U.K.-based drugmaker AstraZeneca has long been leading the race in developing a vaccine to fight off Covid-19. The company partnered with the University of Oxford in the beginning of the pandemic to begin preliminary research on ways to treat and destroy the virus. However, within the last four weeks the team has fallen behind on their trial operations.
AstraZeneca made the announcement in September that they would be temporarily pausing its late-stage clinical studies for the Covid-19 vaccine in the US, Europe and Canada due to participants getting infected with the virus itself. Now, the company has since resumed its trials in multiple countries and is already being reviewed for potential regulatory approvals in Canada and Europe.
However, trial operations within the US have slowed tremendously, leaving the nation way behind in its development. Initially, the trial’s were paused after a participant in the U.K. developed an unexplained illness after receiving the experimental vaccine. This pause in trial is rather routine, as most vaccine and drug trials need to do a full investigation when unexplained results appear; like the illness the participant in the U.K. experiences.
AstraZeneca was obviously transparent in the beginning of this trial that unexpected illnesses and other side effects were to be expected in any sort of medical trial, and luckily the incident with the participant in the U.K. ended up being as routine as any other side effect to appear during a trial; hence the restarting of trials in Europe and Canada.
Regulators in Brazil, India, South Africa, and Japan have reviewed the findings from AstraZeneca’s trial, and have allowed late-stages clinical trials to resume. This is also occurring in Canada and Europe, however, the U.S. Food and Drug Administration (FDA) still hasn’t allowed the company to resume their clinical trial.
AstraZeneca recently claimed that they were working closely with the FDA to provide all the information needed in order for the administration to resume the trial. The FDA has since widened their investigation and are now looking at data from clinical trials regarding similar vaccines developed by the same scientists working on the Covid-19 treatment.
This process is to determine if similar side effects that occured to the patient in the U.K occured in other vaccine trials developed by the same individuals; it is still unknown how long this data analysis will actually take. However, the agency is under immense pressure from the government to resume the trial process as the election gets closer and closer.
Back in May the U.S. government agreed to pay over $1.2 billion for AstraZeneca to supply 300 million doses of their Covid-19 vaccine to the nation. The company won’t be able to send those doses, however, until the FDA gives emergency use authorization, which won’t happen until the trials are able to fully resume.
For now, residents of the U.S. will have to wait to see how long it takes for the FDA to complete their investigation and restart the trial process to get a vaccine on the streets as soon as possible.
Eric Mastrota is a Contributing Editor at The National Digest based in New York. A graduate of SUNY New Paltz, he reports on world news, culture, and lifestyle. You can reach him at email@example.com.