COVID-19 vaccine manufacturers have been under pressure with delays and supply constraints hampering early production, leading to fewer-than-expected doses available to the U.S. public.
While many of the bottlenecks and supply squeezes have been addressed for the two authorized vaccines, other companies, though they are using more traditional production platforms, are still facing some issues as they ramp up. That is in large part because some equipment and supplies needed for one vaccine are the same for all.
It's why a global squeeze for some of the materials and supplies delayed early production. Plus, companies had to balance output with the capital investment into production well before they knew if the vaccines were going to be effective.
For messenger RNA vaccines, like those from Modena (MRNA) and Pfizer (PFE)/BioNTech (BNTX), lipid nanoparticles that are needed to help deliver the vaccine formula were not widely used anywhere, and no mass-production capacity existed. It's one of the items Pfizer has been able to bring in-house and is working to scale up, according to Pfizer chief business officer John Young.
"We've made significant investments into our U.S. supply chain," he said Tuesday, noting that some of the work began before the vaccine was issued emergency use authorization in December.
Young was among a handful of company executives testifying before a U.S. House subcommittee. The 3-hour hearing covered a variety of issues, but vaccine production — and the federal government's role in their creation and distribution — were key themes. Officials from Moderna, Pfizer, AstraZeneca (AZN), Johnson and Johnson (JNJ) and Novavax (NVAX) were all present.
Rep. Paul Tonko (D-NY 20th District) noted that "vaccine production is incredibly complex. With bottlenecks possible up and down the line, from raw materials to supplies, to storage and distribution, even just having enough highly-trained people working in lock-step coordination."
Other lawmakers noted that the significant investment of taxpayer dollars into vaccine development, and in some cases for necessary materials like vials and syringes, helped achieve the feat of an authorized vaccine in less than a year. In addition, use of the Defense Production Act (DPA) by both the Trump and Biden administrations has helped ensure the companies have priority access to the needed supplies.
Just as Pfizer had to figure out how to scale up a new technology, Moderna, which was a significantly smaller company at the onset of the pandemic, had to find partners to do the same.
Moderna president Stephen Hoge said the company partnering with one of the world's largest vaccine manufacturers, Lonza, helped the once small biotech scale up quickly. Between the highly skilled personnel internally at Moderna and externally at partners, learning the new platform in real-time, the company has been able to announce a significant increase in output.
"As they have developed familiarity with that process, they've gotten better and better at it," Hoge said.
Dr. Craig Spencer, director of Global Health in Emergency Medicine at New York-Presbyterian/Columbia University Medical Center, told Yahoo Finance Tuesday that relying on existing capacity was not possible for mRNA.
"A year ago, none of these vaccines existed. We weren't making any of these mRNA vaccines at anywhere close to the scale that we are now," he said.
Johnson and Johnson's contract with the U.S. called for 12 million doses by the end of February, but that appears unlikely as the independent advisory committee — charged with recommending emergency use authorization to the U.S. Food and Drug Administration — only meets Fridays.
J&J's Richard Nettles, vice president of U.S. Medical Affairs in Janssen's Infectious Diseases and Vaccines, said that the company was on track to deliver 4 million doses as soon as the EUA was issued, and intended to have 20 million doses by the end of March. The contract with the U.S. totals 100 million doses by June.
Meanwhile, Pfizer and Moderna have recently announced significant increases to production, in some cases doubling existing amounts. In addition, both have asked the FDA for additional doses in vials — Pfizer through extracting an existing extra dose in vials and Moderna through asking for up to five additional doses to be filled— in order to increase the number of doses delivered at a time.
The two other companies, AstraZeneca and Novavax are still in Phase 3 trials in the U.S., even as their vaccines are being distributed in other countries. Both anticipate an EUA in the spring.
The next pandemic
Rep. Tom O'Halleran (D-AZ 1st District) asked the executives what the U.S. government can do to work better together so a repeat of the deadly pandemic doesn't happen again.
Most touted the investment in the companies and support like the DPA, while others stressed the government's role.
Pfizer's Young noted that "timely interactions" with regulators should be a lesson learned that can be broadly applied throughout the drug industry. In addition, investment in viral surveillance and genomic screening would benefit the U.S. public health system.
Moderna's Hoge said investment in science contributed to the company's success.
In particular, the work done by the National Institutes of Health and agencies within it that identified the spike protein on the virus as the target for the vaccines, which is how all manufacturers created a successful vaccine formula, he said.
White House officials have previously said that the DPA is already being used to grow domestic manufacturing capacity, with announcements expected in the near future, to help ensure shortages of supplies and raw materials are never again a hurdle.
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