| 22 April 2024, Monday |

Pfizer pill becomes first US-authorized home COVID-19 treatment

The first tablet against COVID-19, a Pfizer medicine that Americans will be able to take at home to prevent the virus’s worst symptoms, was approved by US health officials on Wednesday.

The long-awaited achievement comes as cases, hospitalizations, and fatalities in the United States continue to rise, and health officials warn of a flood of new infections from the omicron strain that could overwhelm hospitals.

Paxlovid, the medicine, offers a faster and less expensive option to treat early COVID-19 infections, although initial supplies will be severely limited. All previously approved anti-disease medications require an IV or an injection.

Merck’s antiviral tablet is also anticipated to be approved soon. Pfizer’s medicine, on the other hand, is almost guaranteed to be the favored alternative because to its low side effects and higher effectiveness, including a nearly 90 percent decrease in hospitalizations and fatalities among those most prone to develop severe illness.

“The effectiveness is great, the adverse effects are few, and it is taken orally.” “It ticks all the boxes,” stated Mayo Clinic’s Dr. Gregory Poland. “You’re looking at a 90% reduction in the likelihood of hospitalization and mortality in a high-risk population – that’s incredible.”

Pfizer’s medication has been approved by the Food and Drug Administration for adults and children ages 12 and older who have a positive COVID-19 test and early symptoms and are at high risk of hospitalization. This covers the elderly as well as individuals suffering from illnesses such as obesity and heart disease. Children must weigh at least 88 pounds to be eligible for the medication (40 kilograms).

Both Pfizer and Merck’s tablets are predicted to be successful against omicron since they do not target the spike protein, which contains the majority of the variant’s concerning mutations.

Pfizer presently has 180,000 treatment courses available across the world, with around 60,000 to 70,000 allotted to the United States. Early shipments to the most afflicted areas of the country are anticipated to be rationed by federal health officials. Pfizer stated that the limited availability is due to the production period, which is now roughly nine months. The business claims that it will be able to cut manufacturing time in half next year.

The United States government has committed to buy enough Paxlovid to treat ten million individuals. According to Pfizer, it is on track to supply 80 million courses globally next year, thanks to contracts with the United Kingdom, Australia, and other countries.

Vaccination, according to health experts, is still the best approach to protect against COVID-19. However, with over 40 million American adults remaining unvaccinated, effective medications will be important in mitigating current and future outbreaks of illness.

The United States currently reports more than 140,000 new infections every day, and government officials warn that the omicron variety might cause case counts to skyrocket. Federal officials verified earlier this week that Omicron had already swept across the country to become the prevalent strain.

In light of this, experts caution that Paxlovid’s early influence may be limited.

Biotech-engineered antibody medicines have been the go-to therapy for COVID-19 for more than a year. However, they are expensive, difficult to make, and need an injection or infusion, which is normally administered in a hospital or clinic. Furthermore, laboratory research indicates that the two most commonly used antibody medicines in the United States are ineffective against omicron.

Pfizer’s tablet has its own set of issues.

To obtain a prescription, patients must have a positive COVID-19 test. And Paxlovid has only been shown to be helpful if administered within five days of the onset of symptoms. With testing supplies running low, experts are concerned that people may be unable to self-diagnose, get tested, visit a doctor, and pick up a prescription within the allotted time frame.

“If you move beyond that window of time, I completely anticipate the effectiveness of this medicine to decline,” said Andrew Pekosz, a virologist at Johns Hopkins University.

The FDA made its decision based on the company’s findings from a 2,250-patient trial, which showed that the tablet reduced hospitalizations and fatalities by 89 percent when given to persons with mild-to-moderate COVID-19 symptoms within three days of onset. At the end of the 30-day study period, less than 1% of patients using the medicine were hospitalized, and none died, compared to 6.5 percent of patients hospitalized in the control group.

Pfizer’s medicine is part of a decades-old class of antiviral drugs known as protease inhibitors, which transformed HIV and hepatitis C treatment. The medications inhibit a critical enzyme required for viruses to replicate in the human body.

Each session of Pfizer’s medication, which consists of three tablets taken twice a day for five days, will cost around $500 in the United States. Two of the tablets are Paxlovid, while the third is an antiviral that helps enhance the primary drug’s levels in the body.

  • Associated Press