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Home » Topics » COVID-19

COVID-19
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Composition for COVID-19 Vaccine for 2022-2023 Season Must be Decided by June, Say Califf, Woodcock and Marks in JAMA Editorial

May 5, 2022
A decision on the composition of a COVID-19 vaccine to be administered to the American population beginning this fall will need to be made by June. Read More

FDA Announces Dates for COVID-19 Vaccine AdComs Though No Full Applications Are In Yet

May 2, 2022
The FDA has announced tentative dates for its vaccine-related advisory committee to meet to discuss the much-anticipated full applications for Emergency Use Authorization (EUA) that it expects any day from COVID-19 vaccine manufacturers for children under age six. Read More

Shionogi’s COVID-19 Treatment Rapidly Lowered Virus Counts

April 27, 2022
Shionogi’s investigative COVID-19 therapy is showing some promise in early laboratory studies, rapidly clearing viral levels and decreasing the period of active shedding, the company reported at the European Congress of Clinical Microbiology and Infectious Diseases. Read More

Gilead’s Veklury Approved for Pediatric COVID-19 Patients Under 12

April 26, 2022
The FDA has expanded its approval of Gilead Sciences’ Veklury (remdesivir) for pediatric patients 28 days and older weighing at least 6.6 pounds who have tested positive for COVID-19 and are either hospitalized or are at high risk of developing severe COVID-19. Read More

MEPs Sue European Commission for Details of COVID-19 Vaccine Contracts

April 26, 2022
The five members are asking for disclosure regarding the price of the vaccine’s unit, advance payments, donations, liability and indemnification. Read More

EMA Has More Questions About Valneva’s Inactive COVID-19 Vaccine

April 26, 2022
Valneva has a purchase agreement with the European Commission to supply up to 60 million doses of VLA2001. Read More

Pfizer’s Oral COVID-19 Treatment Scores in Phase 2/3

April 20, 2022
Pfizer’s novel antiviral nirmatrelvir plus ritonavir cut the risk of COVID-19-related death or hospitalization by 89 percent relative to placebo, a phase 2/3 study has determined. Read More

Renewal of Public Health Emergency Means FDA’s Pandemic Guidance Still Applies

April 18, 2022
It’s official: The public health emergency (PHE) that is COVID-19 will continue for at least three more months. Read More

Pfizer’s COVID-19 Vaccine Booster Shows Strong Immune Response in Children

April 18, 2022
Pfizer and BioNTech are expected to file for an FDA Emergency Use Authorization for a booster dose for this age group within days. Read More

Shionogi’s Investigational COVID-19 Drug Linked to Fetal Abnormalities

April 14, 2022
The company said it doesn’t believe the results will affect the regulatory decision. Read More

University of California San Diego-Developed COVID-19 Test Gains EUA

April 14, 2022
The swab samples can be transported within 36 hours at ambient temperature to the laboratory’s San Diego site for testing. Read More

Veru’s Stops COVID-19 Treatment Trial in Face of ‘Overwhelmingly Positive’ Results

April 13, 2022
Veru has stopped a phase 3 study of its COVID-19 treatment sabizabulin after an interim safety analysis found that the drug overwhelmingly reduced the risk of death by 55 percent in patients with moderate-to-severe disease. Read More
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