WASHINGTON, 9 Sept 2020:
AstraZeneca yesterday said it decided to suspend clinical trials of its proposed coronavirus vaccine – after one participant suffered an adverse reaction to the medication.
“This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials,” the UK-based company said in a statement.
“In large trials illnesses will happen by chance but must be independently reviewed to check this carefully. We are working to expedite the review of the single event to minimise any potential impact on the trial timeline.”
AstraZeneca said a volunteer – who was part of clinical trial in the UK – developed a “suspected serious adverse reaction,” health news website Stat reported.
The vaccine, a collaboration between AstraZeneca and scientists at Oxford University, is undergoing Phase 2 and Phase 3 clinical trials in the UK, the US, Brazil and South Africa.
Oxford said last month that more than 11,000 people had enrolled in the trials in the UK, Brazil and South Africa, while the organisers of the US trials are aiming to include as many as 30,000 subjects.
The AstraZeneca/Oxford effort has been accepted into the US government’s Operation Warp Speed and Washington committed to providing as much as US$1.2 billion to aid development of the vaccine and secure 300 million doses.
The governments of Argentina and Mexico reached an accord with AstraZeneca/Oxford to produce the vaccine in their respective countries and distribute it throughout Latin America with the exception of Brazil, which signed a separate pact with the developers.
Argentine president Alberto Fernandez said he envisions producing between 150 million and 250 million doses of vaccine and making it available to the public at a cost of roughly US$4 a shot.
Prior to the interruption of the testing, AstraZeneca was planning to begin mass production and distribution of the vaccine in the first half of 2021.
The World Health Organisation has characterised AstraZeneca/Oxford’s vaccine project as one of the most advanced.
Nine vaccine makers, including AstraZeneca, have pledged not to seek approval from the US Food and Drug Administration (FDA) until after completing Phase 3 trials in strict compliance with FDA standards and requirements.
Two other Covid-19 vaccine candidates – one developed by pharma giant Pfizer and Germany’s BioNTech, the other by Moderna – are also in clinical trials in the US.