COVID-19 News and Discussions

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caltrek
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First Bivalent COVID-19 Booster Vaccine Approved by UK Medicines Regulator
August 15, 2022

Introduction:
(UK Government) An updated version of the COVID-19 vaccine made by Moderna that targets two coronavirus variants (known as a “bivalent” vaccine) has today been approved for adult booster doses by the Medicines and Healthcare products Regulatory Agency (MHRA) after it was found to meet the UK regulator’s standards of safety, quality and effectiveness.

The decision to grant approval for this booster vaccine in the UK was endorsed by the government’s independent expert scientific advisory body, the Commission on Human Medicines, after carefully reviewing the evidence.

In each dose of the booster vaccine, ‘Spikevax bivalent Original/Omicron’, half of the vaccine (25 micrograms) targets the original virus strain from 2020 and the other half (25 micrograms) targets Omicron.

The MHRA’s decision is based on data from a clinical trial which showed that a booster with the bivalent Moderna vaccine triggers a strong immune response against both Omicron (BA.1) and the original 2020 strain. In an exploratory analysis the bivalent vaccine was also found to generate a good immune response against the Omicron sub-variants BA.4 and BA.5.

Safety monitoring showed that the side effects observed were the same as those seen for the original Moderna booster dose and were typically mild and self-resolving, and no serious safety concerns were identified.
Read more here: https://www.gov.uk/government/news/fir ... regulator

This news release was called to my attention by this article: https://www.iflscience.com/uk-approves ... rst-64889
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House Report Shows Trump 'Deliberately and Repeatedly' Undermined Covid-19 Response
by Brett Wilkins
August 24, 2022

Introduction:
(Common Dreams) White House officials during the tenure of former President Donald Trump "deliberately and repeatedly" pressured the U.S. Food and Drug Administration to authorize unproven and potentially dangerous Covid-19 treatments, while working to derail the agency's vaccine guidance ahead of the 2020 presidential election, a congressional report published Wednesday revealed.

The report, published by the House Select Subcommittee on the Coronavirus Crisis, is the second installment in a series documenting what the panel calls the Trump administration's "rampant political interference with the federal public health response" to a pandemic that has now killed more than 1,040,000 people in the United States.

The publication states that "the Trump administration's nearly yearlong crusade against FDA resulted in damaging consequences for the coronavirus response: Morale inside the agency cratered, and public confidence in FDA's scientific integrity was shaken in the midst of a once-in-a-century pandemic."

Former FDA Commissioner Dr. Stephen Hahn told the committee that Peter Navarro, who headed the White House Office of Trade and Manufacturing Policy, "exerted inappropriate pressure" on the FDA to renew the emergency use authorization for the anti-malarial drug hydroxychloroquine as a Covid-19 treatment, even after it was shown to be ineffective and possibly dangerous.
Read more here: https://www.commondreams.org/news/2022 ... -response
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New Antibody Neutralizes All Known COVID-19 Variants
by Jack Dunhill
August 18, 2022

Introduction:
(IFL Science) As experts continue to warn that ignoring COVID-19 and the 15,000 deaths a day it is causing is a grave mistake, it has become clear a lasting solution to the virus will require something that neutralizes all coronavirus variants, else we risk constantly trailing behind. Now, Harvard researchers believe they have found just that – a single antibody that neutralizes all known SARS-CoV-2 variants in their laboratory tests.

The antibody could be used within existing vaccination strategies to finally put an end to the constant cycle, should the results transfer well to human trials. The findings were published in Science Immunology.

“We hope this antibody will prove to be as effective in patients as it has been in preclinical evaluations thus far,” said Frederick Alt, the HMS Charles A. Janeway Professor of Pediatrics at Boston Children’s and a senior investigator on the study, in a statement.

“If it does, it might provide a new therapeutic and also contribute to new vaccine strategies.”

To create a broad-spectrum antibody across multiple variants, the researchers turned to mouse models that were previously created for HIV research. These mice have been turned into models of our own immune system, identifying foreign pathogens and going through the same trial-and-error motions to create antibodies that neutralize them. This way, the mice are essentially mini machines that can efficiently provide new antibodies for use in therapeutics.
Read more here: https://www.iflscience.com/new-antibod ... nts-64956
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Government to pause free at-home COVID tests by Sept. 2
Source: Axios

Time is running out to order free at-home COVID-19 tests after the government said on its coronavirus website that it will pause orders on Sept. 2 or “sooner if supplies run out.”

Why it matters: Consumers should prepare to soon pay for COVID-19 treatments and vaccines as the federal government prepares to shift costs back to health insurers, Axios’ Arielle Dreher reports.

The big picture: White House COVID-19 response coordinator Ashish Jha said on Aug. 16 that the Biden administration will stop buying vaccines, treatments and tests as early as this fall, CNN reported.

