As first reported by Reuters, the FDA is making a wider review of the severe, adverse event suffered by a participant in AstraZeneca’s/Oxford University coronavirus vaccine trial.
AstraZeneca’s large, late-stage U.S. trial has remained on hold since Sept. 6, after a study participant in Britain fell ill with what was believed to be a rare spinal inflammatory disorder called transverse myelitis.
As I previously blogged, the company immediately restarted the trial in the UK and South Africa. That was surprising because of the severity of the adverse event.
In contrast, the FDA did not allow them to restart their studies in the US. The FDA now wants to see trial data for similar vaccines developed by Oxford University for Malaria and other diseases that use their Chimpanzee Adenovirus platform, according to Reuters.
Unlike in the US, AstraZeneca has already resumed testing in the UK, Brazil, India, and South Africa. European pharmaceutical regulators may accelerate their review of the vaccine as early as this week, according to a Bloomberg report.
The widened scope of the FDA probe raises the likelihood of a delay for one of the most advanced COVID-19 vaccine candidates in development. The requested data was expected to arrive this week, after which the FDA would need time to analyze it.
While other vaccine developers have used human adenoviruses as a basis for their COVID-19 vaccine, the AstraZeneca Oxford researchers chose an adenovirus from chimpanzees. They felt this would reduce the likelihood that a human immune system would neutralize the vaccine due to prior exposure to adenovirus. This would prevent a response to the COVID-19 parts of the vaccine.
Reuters reviewed six research papers that detailed safety data of vaccines using the engineered chimpanzee adenovirus (called ChAdOx1) for diseases including ebola, prostate cancer, and influenza. In one of those trials, one serious adverse event cited by researchers was deemed unrelated to the vaccine.
Novavax is a company that has been in existence for over 20 years without a successful product or vaccine. Now that they have entered a Phase III Covid-19 vaccine trial, the last step before approval, its execs are once again cashing out on the soaring stock.
CEO Stanley Erck (left) just sold $4.6 million worth of Novavax stock, while R&D chief Gregory Glenn (right) sold most of his stock (!) for $4.7 million. Both acquired shares at $5.95 while selling them at over $100.
The Maryland-based biotech has one of seven vaccines selected for Operation Warp Speed and received a $1.6 billion contract. Before that, its shares were trading below $10. Currently, they are trading at over $100.
I guess from the actions of their leadership Novavax’s price isn’t going higher….
Finally, Moderna, with one of the most advanced COVID-19 vaccines in development, just immunized the 15,000th subject in their trial. This is the half way point given an expected 30,000 people will be enrolled. That means it will be a couple of months before they can look to see if it protected individuals from COVID. It is likely that they will wait until late November to approach the FDA with results, if positive.