With FDA Authorization, Some Limited Deliveries Could Start Monday or Tuesday
A few weeks ago Johnson & Johnson applied for emergency use authorization of their candidate vaccine. The FDA’s review committee is meeting Friday morning. The FDA just posted all the data on their website. There are several documents in the meeting packet but the one that I like to look at is the FDA’s briefing document to the committee.
I didn’t see any surprises in todays reports. The results from the Phase III clinical trial look good (about 43,000 participants in the trial). Here’s the bottom-line effectiveness (from the summary report):
“… vaccine efficacy against central laboratory confirmed and blind-adjudicated severe/critical COVID-19 occurring at least 14 days and at least 28 days after vaccination of 76.7% and 85.4% respectively.”
In other words, this single dose vaccine is 77% effective at preventing severe COVID disease 14-days after the jab and 85% effective after 28 days.
There were 2 hospitalizations from COVID in the vaccine group (both before 28 days post vaccination) compared with 29 cases in the placebo (saltwater injection) group. None of the persons that were given the vaccine died while 7 people died of COVID in the placebo group.
The vaccine worked equally among subgroups in the trial (age, comorbidity, race, ethnicity) but effectiveness among folks 60 years of age and older with comorbidities was a little lower early on in the study (i.e., counting cases from 14 days rather than 28 days and including cases not yet centrally confirmed).
Side effects within 7 days of injection were the statistically the same among the vaccine and placebo (saltwater) groups. In other words, side effects were no different whether the person got the vaccine or the saltwater injection. Those side effects included injection site pain (48.6%), headache (38.9%), fatigue (38.2%), and myalgia (33.2%).
The independent review committee concluded that:
“… the analysis supported a favorable safety profile with no specific safety concerns identified that would preclude issuance of an EUA”.
The bottom line is that this vaccine is very likely to be authorized for use in the U.S. as early as Monday. Shipments to states will likely start on March 2. I’ve had a really hard time pinning down exactly how much vaccine is actually available and ready for distribution in the U.S. The best info I could find is from a media report in the Washington Post quoting 2 anonymous FDA officials that said there are about 2 million doses available right now and that the supply of this vaccine will be 20 million by the end of March.
If true, that’s pretty disappointing because 2 million doses nationally translates into only 40,000 doses for Arizona right now. If they can really ramp up to 20 million doses by the end March that will be better. That would translate into 400,000 doses but is the equivalent to 800,000 doses of the Pfizer or Moderna vaccines because J&J doesn’t require the booster shot.
The Friday, Feb. 26 at 7 a.m. AZ time FDA Center for Biologics Evaluation and Research’s Vaccines and Related Biological Products Advisory Committee meeting will be online.
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The agenda can be found here.
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FDA’s Briefing Document – Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19 – can be found here.
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Janssen Biotech Inc. Briefing Document Addendum can be found here.
The online web conference meeting will be available at the following:
Note: Globally and in the U.S. this is a very important vaccine. It is simple, inexpensive, doesn’t require complicated storage and handling, and (perhaps most importantly) is a single dose vaccine. This vaccine belongs in doctor’s offices, pharmacies, and community health centers. Using it at mass vaccination sites would be a big mistake because one of this vaccine’s strengths is its flexibility. This vaccine’s flexibility means that we can bring the vaccine to the people rather than bringing the people to the vaccine… which can help us overcome the large disparities that exist in Arizona: ADHS Vaccine Appointment System Favors the Wealthy & Creates Health Disparities
In the U.S., it will be a terrific addition to our current vaccines because it’s perfect for doctor’s offices and pharmacies. Because it’s single dose, it will be a lot less labor intensive. In developing nations, it would be a game changes for the same reasons and because it is inexpensive to make.