The Department of Health and Human Services has a meeting scheduled Tuesday with drugmakers, pharmacies, and state health departments to address the changes, the Wall Street Journal reports.
Read more: https://www.axios.com/2022/08/27/free-c ... ment-pause
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Re: COVID-19 News and Discussions

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caltrek wrote: Fri Aug 26, 2022 4:14 pm House Report Shows Trump 'Deliberately and Repeatedly' Undermined Covid-19 Response
by Brett Wilkins
August 24, 2022

Introduction:
(Common Dreams) White House officials during the tenure of former President Donald Trump "deliberately and repeatedly" pressured the U.S. Food and Drug Administration to authorize unproven and potentially dangerous Covid-19 treatments, while working to derail the agency's vaccine guidance ahead of the 2020 presidential election, a congressional report published Wednesday revealed.

The report, published by the House Select Subcommittee on the Coronavirus Crisis, is the second installment in a series documenting what the panel calls the Trump administration's "rampant political interference with the federal public health response" to a pandemic that has now killed more than 1,040,000 people in the United States.

The publication states that "the Trump administration's nearly yearlong crusade against FDA resulted in damaging consequences for the coronavirus response: Morale inside the agency cratered, and public confidence in FDA's scientific integrity was shaken in the midst of a once-in-a-century pandemic."

Former FDA Commissioner Dr. Stephen Hahn told the committee that Peter Navarro, who headed the White House Office of Trade and Manufacturing Policy, "exerted inappropriate pressure" on the FDA to renew the emergency use authorization for the anti-malarial drug hydroxychloroquine as a Covid-19 treatment, even after it was shown to be ineffective and possibly dangerous.
Read more here: https://www.commondreams.org/news/2022 ... -response

But yet more people died under Biden and Trump did more to develop the vaccine. You just can't give any credit.
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Scientists uncover how SARS-CoV-2 blocks antiviral defenses
https://phys.org/news/2022-08-scientist ... viral.html
by The Francis Crick Institute
Researchers at the Francis Crick Institute have found one way SARS-CoV-2 manipulates the environment within human cells to prevent them raising a full antiviral response.

While vaccines and treatments for COVID-19 have helped protect millions from severe infection, the disease still infects and kills many people around the world and there are still some gaps in our knowledge about how virus infects and replicates inside cells and evades the body's defenses.

In their study, published in PLOS Pathogens on Wednesday, August 25, the scientists studied a group of SARS-CoV-2 proteins, called accessory proteins. Little is currently understood about the role these proteins play in COVID-19.

"Lots of viruses have accessory proteins, which do not form part of the virus particle but help them to replicate, by playing other roles in the course of infection. Our lab usually studies these kinds of proteins in the context of HIV, but because of the pandemic, we refocused some of our work to also investigate the accessory proteins in SARS-CoV-2," says Kate Bishop, lead author and group leader of the Retroviral Replication Laboratory at the Crick.
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Re: COVID-19 News and Discussions

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weatheriscool wrote: Sat Aug 27, 2022 4:51 pm
caltrek wrote: Fri Aug 26, 2022 4:14 pm House Report Shows Trump 'Deliberately and Repeatedly' Undermined Covid-19 Response
by Brett Wilkins
August 24, 2022

Introduction:
...
Read more here: https://www.commondreams.org/news/2022 ... -response
But yet more people died under Biden and Trump did more to develop the vaccine. You just can't give any credit.
But yet more people died under Biden and Trump did more to develop the vaccine. You just can't give any credit.
While Operation warp speed under Trump may have facilitated vaccine distribution, it is worth noting that Pfizer developed the vaccine through private efforts:
Pfizer has distanced itself from Mr. Trump and Operation Warp Speed. In an interview on Sunday, Kathrin Jansen, a senior vice president and the head of vaccine research and development at Pfizer, said, “We were never part of the Warp Speed,” adding, “we have never taken any money from the U.S. government, or from anyone.”
Source: https://www.nytimes.com/2020/11/10/hea ... speed.html

In a November 2021 Washington Post article a comparison was made between Trump and Biden:
The comparison between 2020 and 2021 is also inapt in that Trump was still president in early 2021, and the effects of choices made before Biden took over (such as Trump not really encouraging people to get vaccinated) lingered into Biden’s early presidency. The biggest wave of the coronavirus in this country, in fact, peaked around the exact time Biden was inaugurated on Jan. 20. Inheriting a trendline that showed 3,000 deaths per day, as Biden did, is a recipe for inflating your numbers.

(To a significant degree, that wave was outside Trump’s control, of course; most places in the world were experiencing the worst wave of the virus at the time.)

Even if we assumed all things were equal, though, the comparison still struggles.

Both presidents presided over about 10 months of the pandemic. The World Health Organization declared that label on March 11, meaning Trump was president for a little more than 10 months of the formally declared pandemic. Biden has now passed a little more than 10 months in office as well.

