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With demand for COVID-19 vaccines outstripping global supplies, a frustrated public and policymakers want to know: How can we get more? Much more. Right now.
The Problem: “It’s not like adding more water to the soup,” said vaccine specialist Maria Elena Bottazzi of Baylor College of Medicine.
The makers of COVID-19 vaccines need everything to be okay as they ramp up production to hundreds of millions of doses – and any small hiccup could cause delay. Some of their ingredients have never been produced at the required volume.
And seemingly straightforward suggestions that other factories turn to brewing new types of vaccines can’t happen overnight. Just this week, French drug maker Sanofi took the unusual step of announcing that it would help bottle and package certain vaccines produced by competitor Pfizer and its German partner BioNTech. But those doses won’t start arriving until summer – and Sanofi has the space in a plant in Germany just because its own vaccine is being delayed, bad news for the world’s global supply.
“We think, ‘Well, alright, that’s like men’s shirts, right? I’ll just have another place to get there, ”said Dr. Paul Offit of the Children’s Hospital of Philadelphia, a vaccine advisor to the US government. “It’s just not that simple.
DIFFERENT VACCINES, DIFFERENT RECIPES
The multiple types of COVID-19 vaccines used in different countries all train the body to recognize the new coronavirus, primarily the spike protein that covers it. But to do this, they require different technologies, raw materials, equipment and skills.
The two vaccines licensed in the United States so far, from Pfizer and Moderna, are made by inserting a piece of genetic code called mRNA – the instructions for this spike protein – into a small ball of fat.
Making small amounts of mRNA in a research lab is easy, but “before that, no one was making a billion doses or 100 million or even a million doses of mRNA,” said Dr. Drew Weissman of the University of Pennsylvania, which contributed to the development of mRNA technology. .
Scaling doesn’t just mean multiplying the ingredients to fit a larger tub. The creation of mRNA involves a chemical reaction between genetic building blocks and enzymes, and Weissman said enzymes don’t work as efficiently in larger volumes.
AstraZeneca’s vaccine, already in use in Britain and several other countries, and a soon-to-be-expected vaccine from Johnson & Johnson, is made with a cold virus that introduces the spike protein gene into the body. It’s a very different form of manufacturing: living cells in giant bioreactors cultivate this virus from the cold, which is extracted and purified.
“If the cells get old, tire, or start to change, you might have less of them,” Weissman said. “There is a lot more variability and a lot more things to check.”
An old-fashioned variety – ‘inactivated’ vaccines like the one made by Sinovac in China – requires even more steps and tighter biosecurity because they are made with a killed coronavirus.
One thing that all vaccines have in common: they must be manufactured under strict rules that require specially inspected facilities and frequent testing at every step, a necessity that takes time to be sure of the quality of each batch.
WHAT ABOUT THE SUPPLY CHAIN?
Production depends on sufficient raw materials. Pfizer and Moderna insist that they have reliable suppliers.
Even so, a U.S. government spokesperson said logistics experts are working directly with vaccine makers to anticipate and resolve bottlenecks that arise.
Moderna CEO Stephane Bancel recognizes that challenges remain.
With teams operating 24/7, if on any given day “a raw material is missing, we cannot start making products and that capacity will be lost forever because we cannot catch up with it”, he recently told investors.
Pfizer temporarily slowed deliveries to Europe for several weeks, in order to be able to modernize its factory in Belgium to handle more production.
And sometimes the lots are insufficient. AstraZeneca has told an outraged European Union that it too will deliver fewer doses than what was initially promised immediately. The reason given: “yields” or lower production than expected at certain European manufacturing sites.
More than in other industries, when brewing with organic ingredients, “there are things that can go wrong and that go wrong,” said Norman Baylor, a former head of vaccines with the Food and Drug Administration who has qualified the variability of yield as common.
HOW MUCH IS ON THE ROAD?
It varies by country. Moderna and Pfizer are on track to deliver 100 million doses to the United States by the end of March and an additional 100 million in the second quarter of the year. Looking even further, President Joe Biden announced plans to buy even more over the summer, reaching enough to ultimately vaccinate 300 million Americans.
Pfizer CEO Albert Bourla told a Bloomberg conference this week that his company would end up delivering 120 million doses by the end of March – not through faster production, but because health workers are now allowed to withdraw an additional dose from each vial.
But to get six doses instead of five, you have to use specialized syringes, and there are questions about the global supply. A spokesperson for Health and Human Services said the United States sends kits that include the special syringes with every Pfizer shipment.
Pfizer also said upgrading its plant in Belgium was a short-term pain for a long-term gain, as the changes will help increase global production to 2 billion doses this year instead of the 1.3 billion originally planned. .
Moderna also recently announced that it would be able to deliver 600 million doses of the vaccine in 2021, up from 500 million, and that it was increasing its capacity in hopes of reaching 1 billion.
But perhaps the easiest way to get more doses is to prove that other vaccines in development work. U.S. data on one-dose injection protection from Johnson & Johnson is expected soon, and another company, Novavax, is also in final stages of testing.
OTHER OPTIONS
For months, major vaccine makers lined up “contractors” in the United States and Europe to help them reduce doses and then move on to the final bottling stages. Moderna, for example, works with the Swiss Lonza.
Beyond wealthy nations, the Serum Institute of India has a contract to manufacture one billion doses of the AstraZeneca vaccine. It is the world’s largest vaccine manufacturer and is expected to be a key supplier to developing countries.
But some national efforts to increase supplies appear to be hampered. Two Brazilian research institutes plan to manufacture millions of doses of the AstraZeneca and Sinovac vaccines, but have been delayed by unexplained delays in shipments of key ingredients from China.
And Bottazzi said the world must simultaneously maintain production of vaccines against polio, measles, meningitis and other diseases that still threaten even amid the pandemic.
Penn’s Weissman urged patience, saying that as each vaccine maker gains more experience, “I think every month they’re going to make more vaccines than the month before.”
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The Associated Press’s Department of Health and Science receives support from the Department of Science Education at the Howard Hughes Medical Institute. The AP is solely responsible for all content.
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