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Because of the alleged new COVID variants, the FDA has withdrawn the EUA for AstraZeneca’s Evusheld.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FDA said that it had withdrawn the approval for the use of Evusheld because at least 90 percent of infections are now caused by sublineages that cannot be neutralized by the treatment.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.

The post FDA Revokes Authorization for AstraZeneca’s COVID-19 Treatment Evusheld appeared first on The Gateway Pundit.

Colorado Baker Who Refused to Make ‘Gender Transition’ Cake Loses Appeal

A Colorado baker who refused to make a cake celebrating a “gender transition” has lost an appeal arguing that his decision was protected free speech.

The Colorado Court of Appeals decided on Thursday that Jack Phillips and Masterpiece Cakeshop broke the law when he refused to bake cakes for people based on their gender identity or sexual orientation.

Phillips won a Supreme court case in 2018 over his refusal to bake a cake for a gay wedding. He has since been relentlessly targeted by LGBT activists.

In Thursday’s ruling, the court said that the symbolism in the decorations on the cake requested by activist Autumn Scardina would not be attributed to the baker — and therefore it is not protected free speech to refuse.

“We conclude that creating a pink cake with blue frosting is not inherently expressive and any message or symbolism it provides to an observer would not be attributed to the baker,” the ruling said.

According to a report from Fox News, John McHugh, one of the lawyers who represent Scardina, said Phillips had only refused to bake the cake because he objected “to the idea of Ms. Scardina wanting a birthday cake that reflects her status as a transgender woman because they object to the existence of transgender people.”

“One need not agree with Jack’s views to agree that all Americans should be free to say what they believe, even if the government disagrees with those beliefs,” Jake Warner, senior counsel for Alliance Defending Freedom, who represented Phillips, said in a statement obtained by the network.

It appears the the entire cake and lawsuit were a set up to continue the harassment of Phillips after the previous ruling.

“This case started the day the Supreme Court decided they were going to hear our case. It was a very busy, very crazy day at the shop,” Phillips told Fox News in March. “In the middle of all of this chaos, we got a phone call from an attorney in Denver asking us to create a cake pink on the inside with blue icing on the outside.”

The post Colorado Baker Who Refused to Make ‘Gender Transition’ Cake Loses Appeal appeared first on The Gateway Pundit.