The pill, called Paxlovid, can now be prescribed by doctors for high-risk coronavirus patients over the age of 12 when they first develop symptoms.
This means that use of the drug could prevent hospitals from becoming overwhelmed, as high-risk patients can stay home and may not require further treatment.
The FDA determined that the drug is safe; health officials believe it will be a key factor in reducing the number of deaths and admissions to the hospital among those with Covid-19.
Pfizer Covid pill safe tool to prevent hospitalizations, deaths
Paxlovid has yielded impressive results in clinical trials, reducing hospitalization and death by 89%. The drug could prove to be a gamechanger for those most vulnerable to severe illness, as well as helping countries with less vaccinated populations.
Although the pill was developed and tested before the arrival of the omicron variant, scientists believe that it will be effective against the mutation; they are now conducting studies to test their theory.
Merck & Co and Ridgeback Biotherapeutics submitted their own antiviral pill, called molnupiravir, for authorization in October. Their drug will be reviewed by a panel of advisers and is believed to be approved soon as well. It has already been approved for use in the UK. It was shown to be slightly less effective than the Pfizer pill in studies.
Now that the pill has been authorized, Pfizer will work rapidly to ship thousands of pills across the US before the new year. It is estimated that hundreds of thousands of treatment courses of Paxlovid will be distributed throughout the country in the early weeks of 2022.
The US agreed to pay $2.9 billion to purchase 10 million treatment courses of the drug, which will be delivered by the end of 2022.
Pfizer to offer patent to less wealthy nations
The company also announced that its officials had inked a licensing agreement which will enable less wealthy nations to distribute its antiviral drug Paxlovid in the form of generic anti-Covid pills.
The New York City-based pharmaceutical company agreed to allow generic drug manufacturers to produce their own Paxlovid pills at a much lower price than the original drug.
“Pfizer will not receive royalties on sales in low-income countries and will further waive royalties on sales in all countries covered by the agreement while COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization,” Pfizer said in the statement.
The Medicines Patent Pool, a United Nations-backed public health organization, agreed with the pharmaceuticals behemoth that Paxlovid will be made available to 95 low- to middle-income countries which are home to 53% of the entire population of the world.
Covid pill a “game changer,” according to CEO Dr. Albert Bourla
The anti-Covid pill, also known as PF-07321332, will be given to patients alongside an older antiviral drug called ritonavir, according to a report from CNN.
In an interview with CNBC, the Thessaloniki-born Bourla said that the drug had the power to save millions of lives:
“This is a fantastic demonstration of the power of science — and in fact it’s coming exactly a year to the day after we announced the results of the previous breakthrough of the vaccine, which has 95% efficacy.
“I think this medicine will change the way things are happening right now and save millions and millions of lives.”