COVID-19 vaccine trial will continue after subject given placebo dies in Brazil
AstraZeneca’s coronavirus vaccine trial will continue after officials found no safety issues despite the death of a Brazilian subject, the University of Oxford announced Wednesday.
Oxford, which is developing the drug with AstraZeneca, said that officials have conducted an assessment of the death and “there have been no concerns about safety of the clinical trial.”
“The independent review in addition to the Brazilian regulator have recommended that the trial should continue,” Oxford spokesperson Alexander Buxton said in a statement, according to Reuters.
Brazilian newspaper O Globo said the subject who died had been part of the trial’s placebo group. Federal officials in Brazil currently plan to buy a completed vaccine and manufacture it at the Rio de Janeiro-based FioCruz research center, according to the news service. A competing vaccine, manufactured by Chinese firm Sinovac Biotech, is currently in the resting stage at the Butantan Institute, the state research center in Sao Paolo.
Oxford halted its AstraZeneca trials worldwide early in September to assess whether the vaccine was responsible for an adverse reaction in some subjects. The university resumed trials in Brazil and South Africa shortly thereafter, but they remain paused in the U.S.
The studies are likely to resume in the near future, according to Politico.
“We are writing to let you know that the US drug regulatory authority (Food and Drug Administration or FDA) has also now completed their analysis of the information relating to the participants concerned and has come to the same conclusion as the other drug regulators including the MHRA,” the United Kingdom’s Health Research Authority said in a letter, according to the publication.