The US approved Pfizer Inc’s (PFE.N) COVID-19 antiviral tablet for persons aged 12 and above who are at risk of severe disease on 22nd December 2021, making it the first oral and at-home therapy as well as a new weapon against the fast-spreading Omicron strain.
According to results from Pfizer’s clinical study, Paxlovid, an antiviral regimen, was nearly 90% effective in reducing hospitalizations and deaths in individuals at high risk of severe illness. According to Pfizer, recent lab evidence indicates that the medication is still effective against Omicron.
Pfizer increased its manufacturing predictions for 2022 to 120 million treatment courses, up from 80 million, and said it was ready to begin delivery in the United States immediately. A new medication plus an older antiviral called ritonavir make up the treatment’s two-drug regimen.
By January, the US government will have 265,000 treatment courses on hand, with supplies ramping up in the months after that. White House (Washington, DC) Jeff is the COVID-19 response coordinator.
“Paxlovid’s approval is a major milestone that marks another step towards making COVID-19 a much more manageable infection,” said Amesh Adalja, a senior scholar at the Johns Hopkins Institute for Health Security. “There are two key issues, however, that remain: It will be scarce in the coming weeks and its optimal use requires prompt diagnosis, which can be difficult with the continual testing problems that plague us,” Adalja added.
This year, Pfizer claims to have 180,000 treatment sessions ready to ship. The government of the United States has placed a contract for 10 million courses of medicine for $530 each course.
The FDA’s decision to provide emergency approval for the therapy comes as the United States battles an outbreak of COVID-19 cases caused by the Omicron form, with President Joe Biden announcing plans for new federal immunization and testing locations.
The Monoclonal Antibody Therapies For COVID-19 Were Ineffective?
According to William Schaffner, a prominent infectious disease expert at Vanderbilt University School of Medicine, the tablets potentially cover a therapy gap left by the Omicron variety. The most extensively used monoclonal antibody therapies for COVID-19 have proven ineffective in combating the variation, and the one remaining medication that works is in short supply, he added.
Monoclonal antibodies are usually administered intravenously in hospitals, are not generally available, and cost more than twice as much as a Pfizer tablet.
According to the US Centers for Disease Control and Prevention, the Omicron variety, which was initially discovered in southern Africa and Hong Kong in November, has spread throughout the world, and currently accounts for more than 70% of new coronavirus infections in the United States. Studies have revealed that prior infection and immunizations only partially prevent infection from the variation, while a booster injection does improve protection.
Paxlovid has been approved by the FDA for the treatment of mild-to-moderate illness in adults and adolescents aged 12 and above who are at high risk of developing severe COVID-19.
The medicine is only accessible by prescription and should be started as soon as possible following a COVID-19 diagnosis and within five days of the commencement of symptoms, according to the FDA. For five days, the tablets must be taken every 12 hours.
Clinical Trials by Pfizer
While kids under the age of 18 were not included in the clinical trials, Pfizer stated that the authorized adult dose regimen should result in equivalent blood concentration levels of the medication in pediatric patients 12 and older who weigh at least 40 kg (88.2 lbs).
The second medication, ritonavir, is known to interact with several other prescription medications. According to Pfizer, this should be tolerable, and most patients should be able to reduce their other prescription doses while being treated with COVID-19.
In 2022, Pfizer aims to submit a new medication applied to the FDA for full regulatory clearance. Through a license arrangement with the worldwide public health organization Medicines Patent Pool, Pfizer has committed to allowing generic manufacturers to offer copies of the medication to 95 low- and middle-income countries (MPP).
The FDA is now reviewing a competitor pill from Merck & Co (MRK.N). In a study, the medication molnupiravir, developed with Ridgeback Biotherapeutics, reduced hospitalization and mortality risk by 30%. On Wednesday, Pfizer’s stock rose more than 1% that taking it to $59.45.