The U.S. Food and Drug Administration contacted the company Friday to let it know it can resume the study in the U.S., the Wall Street Journal reported citing sources.
AstraZeneca’s trial was placed on pause in the U.S. after a volunteer developed unexplained neurological symptoms in the U.K. trial. The U.K trial has already been resumed.
AstraZeneca’s vaccine candidate is one of four coronavirus vaccine candidates in late-stage development in the U.S.
Earlier this week, a Brazilian volunteer in a clinical trial of AstraZeneca-Oxford University’s COVID-19 vaccine candidate died, the Brazilian health authority Anvisa said on Wednesday.
In an email to TheStreet, a spokesperson for AstraZeneca said, “All significant medical events are carefully assessed by trial investigators, an independent safety monitoring committee and the regulatory authorities. These assessments have not led to any concerns about continuation of the ongoing study.”
Earlier this month, AstraZeneca received a $486 million investment from the federal government’s Operation Warp Speed fund to supply up to 100,000 doses of a potential vaccine with an option to acquire up to a million doses.
AstraZeneca’s AZD7442 trials will enroll over 6,000 adults for the prevention COVID-19, with around 4,000 adults for the treatment of SARS-CoV-1 infections.
AstraZeneca shares traded flat in afternoon action Friday.
Shares of other companies developing treatments or vaccines for Covid-19 were mixed Friday. Adaptive Biotechnologies (ADPT) – Get Report shares rose $2.58, or 5.49%, to $49.51.
Kiniksa (KNSA) – Get Reportshares rose 72 cents, or 4.02%, to $18.65. BioNTech (BNTX) – Get ReportADRs rose $1.56, or 1.81%, to $87.92.
Among coronavirus stocks lagging Friday, CytoDyn (CYDY) – Get Report shares fell 20 cents, or 7.46%, to $2.48.
Vir Biotechnology (VIR) – Get Report shares fell $2.64, or 7.08%, to $34.63.
And Inovio (INO) – Get Report shares fell 34.5 cents, or 3.07%, to $10.90.