Johnson & Johnson is expected to file for Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine this week, but the much-needed shot has shown to be significantly less effective than its Pfizer/BioNTech and Moderna counterparts and looks to have problems tackling the virus’ highly contagious South African variant. Read More

The European Commission granted a conditional marketing authorization on Friday for AstraZeneca’s (AZ) COVID-19 vaccine just hours after an expert panel gave its blessing to the low-cost vaccine that can be shipped and held at normal refrigerator temperatures — as the bloc intensified efforts to secure delivery of initial doses and some EU members questioned the vaccine’s effectiveness for older individuals. Read More

The Government Accountability Office (GAO) has issued its fifth report on the federal government’s efforts to combat the COVID-19 pandemic, citing concerns that critical issues have still not been addressed, including the need for a “clear and comprehensive vaccine distribution plan.” Read More

Novartis CEO Vas Narasimhan said the company is looking to help other companies scale up production of COVID-19 vaccines and treatments and is currently in talks with “key players.” Read More

Novavax has announced interim results from a phase 3 UK trial that showed its COVID-19 vaccine candidate, NVX-CoV2373, demonstrated 89.3 percent efficacy but faltered in a separate study that evaluated the vaccine for the South Africa variant. Read More

Researchers from Pfizer and the University of Texas Medical Branch have found that the Pfizer/BioNTech COVID-19 vaccine was still able to effectively neutralize key mutations in the highly contagious UK and South African coronavirus strains, offering hope that the prominent vaccine won’t need to be readjusted at this point. Read More

Despite the COVID-19 pandemic making manufacturing site inspections difficult in 2020, the FDA’s Center for Drug Evaluation and Research (CDER) met most of its drug and biologic review goals last year, but — as it warned it would — the agency struggled to meet its inspection goals. Read More

The World Health Organization (WHO) is recommending that pregnant women should not use Moderna’s vaccine, except for those deemed to be at high risk of infection. Read More

Johnson & Johnson (J&J) said it plans to release late-stage trial data for its COVID-19 vaccine candidate next week — a single-dose shot that could help the Biden administration exceed its goal of 100 million vaccinations in 100 days. Read More

The EU’s dispute with AstraZeneca (AZ) over the supply of the company’s vaccine intensified yesterday as European Commission (EC) officials met with the company and called on it to release the full terms of its European supply contract. Read More