The S&P/ASX 200 Index (ASX: XJO) is expected to drop lower this morning, with SPI futures currently pointing to a 0.3% decline at the open.
This decline appears to have been driven by concerns over the AstraZeneca-Oxford University COVID-19 vaccine candidate, AZD1222.
What has happened?
Last week AstraZeneca revealed that its phase three trial data showed that its vaccine candidate was highly effective against COVID-19 with certain dosages.
The data showed that when trial participants were given a half dose, followed by a full dose at least one month apart, the vaccine was 90% effective. Whereas, when given as two full doses at least one month apart, the vaccine showed just 62% efficacy.
Overnight, the pharmaceutical giant revealed that the more effective dosage was actually administered by accident and due to a manufacturing error.
According to CNBC, the head of the U.S. Operation Warp Speed program also revealed that the smaller dose was given to the lowest risk group, which totalled 2,741 people below the age of 55. The group whose results displayed 62% effectiveness, were older and numbered 8,895.
However, the pharmaceutical giant has hit back at criticism, noting that the trial was monitored by the external Data Safety Monitoring Board (DSMB). It also advised that the data constituted interim results and that more data would follow.
It told CNBC: "The studies were conducted to the highest standards. An independent DSMB safety monitoring committee oversees the studies to ensure safety and quality. The DSMB determined that the analysis met its primary endpoint showing protection from COVID-19 occurring 14 days or more after receiving two doses of the vaccine."
"More data will continue to accumulate and additional analysis will be conducted refining the efficacy reading and establishing the duration of protection," the spokesperson said.
What now?
There are concerns that the FDA will not look kindly on this data and could request another trial to prove its efficacy. This could mean that a launch is pushed back to a later than originally expected date.
U.S.-based health care and biotech investment bank SVB Leerink isn't confident the FDA will believe this data is sufficient.
Its analysts said: "We believe that this product will never be licensed in the U.S. This belief is based on the design of the company's pivotal trials which does not appear to match the FDA's requirements for representation of minorities, severe cases, previously infected individuals and elderly and other increase risk populations."
Overnight, AstraZeneca's CEO, Pascal Soriot, admitted that it was likely to run an additional global trial to evaluate the efficacy of the COVID-19 vaccine.
Elsewhere, the CSL Limited (ASX: CSL) share price will be on watch today because of this news. It is currently manufacturing this vaccine in Melbourne.
