With the demand for COVID-19 vaccines exceeding the world’s stock, a frustrated public and policymakers want to know: how can we get more? Much more. Immediately.
The problem: “It’s not like adding more water to the soup,” said vaccine specialist Maria Elena Bottazzi of Baylor College of Medicine.
Manufacturers of COVID-19 vaccines need everything to go smoothly while scaling up production to hundreds of millions of doses – and any small hiccup can cause delays. Some of their ingredients have never been manufactured before with the required quantity.
And seemingly simple suggestions that other factories are switching to brewing new types of vaccinations cannot happen overnight. Just this week, French drugmaker Sanofi took the unusual step of announcing that it would help bottle and package the vaccine manufactured by rival Pfizer and its German partner BioNTech. But these doses will only start arriving in the summer – and Sanofi has the space in a factory in Germany only because its own vaccine has been delayed, bad news for the global supply.
“We think, well, OK, it’s like men’s shirts, right, I’ll just have another place to make it,” said dr. Paul Offit of Philadelphia Children’s Hospital, a vaccine adviser to the U.S. government, said. “It just’s not that easy.”
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DIFFERENT ORIGINS, DIFFERENT RECIPES
The multiple types of COVID-19 vaccines used in different countries all train the body to recognize the new coronavirus, mostly the peak protein it covers. But it requires different technologies, raw materials, equipment and expertise.
The two vaccines approved so far in the US, from Pfizer and Moderna, are made by placing a piece of genetic code called mRNA – the instructions for the acorn protein – in a little fat.
It is easy to make small amounts of mRNA in a research laboratory, but ‘for this, no one has made a billion doses or 100 million or even a million doses of mRNA’, said dr. Drew Weissman of the University of Pennsylvania said. .
Scaling up doesn’t just mean adding ingredients to fit in a larger barrel. Creating mRNA involves a chemical reaction between genetic building blocks and enzymes, and Weissman said the enzymes do not work as efficiently in larger volumes.
The AstraZeneca vaccine, already used in Britain and several other countries, and one soon to be expected from Johnson & Johnson, was made with a cold virus that sneaks the protein gene into the body. This is a very different form of manufacturing: living cells in giant bioreactors allow the cold virus to grow, which is extracted and purified.
“As the cells get old or tired or start to change, you can get smaller,” Weissman said. “There’s a lot more volatility and a lot more things you need to check.”
An old-fashioned variety – “inactivated” vaccines manufactured by Sinovac in China – requires even more steps and tighter biosafety because they are made with killed coronavirus.
One thing all vaccines have in common: they must be made according to strict rules that require specially inspected facilities and must test each step regularly, which is a time-consuming necessity to have confidence in the quality of each group.
WHAT ABOUT THE SUPPLY CHAIN?
Production depends on enough raw materials. Pfizer and Moderna maintain that they have reliable suppliers.
Nevertheless, a U.S. government spokesman said logistics experts are working directly with vaccine makers to anticipate and resolve the bottlenecks that arise.
Stephane Bancel, CEO of Moderna, acknowledges that challenges still exist.
“If one day there is a shortage of raw material with shifts that are running 24/7, we can not start producing products and the capacity will be lost forever because we can not compensate for it,” he recently told investors said.
Pfizer has temporarily delayed delivery in Europe for several weeks, allowing it to upgrade its plant in Belgium to handle more production.
And sometimes the groups fall short. AstraZeneca has told an outraged European Union that it will also deliver fewer doses than was immediately promised. The reason was given: Lower than expected “yields”, or production, at some European manufacturing sites.
More than in other industries, “when brewing with biological ingredients,” there are things that can go wrong and that can go wrong, “said Norman Baylor, a former vaccination chief for the Food and Drug Administration, who said yield variability is common. mention.
HOW MUCH IS ON THE WAY?
It differs by country. Moderna and Pfizer are each on track to deliver 100 million doses to the US by the end of March and another 100 million in the second quarter of the year. Looking even further ahead, President Joe Biden has announced plans to buy even more during the summer, reaching enough to eventually vaccinate 300 million Americans.
Pfizer CEO Albert Bourla said at a Bloomberg conference this week that his company would deliver 120 million doses by the end of March – not through faster production, but because health workers are now allowed to take an extra dose from each vial. press.
But to get six doses instead of five, specialized syringes must be used, and there are questions about the worldwide supply. A health and human services spokesman said the US was sending kits that included the special syringes with each Pfizer shipment.
Pfizer also said that upgrading the plant in Belgium is a short-term pain for longer term, as the changes will help increase production worldwide to 2 billion doses this year instead of the originally expected 1.3 billion.
Moderna also recently announced that it could deliver 600 million doses of vaccine by 2021, up from 500 million, and that it is increasing capacity in hopes of getting 1 billion.
But the easiest way to get more doses is possible if it is proven that other vaccines work. U.S. data on whether Johnson & Johnson’s single-dose shot is protected is expected soon, and another company, Novavax, is also in the final stages of testing.
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OTHER OPTIONS
The main vaccine companies have been setting up ‘contract manufacturers’ in the US and Europe for months to help them drive out doses and then undergo the final bottling steps. Moderna, for example, works with the Swiss Lonza.
In addition to rich countries, the Serum Institute of India has a contract to manufacture one billion doses of AstraZeneca’s vaccine. It is the world’s largest vaccine manufacturer and is expected to be a major supplier to developing countries.
But some efforts to boost home supplies appear to be. Two Brazilian research institutes plan to make millions of doses of the AstraZeneca and Sinovac vaccines, but have been put off by unexplained delays in the shipment of key ingredients from China.
And Bottazzi said the world should continue to produce vaccines against polio, measles, meningitis and other diseases that threaten even during the pandemic.
Penn’s Weissman encouraged patience, saying that as each vaccine manufacturer gains more experience, “I think they’re going to make more vaccines each month than the previous month.”