Medically Necessary: Delaying Second Doses Would Reshape The Vaccine Supply Chain

This is an excerpt from the February 25, 2021 edition of Medically Necessary, a health care supply chain newsletter. Subscribe here.

Good afternoon. Medically Necessary is a newsletter by Matt Blois about the health care supply chain — how we get drugs, devices and medical supplies to health care providers and patients.

Delaying second doses would reshape the vaccine supply chain

The debate: Some scientists argue the U.S. should delay second doses of COVID-19 vaccines and instead give them to people who haven't received a shot yet, hopefully providing some protection to a greater number of people.

• Preliminary data from the U.K. and Israel suggest a single dose of Pfizer's (NYSE: PFE) vaccine provides good, but not perfect, protection from COVID-19. This strategy hasn't been tested in randomized, controlled trials, so there's lots of uncertainty.

A big assumption: Often, scientists who call for delaying second shots assume the supply chain will successfully deliver all of those additional doses, but that's not totally clear.

• Currently, 11 states and Washington, D.C., have yet to administer 10% to 20% of the first doses they've received from the Centers for Disease Control and Prevention, suggesting vaccine supply may not be the only problem. Most states have delivered more than 90% of first doses.

• American territories are further behind. The Virgin Islands have delivered fewer than 70% of first doses. American Samoa and Guam have delivered fewer than 80%.

The backstory: The federal government initially planned to hold back a reserve of COVID-19 vaccines to ensure second doses would be available on time. By January, the federal government had started releasing second doses to boost vaccine supply. (This change happened before the policy was announced, confusing many state officials.)

Though the federal government stopped reserving doses, it has always aimed to deliver the second dose of the vaccine on time — three or four weeks after the first shot.

• The CDC recommends administering the second dose on schedule if at all possible, but in January started allowing for an interval of six weeks in exceptional circumstances.

U.K. officials decided in December to delay the second dose of the AstraZeneca (NASDAQ: AZN) and Pfizer vaccines to stretch supply.

It's not just supply: The limited supply of COVID-19 vaccines is a major issue slowing the rollout, but there are other bottlenecks in the supply chain as well.

• Convoluted information technology systems have caused major headaches and slowed distribution in many states.

• Early on, a shortage of health care workers to administer the vaccine contributed to delays, according to a report from Reuters. Pharmacies are also scrambling to hire enough staff, according to The New York Times.

Mark Sawicki, CEO of the cold chain logistics company Cryoport Systems, said delaying second doses would certainly increase the number of people who get at least one dose, but wouldn't automatically make the supply chain more efficient.

• "You still have the same number of doctors and pharmacists who are giving the vaccines on a global basis," Sawicki told FreightWaves in early February. "You can't arbitrarily manufacture twice as many people to give the doses."

As the vaccine rollout continues, the U.S. has taken steps to address some of those issues. The federal government has deployed thousands of people to help states administer vaccines.

Supply matters a whole lot, though. Tinglong Dai, a health care operations researcher at Johns Hopkins University, said increasing the number of available doses would reshape the supply chain.

• "You almost need to have enough doses to be able to mobilize a lot of people to give doses," he told FreightWaves. "The more supply you have, the more demand you can create because you can get more people to provide the services."

Right now, there aren't enough doses to send vaccines to every pharmacy in America, so those potential distribution points go unused. Increasing supply would allow for more vaccination sites, increasing the country's capacity to deliver vaccines.

Will it happen? So far, U.S. officials haven't shown much enthusiasm for delaying second doses.

The Biden administration's COVID-19 strategy says the White House is exploring "dose-sparing strategies that have the potential to substantially expand vaccine supply," but White House officials have also said there's not enough data to support delaying second doses.

• "What we have right now, and what we must go with, is the scientific data that we've accumulated," White House COVID-19 adviser Anthony Fauci told NBC's "Meet the Press" in February.

Earlier this week, National Institutes of Health Director Francis Collins wrote a blog post expressing some optimism about giving a single shot to people who have already recovered from COVID-19, based on early data showing that they have an especially strong immune response.

• "Such a policy is already under consideration in France and, if implemented, would help to extend vaccine supply and get more people vaccinated sooner. But any serious consideration of this option will require more data," Collins wrote.

Change is coming: Right now, most vaccine clinics know how many doses they will receive over the next three weeks, according to Prashant Yadav, a supply chain researcher at Harvard Medical School.

• "It's just about at that level where second doses can be reserved ... [with] incoming supply," Yadav wrote in an email.

But there's very little room for error. That type of planning becomes much easier when the supply is predictable. With an emergency use approval for Johnson & Johnson's (NYSE: JNJ) COVID-19 vaccine on the horizon (keep reading) and indications that Moderna (NASDAQ: MRNA) and Pfizer are accelerating production (keep reading), vaccine administrators may soon have that predictability.

Johnson & Johnson close to emergency approval

A Johnson & Johnson scientist in Leiden, The Netherlands. (Credit: Johnson & Johnson)

A new COVID-19 vaccine from Johnson & Johnson is close to receiving emergency approval from the U.S. Food and Drug Administration.

• An FDA analysis released this week found that the company's vaccine is safe and effective. An FDA community will meet on Friday to determine whether the data warrant an emergency approval.

Logistically easier: The Johnson & Johnson vaccine will be much easier to distribute. The vaccine is administered in a single dose, compared to two shots for both vaccines currently approved in the U.S.

The Johnson & Johnson vaccine also has less rigorous temperature requirements for transportation and storage. It has a shelf life of three months when stored at normal refrigeration temperatures, about 36 to 45 degrees Fahrenheit.

• Moderna's vaccine must be shipped at minus 4 Fahrenheit, and Pfizer's must be shipped and stored at minus 94 Fahrenheit.

Ready to go: During a press briefing on Wednesday, White House COVID Coordinator Jeff Zients said he had recently updated governors on plans to distribute the vaccine.

He said the U.S. would use the same allocation process for the Johnson & Johnson vaccine that it's using for the current vaccines.

• "We will waste no time getting this lifesaving vaccine into the arms of Americans," Zients said.

Analysts predict a big boost in vaccine supply

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