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Because of the alleged new COVID variants, the FDA has withdrawn the EUA for AstraZeneca’s Evusheld.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FDA said that it had withdrawn the approval for the use of Evusheld because at least 90 percent of infections are now caused by sublineages that cannot be neutralized by the treatment.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