This morning pharmaceutical and medicine giant AstraZeneca ($AZN) announced an immediate interruption of the COVID-19 vaccine test during the Phase 3 study, after a participant in from the UK showed severe neurological symptoms of an unexplained disease. As a result, the company has discontinued the standard process in order to review the safety data first. In a later update, the company announced that the participant has already been released from the hospital. Despite this update, the competition saw green numbers in the early premarket.
There is a lot of speculation on social media about the course of events. While some sources suggest that this is an abundance of caution, other sources point out that this event is affecting other AZN vaccine trials, as well as trials being conducted by other manufacturers. It’s still unclear how long AstraZeneca will be out of the running with the Phase 3 study and which other pharmaceutical companies should be more alert. Currently, nine vaccine candidates are in Phase 3 studies.
Is AstraZeneca doing something wrong?
It’s not uncommon for a pause to be initiated when complications arise. The company speaks of a routine action so that the integrity of the investigations is preserved. By acting quickly, AstraZeneca strives to minimize the potential impact on the trial timeline. Researchers conducting other vaccine trials are looking for similar cases of side effects by studying databases reviewed by the Data and Safety Monitoring Board.
Earlier in July it was found that 60% of the participants in the Phase 1/2 study had side effects of mild to moderate nature. This may include symptoms such as: fevers, headaches and reactions to the injections. With time, the side effects disappeared in further vaccine studies. Because in this new situation there was talk of serious symptoms, the recruitment of new candidates and dosing of existing participants has been discontinued. How long this pause takes will be announced later.
Caution is always advised
The “big nine” of today – including AstraZeneca, had signed a pledge on Tuesday promising not to seek early government approval for a COVID-19 vaccine. The pledge also stated that pharmaceutical companies will wait until sufficient data is collected showing that a possible vaccine will not damage public health. Regulators and companies are committed to give our society confidence in the vaccine licensing process. The Food and Drug Administration (FDA) must give emergency use or full approval to any vaccine before it can be distributed. It’s important to emphasize this since discussions have increased about the early authorizations, test reports and the pressure from the White House to publish an effective vaccine. In response, distrust around the vaccine race hasn’t been uncommon.
A storm in a teacup
For now, the development from the pharmaceutical giant is not alarming. The participant is doing well on basis of the latest press releases. Also the process of pausing the trial is not unusual. Complications arise often in a search for a new vaccine. Experts suspect that the incident will have no further consequences in the short and long term. It is a wake-up call though for the competition since various Phase 3 studies have started. They will closely monitor their own trial and vaccine candidate to avoid a similar situation, including AstraZeneca’s follow-up trial itself. The White House considers AstraZeneca’s response to be a sign of big responsibility and shows our society that no risks are taken to the detriment of patients.
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