As Cortney noted this morning, Johnson & Johnson's single-dose vaccine has been found to be highly safe and effective by the FDA, likely clearing the path for its approval for use inside the United States within a matter of days. J&J's efficacy rates aren't as sky high as Pfizer and Moderna's -- which look even better than anticipated, based on a huge quantity of Israeli data -- but the trial results show another major vaccine that will do wonders to help crush the pandemic. More important than any other detail is this broad outcome:
New: FDA review of Johnson & Johnson Covid single-shot vaccine finds it safe, effective and that it *completely prevented hospitalizations and deaths* in a large clinical trial. https://t.co/VZpOWR2bH3— Michael Del Moro (@MikeDelMoro) February 24, 2021
The New York Times reports more specifics:
The one-shot coronavirus vaccine made by Johnson & Johnson provides strong protection against severe disease and death from Covid-19, and may reduce the spread of the virus by vaccinated people, according to new analyses posted online by the Food and Drug Administration on Wednesday. The vaccine had a 72 percent overall efficacy rate in the United States and 64 percent in South Africa, where a highly contagious variant emerged in the fall and is now driving most cases. The efficacy in South Africa was seven points higher than earlier data released by the company. The vaccine also showed 86 percent efficacy against severe forms of Covid-19 in the United States, and 82 percent against severe disease in South Africa. That means that a vaccinated person has a far lower risk of being hospitalized or dying from Covid-19.
This is a highly effective vaccine, even if the numbers don't quite surge to the competitors' near-perfect rates. What's critical is that the shot is extremely effective in general, even more so against severe COVID infections, and had a perfect batting average in preventing hospitalizations and deaths within the wide trial population. J&J also provides additional benefits, compared to Pfizer and Moderna. The one-and-done nature of the inoculation obviously makes administration far more efficient (no three week/second jab circle back necessary). And there's this: "Johnson & Johnson’s vaccine can be stored at normal refrigeration temperatures for at least three months, making its distribution considerably easier than the authorized vaccines made by Moderna and Pfizer-BioNTech, which require two doses and must be stored at frigid temperatures." Much easier distribution, in other words. The Times reports that final approval could arrive as soon as this weekend. But will the newly-green-lit doses be ready to roll immediately? There's some confusion over that, it seems. In late January, the Baltimore Sun reported that a local warehouse was producing and stockpiling "tens of millions of doses" of J&J's vaccine, awaiting regulators' thumbs-up and subsequent shipment:
Covered head to toe in sterile garments, workers inside a modern manufacturing plant in East Baltimore have been making coronavirus vaccine for months — tens of millions of doses that, for now, are being stockpiled with no date set for distribution. None of the vaccines at the Emergent BioSolutions factory has yet been authorized for use. But among the pharmaceutical companies contracting with Emergent is Johnson & Johnson, which reported promising trial results Friday and is expected to submit data to federal regulators within a week for emergency authorization.
But the Times report states that the actual number of doses currently prepared is just about four million, well short of initial targets in the eight-figure range. Available doses will increase substantially, of course, but it will take take, which explains why Dr. Anthony Fauci was urging patience in a recent interview. Twenty million doses by the end of next month ain't bad, especially since that equates to 20 million people; not ten million, each receiving two shots. Relatedly, given the increasingly clear data pointing to very strong immunity (in the same ballpark as J&J) conferred by just a single dose of the existing vaccines, should the smartest path to herd immunity and normalcy involve delaying follow-up or 'booster' second doses and redirecting existing supplies to crucial first shots? Many voices like this answer that question in the affirmative:
A *majority* of US vaccines are now going into people who have already been vaccinated.— Daniel Bier (@FT__Dan) February 24, 2021
Boosters appear to raise protection from ~85% to ~95%. Primary doses raise it from 0% to ~85%.
Delaying boosters would immediately *double* the number of people going from 0% to 85%. pic.twitter.com/Z0FlFUdqlm
I'll leave you with an absolutely essential point being underscored by a top Times journalist who's been covering COVID for months. Many people need to hear it, including some teachers unions, and perhaps even Dr. Fauci. The realistic goal of these vaccines is not to eliminate COVID completely. It never has been, and never will be:
Ten years ago, a deadly infectious disease killed more than 36,000 Americans. And over each of the next nine years, the same disease caused between 12,000 and 62,000 deaths.— David Leonhardt (@DLeonhardt) February 24, 2021
That disease was the flu — and it should affect how we think about the future of Covid.
Only 3.5 out of every 100,000 vaccinated Israelis were later hospitalized with Covid symptoms.— David Leonhardt (@DLeonhardt) February 24, 2021
During a typical flu season in the U.S., roughly 150 out of every 100,000 people are hospitalized with flu symptoms.https://t.co/GQh4nOG6DI
"The reasonable goal is to make Covid manageable, like the flu. Fortunately, the vaccines are doing that. In fact, they’re doing better than that. For fully vaccinated people, serious illness from Covid is extremely rare, much rarer than serious illness from the flu," Leonhardt writes. Exactly. A 100 percent obliteration of Coronavirus is not going to happen. Immunization is never perfect. The very attainable objective is to crush the pandemic and make the virus a much smaller-scale problem, akin to the flu. That's a status quo we can obviously live with, as normal, and without major disruptions. And as the above thread notes, the COVID vaccines are far superior to the annual flu vaccines doctors recommend each season. Demanding or expecting total perfection is wildly counter-productive and unscientific. These vaccines are remarkably good and are doing the job we need them to do. Faster, please.