Vaccine 'Anyone Can Get it Day' moves from April to June. We should talk about that

Johnson and Johnson jab supplies at launch are disappointing

Click to see Anthony Fauci explain why general vaccine availability has been pushed to June.

When is “Anyone Can Get It” day in the U.S Covid-19 vaccine rollout? Well, it recently moved from April to late May or June. And I’m confused why more people aren’t talking about this.

Anthony Fauci made this disappointing revelation earlier this week, blaming the smaller-than-expected initial availability of doses from the Johnson & Johnson vaccine — which is slated for approval later this month. Fauci told CNN that he had been hopeful J&J’s addition to the vaccine club would mean widespread availability by April. But since J&J will come out the gate with only a few million doses, Anyone Can Get It Day is now two months later.

Whatever happened to “Manufacturing at Risk?” That was Operation Warp Speed’s plan to encourage mass production of vaccines by drugmakers simultaneous with drug trials, so they’d be ready for widespread distribution the day they proved effective. The “risk” suggested there’d be millions of doses that might have to be discarded because at least some of the drugs would fail at trial.

Instead, the risk, it seems, is ours.

Regular readers of this column were not surprised by this news. Just by reading company press releases and promises, I predicted this two weeks ago: “The simple problem we have right now is there is not enough vaccine, and there won’t be until sometime in the second quarter of this year — likely towards the end of the second quarter.”

Here’s that math again: There are roughly 130 million people over 65 and essential workers in the U.S., and companies have only promised 100 million-people worth of vaccines by the end of April. Another 200-million-people worth of doses are promised by June, when the backlog should be eased. But until then, we should expect wait times, long lines, line-cutters, and other frustrations.

For weeks, pandemic optimists have chided me for being too pessimistic, and boy did I hope they were right. The wild card in my sobering assessment was the J&J jab, which is supposedly easier to make (it takes half the time of the Moderna vaccine, 110 days to 60 -70 days) and is definitely easier to distribute. J&J’s contract calls for 100 million doses by the end of June, but many hoped the drug giant would come out the gate with an upside surprise, ready to vaccinate tens of millions much earlier than that.

Well, that hope seems crushed. Various reports suggest fewer than 10 million J&J shots — and as few as 2 million — will be ready when the drug is expected to get approval at the end of this month. It seems there will be no pleasant March or April surprise.

Dr. Fauci sounded disappointed talking about this on CNN.

“(April) was predicated on J&J having considerably more doses than now we know they are going to have so that timeline will be prolonged into mid to late May and early June,” Fauci said.

This strikes as a big deal. Unvaccinated Americans without priority access who were hoping for a shot in April are now being asked to sit on the sidelines for two more months. Hey, it’s still a miracle that a vaccine was developed this quickly. But that shouldn’t prevent us from asking what happened to manufacturing at risk, and from noting that V-E Day (Vaccines for Everyone Day) has changed significantly.

Why?

The Government Accountability Office issued a report last week citing a variety of reasons for slower-than-hoped-for production. You should read it. It suggests workforce gaps and limited manufacturing capacity are to blame. Here’s another good nugget:

Representatives from one facility manufacturing COVID-19 vaccines stated that they experienced challenges obtaining materials, including reagents and certain chemicals. They also said that due to global demand, they waited 4 to 12 weeks for items that before the pandemic were typically available for shipment within one week.

When there’s a hurricane that destroys a bunch of homes, the price of lumber goes up. That’s to be expected.

But there are more questions to be asked around manufacturing at risk. Last year is full of massive deals to line up production, like this July announcement of a $480 million pact between Johnson & Johnson and Emergent BioSolutions to ramp up production in Baltimore. And this deal with Indiana-based Catalent, which promised 24/7 operations by January. Emergent is a special case. It’s one of a handful of “Centers for Innovation in Advanced Development and Manufacturing (CIADMs)” around the country, and has received hundreds of millions in government dollars to be prepared for just such a pandemic.

Back to the timeline. In October, J&J announced really positive results from Phase 1 and Phase 2 trials. Certainly, it would have been risky to begin making millions of doses of the vaccine then, which would have been ready around now. But wasn’t that the point of Operation Warp Speed?

When photographers used to take pictures with film, art teachers would tell them if some of their frames didn’t look bad, they weren’t pushing themselves. I’d say the same applies here. If we don’t have millions of doses that won’t go into arms because they were based on a vaccine trial that failed, it strikes me that we weren’t trying hard enough last year. It seems clear that drugmakers didn’t risk much — after all, Operation Warp Speed spread $13 billion among them last year for just this kind of moment. I would have thought they’d be ready with more doses by now. Or at least, by April. So, why are there only a few million J&J doses ready to go? Why will the general public have to wait until June?

Fauci is very careful with his words. His disappointment this week, and ours, deserves more careful scrutiny.