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 the number of illnesses, hospitalizations, and deaths in the United States continue to rise, and health experts worry that a wave of new infections caused by the Omicron variety might overwhelm hospitals.
At first, Paxlovid, a faster way to treat early COVID-19 infections, will be available in limited quantities. All of the previously approved anti-disease medications need an IV or injection.
Merck’s antiviral pill is also likely to get FDA approval shortly. However, because of its low side effects and greater efficacy, including a nearly 90% decrease in hospitalizations and fatalities among patients most prone to developing severe illness, Pfizer’s medicine is almost guaranteed to be the preferred alternative.
“It has good effectiveness, few adverse effects, and it’s an oral medication.” “It ticks all the criteria,” Mayo Clinic’s Dr. Gregory Poland stated. “In a high-risk population, you’re looking at a 90% lower chance of hospitalisation and mortality – that’s incredible.”
Pfizer’s medication has been approved by the Food and Drug Administration for adults and children aged 12 and up who have a positive COVID-19 test and early symptoms and are at high risk of hospitalisation. This includes the elderly and those suffering from obesity or heart disease, while the medicine is not suggested for anyone suffering from severe renal or liver illness. The medicine is only available to children who weigh at least 88 pounds (40 kilograms).
Both Pfizer and Merck’s pills are expected to be effective against Omicron because they don’t target the spike protein, which contains the majority of the variant’s worrisome mutations.
Pfizer presently has 180,000 treatment courses accessible across the globe, including 60,000 to 70,000 in the United States. Early supplies to the hardest-hit areas of the nation are anticipated to be rationed by federal health authorities. The limited supply is owing to the production period, which is now about nine months, according to Pfizer. Next year, the business claims it will be able to cut manufacturing time in half.
The US government has committed to buying enough Paxlovid to treat ten million individuals, and patients will get it for free. According to Pfizer, it is on pace to deliver 80 million courses worldwide next year thanks to contracts with the United Kingdom, Australia, and other countries.
President Joe Biden described the pill as a “major step forward on our route out of the pandemic,” adding that his government would work with states to ensure that it is distributed fairly.
According to health experts, vaccination remains the best strategy to protect against COVID-19. However, with about 40 million individuals in the United States remaining unvaccinated, effective medications will be vital in thwarting current and future outbreaks.
More than 140,000 new infections are reported every day in the United States, and government authorities worry that the omicron type may send case numbers rising. Federal authorities verified earlier this week that Omicron had already spread throughout the country to become the prevalent strain.
Experts caution that Paxlovid’s initial effect could be limited.
COVID-19 has been treated with biotech-engineered antibody medicines for more than a year. However, they are costly, difficult to make, and require an injection or infusion, which is usually administered in a hospital or clinic. In addition, laboratory data 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 problems.
To acquire a prescription, patients must have a positive COVID-19 test. Paxlovid is only effective if taken within five days of the onset of symptoms. With testing supplies running low, experts are concerned that patients may be unable to self-diagnose, get tested, visit a doctor, and pick up a prescription within the allotted time.
“I completely anticipate the efficacy of this medicine to fall outside that window of time,” said Andrew Pekosz, a virologist at Johns Hopkins University.
The FDA made its decision based on data from a 2,250-patient study that showed the drug reduced hospitalizations and fatalities by 89% when given to people with mild-to-moderate COVID-19 symptoms within three days of starting. At the conclusion of the 30-day research period, less than 1% of patients using the medicine were hospitalised, and none died, compared to 6.5% of patients hospitalised in the dummy pill group, which included nine fatalities.
Pfizer’s medication is a protease inhibitor, a family of antiviral drugs that has changed HIV and hepatitis C therapy for decades. The medications prevent viruses from multiplying in the human body by inhibiting a critical enzyme.
Each treatment of Pfizer’s medication, which consists of three tablets taken twice a day for five days, will cost roughly $500 in the United States. Two of the tablets are Paxlovid, while the third is an antiviral that aids in increasing the body’s levels of the main medicine.
Source: The Hindu