US trials of AstraZeneca’s experimental COVID-19 vaccine AZD1222 have been cleared to restart by the FDA, several weeks after testing was suspended following a serious adverse reaction in one patient who received the shot. Separately, Johnson & Johnson has also announced it is resuming recruitment… Read More »AZ, J&J COVID-19 vaccine trials okay to restart in US
Shots: The US FDA authorizes the restart of the P-III clinical study in the US following the resumption of trials in other countries in recent weeks. The FDA reviewed all safety data from studies globally and concluded it was safe to resume the trial A… Read More »AstraZeneca Resumes P-III Study of AZD1222 Against COVID-19 in the US
European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. It’s an historic announcement, bringing hope that the vaccine could be approved in the near future, although the European Medicines… Read More »European regulators begin rolling review of AZ’s COVID-19 vaccine
Reuters reported Wednesday that U.S. regulators would look at data from previous clinical trials that came from the same scientists who created the vaccine, AZD1222, which originated at the University of Oxford and is also known as ChAdOx1 nCoV-19.
AstraZeneca Signs an Agreement with Emergent BioSolutions to Expand Manufacturing of AZD1222 for COVID-19
Shots: Emergent will provide CDMO services for AstraZeneca’ AZD1222. The agreement valued ~174M through 2021 and follows an $87M agreement signed in June for development services, performance and process qualification, raw materials, and an initial capacity reservation The two companies may enter additional commercial manufacturing… Read More »AstraZeneca Signs an Agreement with Emergent BioSolutions to Expand Manufacturing of AZD1222 for COVID-19
AstraZeneca and Oxford University’s AZD1222 Delivers Dual Immune Response in its P-II/III COV001 Study Against COVID-19
Shots: The P-II/III COV001 designed to determine the safety, immunogenicity, and efficacy of the AZD1222 (single dose or two doses of AZD1222 at 5×1010 viral particles) vs single dose of meningococcal conjugate vaccine (MenACWY) as control vaccine in up to 1,077 healthy adults aged 18-55yrs.… Read More »AstraZeneca and Oxford University’s AZD1222 Delivers Dual Immune Response in its P-II/III COV001 Study Against COVID-19
The company announced the publication of interim data from the Phase I/II study of a vaccine it is developing with the University of Oxford. The news comes the week after Moderna announced the publication of data for its vaccine.