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Friday, January 22, 2021

Covid-19 vaccine supply is running low. Here's how Biden hopes to fix that - STAT

WASHINGTON — The Biden administration is willing to consider almost anything to boost the nation’s dwindling supply of Covid-19 vaccines.

A new strategy document released Thursday, totaling nearly 200 pages, offers the first clear list of the options President Biden has before him, though it doesn’t specifically say he’ll actually take all of the steps. On the list are some controversial ideas, like cutting the amount of vaccine being administered to each American. He’s also made it clear he wants to utilize the Defense Production Act to ramp up production of key supplies, and some more straightforward options like buying more doses.

Governors and mayors around the country have complained in recent weeks that they do not have enough vaccines to meet current demand. Biden, too, has acknowledged that the supply of physical vaccines is not where it needs to be to vaccinate a majority of Americans. Already, the Trump administration stopped holding vials in reserve, in hopes of releasing more vaccines to the public.

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The easiest idea, of purchasing more vaccines, may not be particularly helpful in the short term. The U.S. has already purchased 200 million doses of Pfizer’s vaccine as well as 200 million from Moderna, but the full orders won’t be delivered until the middle of the year. The country has the option to buy hundreds of millions more, but they wouldn’t be delivered until after that.

The Biden administration will also “explore” so-called dose-sparing strategies to stretch vaccine supply, the report reveals. When the Trump administration considered one dose sparing strategy, of administering a smaller volume of vaccine to each patient, the Food and Drug Administration balked.

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It said the idea “is premature and not rooted solidly in the available evidence.”

“Without appropriate data supporting such changes in vaccine administration, we run a significant risk of placing public health at risk, undermining the historic vaccination efforts to protect the population from COVID-19,” then-FDA Commissioner Stephen Hahn and the agency’s top vaccine regulator Peter Marks said in a statement.

The Biden administration acknowledged that, saying it will look at dose-sparing “while maintaining a commitment to abiding by FDA recommendations.”

The Biden administration also plans to negotiate with existing suppliers of vaccines to reduce minimum shipment sizes. The current minimum order for the Pfizer vaccine is 975 doses, which some rural hospitals have complained would be difficult to use up before the vaccine must be thrown out. Moderna does not have this problem: Its minimum shipment is 100 doses.

Biden’s new plan stops short of promising to use the Defense Production Act to order companies to make more physical vaccines, although Biden’s Covid-19 coordinator Jeff Zients recently told the Washington Post that that option is on the table.

Instead, the plan foreshadows two uses of the Defense Production Act that the Biden administration believes will increase the availability of vaccines.

The first is using the law to produce so-called low dead space needles, which are needed to extract a sixth dose of Pfizer’s vaccine from the vial. The second is to increase the supply of the lipid nanoparticles needed to make all mRNA vaccines — the category that both Pfizer and Moderna’s products fall into.

The Biden administration is also pledging to closely supervise the vaccine manufacturing process. Federal officials will be on site at so-called contract manufacturing organizations that make vaccine components like syringes and vials “to monitor and support operations.”

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