Pfizer Inc. said Friday that its COVID-19 antiviral tablet reduced hospitalization and mortality rates in high-risk people by over 90%, as the company joins the race to bring the first easy-to-use coronavirus treatment to market in the United States.
In the United States, all COVID-19 treatments involve an IV or injection. After demonstrating promising early results, competitor Merck’s COVID-19 tablet is already under evaluation by the Food and Drug Administration, and the United Kingdom became the first country to approve it on Thursday.
After independent experts suggested ending the company’s trial due to the strength of its results, Pfizer said it will approach the FDA and international authorities to approve the drug as soon as feasible. The FDA might reach a judgment in weeks or months after Pfizer submits its application. If approved, the medicine would be sold under the brand name Paxlovid.
Researchers from all around the globe have been hurrying to develop a COVID-19 tablet that can be used at home to alleviate symptoms, expedite recovery, and lessen the strain on hospitals and doctors.
Pfizer revealed early findings from a 775-person trial on Friday. When compared to patients who took a placebo tablet, individuals who got the company’s medicine paired with another antiviral quickly after developing COVID-19 symptoms had an 89 percent lower combined incidence of hospitalization or death after a month. Only around 1% of people who took the medicine needed to be admitted to the hospital, and no one died. In the comparison group, 7% of people were admitted to the hospital, and seven people died.
In an interview, Dr. Mikael Dolsten, Pfizer’s chief scientific officer, stated, “We were expecting for something remarkable, but it’s uncommon that fantastic treatments come through with over 90% effectiveness and 100% protection against mortality.”
Participants in the study were unvaccinated, had mild-to-moderate COVID-19, and were at high risk of being admitted to the hospital owing to health issues such as obesity, diabetes, or heart disease. Treatment started three to five days after the onset of symptoms and lasted five days. Patients who received the medicine sooner had somewhat better outcomes, emphasizing the need of prompt assessment and treatment.
Pfizer provided limited information on side effects, but indicated that the rates of difficulties were roughly 20% in both groups.
When intermediate findings reveal such an obvious benefit, an independent committee of medical professionals overseeing the study suggested discontinuing it early, as is customary protocol. The data has not yet been made public for outside assessment, as is customary when new medical research is being evaluated.
Vaccination, according to top US health authorities, will continue to be the greatest approach to guard against infection. However, with tens of millions of people worldwide remaining unvaccinated, effective, easy-to-use therapies will be vital in preventing future outbreaks.
The FDA has scheduled a public meeting for later this month to discuss Merck’s molnupiravir tablet. In September, the business said that their medicine reduced hospitalization and mortality rates by 50%. Because of the disparities in research, experts advise against comparing preliminary results.
Although Merck’s tablet is further along in the regulatory process in the United States, Pfizer’s medicine might benefit from a more recognizable safety profile with fewer red flags for regulators. Pregnant women were not allowed to participate in the Merck study owing to the danger of birth abnormalities, whereas Pfizer’s medication had no such limits. The Merck medicine disrupts the coronavirus by interfering with its genetic coding, which is a unique approach to virus disruption.
Pfizer’s medication is a protease inhibitor, a class of antiviral agents that has changed HIV and hepatitis C treatment for decades. The medications prevent viruses from multiplying in the human body by inhibiting a critical enzyme.
During the SARS pandemic in Asia in 2003, the drug was discovered for the first time. Given the similarities between the two coronaviruses, business researchers decided to resurrect the medicine and test it for COVID-19 last year.
The United States has approved remdesivir, a new antiviral medicine for COVID-19, as well as three antibody therapy to assist the immune system combat the virus. However, they must be administered by IV or injection in hospitals or clinics, and limited supplies were stressed by the delta variant’s recent increase.
Pfizer’s stock jumped more than 9% before the market opened on Friday.