November 29, 2021 by John Fernandez
Roundup: Pfizer to Submit Its COVID-19 Pill for Approval; Boosters Could Expand to All Adults; and More
Pfizer Says Its COVID-19 Pill Reduces Death, Hospitalization Risk by 89%; Will Submit for FDA Approval
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.
U.S. to Study Long-term Effects of COVID-19 in Women Infected During Pregnancy
The National Institutes of Health will fund a four-year follow-up study on the potential long-term effects of COVID-19 on women infected with COVID-19 during pregnancy. The study will also “follow their offspring for any potential long-term effects,” the NIH said.
The effort is part of NIH’s ongoing initiative to understand why some individuals who have had COVID-19 don’t fully recover or develop symptoms after recovery — commonly referred to as “long COVID.” These conditions affect all ages. Long-term effects of long COVID can include fatigue, shortness of breath, difficulty concentrating, sleep disorders, fevers, anxiety and depression.
The current study will enroll some participants from an earlier study by the Maternal-Fetal Medicine Units (MFMU) Network, a 36-site research project by NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Participants will be recruited from about 4,100 patients with asymptomatic and symptomatic COVID infections during pregnancy who gave birth at hospitals that are part of the MFMU network.
“The research teams will assess patient symptoms periodically during the four-year period and evaluate their offspring for neurologic symptoms and cardiovascular conditions,” the NIH states. The goal of researchers is to contribute comprehensive findings that will advance efforts to reduce the risk of long COVID after pregnancy and to treat its symptoms.