Florida doctor pleads guilty to clinical trial data fraud A Miami physician has owned up to falsifying research data and patient participation figures for a pediatric asthma trial conducted from 2013 to 2016.
Yvelice Villaman Bencosme of Miami, Florida, has entered a guilty plea in US District Court for the Southern District of Florida, in response to one count of conspiracy to commit wire fraud.
Bencosme (who served as primary investigator for clinical purportedly conducted at the medical clinic Unlimited Medical Research in Miami) admitted that from approximately 2013 to 2016, she participated in a scheme to defraud an unnamed pharmaceutical company by fabricating the data and participation of subjects in a clinical trial at UM Research.
The European Commission had held discussions with French pharma company, Valneva, with a view to securing up to 60 million doses of its inactivated virus COVID-19 vaccine, VLA2001.
Indonesia s food and drug agency, BPOM, today granted emergency use authorization to Sinovac’s vaccine against COVID-19.
In doing so, it became the first country outside China to greenlight the vaccine, according to a report on
Reuters.
Sinovac is carrying out COVID-19 vaccine Phase 3 trials in Turkey, Indonesia and Brazil. Interim data from a phase 3 trial in Indonesia showed the shot, called CoronaVac, was 65.3% effective, said Penny K Lukito, who heads up BPOM.
Phase 3 findings
Having shown a substantial immune response and minimal safety concerns (mostly mild pain at the injection site) in phase 1 and 2 clinical trials, CoronaVac was then tested in phase 3 clinical trials carried out in Brazil, Indonesia and Turkey.
The EU Commission has obtained 300 million more doses of the Pfizer-BioNTech COVID-19 vaccine, doubling the amount currently available to EU-27 countries.