A pharmacist prepares a COVID-19 vaccine in Arizona. (Photo: Department of Health and Human Services)

This is an excerpt from Medically Necessary, a health care supply chain newsletterSubscribe here.

The news: A panel advising the Food and Drug Administration recommended approving COVID-19 booster shots only for people over age 65 and people who have a high risk of developing severe COVID-19.

FDA regulators will now need to make an official decision on boosters. After that, a separate vaccine panel will vote on whether the Centers for Disease Control and Prevention should recommend the approved vaccine. 

The recommendation, delivered on Friday, was based purely on scientific considerations. Logistical challenges associated with distributing boosters weren’t a factor in the committee’s decision, according to Peter Marks, director for FDA’s Center for Biologics Evaluation and Research.

“I would ask that we do our best to focus our deliberations on the science related to the application under consideration today, and not on operational issues related to a booster campaign or on issues related to global vaccine equity,” Marks warned at the beginning of the meeting.

Of course, the recent recommendation raises all sorts of logistical questions. Details are sparse, but companies in the health care supply chain are preparing for a booster campaign. On Tuesday, Johnson & Johnson issued a press release arguing that a booster shot was warranted for its vaccine as well, but that plan hasn’t been evaluated by regulators.

In addition to boosters, the federal government hopes to implement a rule requiring large employees to vaccinate or test workers, and Pfizer and BioNTech recently released data supporting the efficacy of their vaccine for children. 

All of these developments could increase demand for the vaccine. However, Soumi Saha, who oversees supply chain issues related to government policy for the group purchasing organization Premier, believes the vaccine supply chain is up to the task.

“We’re at a point now where supply outpaces demand for the vaccine. Most entities are sitting on an abundance of vaccine,” she told FreightWaves. “When it comes to boosters … we feel fairly confident that the supply can support the boosters.”

Open questions: In August, the White House preempted the FDA and CDC and announced that the federal government hoped to start administering boosters in September. 

At that time, White House COVID-19 coordinator Jeff Zients indicated that boosters would be doled out at locations already administering vaccines, rather than the mass vaccination sites seen at the beginning of the vaccine rollout. 

The White House’s recent COVID-19 plan specifically mentions pharmacies, doctors’ offices and health centers as locations that will administer boosters. However, Zients also said during an August press briefing the Federal Emergency Management Agency would be available to help.

“We’re going to be working very closely … with governors and local and state officials to make sure that we have the number for people to get vaccinated in a convenient way, enough vaccinators in the field,” Zients said during the briefing. 

However, the recommendation from the FDA’s advisory panel last week is much more limited than the original White House announcement, and it’s not totally clear how that will affect vaccine allocation. A spokesperson for the Department of Health and Human Services didn’t answer questions about boosters.

In addition, the FDA advisory committee didn’t clearly define who is at high risk for severe COVID-19 disease. A broad definition would mean far more people are eligible. 

The good news is that the U.S. is much more prepared to distribute vaccines now than in late 2020.

“We’ve got tons of vaccines. I don’t think that’s going to be a problem,” North Carolina State University supply chain researcher Rob Handfield told FreightWaves.

There are already about 80,000 locations distributing vaccines across the U.S. Zients said 90% of Americans live within 5 miles of a vaccine administration site.

The FDA has also relaxed temperature requirements for storage and transportation of the vaccine and extended expiration dates. Thawed vials of the Pfizer-BioNTech vaccine can now be stored in a regular refrigerator for up to a month.

The challenge could be finding enough people to staff those vaccine sites if demand spikes quickly, according to Saha.

“We have a workforce shortage in health care,” she said. “Hospitals are always willing to do what it takes, but they are struggling.”

While the White House has offered resources from FEMA to administer vaccines, Saha pointed out that the agency is in the midst of hurricane season and could be stretched thin.

In addition, many states relaxed licensing rules to allow retired medical professionals or students to assist with COVID-19 vaccination or treatment efforts. In some cases, those rules have expired, meaning those workers may not be available for a booster campaign.

So far, 22 states have ended their states of emergency, according to the COVID-19 U.S. State Policies database. Two states have since reinstated a state of emergency.  

Double whammy: The recommendation about boosters comes on the heels of several other announcements that could have a big impact on vaccine delivery. 

The Department of Labor still hasn’t released specific language detailing the proposed rule requiring large employers to test or vaccinate workers, but it will likely increase demand.

The Department of Defense instituted a vaccine mandate for all service members on Aug. 24. The number of service members with at least one shot increased by nearly 200,000 in the first three weeks after the mandate.

About 1.3 million people in France made appointments for vaccinations after the country announced the shot would be required for shopping, eating out and other activities, according to a report from The Associated Press.

On Monday, Pfizer and BioNTech released data that supports the safety and efficacy of their vaccine for children 5 to 11 years of age. The companies plan to share the data with the FDA soon and could have data for younger children by the end of the year.

Almost 25 million children from the ages of 0 through 11 haven’t had a chance to get a vaccine, according to Census Bureau data.

Saha said the number of people who get a booster shot will likely depend on how much additional protection a third dose provides. More protection provides more incentive to go get the shot.
Pfizer says its third dose restores protection to levels seen earlier this year, before more contagious variants eroded vaccine effectiveness somewhat.

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