Two major drug makers — AstraZeneca and Johnson & Johnson — have resumed trials for their experimental covid-19 vaccines in the United States on Friday after being paused for a short duration.
AstraZeneca’s vaccine candidate being developed with Oxford has resumed the trials in the US, where it was paused six weeks ago due to adverse effects in one of the participants.
“The Food and Drug Administration (FDA) today authorized the restart in the US, following the resumption of trials in other countries in recent weeks,” the drugmaker said.
The trials of the vaccine candidate were suspended worldwide on September 6, but resumed shortly in Britain followed by South Africa, Brazil and Japan.
In a recent incident, a volunteer for the vaccine died in Brazil but the company said they would not stop trials as the volunteer was not given the shot.
Meanwhile, Johnson & Johnson trials were paused on October 12 after a man who received vaccine shot suffered a stroke which triggered infection. Later, the investigators found out that the said incident was not caused by vaccine shot.
The investigation examined volunteer’s medical records and as well as database of 100,000 people who received the same vaccination. While concluding, they said a “clear cause” of the illness could not be found, however, the company assured that it was not due to the vaccine.
“Based on the information gathered to date and the input of independent experts, the Company has found no evidence that the vaccine candidate caused the event,” J&J said in a statement.
In the process of vaccine trials, if any adverse events are reported, the testing is stopped immediately. Thereafter, an independent data and safety monitoring board investigates the case and determines if the trials should be resumed or not. They also determine whether the ill effects were likely caused by the vaccine.
The United States have been one of the worst-affected country by the Covid-19 pandemic. As of now, more than 223,000 Americans have died due to the novel virus.
