A large scale trial has kicked off today. Johnson & Johnson’s coronavirus vaccine began its Phase 3 clinical trials.  This is the fourth COVID-19 vaccine candidate to enter the final stage here in the US.

I’ve very excited about this particular clinical trial.  It’s different from the other COVID-19 vaccine trials in several ways.  First of all, Johnson & Johnson’s Phase 3 trial will be much larger.  They plan to enroll up to 60,000 participants at nearly 215 sites in the US and internationally as well.  Also, all the participants will get only one dose of the vaccine.  Whereas Pfizer and Moderna’s vaccines require two doses a few weeks apart.  Now as you can imagine, the benefits of one-shot versus two shots mean one less trip for folks, and it potentially means that more people can get fully vaccinated at a faster rate.   And lastly, Johnson & Johnson’s vaccine only needs to be refrigerated.  Whereas Pfizer and Moderna’s vaccines need to be kept frozen. And that could be more challenging when it comes to distribution.

Since Johnson & Johnson’s Phase 3 trial started later than Pfizer and Moderna, does this mean it’ll take longer for us to know if it works? 

That’s right, Johnson & Johnson phase 3 trial did start behind Pfizer and Moderna’s by a couple of months. And the earliest Johnson & Johnson’s interim results are expected is in late November.  Now, if the vaccine shows that it does works and that it’s also safe, then Johnson & Johnson could possibly be granted emergency use authorization by early 2021.

Do you have any updates regarding Pfizer and Moderna’s vaccine trials?

Pfizer has said that they’ll likely have some conclusive results from their phase 3 trials next month, sometime in October. While Moderna says it hopes to know its vaccine results sometime in November. Now, these trials only include adults.  But it’s just as important to have children safely vaccinated as well.  And the good news is that both Pfizer and Moderna are working towards pediatric trials.

Last question, is the Astra Zeneca trial still on pause here in the US?

Yes AstraZeneca’s Phase 3 vaccine trial is still on hold for Americans.  The company had recently begun its phase 3 trial here in the US.  But then two participants in The United Kingdom, both of them women, reportedly developed serious neurological illnesses.  Now, while the trials have resumed in the UK, the FDA has not allowed AstraZeneca to start back up in the US again.  They’re waiting on further evaluation before giving them the green light.