The US Food and Drug Administration (FDA) approved Pfizer’s Paxlovid for patients at high risk of severe COVID-19 this week. The move is based on a randomized clinical trial that found that unvaccinated patients who had not been infected by COVID-19 before were 86% less likely to be hospitalized if […]
US Runs Out of J&J’s COVID-19 Vaccine
The US Centers for Disease Control and Prevention (CDC) has announced that the US is officially out of J&J’s COVID-19 vaccine. The final batches of the vaccine expired earlier this month and now the agency is ordering all remaining vials to be disposed of. The vaccine’s administration has long […]
WHO: The COVID-19 Pandemic Is Over
The World Health Organization (WHO) has announced the end of the COVID-19 public health emergency (PHE). The move comes after reported deaths and hospitalizations for the disease have plummeted in recent months. PHE status as declared by the WHO won’t immediately rescind healthcare policy changes in […]
Responding to Next Public Health Emergency With Real-World Data
The COVID-19 pandemic spurred a sea change in the real-world data (RWD) landscape, bolstering its utilization and recognition. Eventually, another public health crisis will emerge, and by continuing to support the development of RWD resources and utilization, we can rise to the challenge even more […]
The End of the COVID-19 PHE Draws Near
The COVID-19 public health emergency (PHE) is set to expire in the US next week, leaving much up in the air. The pandemic-era pause on Medicare redeterminations will hit patients soon, kicking millions off of healthcare coverage. In addition, vaccines and treatments for COVID will hit the private […]
Biden Administration to Provide Free COVID-19 Vaccines to Uninsured People
The Biden administration is finalizing its plan to make COVID-19 vaccines, tests, and treatment free for uninsured people as the vaccines enter the commercial market. Once fully commercialize, prices for the mRNA-based shots from Moderna and Pfizer/BioNTech are set to spike to $100+. To curb this, […]
FDA Plans to Authorize Additional Omicron Booster for Select Populations
A report by the Washington Post indicates that the US Food and Drug Administration is set to approve another round of boosters for adults 65 and up. The approval will also include adults who are immunocompromised. Boosters will be available for these patients for free 4 months after their last […]
FDA Adcomm Recommends Paxlovid for Mild-to-Moderate COVID-19
Pfizer’s Paxlovid has received a nod from the US Food and Drug Administration’s (FDA’s) Antimicrobial Drug Advisory Committee for use in mild-to-moderate cases of COVID-19 in adults. The 16-1 vote came after Pfizer’s previous request for full approval hit a roadblock last year when the agency […]
US FDA Issues Emergency Use Authorization for First At-Home COVID and Flu Combo Test Kit
After a winter hallmarked by coexiting waves of COVID-19, seasonal flu, and RSV, the US Food and Drug Administration has given the Lucira COVID and Flu Home Test emergency use authorization (EUA). The at-home test kit is the first of its kind approved by the agency, simultaneously testing for […]
Pfizer and BioNTech Apply for FDA Emergency Use Authorization of Omicron Booster in Children
Pfizer and BioNTech have applied for emergency use authorization from the US Food and Drug Administration for their Omicron-targeted bivalent COVID-19 vaccine in children 4 and under (to 6 months). The application specifically is for the vaccine as a second booster, or fourth dose, as it is already […]
