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Home » Topics » COVID-19

COVID-19
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J&J’s Single-Dose Vaccine Nears FDA Authorization, but Appears Weakened by South African Strain

February 1, 2021
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

EU Authorizes AstraZeneca’s COVID-19 Vaccine as Dose Delivery Crisis Deepens

February 1, 2021
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

GAO Finds Pandemic Response Hampered by Vaccine Distribution Issues

January 29, 2021
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 to Help Produce Covid-19 Vaccines or Treatments Made by Other Companies

January 29, 2021
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’s COVID-19 Vaccine Shows Over 89 Percent Efficacy in Late-Stage Trial

January 29, 2021
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

Pfizer/BioNTech’s Vaccine Holds Up Against UK, South African Coronavirus Variants in In Vitro Studies

January 29, 2021
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
COVID-19  Clinical Trial

EmitBio Unveils Positive Early Results for Handheld COVID-19 Therapeutic

January 29, 2021
The handheld device directs precise wavelengths of targeted light to the back of the throat and surrounding tissues and is designed for at-home treatment of mild-to-moderate COVID-19 in adult patients. Read More
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FDA Tightens Up Emergency Use Conditions for N95 Respirator Decontaminators

January 29, 2021
“The FDA has determined that it is appropriate to protect the public health or safety to revise certain decontamination system EUAs to limit the number of decontamination cycles and respirator reuses permitted under each authorization,” the agency said. Read More

CDER Hit Most Review Targets in 2020 Despite Pandemic Obstacles

January 28, 2021
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

WHO Recommends Against Pregnant Women Getting Moderna Vaccine

January 28, 2021
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

J&J to Release Vaccine Trial Results Next Week, on Track to Deliver 100 Million Doses

January 28, 2021
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

AstraZeneca Clashes With EU Over ‘Best Effort’ Vaccine Supply

January 28, 2021
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
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