Equipo Nizkor - FDA authorizes Pfizer pill to treat COVID-19 in major advance.

The Food and Drug Administration (FDA) on Wednesday authorized a new COVID-19 treatment from Pfizer, the first pill to treat the virus to become available.

The pill, known as Paxlovid, is seen as a major step forward in the fight against the virus, with trials showing it reduced the risk of hospitalization or death by 89 percent in high-risk patients.

The treatment is expected to be in short supply to begin with, though, leading to calls for the Biden administration to do more to boost supply.

"Today's authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic," said Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research. "This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19."

The fact that Paxlovid is a pill, rather than previous treatments which required injections, should make it more accessible and easier to take. It has also shown very promising results in trials in reducing the worst outcomes from the virus, putting the country on the path to defanging COVID-19.

But experts are warning that supply will be constrained in the short term, and they have called on the Biden administration to take actions like enlisting other manufacturers to help make it.

The company has said about 180,000 courses will be available this year. That is not a sufficient amount given there are more than 100,000 cases of COVID-19 every day just in the U.S.

The treatment is intended to be started within five days of the onset of symptoms, which could pose a challenge. Plentiful testing will be needed to ensure that people know that they have COVID-19, and can get results in time to be able to seek the treatment.

Pfizer expects to have 120 million courses available next year, with about 30 million of those available by the beginning of next year, the company told The Washington Post.

The company has also entered into an agreement with the United Nations-backed Medicines Patent Pool to share the treatment with 95 lower-income countries, a step that experts praised.

But there is worry that production for those lower-income countries could take months to begin, and some advocates are warning of a disparity between wealthy and poor countries that took its toll on vaccine production.

22Dec21

FDA authorizes Pfizer pill to treat COVID-19 in major advance

[Source: By Peter Sullivan, The Hill, Washington, 22Dec21]

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