Marysville Appeal-Democrat

Why isn’t more COVID-19 vaccine available immediatel­y?

- Los Angeles Times (TNS)

To truly control the pandemic, most people around the world need to be vaccinated against COVID-19. That’s a tall order involving billions of shots.

By the end of this year, only about 70 million doses of the COVID-19 vaccines from Pfizer and Biontech and from Moderna and the National Institutes of Health are expected to be shipped out worldwide. Next year, that number will jump to more than 1 billion. Other companies are also working on vaccines, but some population­s still might not gain access until 2024.

In the meantime, the death toll continues to rise.

So why can’t doses be pumped out and distribute­d faster?

Considerin­g that vaccines can take years just to create — and that Pfizer’s and Moderna’s vaccines went from concept to testing to deployment in less than a year — the pace is already swift.

Then there’s the issue of how many people need it: an amount unpreceden­ted in the pharmaceut­ical industry.

“We’ve never distribute­d vaccines on this scale before,” said Lois Privor-dumm, director of adult vaccines at the Internatio­nal Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health. “We’re talking about trying to reach the whole planet, essentiall­y.”

On the manufactur­ing side, there’s a hustle to expand production to more factories, which need to be fitted out with specialize­d equipment, and to train workers. And once made, Pfizer’s and Moderna’s vaccines must be kept at freezing temperatur­es, so they can’t be distribute­d in just any vehicle or stored in just any warehouse.

“It’s not like making widgets,” said Nancy Pire-smerkanich, assistant professor of regulatory and quality sciences at the USC School of Pharmacy.

Instead of spending the time and money to build new factories to expand their capacity, pharmaceut­ical firms — including Pfizer and Moderna — are largely turning to contractor­s that specialize in vaccine manufactur­ing.

Pfizer is using several of its own factories in the U.S. and Belgium and is teaming up with outside companies to scale up manufactur­ing, a spokeswoma­n said. Moderna, whose business historical­ly has not involved much production, is more reliant on third parties.

Developing vaccines can be a lengthy process, but the yearly flu vaccine is produced on a much shorter timescale than some other shots. That’s possible because all the technology has already been establishe­d — it’s only a matter of switching in the flu strains that researcher­s anticipate will be dominant that year, PireSmerka­nich said.

For the 2020-2021 flu season, vaccine manufactur­ers expect to make up to 198 million doses for the U.S. alone, according to the Centers for Disease Control and Prevention.

Making COVID-19 vaccines is different: Manufactur­ers started from scratch, but they’re using a faster process.

The Pfizer and Moderna shots both use a technology called messenger RNA, or MRNA.

Those molecules instruct cells how to make a specific type of protein that’s also found on the coronaviru­s, and this protein stimulates the immune system to make antibodies that would target the virus.

The MRNA technique speeds up the vaccine developmen­t process.

Many flu vaccines take about six months to make because they rely on growing the virus in chicken eggs. The MRNA technique, on the other hand, is developed in a lab and can be done much faster — in 2013, it took researcher­s at Novartis eight days to make a potential influenza vaccine.

This MRNA technology has been studied for decades, but no vaccine for humans has used the technique until now.

A major challenge for this technique is that the MRNA is fragile, which is why Pfizer and Moderna’s vaccines must be frozen. Pfizer’s vaccine must be kept at minus-94 degrees Fahrenheit; Moderna’s is more stable and can be stored at minus-4 degrees and last 30 days in a regular refrigerat­or.

Both vaccines can keep for short periods of time outside of refrigerat­ion.

The ultra-cold temperatur­es needed for Pfizer’s vaccine complicate the shipping process: Vials must be packed in freezer cases with dry ice, and a big shipment can contain more dry ice than is normally allowed on planes — a limit imposed because of the risk of carbon dioxide poisoning.

If production and shipping could be instantly ramped up, the bottleneck would be finding places for all those doses to be kept until use. Companies specializi­ng in cold storage operations are now in high demand; L.A. County has acquired more than a dozen ultra-cold storage freezers to keep the vaccine before distributi­on. As it is, this need is likely to pose a problem in countries whose electric grids are less built out.

“If 90% of the world is not vaccinated, the virus will still be out there,” said Rhiju

Das, an associate professor of biochemist­ry at Stanford University School of Medicine. “This really needs to be a worldwide immunizati­on effort, otherwise COVID will be with us for a long time.”

Both vaccines require two doses, which means health systems will need to keep tabs on who has gotten the first shot and remind people to come back for the second, said Christophe­r Tang, a distinguis­hed professor and chair in business administra­tion at the UCLA Anderson School of Management.

And the process of making vaccines is specialize­d, involving equipment that is sometimes custom-made and workers trained in the raw materials, equipment operation, packaging and quality control. Every batch of vaccine is tested and inspected before the doses are sent out for distributi­on, and that all takes time.

“As much as we’ve automated the business, there’s still a level of expertise required when doing this,” Pire-smerkanich said.

Experts say the speed of the process has been a major achievemen­t.

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 ?? Tampa Bay Times/tns ?? Vanessa Arroyo, a nurse, receives a COVID-19 vaccine from nurse Rafael Martinez on Dec. 14 at Tampa General Hospital in Tampa, Florida.
Tampa Bay Times/tns Vanessa Arroyo, a nurse, receives a COVID-19 vaccine from nurse Rafael Martinez on Dec. 14 at Tampa General Hospital in Tampa, Florida.

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