Vaccine supply challenges hamper national rollout

Coronavirus vaccine distribution is taking longer than expected, but the medical and plastics industries both are putting in overtime to get the shots into arms.

The pressure is on manufacturers of syringes, safety seals for vaccine doses and the vaccine production and delivery pipeline.

"One of the challenges is how fast [processors] can transfer what was production overseas to local production in the U.S.," Peter Schmitt, managing director and founder of consulting firm Montesino, said in a phone interview.

"It's not clear to me how tight that timeline is, although we're all hopeful that they've been very successful at it," Schmitt said. "The speed of that transfer is something … that's a concern and it would obviously stress out the supply chain.

"If two years ago you were buying most of your syringes and injectables from Asia … how fast could you get that transferred?" he said. "How much did people buy up before the U.S. government got around to buying it?

"I'm not aware of the answer, but obviously that would be a problem," Schmitt added. "If they bought up the capacity, we're going to be in a line or outbidding each other, either of which is not a pleasant situation."

Wilmington, Del.-based Montesino serves the health care packaging sector.

As of December, Franklin Lakes, N.J.-based medical device maker Becton, Dickinson & Co. received global orders for more than 1 billion injection devices related to COVID-19, company officials said. That includes orders from the U.S., United Kingdom, Canada and nongovernmental organizations around the world.

"We are actively producing and shipping devices to fulfill these orders," officials said. "This is no small task — to produce a billion devices in the next 12 months equates to nearly 2,000 devices every minute on top of BD's normal volumes to fully support routine health care needs."

BD makes injection devices in the U.S. at plants in Canaan, Conn.; Columbus, Neb.; and Holdrege, Neb. A company spokeswoman said polypropylene and polyethylene are commonly used resin grades in the industry.

BD is the world's largest manufacturer of needles and syringes, making billions each year for applications ranging from insulin injection to vaccines.

In addition to supporting immediate efforts for COVID-19 vaccinations, BD is partnering with the U.S. government on a $70 million capital project to expand its operations in Nebraska. The new capacity is expected to be online in mid-2021. Once completed, the federal government will have priority access to hundreds of millions of injection devices to support vaccination efforts for COVID-19 and future pandemics.

BD is also investing approximately $1.2 billion over a four-year period to expand and upgrade manufacturing capacity and technology for pre-fillable syringes and advanced drug delivery systems to allow for continued growth of new injectable drugs and vaccines. The new production also will provide surge capacity for increased pre-fillable syringe demand during times of pandemic response.

Syringes aren't the only plastic product needed in the race to vaccinate. Miami Lakes, Fla.-based National Molding LLC increased its production of tamper-evident seals for the billions of liquid injectable vials that it produces annually.

"The tamper-evident seals for liquid injectable vials ramp-up caused us to run overtime most weekends since mid-2020," said Mike Connell, vice president of sales and marketing.

The injection molder has been challenged to recruit trained manufacturing staff as it ramped up production, Connell said.

"We also have launched an airway management system for a new customer who is experiencing high demand from COVID patients and has elected to reshore production from Asia to the U.S.," Connell said.

The University of Michigan Medical Center in Ann Arbor, Mich., received its first doses of the Pfizer vaccine on Dec. 14 and has now vaccinated more than 25,000 people, Stan Kent, chief pharmacy officer at U-M, told Plastics News.

The college has converted Michigan Stadium, two auditoriums and a clinic to become stations for administration of the vaccine.

"We are all ready to vaccinate up to 3,000-4,000 people a day, but there's limited amount of vaccine," Kent said. "We were ready to do that on the first of the year."

On average, U-M vaccinates a little more than 1,000 people a day. It started administering second doses in the beginning of January.

The big problem, he said, is vaccine supply, leaving those in charge of distributing the vaccine to use a "wonky" ordering system for small batches weekly.

"You order the vaccine every week on Thursday from the state [of Michigan]," Kent said. "Usually on Sunday we find out from the state what our allocation will be."

The supply the state receives from the federal government dictates if it will be enough to fulfill the order, he said, "which it never has been."

The shortages in orders also leave a "big challenge" for distributors: prioritizing vaccine for workers with direct or indirect contact with patients in health care and long-term care settings.

"There's a lot of people in that category," Kent said, and it isn't as simple as just getting the vaccine to physicians and nurses.

"You have to think about science, but also equity," he said. "For example, security officers have to deal with situations directly with patients, sometimes physically going into patients' rooms. Housekeepers who are cleaning these rooms are exposed to viruses all day long and they deserve the vaccine as much as anyone else."

Michigan's phase 1B of its vaccination prioritization plan, which began on Jan. 11, includes people over age 65; front-line essential workers — including police officers, first responders, front-line state and federal workers, and jail and prison staff — and pre-K-12 teachers and childcare providers.

U-M was forced to pause 1B vaccinations because it was still working to vaccinate people in the state's 1A category.

"It's frustrating, because we don't know what the holdups are, what the logistical issues are," Kent said. "Once they said we could vaccinate people over 65, there was no vaccine."

"Most of the angst and issues over prioritization and explaining to people the logic behind prioritization, that would all evaporate, as soon as there's more vaccine," he said.

An extra, sixth dose found in some vials of Pfizer's vaccine was a happy surprise for pharmacists as supply runs low.

U-M receives all medical devices for administration of the vaccine, including syringes, needles and alcohol pads, from the state.

"Because we were getting more doses out of each vial, we were concerned about getting enough ... syringes and small-gauge needles," Kent said.

The state sent U-M extra supplies to account for the extra doses, and the federal government later began shipping additional syringes with the Pfizer vaccine to cover the extra doses.

"If the vaccine supply really starts to increase, we'll be able to vaccinate a lot of people quickly," Kent said. "I think in a couple of months the big challenge will be convincing people to get vaccinated. Unless we can vaccinate 70-80 percent of the population, this pandemic is going to continue."