Each week, OMRF President Dr. Stephen Prescott opens “Adam’s Journal” to answer a medical question from OMRF Senior Vice President and General Counsel Adam Cohen.
We were all excited last week by the good news about Pfizer’s Covid-19 vaccine. But what does that news really mean about when we can all expect to start getting vaccinated?
Dr. Prescott Prescribes
Pfizer and BioNTech are two of the companies jointly developing a vaccine for the virus technically known as SARS-CoV-2, and they announced that preliminary data from clinical trials shows the vaccine is more than 90% effective.
In other words, in more than nine out of 10 research subjects who were vaccinated, the experimental vaccine seems to have protected them from the virus. The companies also indicated that the vaccine showed no significant side effects.
Especially with cases surging in Oklahoma and around the country, this is fantastic development. But don’t take your mask off quite yet.
Before applying for FDA approval, the companies need further results from the trials, which involve over 40,000 patients. Specifically – and this may sound odd – more trial participants must develop Covid-19, so researchers can ensure the current results (people who got placebo shots are getting sick, but those received experimental vaccines aren’t) will hold true in the general population.
Given the preliminary numbers, I expect we’ll have this data within weeks. At that point, the companies can move forward with an emergency application to the FDA.
As with Covid-19 diagnostic tests and treatments, the FDA will review vaccine applications in an expedited process. Given the vaccine’s apparently clean safety profile and that the FDA will require only 50% effectiveness, I’d look for approval before the year is out.
On this timetable, small groups of people (frontline healthcare and nursing home workers, for instance) could be vaccinated in 2020. But given the huge demand, it will probably be mid-2021 before vaccine manufacturing and distribution efforts ramp up sufficiently to allow most of us to get our shots.
This is all wonderful news, and we can anticipate additional promising reports for other experimental vaccines soon, especially Moderna’s, which uses similar technology.
In the meantime, stay vigilant. Now is precisely the time to do all the simple things – masks, physical distancing, hand hygiene – to remain safe until a vaccine arrives.