Pfizer says that its COVID-19 pill reduced the risk of hospitalization or death by 89 percent in a clinical trial involving adults “at high risk of progressing to severe illness.” Based on the encouraging results of its trial, Pfizer says it will submit the oral medicine, called Paxlovid, to the U.S. Food and Drug Administration to seek emergency use authorization.
The pill is similar to Merck’s new pill, which was approved in the United Kingdom last week and is being considered for emergency use by the FDA. Like Merck’s pill, Pfizer said its drug showed promising results when administered within five days of the first COVID-19 symptoms.
Both of the antiviral medicines from Pfizer and Merck attack COVID-19 by interfering with its ability to replicate itself.
“These data suggest that our oral antiviral candidate, if approved or authorized by regulatory authorities, has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of ten hospitalizations,” said Albert Bourla, chairman and chief executive officer, Pfizer.
After authorization, Pfizer said its pill could be “prescribed more broadly as an at-home treatment to help reduce illness severity, hospitalizations, and deaths, as well as reduce the probability of infection following exposure, among adults.”
Pfizer-BioNTech Seek Expansion of FDA Booster Approval for All Individuals 18 and Older
Pfizer-BioNTech have submitted a request with the U.S. Food and Drug Administration (FDA) to amend its “emergency use authorization” for a booster dose of the company’s COVID-19 vaccine to include all individuals 18 years of age and older.
The request is based on results from a “Phase 3 randomized, controlled trial evaluating the efficacy and safety” of a booster dose of the vaccine. The study enrolled more than 10,000 participants during a period when the Delta variant was prevalent, Pfizer-BioNTech said in a news release.
Results from the trial showed that a booster dose administered to those who previously received the Pfizer-BioNTech primary two-dose series demonstrated “a relative vaccine efficacy of 95 percent when compared to those who did not receive a booster,” the companies stated.
A booster, or third dose, of the Pfizer-BioNTech COVID-19 Vaccine is now authorized by the FDA for individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19, and individuals 18 through 64 years of age with “frequent institutional or occupational exposure” to COVID-19.
Currently, adult recipients of both the Pfizer-BioNTech and Moderna vaccines are eligible for a third shot, or booster, six months after their second injection.
Source: B Health
