AstraZeneca plc (NASDAQ:AZN) and Johnson & Johnson (NYSE:JNJ) announced on Friday announced that they received the regulatory green light from the Food and Drug Administration (FDA) to resume their COVID-19 trials.
The two companies decided to put their clinical trials for the pipeline vaccine after reports of a severe reaction in which a patient participating in a clinical trial in the UK suffered transverse myelitis. AstraZeneca put its COVID19 vaccine trial on hold on September 9, while J&J paused their clinical trial on October 12.
It only took AstraZeneca three days to resume the clinical trial in the UK after the Medicines Health Regulatory Authority determined that the patient's adverse reaction was not tied to the developmental vaccine. Meanwhile, in the U.S, the FDA took a while longer to conduct a review before giving its approval on October 23. The FDA allowed AstraZeneca to continue its clinical trial on October 23. J&J is also resuming its developmental COVID-19 vaccine's clinical trial about two weeks after putting it on pause due to safety concerns.
Researchers have so far not established any link between the vaccine and the adverse reaction
The investigations into the case where the UK patient experienced a severe reaction have not been linked to the vaccine. In other words, the adverse reaction was not caused by the COVID19 vaccine; thus the safety profile remains favorable and in support of the clinical trials.
"With the information which we gathered to date and the information from external experts, the company found no evidence the vaccine candidate caused it,” stated Paul Stoffels, the Chief Scientific Officer at J&J.
Pascal Soriot, the CEO of AstraZeneca, added to the positive sentiment by pointing out that resuming the clinical trial in different world markets is great news. It allows the company to continue working towards developing a vaccine that can help subdue the coronavirus pandemic.