- Federal regulators have authorized Pfizer’s antiviral pill, Paxlovid, to treat early symptoms of COVID-19.
- The medication will be available to adults as well as children age 12 and older.
- Initial supplies will be limited. Officials will send the early shipments to the parts of the country hardest hit by COVID-19.
- The federal government has agreed to purchase enough Paxlovid to treat 10 million people. It will be administered free of charge.
- Earlier this month, Pfizer reported the pill significantly reduced the risk of hospitalization and death for people with COVID-19.
Officials at the Food and Drug Administration (FDA) has given authorization for Pfizer’s new antiviral pill to be given to adults and children over the age of 12 who face a high risk of hospitalization.
The drug, Paxlovid, is designed to treat people with early symptoms of COVID-19.
It’s the first COVID-19 treatment in pill form. The drugs previously authorized require an IV or injection. People will be able to take Paxlovid at home and it will be free of charge.
Initial supplies are limited and federal officials will send early shipments to parts of the country hit hardest by the latest COVID-19 surge fueled by the Omicron variant.
The federal government has agreed to purchase enough Paxlovid to treat 10 million people. Pfizer officials said the company will produce 80 million courses for global distribution in 2022.
A new antiviral pill from Merck is expected to receive FDA authorization soon.
Both the Merck and Pfizer pills are expected to be effective against the Omicron variant because they don’t target the novel coronavirus’ spike protein, where the variants’ mutations reside.
Early this month, Pfizer announced that Paxlovid reduced the risk of hospitalization due to severe COVID-19 by 89 percent within 3 days of symptom onset.
Pfizer confirmed that these findings replicate the results of a smaller-scale trial the company announced last month.
Pfizer shared its data with FDA as part of an ongoing rolling submission for emergency use authorization (EUA), according to its press release.
The Pfizer study involved more than 2,200 people with a high risk of developing severe COVID-19.
Researchers found Paxlovid significantly reduced the risk of hospitalization or death compared with placebo when it was taken within 3 days of initial symptoms.
Even when given within 5 days, the drug still reduced the risk of hospitalization and death by 88 percent.
“The anticipated approval of Paxlovid as another weapon to fight COVID-19 is welcome news, especially with a recent surge in cases and hospitalizations in many regions of the U.S., including the Northeast and Midwest,” Dr. Robert Glatter, an emergency physician at Lenox Hill Hospital in New York, told Healthline.
According to Pfizer data, the drug is extremely effective at reducing viral load (amount of virus in the body). The findings suggest a 10-fold reduction compared with a placebo group.
According to Pfizer, Paxlovid is a protease inhibitor intended to stop the novel coronavirus taking hold in our bodies.
Protease inhibitors are a drug type that can prevent viruses from replicating within cells in the human body, making them less able to spread and cause severe disease.
“Paxlovid is a combination of a protease inhibitor, nirmatrelvir, along with ritonavir, [which is] a drug which helps slow metabolism of the protease inhibitor so it remains in the body for longer periods of time at increased concentrations,” explained Glatter.
“This promising treatment could help accelerate our path out of this pandemic by offering another life-saving tool for people who get sick with COVID-19,” said Health and Human Services (HHS) Secretary Xavier Becerra in a statement.
“For people who do get sick in the future and are at risk of severe outcomes, having pills they can take to keep them out of the hospital could be a lifesaver,” he emphasized.
According to the HHS officials, monoclonal antibody treatment can block the coronavirus from entering cells and limit the amount of the virus within the body, which is similar to the benefits of Paxlovid.
So why do we need a new therapy that’s so similar to one already in use?
“While monoclonal antibodies may certainly have a role in managing high risk patients who test positive for COVID-19, the ability to rapidly receive this treatment is quite limited by resources to infuse the product,” explained Glatter.
He pointed out that subcutaneous (under the skin) and intramuscular injections have been an alternative, “but access still remains an important issue.”
“Paxlovid gives us another treatment option with outpatients. It’s easily prescribed and administered, there’s no need to go to an infusion center or to have IV (intravenous) lines placed,” said Michael Ganio, PharmD, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists.
“Right now, there is no other substitute for vaccination,” said Ganio. “What this [Paxlovid] does do is that it’s [a] treatment for patients who do have a confirmed infection.”
Ganio said likely at first only a patient with underlying illness diagnosed with COVID will get access to this drug.
“So, not everyone will have access to the Paxlovid or probably molnupiravir (an antiviral drug approved in the U.K.). When that gets authorization, they’re going to be limited to specific groups,” said Ganio.
According to Priscilla Marsicovetere, dean of the college of health and natural sciences at Franklin Pierce University in New Hampshire, while vaccination is key to quelling infection transmission, there are many reasons people do not get vaccinated, such as personal choice, vaccine availability, or religious reasons.
“It is important to have a multipronged approach to COVID-19 disease management,” she said. “While preventing the spread of infection is always our primary goal, being able to treat symptoms and shorten the disease process once infection occurs is an equally important step and can be a huge benefit to communities and healthcare institutions.”
Marsicovetere noted that any advancement toward slowing the public health threat of COVID-19 is great news to hear, and Paxlovid looks to be a “wonderful addition” to that effort.
She emphasized that access to this new drug must be equitable across the population.
“If emergency use of the medication is authorized, we will need to ensure equitable distribution — ensuring the patients and communities at highest risk for poor outcomes are able to access the medication,” Marsicovetere said.