After months of lockdown, nearly 5 million confirmed cases of COVID-19 in the United States, and more than 157,000 deaths, people in the United States are increasingly desperate for an end to the pandemic.
According to most experts, however, that end isn’t likely to come until a viable vaccine is available and most people are vaccinated.
But the road to researching, testing, approving, and safely manufacturing and distributing more than 300 million doses of a vaccine is a daunting and unprecedented one.
“From the very start of the pandemic, we knew that the entire American pharmaceutical distribution industry would have to be leveraged to meet the immense scope and speed to market requirements of a COVID-19 vaccine,” Heather Zenk, RPh, PharmD, senior vice president of strategic global sourcing at the drug wholesale and distribution company AmerisourceBergen, told Healthline. “This will be the fastest timeline a vaccine has ever come to the market.”
To that end, several promising vaccines have entered phase III clinical trials, the final step before obtaining federal approval when the vaccine is tested on people.
However, it may still be a long time before the average American is able to get a dose. Perhaps months and months after a vaccine is first available.
“Vaccines, like other biopharma products, undergo clinical development and then clinical trials for safety and efficacy. However, phase III clinical trials for vaccines are unique because of the scale of participants required — a fundamental part of vaccine development,” Richard Hughes IV, JD, MPH, a managing director who leads the vaccines team at Avalere Health, a healthcare consulting firm, told Healthline.
“Tens of thousands of participants are required for vaccine trials, a much higher number of participants than for other biopharma products,” he said.
But the good news is that vaccine development has been a bright light amid a grim pandemic, says Dr. Don L. Goldenberg, an emeritus professor of medicine at Tufts University School of Medicine in Massachusetts.
“Although the overall U.S. pandemic response has been chaotic and unsettling, the single united effort has been in vaccine development,” Goldenberg told Healthline.
“Facing the greatest health emergency of our generation has led to COVID-19 vaccine development and trials in record time, never before imaginable,” he said. “Instead of the usual 5 to 10 years, it is likely that a vaccine will come to market within the next 5 to 10 months.”
The reason is at least in part because the government has ponied up a lot of money to ameliorate drug companies’ risk to start mass manufacturing early vaccines that are pending Food and Drug Administration (FDA) approval.
If the vaccines don’t succeed in their phase III trials, these vaccines will need to be discarded at great cost to manufacturers.
“Because of the billions of dollars of upfront money provided to vaccine developers, the usual time lag has been eliminated,” Goldenberg explained.
About 63 percent of healthcare workers felt that Moderna’s vaccine — currently in phase III trials — will be first approved, manufactured, and distributed in the United States, according to research from InCrowd, a life sciences research firm.
Moderna is using a newer vaccine development technique that uses modified mRNA to induce immunity in human participants.
One of the benefits of this approach is easier manufacturing, so if the vaccine is successful, it will be simpler to mass produce quickly and therefore get into the hands of the public.
“It takes a long time to grow the virus in eggs and to grow enough virus to make the vaccine,” Linda Thompson, PhD, an immunologist at the Oklahoma Medical Research Foundation, told Healthline.
“[Moderna’s technique] is so much easier than a vaccine where you actually have to grow the virus and purify the spike protein,” she said.
But whether federal regulators first approve Moderna’s formulation or another vaccine, those regulators have cleared the runway for a rapid approval process.
“From a regulatory standpoint, we are quite likely to see the FDA issue an emergency use authorization (EUA) for a COVID-19 vaccine’s use prior to licensure,” Hughes said.
“An EUA for a vaccine is nearly unprecedented. The only other time EUA authority was invoked for a vaccine was for anthrax and specifically for military personnel,” he said.
If everything goes perfectly, many experts say a vaccine could be available as early as the first or second quarter of 2021. The problem is that it won’t be available to everyone. At least not right away.
A successful vaccine would likely be distributed to frontline workers and medical professionals first, then other essential workers and at-risk individuals.
The question of the actual “who” of who gets the vaccine first when one becomes available hasn’t been settled, however.
Upscaling manufacturing capacity as well as safely distributing the vaccine will be a big hurdle to getting the product to everyone.
That includes not just quantities of the vaccine itself but also storage, transportation, and coordination with doctors and pharmacies.
And even with all the focus on COVID-19, other diseases that require vaccines haven’t gone away, either.
“The COVID-19 vaccination will be in addition to the regular vaccine programs, like MMR, HPV, etc., so the need for a significant increase in syringes and needles are also needed,” Dr. Soren Bo Christiansen, chairman and CEO of Sharps Technology Inc., a safety syringe company, and a former head of vaccines at Merck, told Healthline.
“Some pharma companies may prioritize COVID-19 over other vaccines, which can create a whole different challenge. To make things worse, it is anticipated that many more people will opt for a flu shot in this coming season. Who wants to get the flu and COVID-19 at the same time?” he said.
Christiansen’s company is trying to address another problem via his company’s proprietary syringe: that of vaccine waste.
“You can get a vaccine in two ways: in a vial, with typically 10 doses, or in a prefilled syringe with 1 dose. For COVID-19, the first approach will be vials because it’s faster and cheaper,” he said.
“The vaccinator will then withdraw a dose from the vial, change the needle, and inject the patient. In all currently available syringes, there is waste when you are done with the injection,” he explained.
This means that the manufacturer typically overfills the vial to ensure the correct number of doses, Christiansen says. A syringe that eliminates this waste can increase available doses by 10 percent — a significant percentage when looking at doses in the tens of millions.
Another concern is providing adequate transportation of the vaccines, which may need to be stored at cold temperatures to stay viable.
“It is possible that a COVID-19 vaccine will need to be stored between -20 Celsius and -80 Celsius, which has never been done before with high-demand products,” Zenk said.
“To ensure product integrity, the temperature range may need to be maintained from development to patient treatment — through transport, storage, and distribution,” she said.
Then there are the massive logistics of getting the vaccines where they need to go.
“When you consider the number of providers in our country — nearly 90,000 pharmacies, 230,000-plus physician practices, 1,200 health clinics and 6,000-plus hospitals — the entire distribution industry will need to support this vaccine to reach across America in a meaningful way,” Zenk explained.
And pharmacies, not just doctors’ offices, will have to play a part.
“Many Americans are now accustomed to getting their annual flu shot from their local, trusted pharmacist,” Zenk said.
“Giving pharmacists the ability to administer as well as allowing pharmacies the ability to order these vaccines within their normal distribution channels will be crucial in our fight against COVID-19 in the coming year,” she said.