Anonymous ID: 64f29f Jan. 29, 2023, 10:48 a.m. No.18249028   🗄️.is 🔗kun   >>9046 >>9122

>>18248964

[Rev 11:18 KJV] 18 And the nations were angry, and thy wrath is come, and the time of the dead, that they should be judged, and that thou shouldest give reward unto thy servants the prophets, and to the saints, and them that fear thy name, small and great; and shouldest destroy them which destroy the earth.

 

[Psa 2:1-3 KJV] 1 Why do the heathen rage, and the people imagine a vain thing? 2 The kings of the earth set themselves, and the rulers take counsel together, against the LORD, and against his anointed, [saying], 3 Let us break their bands asunder, and cast away their cords from us.

 

[Psa 46:6 KJV] 6 The heathen raged, the kingdoms were moved: he uttered his voice, the earth melted.

 

[Psa 115:13 KJV] 13 He will bless them that fear the LORD, [both] small and great.

Anonymous ID: 64f29f Jan. 29, 2023, 12:15 p.m. No.18249375   🗄️.is 🔗kun   >>9424 >>9525 >>9583

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TexasLindsay™

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The most important whistleblower case in history & the FIRST Pfizer whistleblower to come forward in 2020—who’s suing Pfizer on behalf of the people in the biggest fraud case in history—will be in spaces @ 5pm EST. You don’t want to miss this.

https://twitter.com/i/spaces/1YpKkgeBRYMKj

 

https://twitter.com/TexasLindsay_/status/1619713601971056642

Anonymous ID: 64f29f Jan. 29, 2023, 12:53 p.m. No.18249563   🗄️.is 🔗kun   >>9571 >>9584

Melissa McAtee

@MelissaMcAtee92

Things are happening 👀

https://twitter.com/MelissaMcAtee92/status/1619795729207402497?s=20&t=btEvANJJgfskVh0bUPdIXw

 

FDA withdraws emergency use authorization of COVID drug because it is unlikely to be effective against new variants

 

The U.S. Food and Drug Administration said Thursday it is withdrawing its emergency use authorization of a COVID-19 antibody therapy as a prevention tool because it is unlikely to be effective against variants that are currently circulating.

Evusheld, which is made by British-Swedish pharmaceutical and biotechnology company, AstraZeneca, was first authorized in December 2021 as pre-exposure prophylaxis against the virus for those who are immunocompromised and less likely to generate antibodies from vaccination.

However, the FDA said the medication does not neutralize several omicron subvariants including BQ.1, BQ.1.1, BF.7, BF.11, BA.5.2.6, BA.4.6, BA.2.75.2, XBB and XBB.1.5.

According to the Centers for Disease Control and Prevention, these subvariants make up at least an estimated 90% of cases in the U.S.

 

"This means that Evusheld is not expected to provide protection against developing COVID-19 if exposed to those variants," the FDA said in a press release.

"Today's action to limit the use of Evusheld prevents exposing patients to possible side effects of Evusheld such as allergic reactions, which can be potentially serious, at a time when fewer than 10% of circulating variants in the U.S. causing infection are susceptible to the product," the press release continued.

The FDA has been warning for months that Evusheld might not be very effective, starting in February 2022 when data showed a higher dose may be able to prevent against infection from omicron subvariants BA.1 and BA.1.1 than the originally approved dose.

 

As recently as Jan. 6 of this year, the FDA said it didn't believe Evusehld would be able to neutralize the XBB.1.5 subvariant "because of its similarity to variants that are not neutralized by Evusheld."

 

AstraZeneca did not immediately reply to ABC News' request for comment. In a statement, the pharmaceutical company said it is aware of the decision and that it is cooperating with the FDA.

 

"AstraZeneca will continue to work with the FDA and other health authorities to collect, assess and share relevant data regarding Evusheld and SARS-CoV-2 variants," the statement read. "Evusheld currently remains authorized in other countries where it is approved for COVID-19 pre-exposure prophylaxis and treatment, including the EU and Japan."

 

MORE: The COVID pill is a game-changer, but for some it might be a danger: Experts

Evusheld is a type of monoclonal antibody treatment, which are a cocktail of antibodies that are manufactured in a lab and mimic the antibodies the body naturally creates when fighting the virus.

 

They bind to the spike protein, which prevents the virus from attaching to and infecting cells.

 

The FDA said if someone tests positive for COVID-19 and develops symptoms, they should contact their primary care provider and, if needed, ask to receive antiviral medications Paxlovid, molnupriavir or remdesivir, which work against the currently circulating variants.

Despite Evusheld losing emergency use authorization status, the FDA urged providers not to discard their doses of the drug.

"The U.S. Government recommends that facilities and providers with Evusheld retain all product in the event that SARS-CoV-2 variants which are neutralized by Evusheld become more prevalent in the U.S. in the future," the FDA said in its press release.

 

https://abcnews.go.com/Health/fda-withdraws-authorization-covid-drug-effective-new-variants/story?id=96715718