Coronavirus / COVID

The FDA’s biologics center faces another leadership shake-up as Vinay Prasad, MD, MPH, plans an exit in April, leaving questions over vaccine rules and gene-therapy approvals.

Despite increased risk for severe outcomes, most older adults and those with comorbidities do not receive antiviral treatment for COVID-19.

Moderna has cleared a major regulatory milestone in Europe after the EMA’s CHMP recommended approval of mRNA-1083 (mCOMBRIAX), the world’s first combined influenza and COVID-19 vaccine for adults aged 50 and older.

Traws Pharma announced positive phase 2 results showing its investigational COVID-19 antiviral ratutrelvir as a possible alternative to Paxlovid, including for ineligible patients, while advancing tivoxavir marboxil as a once-monthly oral prophylactic for seasonal influenza.

Invivyd has aligned with the FDA on the design of a phase 3 trial evaluating the safety and immunology of the company's monoclonal antibody, VYD2311, vs mRNA COVID vaccines and in co-administration.

Findings from a growing body of randomized trials and real-world analyses show that starting metformin during acute SARS-CoV-2 infection is safe and significantly reduces the risk of developing long COVID.

The American Academy of Pediatrics (AAP) has published its 2026 immunization schedule, reaffirming routine vaccination to protect children and adolescents against 18 preventable diseases.

The federal agency gave the nod for Acon Laboratories’ Flowflex Plus RSV + Flu A/B + COVID 4-in-1 test that can detect all those respiratory viruses in a single test, which is indicated for use in both adults and children as young as 6 months.

Although the declared COVID-19 pandemic public health emergency has passed, the CDC reports continued high numbers of illnesses, medical visits, hospitalizations and deaths.

The COVID-19 pandemic intensified long-standing problems in scientific production and communication—driven by perverse academic incentives, peer review strain, media hype, and growing misuse of AI—highlighting the urgent need for stronger critical appraisal skills across research and medicine.

A series of politically driven actions in 2025—including defunding mRNA research, dismantling vaccine advisory bodies, and restricting CDC recommendations—has undermined US vaccine access and pandemic preparedness, but professional societies and some states are stepping in to preserve evidence-based public health.

Questions raised about unverified FDA claims linking COVID-19 vaccines to pediatric deaths, and concerns that proposed vaccine testing requirements could delay access to key immunizations.

Anticipating possible constraints on the approval of COVID-19 vaccines and their removal from the CDC pediatric vaccine schedule, a medical ethicist and legal scholar consider off-label vaccination.

A review of vaccine safety and effectiveness conducted by the Vaccine Integrity Project, independent of the CDC's ACIP, reflects its stated purpose as "dedicated to safeguarding vaccine use in the US."

Seven months of clinical data corroborated emergency authorization of 2024-2025 mRNA COVID-19 vaccines for circulating JN.1 subvariants.

Dynavax and Vaxart have entered into a license and collaboration agreement to advance Vaxart’s investigational oral COVID-19 vaccine, with phase 2b data expected in late 2026.

FDA clearance paves the way for Invivyd to launch 2 phase 3 trials of VYD2311, a monoclonal antibody designed as a safe, convenient, vaccine alternative for COVID-19 prevention.

Georges C.Benjamin, MD, executive director of the American Public Health Association, details practical implications for clinical teams.

Part 2 on coverage across payers, evidence needs for COVID-19, hepatitis B, and MMRV, and clinician messaging for maternal and newborn protection.

In part 1 of our conversation, the VP of the NFID discusses ACIP’s recent meeting, including COVID-19 shared decision-making, informed-consent debates, and new policy actions on hepatitis B and MMRV.

Insights from Jaya Aysola, MD, MPH, DTMH; and John C. Lin, MD candidate, on clinical workflows, social needs screening, and policy levers.

Oxford’s Prof Katrina Lythgoe and Mahan Ghafari, DPhil, report ONS-CIS data on 576 persistent UK infections with rapid within-host evolution and rare transmission after one month.

William Hanage, PhD, discusses viral evolution, transmission risk, and clinical implications for immunocompromised patients.

Single-center randomized trial shows lower infection rates and extended time to SARS-CoV-2 infection, though larger studies are needed to confirm findings.

Supported by phase 3 SCORPIO-PEP trial data, ensitrelvir could become the first oral therapy to prevent COVID-19 following exposure, with an FDA decision due June 16, 2026.