Published: Wed, September 16, 2020
Medical | By

AstraZeneca’s United States trial remains on hold pending review by FDA

AstraZeneca’s United States trial remains on hold pending review by FDA

"The hope is that directly targeting the cells lining the airways - the typical point of infection for respiratory viruses - may induce a more effective immune response against the SARS-CoV-2 virus", the Medical Research Council (MRC) coordinating body said in a statement.

Temporary pauses in clinical trials aren't unusual.

A unit of state pharmaceutical giant, China National Pharmaceutical Group (Sinopharm) and USA -listed Sinovac Biotech are developing the three vaccines under the state's emergency use programme.

The comments follow rival AstraZeneca's COVID-19 vaccine trials being put on hold worldwide on September 6 after a serious side effect was reported in a volunteer in Britain.

AstraZeneca on Saturday said it had restarted its trial in Britain after regulators completed their review of a serious side effect in one trial participant there.

Pfizer and BioNTech are expected to approach the US Food and Drugs Administration (FDA) for emergency authorisation use, but Bourla said "timing remains unclear". Sources told the news agency that enrollment of new patients and other trial procedures for the pivotal USA trial was being rescheduled until at least midweek and that it was not clear how long it would take for the FDA to complete its probe.

The institute had said that they were not facing any issues in trials on Wednesday.

Global pharma major AstraZeneca announced on Tuesday that the clinical trials will be temporarily halted. Meanwhile, the decision regarding when to resume the clinical trials rests with the DGCI.

The investigator, Alberto Borobia, said there were enough reserve volunteers for the trial to continue as normal, however.

The company has enrolled more than 29,000 people in its 44,000-volunteer trial to test the experimental COVID-19 vaccine it is developing with German partner BioNTech. Volunteers have been recruited in Sao Paulo, Rio de Janeiro, and Salvador in the northeastern state of Bahia where a hospital is conducting the tests.

Previous studies have shown vaccines delivered by inhalation require lower doses than by injection, which might help stretch limited supplies. The pharmaceutical giant, along with Moderna (MRNA) and AstraZeneca (AZN), are all in the late-stage testing phase.

The first vaccines are due to be available in early 2021.

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