US President Joe Biden on Wednesday said that the authorisation of the first pill against COVID-19, Pfizer’s Paxlovid, marks a ‘significant step forward’ on the path out of the pandemic.
The FDA authorised the Pfizer drug that Americans will be able to take at home to head off the worst effects of the virus. It is a faster way to treat early COVID-19 infections, though initial supplies will be extremely limited. All of the previously authorized drugs against the disease require an IV or an injection.
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Biden said his administration will work with states to ensure equitable distribution. He pledged more than 250,000 treatment courses of Paxlovid will be available starting in January.
“With today’s action, we add the first-ever oral treatment to our nation’s medicine cabinet and take a significant step forward in our path out of the pandemic. As soon as emerging science showed the promise of this antiviral, we acted quickly and aggressively to pre-purchase 10 million treatment courses — more than any other country in the world,” the President said.
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“We will have over 250,000 treatment courses available to us in January and we will be working with states to ensure those are being distributed equitably and fairly and that our hardest-hit communities are reached,” he added.
The Pfizer antiviral pill is for high-risk individuals age 12 and older who weigh at least 88 pounds and have a positive SARS-CoV-2 test. One will need to have it prescribed by a doctor.
The pill “should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset,” the FDA said.
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White House COVID-19 Response Coordinator Jeff Zients said that the treatment will reduce hospitalisations and deaths.
“According to Pfizer, the complex chemistry involved in creating the active ingredient in the pill means production takes about six to eight months, so supply of this product will ramp up over the next several months,” Zients said.
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“Knowing that these pills take time to manufacture, Pfizer continues to increase their production plans, and now that the pill is authorized, we’ll have discussions to explore how we can help them improve their manufacturing capacity even further by providing any resources needed.”
An antiviral pill from Merck also is expected to soon win authorization. But Pfizer’s drug is all but certain to be the preferred option because of its mild side effects and superior effectiveness, including a nearly 90% reduction in hospitalizations and deaths among patients most likely to get severe disease.
With inputs from the Associated Press