For those who’ve been vaccinated for COVID-19, chances are high fairly excessive that you simply’re benefiting from a product made by BioNTech. The German biotech firm, co-founded by a husband-and-wife workforce of scientists, developed the vaccine that grew to become not solely the primary to earn authorization within the U.S. for COVID-19 in December but in addition the primary ever based mostly on a brand new know-how involving the genetic materials mRNA.

In interviews in December and March, co-founders Ugur Sahin and Ozlem Tureci spoke about their whirlwind 12 months and their partnership with U.S. pharmaceutical firm Pfizer to check and manufacture the vaccine. Over three days in late March, in addition they opened up their new manufacturing plant to TIME for the primary step-by-step have a look at how their lifesaving, and doubtlessly pandemic-ending, vaccine is made.

Luca Locatelli for TIMEThe brand new BioNTech manufacturing facility is in a wooded valley in Marburg. Technicians working in one of many prep labs typically spot deer roaming within the close by forest.
The machinery that acts as the heart of the vaccine-manufacturing facility, regulating the flow of gas, water, electricity, wastewater and more throughout the building in Marburg, where 400 employees working around the clock produce several million doses of the vaccine each week.
Luca Locatelli for TIMEThe equipment that acts as the guts of the vaccine-manufacturing facility, regulating the stream of fuel, water, electrical energy, wastewater and extra all through the constructing in Marburg, the place 400 workers working across the clock produce a number of million doses of the vaccine every week.
Luca Locatelli for TIMEAs High quality Management Lab Supervisor, Witali Schmidt oversees the testing of all uncooked supplies coming in, in addition to the completed product going out. “The product produced right here goes into the human physique,” he says. “So it’s essential that the standard is ideal, that the individual solely will get the vaccine and nothing apart from that.”

When Sahin learn a scientific paper in late January 2020 describing the primary recognized circumstances of COVID-19 in Wuhan, China, “it was very clear to me that this was not an area outbreak anymore,” he says. “And most probably the virus had already unfold worldwide.”

He knew there was no time to waste. However BioNTech, based mostly in Mainz, was then primarily a cancer-vaccine firm; after greater than a decade of analysis and growth, the corporate had examined its mRNA-based most cancers vaccines in about 400 folks, with encouraging outcomes. They had been simply exploring the opportunity of creating vaccines in opposition to infectious illnesses–particularly an mRNA-based vaccine in opposition to flu–when COVID-19 hit.

To keep it protected in the body, the mRNA is encased in a bubble of lipids through a process that uses pure, pressurized ethanol. Because ethanol is highly explosive, technicians must wear special static-free boots.
Luca Locatelli for TIMETo maintain it protected within the physique, the mRNA is encased in a bubble of lipids via a course of that makes use of pure, pressurized ethanol. As a result of ethanol is very explosive, technicians should put on particular static-free boots.
Operations at the Marburg production site never stop, not even at night.
Luca Locatelli for TIMEOperations on the Marburg manufacturing website by no means cease, not even at night time.
Sylvia Groeb works in the early stages of the process, encoding the mRNA that teaches human cells how to trigger the antibody response needed to combat the virus.
Luca Locatelli for TIMESylvia Groeb works within the early phases of the method, encoding the mRNA that teaches human cells how one can set off the antibody response wanted to fight the virus.

“[Ugur] satisfied all of us, together with our board, colleagues and scientific groups, that this was now our calling and we now have to observe this mission,” says Tureci. At an emergency assembly, Sahin urged a 40-member workforce to “transfer with the pace of sunshine” towards the corporate’s new objective of creating a COVID-19 vaccine. The workforce, which grew to greater than 200, labored nights and thru holidays on Mission Lightspeed, and after a number of weeks had produced 20 candidates. An unprecedented 4 confirmed promise in neutralizing the virus. “There was a transparent message that this needs to be the precedence,” says Andreas Kuhn, senior vice chairman of RNA biochemistry and manufacturing at BioNTech. “No matter you’re doing proper now, type of neglect about it as a result of that is an important factor now.”

With so little recognized in regards to the new virus, the workforce turned to what was recognized about two associated coronaviruses: SARS and MERS. Quickly it had a 50,000-step course of for constructing an mRNA vaccine in opposition to the brand new coronavirus, SARS-CoV-2.

