FDA Revokes Authorization for AstraZeneca’s COVID-19 Treatment Evusheld

On Thursday, the Food and Drug Administration (FDA) revoked emergency use authorization (EUA) for the COVID-19 antibody combo Evusheld from AstraZeneca because it failed to neutralize the currently dominant Omicron subvariant XBB.1.5.

The EUA for Evusheld, a combination of two human monoclonal antibodies, tixagevimab and cilgavimab, was approved by the FDA in December 2021 for use in the pre-exposure prophylaxis of COVID-19 in adults and adolescents (aged 12 and older).

Unlike earlier antibody therapies, Evusheld was not intended for sick patients; rather, it was administered as a preventative measure to those who were at very high risk for serious Covid-19 infection, such as the elderly and those with compromised immune systems, as well as in those individuals who have a history of severe side effects from COVID vaccines.

Because of the alleged new COVID variants, the FDA has withdrawn the EUA for AstraZeneca’s Evusheld.

“The US Food and Drug Administration (FDA) has stated that AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab) is not currently authorized for Emergency Use for pre-exposure prophylaxis (prevention) of COVID-19 in the US until further notice, due to the sustained high frequency of circulating SARS-CoV-2 variants that Evusheld does not retain in vitro neutralization against,” AstraZeneca said in a statement.

“The FDA has notified AstraZeneca that the Agency will make a determination about reinstating authorization of Evusheld if the national prevalence of resistant variants decreases to 90% or less on a sustained basis. The US government recommends all Evusheld product be retained and properly stored in the event that variants susceptible to Evusheld, including those currently circulating at lower prevalence, become more prevalent in the future,” the company added.

FDA said that it had withdrawn the approval for the use of Evusheld because at least 90 percent of infections are now caused by sublineages that cannot be neutralized by the treatment.

“Based on in vitro pseudovirus assay laboratory data, Evusheld does not neutralize Omicron subvariants BQ.1, BQ.1.1, BF.7, BF.11, BA.5.2.6, BA.4.6, BA.2.75.2, XBB and XBB.1.5.1 The combined proportion of COVID-19 cases caused by these subvariants is currently greater than 90% in the US, according to the Centers for Disease Control and Prevention (CDC) Nowcast modelling data,” AstraZeneca said.

If we go by what science says, none of the Covid vaccines work for the Omicron subvariant, which is the most common right now.

Two studies from Columbia and Harvard revealed new Omicron boosters from Moderna and Pfizer were just as ineffective as previous Covid shots.

The updated booster shots against Omicron got emergency authorization, and a CDC panel voted to recommend the shots for children as young as 5 to 11 and for people over the age of 12.

The new vaccine is called Bivalent which means it contains two messenger RNA (mRNA) components of the coronavirus. Half of the vaccine targets the original strain, and the other half targets the BA.4 and BA.5 Omicron subvariant lineages.

These new COVID boosters were not tested on humans – only mice.

two independent studies conducted by scientists from Columbia University in New York City and Harvard University found that the new boosters did not produce a better antibody response in humans against BA.5 than the first-generation vaccines, NBC reported.

They compared samples from 21 patients in the Columbia research and 18 people in the Harvard study who received the new boosters to people who received the old vaccine as their fourth shot.

However, the FDA said these two studies are “small and subject to limitations.”

“It’s important to note that the two studies were done independently. They’re small studies but there are two of them —it’s not just a fluke,” said Dr. Dan Barouch, the lead author of the Harvard study.

https://www.thegatewaypundit.com/2023/01/fda-revokes-authorization-astrazenecas-covid-19-treatment-evusheld/

Biden’s Defense Department Gives Huge Research Funding to Institutions Linked to Chinese and Russian Biowarfare Programs

Biden’s Defense Department gives huge research funding to institutions linked to Chinese and Russian biowarfare programs

Perhaps, the Biden regime considers it “Genocide-Affirming Care.”

Whatever you call it, U.S. government funding and the potentially dangerous experiments resulting from it is reckless and out of control.

As if the COVID-19 pandemic and the mass administration of unsafe and ineffective mRNA vaccines never happened, it is business as usual for the lucrative “biodefense” racket.

Despite millions of deaths and hundreds of millions infected, Biden’s Defense Department just awarded a multi-year grant worth $3 million to EcoHealth Alliance, a long-time collaborator with the Wuhan Institute of Virology, the Chinese military-linked research center believed to be involved in the laboratory origin of the COVID-19 virus.

That award is on top of a $3.3 million research grant to the EcoHealth Alliance from Anthony Fauci’s National Institute of Allergy and Infectious Diseases (NIAID), given last September.

In 2020, the U.S. government provided EcoHealth Alliance with nearly $25 million. In total, EcoHealth Alliance received $79.4 million for biodefense work, the knowledge from which has undoubtedly ended up in China.

That all occurs in conjunction with a recently-released 72-page report from the Department of Health and Human Services Office of the Inspector General, which states that the National Institutes of Health did not give proper oversight to EcoHealth Alliance, even after it awarded the organization millions of dollars to study bat coronaviruses.

Senator Rand Paul issued the following comment in response to the Inspector General’s report.

https://www.thegatewaypundit.com/2023/01/lawrence-sellin-bidens-defense-department-gives-huge-research-funding-institutions-linked-chinese-russian-biowarfare-programs/

Russian foreign ministry puts question to Stoltenberg

Did the NATO chief take people for “morons” when he claimed the bloc is not party to the Ukraine conflict, Moscow asked

NATO is fully engaged in the Ukrainian conflict, and people in its member states should see through the deception, when the bloc's leadership claims otherwise, Russian Foreign Ministry spokeswoman Maria Zakharova has said. She cited recent remarks made by its Secretary General Jens Stoltenberg to German media, in which he reiterated the non-involvement claim.

“Do you actually consider the citizens of the EU and NATO total morons?” she wondered, during a media briefing on Friday. “Do you believe that as you send tanks, which require maintenance … you still are not party to the conflict? Who are you, then? Explain. Just invent some new term to identify yourself.”

Citizens of NATO states should know: their bloc is fully engaged in confrontation with our nation, and this confrontation is escalating.

Stoltenberg and others who deny Western participation are at odds with German Foreign Minister Annalena Baerbock, who this week shared her assessment that the EU was “at war with Russia,” Zakharova observed. Berlin’s foreign policy chief has “crossed out” all assurances to the contrary made by the NATO chief, she added.

Baerbock’s remark faced pushback from other members of the EU, who rejected the German official’s narrative. Croatian President Zoran Milanovic commented that his nation’s being at war with Russia was news to him and wished Berlin “good luck this time” unlike during World War II.

Zakharova accused Stoltenberg of “lying to the people of Ukraine for many years” to incite hostilities with Russia. Western leaders also lied when they negotiated the Minsk Agreements, she added, referring to the 2014-2015 deal that was supposed to resolve the conflict in Donbass.

Those agreements were mediated by then-Chancellor of Germany Angela Merkel and then-President of France Francois Hollande, who co-signed a declaration of their endorsement with then-Ukrainian President Pyotr Poroshenko and Russian President Vladimir Putin. Poroshenko, Merkel and Hollande acknowledged last year that, in reality, the process was meant to afford Ukraine time for a military build-up.

https://www.rt.com/russia/570568-stoltenberg-zakharova-nato-lies/