Tuesday, March 21, 2023

Will the U.S. Have COVID Vaccine Doses for Everyone by the End of May? Probably

President Biden confidently declared last week that there would be enough Covid-19 vaccine delivered to the U.S. government by the end of May to vaccinate every American.

But predictions about vaccine availability have repeatedly been proven wrong. How confident should Americans be this time? The short answer: somewhat.

There is no doubt that the U.S. is moving from a time of vaccine scarcity, when there is not enough vaccine to go around, to one of vaccine surplus, when it will be far easier for people who want a Covid vaccine to receive one. By early summer, barring a manufacturing catastrophe, there should be enough vaccine for every American.

But the math behind Biden’s pledge that the U.S. will have enough supply to vaccinate roughly 260 million by the end of May depends a great deal on new, more aggressive timelines from Johnson & Johnson. A closer look at administration and industry statements also suggests officials know this. Even if J&J misses the goals stated by it and the administration, it is likely the supply would hit this 260 million figure.

The March 2 announcement was based not only on current expectations of supplies from vaccine manufacturers Moderna and the partnership of Pfizer and BioNTech but on expectations that the U.S. will have 100 million doses of the newly authorized vaccine from Johnson & Johnson by the end of May.

J&J is able to deliver more sooner in part because of an agreement under which Merck will help manufacture its vaccine, but also due to other steps taken by the company and the administration.

In its press release announcing the new timeline, the Department of Health and Human Services said its plan will allow the administration to accelerate the delivery of J&J’s vaccine doses “from 100 million doses by the end of June to at or near 100 million doses by the end of May.”

There is, of course, a difference between “at” and “near.” And in its own statements, J&J seems to hedge its commitment as well.

When asked about the May time frame last week at a Washington Post virtual event, J&J CEO Alex Gorsky responded, “That’s our goal.” Then, he added: “Our engineers and our scientists are working hand in hand with the Merck supply chain as we speak to make this possible.”

Explaining the reason for his optimism, however, Gorsky spoke of “if” not “when.”

“The reason for optimism is that if we can achieve this distribution of several hundred million additional doses during this time frame, we are going to be at a point where there will be enough doses available for every American that can realistically be vaccinated.”

In a statement, J&J reiterated: “In partnership with the U.S. Government, we are aiming to deliver nearly 100 million doses by the end of May.” But to have just enough for every adult, J&J would need to deliver only 6o million of those 100 million doses.

A Biden administration official told STAT that J&J did tell the administration the timeline is reasonable, in part because of other steps the administration took. The administration is using the Defense Production Act to help the company obtain needed materials, such as single-use bags for the vaccine. It has helped locate teams of experts who can be on call at factories to quickly troubleshoot any manufacturing problems. Biden said that he also pushed J&J to move to a 24/7 production schedule.

All of those steps should move up the timeline, whether or not the 100 million doses arrive by May 31 or some come straggling in in June.

What the Biden administration isn’t doing, the official said, is counting potential doses that could come from vaccines that still haven’t been authorized. Results of a U.S. trial of AstraZeneca’s vaccine, which has been cleared in other nations based on studies conducted in the United Kingdom, South Africa, and Brazil, are expected any day. Novavax, a small Maryland biotech firm, has shown positive results for its vaccine from studies conducted in the U.K. and South Africa. It says it has been discussing whether the Food and Drug Administration would consider reviewing those results, which could lead to the vaccine being authorized in May. It is also conducting its own U.S. study. If either vaccine were cleared, it would increase supply further and faster. Even if neither happens, Pfizer/BioNTech and Moderna are due to together deliver enough for another 100 million people by the end of July.

That could mean a major turnaround in the way that both U.S. officials and the general populace think about vaccines. In the coming months, we’re likely to go from having to determine who gets a limited supply of shots to distributing vaccines to every American and convincing the millions of people who are hesitant to be vaccinated to roll up their sleeves.

Once again, the hardest part is likely ahead.