of Tuesday morning, more than 2.49 million coronavirus cases have been diagnosed worldwide, at least 787,960 of which are in the U.S. The disease has accounted for at least 171,255 deaths around the world, including at least 42,364 people in the U.S.

Follow James Rogers on Twitter @jamesjrogers

Source: https://www.foxnews.com/science/fda-authorizes-first-at-home-coronavirus-test

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The post President Donald Trump Invokes National Defense Production Act first appeared on Garner Ted Armstrong Evangelistic Association.

“It can do a lot of good things if we need it,” he said at a White House press conference. “We’ll have it all completed, signing it in just a little while.”

TRUMP INVOKES DEFENSE PRODUCTION ACT: WHAT IS IT?

The act ensures the private sector can ramp-up manufacturing and distribution of emergency medical supplies and equipment. The move gives the White House the authority to increase production of masks, ventilators, and respirators, as well as expand hospital capacity to combat the coronavirus.

Asked if he saw the nation as being on a wartime footing he said he did and described himself as “in a sense a wartime president.”

He made the remarks at a press conference along members of the coronavirus pandemic task force. The U.S. has largely shuttered many aspects of daily life in order to stem the rapid onset of the virus, echoing efforts across the globe. As of Wednesday morning, there were 6,519 cases and 114 deaths in the United States.

The Centers for Disease Control and Prevention reported that coronavirus deaths in the U.S. mirror what has been reported in other countries, with approximately 4 out of 5 deaths occurring in people 65 and older — and no deaths in children.

TRUMP SAYS HUD WILL SUSPEND ‘ALL FORECLOSURES AND EVICTIONS’ AMID COVID-19 OUTBREAK

The crisis has caused chaos in the markets and the economy as a whole. Schools have closed and restaurants and bars have been reduced to takeout and delivery in many parts of the country. San Francisco declared a shelter-in-place order this week, while many states have put restrictions on large gatherings.

The administration has been working with Congress on a nearly $1 trillion stimulus package to reinvigorate the U.S. economy and to provide relief to businesses and workers who have been hit hardest by the crisis.

On Wednesday, Trump also announced that the Housing Department is suspending all foreclosures and evictions until the end of April. Earlier in the day he had announced that the U.S. and Canada had agreed to temporarily close their shared border to non-essential traffic.

Vice President Mike Pence, who is leading the taskforce, announced that Health and Human Services are suspending a regulation that prevents medical professionals from practicing medicine across state lines. He also called on the nation to postpone all elective medical procedures.

TRUMP ANNOUNCES US, CANADA CLOSING BORDER TO ‘NON-ESSENTIAL TRAFFIC’ AMID CORONAVIRUS FEARS

Trump has held a number of press conferences as the crisis has escalated, in an effort to keep the public informed and to preview measures the administration is taking.

He had previewed Wednesday’s conference by saying he would “discuss very important news from the FDA concerning the Chinese Virus!” However, he indicated that that announcement would be coming later in the day or Thursday..

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On Saturday he announced that he was extending the European travel ban to include the U.K. and Ireland.

On Tuesday, he spoke at a press conference where Treasury Secretary Steven Mnuchin said that the administration wants to send checks to Americans “in the next two weeks” in an effort to help people cope with the economic fallout due to the pandemic.

Fox News’ GIllian Turner and The Associated Press contributed to this report.

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