(Benzinga) – The U.S. Food and Drug Administration (FDA) has completed a review of adverse events observed in participants of AstraZeneca Plc’s (NASDAQ: AZN) COVID-19 vaccine clinical trial, according to Reuters.
What Happened: The U.S. trial of the British company’s vaccine candidate could resume as soon as this week, people familiar with the matter told Reuters. It remains unclear how the FDA will characterize the illnesses observed in the participants.
The U.S. FDA could reportedly mandate that researchers conducting the trial include information about the adverse events in participant consent forms.
Why It Matters: AstraZeneca announced in early September that its coronavirus vaccine candidate AZD1222 was moving into phase three clinical trials in the U.S., with about 30,000 participants. The trials, in the U.S. and other countries, were paused later in the month when a trial participant in the United Kingdom suffered complications — exhibiting neurological symptoms.
The trials have since resumed in the U.K, Brazil, India, and South Africa, but remain paused in the U.S., pending FDA approval.
The U.K.’s Medicines and Healthcare products Regulatory Agency determined that the evidence was insufficient to link AstraZeneca’s U.K trial program setback with the vaccine, as per Reuters.
On Tuesday, AstraZeneca also announced the receipt of a “Recommendation of Approval” in the European Union for two of its treatments against heart failure and a lung disorder.
Price Action: AZN stock fell 0.48% to close Tuesday’s trading session at $52.19.