The UK’s NHS has begun the rollout of Pfizer/BioNTech’s bivalent COVID-19 boosters. The launch comes after the Medicines and Healthcare Products Regulatory Agency (MHRA) approved the shot for those 12 and older last week. The vaccine contains spike protein mRNA from both the original SARS-CoV-2 […]
COVID-19 Antibody Treatments Continue Well After FDA Deauthorization
Despite the best efforts of the US Food and Drug Administration (FDA), the use of Eli Lilly and Regeneron’s monoclonal COVID-19 antibody treatments is still prevalent. Nearly 160,000 doses of the therapeutics have been given since the two were deauthorized by the FDA this January. An estimate of the […]
Pfizer and BioNTech’s Bivalent COVID-19 Vaccine Boosters Get EU Approval
The European Medicines Agency (EMA) has just issued conditional marketing authorization (CMA) for both Pfizer and BioNTech’s bivalent COVID-19 vaccines. The agency’s Committee for Medicinal Products for Human Use (CHMP) approved the vaccines as boosters for people 12 and up. These vaccines contain […]
UK MHRA Approves Novavax COVID-19 for Ages 12-17
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has given expanded conditional marketing authorization (CMA) to use the Novavax COVID-19 vaccine in people ages 12-17. The decision was made based on data from the PREVENT-19 phase 3 trial. Early data showed that it had an 80% […]
FDA Approves Bivalent COVID-19 Vaccines from Moderna and Pfizer/BioNTech
The US Food and Drug Administration (FDA) has approved both bivalent COVID-19 vaccine boosters from Moderna and Pfizer/BioNTech. The boosters contain spike pro mRNA from the original SARS-CoV-2 virus and the BA.4/BA.5 omicron strains currently dominant worldwide. The approval comes as the agency […]
AstraZeneca Launches New Real-World Evidence Study for Evushield COVID-19 Therapeutic in Abu Dhabi
AstraZeneca has announced the launch of a real-world evidence (RWE) study to investigate the safety and efficacy of Evushield, its COVID-19 treatment. Evushield is an antibody combination with an extended duration that is intended to help immunocompromised patients avoid symptomatic COVID-19. The […]
Authorization for Bivalent Omicron Boosters
Insider sources say that the US Food and Drug Administration could authorize the new bivalent COVID-19 vaccines from Moderna and Pfizer/BioNTech as early as Labor Day, September 5th. The vaccines contain mRNA for spike protein from the BA.4/BA.5 SARS-CoV-2 that currently dominating worldwide and the […]
FDA Commissioner Rob Califf Emphasizes Need to Combat Misinformation
Rob Califf, the commissioner of the US Food and Drug Administration (FDA), spoke about his current goals for the agency. Califf emphasized the need to continue focusing on the ongoing COVID-19 pandemic and the opioid epidemic. The nation is behind its peers in terms of vaccinations, and Americans […]
Pfizer, BioNTech Apply for FDA Emergency Use Authorization for Omicron Booster
The makers of the Comirnaty COVID-19 vaccine have applied to the US Food and Drug Administration (FDA) for an emergency use authorization for their new Omicron BA.4 and BA.5 booster shots. The new version of Pfizer and BioNTech’s vaccine is bivalent, containing spike protein mRNA from the original […]
Anthony Fauci to Step Down in December
On Monday, August 23rd, Anthony Fauci announced his plans to step down from his roles in the National Institute of Health (NIH) and the Biden Administration. Fauci had served as the director of the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) for 38 years, and had spent over […]
