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Vaccine trials are in the final stage of testing before they can be approved. Kirsty O’Connor – PA Images / Getty Images
  • Even after a vaccine is approved, there could be delays in getting the vaccine to Americans.
  • Health officials will need enough supplies that could end up in short supply, like vials, syringes, and PPE.
  • Additionally, they may need specialized cold storage units and safe locations where the vaccine can be administered to hundreds of millions of Americans.

In less than a year, pharmaceutical companies have already reached the final stages of testing COVID-19 vaccines before they can request approval from the Food and Drug Administration (FDA) to release them to the public.

Experts, including Dr. Anthony Fauci, the director of the National Institute of Allergies and Infectious Diseases, say it’s possible that a COVID-19 vaccine may be approved as soon as by the end of this year, and that it could be made available to most Americans by the middle of next year.

But that timeline assumes everything involved with bringing a vaccine to market goes to plan.

After researchers test and vet a vaccine — a process that will likely contain its own obstacles, as we’ve just seen with Johnson & Johnson’s vaccine — hundreds of millions of doses will need to be shipped, distributed, stored, administered, and tracked.

Bringing a vaccine to market isn’t as simple as making a vaccine, putting it on a truck, taking it to a healthcare provider, and giving it to people, said Dr. Samantha Penta, an assistant professor in the College of Emergency Preparedness, Homeland Security and Cybersecurity at the University at Albany.

On top of the vaccine itself, we need tools to administer the vaccine (think: vials and syringes); large cooling units to store the vaccine; additional supplies of personal protective equipment (PPE) for those administering the vaccine; safe, accessible locations where the vaccine can be given; and a system to track who’s gotten the vaccine.

Within months, we may need hundreds of millions of glass vials, syringes, and other basic supplies that may be difficult to manufacture on that scale.

And if there’s a shortage of any item — even one as basic as a glass vial to store the vaccine — the entire distribution could be delayed by weeks or months.

“There are a lot of pieces involved with the vaccine itself, and there are a lot of logistics to consider that are important around vaccine,” Penta said.

To administer the vaccine, we need hundreds of millions of glass vials, needles, and syringes. Doctors and those administering the vaccine will also need more PPE and bandages.

“Whenever you have a sudden, large-scale need for something, that then puts a stressor or a strain on the supply chain,” Penta said.

We saw this play out earlier in the year with test kits, ventilators, and PPE. The supply chain wasn’t prepared for the sudden increase in demand, and it took months to catch up and produce enough supplies.

No one knew a pandemic was coming back then. This time around, however, we can assume a vaccine will be available in the near future, giving the supply chain more time to prepare.

Soumi Saha, the senior director of advocacy at the healthcare improvement firm Premier Inc., said suppliers who make materials like vials and syringes are already gearing up to produce enough supplies to vaccinate a large population.

“Starting around March is when we started thinking about needles and syringes and glass vials, for example, and started proactive outreach to suppliers of those products to say, ‘Hey, can we start ramping up production today in anticipation of needs 6 to 12 months from now?’” Saha said.

Dr. Richard Gannotta, a senior lecturer of health administration at New York University’s Robert F. Wagner Graduate School of Public Service, said we need to make sure we have enough supplies used for administering the vaccine ready as soon as a vaccine is approved.

Many of the supplies used to take care of people with COVID-19, like PPE, will also be needed to vaccinate people.

A second or third surge in cases this fall or winter could further stress the supply chain.

“We saw that there was an issue with nasal swabs just with the testing, so we need not take this lightly. It’s something that needs to be considered,” Gannotta said.

A huge question on people’s minds is where the vaccine will be given.

According to Saha, there are dozens of options — like retail pharmacies, government clinics, hospitals, schools — but it’s currently unclear who will provide it.

The Centers for Disease Control and Prevention (CDC) has provided guidelines for storing and administering the vaccine, but it’s ultimately up to local jurisdictions to come up with a plan.

And in the case of schools or offices, where vaccines like the flu shot are often given, there’s a question of whether these will be open.

If these venues aren’t open, many people could run into access issues and face long wait lines.

“There’s a loaded proposition when you think about how we’re going to distribute and actually have folks come to get the vaccine,” Gannotta said.

The uncertainty about who will be administering the vaccine, and how, has made it difficult for facilities to move forward with plans.

“There is so much unknown, and it’s really hard for a hospital to move forward with implementing a plan and investing in the resources necessary to develop that plan at this juncture,” Saha said, noting the hospitals she works with would rather get a plan right than rush it.

Take the large cooling units that are needed to store the vaccines.

Both the Pfizer and Moderna vaccines need to be stored in ultra-low freezer temps, but most hospitals don’t have the type of expensive ultra-cold freezers needed to store these vaccines on top of all the other routine vaccinations given, according to Saha.

The big dilemma, according to Saha, is why a hospital would move forward in investing in an expensive freezer if they don’t even know whether they’re going to be a vaccine site.

Consequently, hospitals are currently holding off on ordering the units until the government provides more information.

“It’s almost like the ‘chicken or the egg’ concept that’s coming up, where they want to do the right thing and they want to make sure that you’re prepared, but at the same time you don’t want to make those investments and you don’t want to make plans when you’re not sure what your jurisdiction’s microplan might be,” Saha said.

Pfizer also recently announced it will be shipping doses in cases with dry ice that will be able to keep the vaccine cool for 10 days.

The announcement caused healthcare providers to not only think about investing in cooling units but in dry ice, too.

“Once Pfizer stated that, the discussion went from are we going to have a freezer shortage to are we going to have a dry ice shortage,” Saha said.

Hospitals and healthcare providers are now trying to prepare for the various scenarios that might unfold: securing enough freezers to store the vaccines, replenishing dry ice into the shipment containers, administering all the vaccines before the dry ice expires, or having to waste any doses that couldn’t be frozen.

“Is there enough storage facilities, transportation facilities, just cold chain in general? Are there enough supplies to keep things cold, like CO2, freezers, etc.? Is that in place?” Gannotta said.

Most of the vaccine candidates are expected to be given in two doses a few weeks apart if they’re approved for widespread use.

Both doses will be necessary to build some immunity against the new coronavirus, so it’s critical to ensure people get the full dosage.

The vaccines are also not interchangeable: You can’t give a Pfizer dose to someone who first received a Moderna dose.

A universal platform could help healthcare providers across the country track and trace who got what vaccine and ensure people get the full dosage.

“You have to have some reconciliation of data and the ability to track folks to make sure they’re getting their second dose. If they’re moving around, if they move to a different state, logistically, this is an issue with compliance we see with other inoculations and vaccines,” Gannotta said.

Bringing a vaccine to market isn’t a simple process.

On top of the vaccine itself, we need supplies (like vials, syringes, and PPE), cold storage units, safe locations where the vaccine can be administered, and a system to track who has been vaccinated.

Any hiccup in the process could push the vaccine distribution timeline back even further.