Thus far, according to data from the Centers for Disease Control and Prevention, Biden has presided over about 353,000 deaths in a little over 10 months, compared to about 425,000 for Trump in his final 10-plus months. So there have still been fewer deaths under Biden than under Trump, in a similar time period.

Since Biden took over, the world as a whole has seen more deaths in his 10 months (3.07 million) than the preceding 10 months (2.14 million), but the United States has seen fewer. In Biden’s 10-plus months, the United States has accounted for less than 12 percent of worldwide deaths, which is down from 19.9 percent under Trump. That’s a decline of more than 40 percent in our proportion of the worldwide death rate.

Source: https://www.washingtonpost.com/politic ... vid-deaths


If the numbers for Biden are higher, it is only because he has been president for a longer period in which the epidemic has been active. As my previous citation indicated, Trump also helped to sabotage efforts to contain the epidemic through supporting people who opposed mask mandates, pushing phony cures, etc.

If others want to argue on behalf of Trump, be my guest. That is not my job or anything to which I wish to lend my energy. Trump receives enough help from billionaire contributors, Fox News, etc. None of which have been fair or balanced. (Although Fox News does show signs of finally having had enough of Trump)
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Re: COVID-19 News and Discussions

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Of course, after pointing out Pfizer's insistence that it developed its vaccine free of governmental help, I suppose it would be unfair to ignore this controversy:

Moderna is Suing Pfizer Over Its Coronavirus Vaccine
by Nicole Wetsman
August 26, 2022

Introduction:
(The Verge) Moderna is suing Pfizer and BioNTech over alleged infringement of its mRNA vaccine technology patents, the company announced today.

“We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented during the decade preceding the COVID-19 pandemic,” said Moderna chief executive officer Stéphane Bancel in a statement.

Moderna said in 2020 that it would not enforce its patents during the pandemic to allow for an unhindered public health response. It’s still not planning to enforce patents in low- and middle-income countries, the company said in a statement. But it’s coming after Pfizer and BioNTech, which it said it expected to “respect its intellectual property rights.” In the filing, the company said, “Moderna refrained from asserting its patents earlier so as not to distract from efforts to bring the pandemic to an end as quickly as possible.”

The lawsuit shouldn’t have a major effect on vaccine availability — Moderna said that it’s not looking to remove the Pfizer / BioNTech vaccine, known commercially as Comirnaty, from the market. It’s looking for payment, said Shannon Thyme Klinger, Moderna’s chief legal officer, in the statement: “Moderna expects Pfizer and BioNTech to compensate Moderna for Comirnaty’s ongoing use of Moderna’s patented technologies.”

It’s not asking for damages from vaccines sold to the United States government. But the US is planning to stop paying for COVID-19 vaccines, and they’ll be sold through normal commercial pathways.
Read more here: https://www.theverge.com/2022/8/26/233 ... ne-patent
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Research Reveals Widespread Use of Ineffective COVID-19 Treatments After FDA Deauthorized Their Use
August 29, 2022

Introduction:
(EurekAlert) BOSTON – Monoclonal antibodies are laboratory-designed treatments tailor-made to fight specific infections. In early 2021, the U.S. Food & Drug Administration issued emergency use authorization for two monoclonal antibodies (bamlanivimab/etesevimab and casirivimab/imdevimab) for the treatment of mild to moderate COVID-19 in high-risk, non-hospitalized patients. However, these treatments were shown not to work against the Omicron variant of COVID-19, which emerged in the United States in December 2021 and was responsible for a record-breaking COVID-19 surge in the winter of 2021-22. As a result of the monoclonal antibodies’ reduced efficacy against the variant, the FDA deauthorized their use in early January 2022.

In a paper published in JAMA Network Open, physician-scientists at Beth Israel Deaconess Medical Center (BIDMC) assessed the use of these two monoclonal antibodies for patients with COVID-19 before and after FDA deauthorization. The team observed that though overall use of the two monoclonal antibodies declined gradually following deauthorization, a large number of doses were administered to patients well into 2022.

Altogether, over 158,000 doses of monoclonal antibodies were administered, providing little to no benefit to patients and potentially contributing millions of dollars in costs. Whether the FDA will take regulatory action against those violating guidance remains unknown at this time.

“Continued use of these treatments represents low value care and may reflect conflicting state government guidance or a lack of hospital awareness of deauthorization,” said lead author Timothy Anderson, MD, MAS, Lead for Improving Value in Healthcare at Center for Healthcare Delivery Science at BIDMC and assistant professor of medicine at Harvard Medical School. “Though the FDA clearly stated these treatments were no longer authorized for use, the FDA did not fully revoke their emergency use authorizations based on the possibility that they may work to treat future COVID-19 variants. This could have led to confusion and misinterpretation.”


Read more of the EurekAlert article here: https://www.eurekalert.org/news-releases/962937

Read more on the JAMA Network Open paper here: https://jamanetwork.com/journals/jaman ... e/2795735 .
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