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An increasing number of vaccines are in clinical trials for the prevention of COVID-19. Some of the vaccines are modifications of platforms that are the basis of previously approved vaccines for other infectious diseases. Others, like the mRNA-based vaccines, are new vaccine technology.
News provided by WCG FDAnews and WCG CenterWatch
Gilead’s Remdesivir Gains Full FDA Approval for COVID-19
The FDA on Thursday granted full approval to Gilead Sciences’ Veklury (remdesivir) to treat hospitalized COVID-19 patients, making it the first approved COVID-19 treatment in the U.S.
AstraZeneca’s COVID-19 Vaccine Delivers Strong Immune Response, Study Confirms
AstraZeneca’s COVID-19 vaccine candidate, AZD1222, currently being evaluated in phase 3 global trials, delivers a strong immune response, according to a new UK study.
In Ongoing Hahn-Azar Feud, Azar Denies Plotting Hahn’s Ouster
HHS Secretary Alex Azar denies a report that he and colleagues are plotting the ouster of FDA Commissioner Stephen Hahn over Hahn’s holding fast to stricter, more time-consuming rules for makers of novel COVID-19 vaccines than what the White House wants.
FDA Vaccines Advisory Committee Reviews EUA Requirements, Postmarket Studies
The FDA’s Vaccines and Related Biological Products Advisory Committee took no action Thursday after a lengthy discussion of the agency’s COVID-19 vaccine requirements, considerations for continuing blinded phase 3 trials after an Emergency Use Authorization (EUA) is issued and postmarket studies.
New Report Sounds Alarm on Pandemic-Induced Drug Shortages
The COVID-19 pandemic is worsening a pre-existing problem of drug shortages in the U.S., University of Minnesota researchers report in a new analysis.
Moderna Finalizes Enrollment for Phase 3 COVID-19 Vaccine Trial
CEO Stéphane Bancel said the company’s COVID-19 vaccine won’t be available for widespread distribution until Spring 2021.
Roche Forges Deal With Atea for COVID-19 Antiviral Pill
The drug works by interfering with the viral RNA polymerase, responsible for replication.
Researchers Urge Greater Transparency for Government-Funded Vaccine Trials
More than two dozen researchers and experts have penned a letter to HHS Secretary Alex Azar, National Institutes of Health (NIH) officials and pharma company executives, imploring them to shed more light on the clinical trial designs for federally funded COVID-19 vaccine studies.
Brazil’s President Bolsonaro Says No Deal With Sinovac for COVID-19 Vaccine
Brazil’s President Jair Bolsonaro announced Wednesday that his government will not purchase a COVID-19 vaccine developed by Beijing-based Sinovac, just one day after the country’s health minister announced it would be placing an order.
EU Finalizes Deal With J&J for 400 Million Doses of COVID-19 Vaccine
Johnson & Johnson has finalized a deal with the European Commission for 400 million doses of its COVID-19 vaccine candidate, Ad26.COV2.S.
Brazilian Regulator Announces Patient Death in AstraZeneca Vaccine Trial
Brazil’s health regulator ANVISA (Agência Nacional de Vigilância Sanitária) disclosed Wednesday that a participant had died in AstraZeneca’s Brazilian late-stage COVID-19 vaccine trial, though the UK drugmaker said the incident was not grounds for stopping the study.
California Will Independently Verify COVID-19 Vaccine
California Governor Gavin Newsom has named an 11-person scientific review panel to verify the safety of any FDA-approved COVID-19 vaccine before it is distributed in the state.
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