FDA approves Pfizer's COVID-19 pill for emergency use

Woman taking white tablets
Woman taking white tablets

AsiaVision / iStock

Today the US Food and Drug Administration (FDA) approved for emergency use Pfizer's Paxlovid, the first oral pill meant to treat mild-to-moderate COVID-19 infection in patients who are at high risk of progressing to severe illness.

The pill is authorized for patients ages 12 and older, and should be started within 5 days of COVID-19 symptom onset. It could be available for US doctors to prescribe in a matter of days.

The drug is highly effective: Earlier this year Pfizer shared study results that showed a 30-pill regimen reduced the risk of hospitalization or death by 88% in unvaccinated patients, and newer data suggest it is effective against the Omicron variant.

Last week, the White House confirmed that the federal government had ordered enough Paxlovid to treat 10 million Americans.

"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," said Patrizia Cavazzoni, MD, director of the FDA's Center for Drug Evaluation and Research, in a press release.

Supply will be limited through January

Though the development adds another tool in America's medicine cabinet, White House chief medical adviser Anthony Fauci, MD, said today the drug is difficult to make.

"The sobering news is it is a quite complicated and synthetic process, and there's a long duration to make the drug," said Fauci during a White House press briefing.

Paxlovid is taken as three pills, taken together orally twice a day for 5 days. The regimen includes two tablets of nirmatrelvir, and one tablet of ritonavir, an HIV medicine. Paxlovid is not authorized for use for longer than 5 consecutive days. The drug is not meant to be taken prophylactically.

Thirty pills cost $530 per patient. According to the New York Times, only enough pills to cover 65,000 Americans would be available before the end of the year, with another 200,000 treatment courses available in January.

The news comes with US cases surging. The United States reported 172,072 new COVID-19 cases yesterday, and 2,093 deaths, according to the Johns Hopkins COVID-19 tracker.

Rochelle Walensky, MD, MPD, director of the Centers for Disease Control and Prevention (CDC), said the 7-day daily average of cases was 149,000 cases, a 25% increase from the previous week.

Walensky and Fauci both urged caution when considering upcoming holiday plans. Gatherings with families and friends with known vaccination status is likely safe, they said, but large parties with upwards of 50 people are more risky.

Both Walensky and Fauci said pre-party at-home testing could be a good tool for people to use to gather safely, but pharmacy chains Walgreens and CVS announced yesterday that they will limit the number of at-home COVID-19 tests people can buy as demand for the products surges, CNN reports.

Omicron could boost booster uptake

Throughout the White House press briefing, Walensky and Fauci emphasized that getting vaccinated and boosted was still the best way for Americans to protect against severe COVID-19 illness, hospitalization, and death. Though Omicron is expected to raise the number of breakthrough cases significantly, most of those will be asymptomatic or mild.

The CDC COVID Data Tracker shows 61.6% of Americans are fully vaccinated against COVID-19, 72.6% have received one dose of vaccine, and 30.4% of fully vaccinated Americans have received a booster dose.

Half of US adults who have not yet received a booster dose say the news about the Omicron variant makes them more likely to get one, according to the latest Kaiser Family Foundation poll. But 87% of unvaccinated adults say Omicron has not changed their mind about vaccination.

Half of unvaccinated adults said nothing could convince them to get vaccinated, while 12% said they would get vaccinated after more research, and 6% would if it was mandatory.

Several states and cities have taken up new vaccine mandates in light of Omicron. California Gov. Gavin Newsom said yesterday that he will require that all healthcare workers in the state get their booster shot, ABC News reports.

And Chicago will require proof of coronavirus vaccination at restaurants, bars, gyms, and other indoor venues, the Associated Press reports. The requirement will take effect Jan 3.

Other US developments

  • US Army researchers expect to release promising human trial findings in the next few weeks for a single vaccine against all COVID and SARS variants.

  • A recent survey of US companies shows that 44% have pushed back or altered their reopening plans because of the Omicron variant, NBC News reports.

  • New data released by the CDC show that COVID-19 was the nation's third leading killer in 2020 behind cancer and heart disease, and was the underlying cause in about 351,000 deaths, the Wall Street Journal reported today. Americans' life expectancy fell 1.8 years in 2020.

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