Why is it difficult to make vaccines and increase supply?


With the demand for COVID-19 vaccines replacing the supply of the world, a frustrated public and policy makers want to know: how can we get more? Too much. right away.

The problem: “It’s not like adding more water to the soup,” said Maria Elena Botazzi, of the vaccine specialist Boiler College of Medicine.

The manufacturers of the COVID-19 vaccine need everything to go correctly as they increase production to hundreds of millions of doses – and any kind of hiccups can cause delays. Some of their ingredients have never been produced in the required amount before.

And the simple suggestion seems to be that other factories switch to beating new types of vaccines, cannot happen overnight. Just this week, French drug maker Sanofi took the unusual step of announcing that it would help bottle and package some vaccines produced by competitor Pfizer and its German partner BioNotech. But those supplements won’t start arriving until summer – and Sanofi’s location in a factory in Germany is simply because its own vaccine is delayed, bad news for the world’s overall supply.

“We think, ‘Okay, okay, this is like a men’s shirt, right? I’ll have another place to make it,'” Dr. of the Children’s Hospital of Philadelphia, a vaccine advisor to the US government. Paul Offit said. “It’s not that easy.”

Different facilities, different receipts

Different types of COVID-19 vaccines are being used in different countries, which train the body to recognize all new coronaviruses, mostly spike proteins that coat it. But they require different technologies, raw materials, equipment and expertise to do so.

Two vaccines, now authorized in the US from Pfizer and Moderna, are made by inserting a piece of genetic code called mRNA – which is the instruction for the spike protein – inside a small ball of fat.

It is easy to make small amounts of mRNA in a research laboratory, but before that, no one made a billion doses, or 100 million, or even a million doses of mRNA, ”Dr. of the University of Pennsylvania. Said Drew Weissman, who helped pioneer Mano Technique. .

Scaling does not just mean multiplying the material to fit larger content. Creating mRNAs is a chemical reaction between genetic building blocks and enzymes, and Weisman said that enzymes do not work efficiently in larger versions.

AstraZeneca vaccine, already used in Britain and many other countries, and expected soon from Johnson & Johnson, is made with a cold virus that sniffs the spike protein gene in the body. This is a very different form of manufacturing: living cells in giant bioreactors develop the cold virus that is extracted and purified.

“If cells are old or fatigued or have started to change, you may be reduced,” Weisman said. “There is too much variability and too many things that you have to check.”

An old-fashioned variety – much like vaccines made by Synovac of “dormant” China – requires even more stages and biosynthesis as they form with killed coronaviruses.

All vaccines have one thing in common: they must be made under strict rules, requiring particularly inspection facilities and frequent testing of each stage, a time-consuming requirement to assure the quality of each batch .

What about the supply chain?

Production depends on sufficient raw materials. Pfizer and Modern insist that they have reliable suppliers.

Nevertheless, a US government spokesman said that logistics experts are directly working with the vaccine makers to anticipate and resolve any bottlenecks that may arise.

Modern CEO Stephen Bansell acknowledges that the challenges remain.

He recently told investors that 24/7 is going on, if on any given day “a raw material is missing, we cannot start making products and this capability will be lost forever.”

Pfizer has temporarily slowed distribution in Europe for several weeks, so it can upgrade its factory in Belgium to handle more production.

And sometimes batches fall short. AstraZeneca told an angry EU that it, too, would deliver lower doses than originally promised. Reason cited: “yields,” or lower than output, at some European manufacturing sites.

Norman Boiler, former head of the Food and Drug Administration’s vaccine, said that when compared with other industries with organic ingredients, ripening with organic ingredients, “there are things that can and will go wrong.”

How is it on the way?

It varies by country. Modern and Pfizer are on track to deliver 100 million doses to the US by the end of each March and another 100 million in the second quarter of the year. Looking even further, President Joe Biden has announced plans to buy still more in the summer, enough to eventually vaccinate 300 million Americans.

Pfizer CEO Albert Borla reported at the Bloomberg conference this week that his company would actually deliver 120 million doses by the end of March – not by rapid production, but because health workers are now allowed to squeeze an extra dose from every vial. is.

But receiving six doses instead of five requires the use of special syringes, and there are questions about global supply. A Health and Human Services spokesperson said the US is shipping kits that include special syringes with each Pfizer shipment.

Pfizer also said that its factory upgrade in Belgium is a short-term pain for long-term profit, as this change will help boost worldwide production to 2 billion doses this year, instead of the originally estimated 1.3 billion.

Similarly, the recently announced mod will be able to supply 600 million doses in 2021, up from 500 million, and it was expanding capacity in the hopes of up to 1 billion.

But probably the easiest way to get a higher dose is if other vaccines in the pipeline are proven to work. US data on one-dose shot protections from Johnson & Johnson are expected soon, and another company, Novavax, is also in the final phase of testing.

other options

For months, the main vaccine companies prepared “contract manufacturers” in the US and Europe to help them reduce the dose and then go through the final bottling stages. Modern, for example, is working with Lonja of Switzerland.

Beyond the rich countries, the Serum Institute of India has a contract to manufacture one billion doses of AstraZeneca vaccine. It is the world’s largest vaccine manufacturer and is expected to be a major supplier to developing countries.

But some domestic efforts to boost supply appear to be hobbled. Two Brazilian research institutes plan to make millions of doses of AstraZeneca and Synovac vaccines, but have been set back by unexplained delays in shipments of vital material from China.

Botazzi said that the world would have to continue producing vaccines of polio, measles, meningitis and other diseases simultaneously which still remain a threat even in the midst of the epidemic.

Penn’s Weisman urged patience, saying that as each vaccine manufacturer gains more experience, “I think every month they’re going to make more vaccines than the prior month.”

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The Associated Press Department of Health and Sciences has support from the Science Education Department of Howard Hughes Medical Institute. AP is solely responsible for all content.

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