The FDA first released Paxlovid available under an emergency authorization for use. The new ruling means that numerous studies prove that the drug is safe and effective.
Paxlovid, an antiviral drug made by Pfizer’s Covid, received full approval from the Food and Drug Administration on Thursday for use in people who are at high risk of developing a severe case of the virus.
Medical guidelines recommend Paxlovid for the treatment of moderate to mild Covid in adults over 50 years old and those with specific medical conditions that increase their risk of hospitalization or death from Covid.
This includes those with heart disease, diabetes, or cancer, as well as a flawed immune system.
Up to 75% of adults in the United States are at very high risk of developing severe COVID.
The FDA first released Paxlovid available in December 2021, under emergency use approval for people at high risk aged 12 and over. Following the results of an early clinical trial, the FDA swiftly approved the treatment with this designation.
The FDA’s recent decision means there’s now ample research evidence that suggests Paxlovid is safe and effective.
The treatment comprises two medicines: Nirmatrelvir, which blocks an important enzyme required by the Covid virus for reproduction, and ritonavir, which enhances the first medication’s capacity to fight off the disease.
Both Pfizer as well as the FDA consider the treatment an important tool in addition in conjunction with vaccination. It can help those at-risk Americans to manage their Covid illnesses and eventually save lives.
According to January estimates from FDA researchers, Paxlovid may “lead to 1,500 lives saved and 13,000 hospitalizations averted each week” in the United States using Covid rates.
It’s not clear what the future developments will be like later this year.
The U.S. has 1.1 million doses of the treatment everyone for free. When the government exhausts that, it will move Paxlovid’s distribution into the market for commercial use.
This implies that Pfizer will offer Paxlovid straight to healthcare professionals at a cost the company hasn’t yet disclosed. The current price for a course of Paxlovid is around $530.
Pfizer has seen Paxlovid sales increase to almost $19 billion by 2022. However, it expects sales of the medicine to decline by 58% by 2023
In March an advisory panel composed of independent experts of the FDA suggested the treatment in light of three of Pfizer’s clinical studies.
One study investigated the risk of high-risk individuals who had not received vaccination and had no prior Covid infection.
The study found that Paxlovid decreased the chance of hospitalization or death by:
- 86% among patients who were treated in the first five days following initial symptoms.
- 89% of patients were treated within 3 days, as per an FDA examination of data from the company.
There were no significant safety issues discovered in the study, as per the review. However, the agency did flag 137 medicines that could result in serious adverse reactions if combined with Paxlovid.
The FDA stated that the most commonly used medications that caused safety concerns included:
- Immunosuppressants, which are frequently employed to treat HIV.
- Immunosuppressants used in patients undergoing organ transplants.
The Office for Surveillance and Epidemiology of the FDA reported 271 cases of serious adverse events that interactions between drugs and Paxlovid could cause. This included six deaths and 147 hospitalizations at the end of January.
Altering the dosage of specific drugs and increasing the monitoring of patients. Making sure that labeling on products provides patients and their prescribers with information about possible interactions between drugs.
Some doctors have another aspect of concern: “rebound cases” of Paxlovid. That’s when patients who receive the medication notice that their Covid symptoms recur or they test positive shortly after their initial recovery.
The reports of these cases came in the days following Paxlovid first came on the market.
President Joe Biden and Dr. Anthony Fauci, his former chief medical advisor, both appeared to be able to recover from Covid after consuming the antiviral drink, but they later tested positive again.
The FDA review of Pfizer’s clinical trials found that the overall rate of comeback varied between 10 and 16 percent. Those who took Paxlovid compared to those who received a placebo observed no evidence of a higher rate of symptom rebound or moderate symptom rebound.
As per an FDA review, the results were valid regardless of the risks of getting sick. It was also valid regardless of whether the Omicron variant or a prior variant of the virus was dominant.
