AstraZeneca Plc has asked the U.S. Food and Drug Administration (FDA) to authorize the first-ever prophylactic drug for COVID-19.
This monoclonal antibody treatment, which uses lab-made immune system proteins to protect patients from developing Covid symptoms, would likely be limited to people with compromised immune systems.
Lab-trials showed that the drug reduced the risk of developing symptomatic disease by 77 percent.
Other monoclonal antibody treatments have been in high demand across the country in recent months as states like Florida and Texas rely on these drugs to treat unvaccinated patients.
AstraZeneca’s new treatment is not meant to be used instead of vaccines – rather, it would work in conjunction with the shots for those who are more vulnerable to Covid.
Along with Oxford University, AstraZeneca developed one of the first Covid vaccines – but this vaccine has yet to be authorized in the U.S. after months of setbacks.
AstraZeneca has applied for FDA Emergency Use Authorization for a new monoclonal antibody drug. Pictured: AstraZeneca’s logo, seen outside its North America headquarters in Wilmington, Delaware, March 2021
Unlike other monoclonal antibody treatments currently used in the U.S., AstraZeneca’s drug would be preventative – stopping Covid infections from occurring. Pictured: A nurse administers Regeneron’s treatment, Sarasota, Florida, September 2021
Monoclonal antibody treatments have become widely used in the U.S. during the recent Delta variant surge.
These treatments include lab-made antibodies, immune system proteins that are designed to fight off a coronavirus infection.
When injected into a patient, the antibodies can boost a patient’s immune system – reducing the risk of severe Covid symptoms.
During the recent Covid surge, states such as Florida and Texas made monoclonal antibodies a significant part of their pandemic prevention strategies.
Seven states – including Florida, Texas, and five other southern states – made up 70 percent of monoclonal antibody treatment orders in early September.
The Department of Health and Human Services (HHS) restricted access to the treatments as a result.
A new treatment from the British company AstraZeneca may help address this demand – and prevent Covid infections in some of the most vulnerable Americans.
The treatment, formally called AZD7442, is unlike other monoclonal antibody drugs in that it acts proactively over a long period of time – providing protection against Covid for up to a year.
AstraZeneca announced Tuesday that it has applied for emergency use authorization from the FDA.
If the FDA authorizes this treatment, it will likely be limited to people with compromised immune systems who don’t get sufficient protection from vaccination.
Unlike the monoclonal antibodies currently authorized in the U.S. – which are used by Covid patients after they become infected with the virus – AstraZeneca’s drug would be a preventative measure for more vulnerable Americans.
AstraZeneca’s antibody cocktail reduced patients’ risk of contracting a symptomatic Covid case by 77 percent, a recent clinical trial showed.
More than three-quarters of the patients in this trial had weakened immune systems or other conditions making them more susceptible to severe Covid.
‘Vulnerable populations such as the immunocompromised often aren’t able to mount a protective response following vaccination and continue to be at risk of developing COVID-19,’ Mene Pangalos, AstraZeneca’s executive vice president for pharmaceutical research, said in a statement.
‘With this first global regulatory filing, we are one step closer to providing an additional option to help protect against COVID-19 alongside vaccines.’
AstraZeneca said it is in purchase talks with the U.S. and other governments around the world.
Still, the FDA says that monoclonal antibody drugs are no substitute for vaccination – which provides the best, long-lasting protection against Covid.
Antibody drugs are also more expensive than vaccines. One dose of Regeneron, a common monoclonal antibody cocktail, costs $2,100 in the U.S. – one hundred times more than a vaccine dose.
Monoclonal antibodies are also difficult to administer, requiring an IV or injection and healthcare workers who are trained in using the treatments.
The main antibody treatments being used in the U.S. are from Regeneron and Eli Lilly & Co.
The U.S. government has purchased bulk quantities of both drugs and the HHS oversees their distribution.
AstraZeneca also developed one of the world’s first Covid vaccines, along with Oxford University.
This vaccine is widely used around the world but has not received authorization in the U.S., due to concerns over the shots’ safety.
In September 2020, the U.S. arm of AstraZeneca’a vaccine trial was paused after a British participant was rushed to the hospital following a serious reaction that triggered spinal cord inflammation.
Then the company did not turn over trial safety data to the FDA for a month, further delaying the study’s resumption.
When AstraZeneca released results from an interim analysis of its clinical trial showing 79 percent efficacy in March 2021, U.S. health officials claimed the figure was based on ‘outdated information.’
The British drugmaker revised the figure days later to 76 percent.
AstraZeneca’s shot was also found to trigger a nerve disorder called Guillain-Barre syndrome in a small number of patients – fewer than one in 10,000.
Though the U.S. purchased millions of doses of AstraZeneca vaccines, the country is sending many of these doses abroad to other countries.
In addition, foreign tourists who received AstraZeneca jabs have been unable to participate in some American activities – like Broadway shows – which require FDA-authorized vaccination.