Luca Locatelli for TIMEEarlier than pivoting to the COVID-19 vaccine, BioNTech was largely centered on utilizing the brand new mRNA know-how to develop most cancers vaccines. “What the success of the coronavirus vaccine has now proven is that mRNA can be a confirmed know-how for infectious illnesses,” says Andreas Kuhn, senior vice chairman of RNA biochemistry and manufacturing at BioNTech. “We haven’t forgotten in regards to the most cancers sufferers—the most cancers packages are nonetheless operating as a lot because it’s attainable underneath the present circumstances. We are going to after all return.” Kuhn was just lately vaccinated. “It was the primary time that I received a vaccine, or any type of remedy, the place I used to be truly concerned in making it,” he provides. “In order that was actually particular.”

It begins in a 50-L stainless-steel tank that extra carefully resembles a beer keg than what you may think to be a part of a lifesaving bioreactor. Inside are fragments of mRNA coding for the SARS-CoV-2 spike protein, the Achilles’ heel of the virus that the vaccine will exploit. The complete manufacturing course of occurs in a hermetically sealed system, with merchandise from every stage transported to the following through a community of clear plastic tubing.

Even so, simply to be protected, technicians routinely check the air within the manufacturing rooms for any extraneous micro organism or pathogens, and people working with the vaccine frequently faucet every gloved finger onto petri dishes crammed with agar that may tradition for any stray microbes that may have made their method into the power.

From start to finish, the entire manufacturing process flows through hermetically sealed plastic tubing. After the vaccine is pumped into bulk packaging, the tubes are sealed, then cut, to finish the process.
Luca Locatelli for TIMEFrom begin to end, all the manufacturing course of flows via hermetically sealed plastic tubing. After the vaccine is pumped into bulk packaging, the tubes are sealed, then reduce, to complete the method.
BIONTECHLab technician Nabil Jajila is responsible for moving the bags of finished vaccines in bulk to the pallets that will eventually be shipped to another facility for putting into vials.
Luca Locatelli for TIMELab technician Nabil Jajila is accountable for transferring the baggage of completed vaccines in bulk to the pallets that may finally be shipped to a different facility for placing into vials.
Manufacturing the vaccine requires large amounts of raw material, technical equipment and sterile supplies. Most of it is stored on-site in Marburg—where warehouse operator Tolga Dik is shown—and delivered to the labs on an as-needed basis.
Luca Locatelli for TIMEManufacturing the vaccine requires massive quantities of uncooked materials, technical tools and sterile provides. Most of it’s saved on-site in Marburg—the place warehouse operator Tolga Dik is proven—and delivered to the labs on an as-needed foundation.

As a result of mRNA is comparatively unstable, it wouldn’t survive in its uncooked kind within the human physique. As a way to hold the mRNA protected, it’s encased in a fatty bubble utilizing pressurized ethanol–a extremely flammable substance. The method occurs in one among six 50-L tanks, every in its personal sealed-off room. The few folks approved to enterprise out and in of the rooms placed on particular static-free footwear to keep away from producing an unintended friction spark that would set off an explosion. 5 of the tanks are named for workforce members who had been instrumental in creating the method, and the sixth is called Margaret, after the U.Okay. grandmother who was the primary individual to obtain the vaccine.

As soon as the ethanol has executed its job of making the mRNA-containing bubbles, it’s filtered out. The result’s then filtered a number of instances extra, finally ending up as a milky resolution that fills 10-L plastic luggage. That liquid is shunted to the so-called fill-and-finish part, the place it’s purified in tanks after which squirted into sterile vials–every containing as much as six doses–which can be shipped to clinics around the globe.

Lukas Knof, manufacturing engineer at the fill-and-finish facility operated by Baxter International in Halle. "It makes me very proud to work on this product, to help the whole world," Knof says. "My first day [working with the BioNTech vaccine], I was really nervous because I had the feeling that the whole world was watching. It was a big day. For Baxter, and for me."
Luca Locatelli for TIMELukas Knof, manufacturing engineer on the fill-and-finish facility operated by Baxter Worldwide in Halle. “It makes me very proud to work on this product, to assist the entire world,” Knof says. “My first day [working with the BioNTech vaccine], I used to be actually nervous as a result of I had the sensation that the entire world was watching. It was an enormous day. For Baxter, and for me.”
At the fill-and-finish facility operated by Baxter in Halle, 120 miles north of Marburg, technicians monitor the washing and sterilization of the vials before they are filled with vaccine, then stoppered and sealed.
Luca Locatelli for TIMEOn the fill-and-finish facility operated by Baxter in Halle, 120 miles north of Marburg, technicians monitor the washing and sterilization of the vials earlier than they’re crammed with vaccine, then stoppered and sealed.
At the Baxter facility in Halle, 220 vials can be filled and capped every minute. Before they are labeled, the filled vials go through one final inspection.
Luca Locatelli for TIMEOn the Baxter facility in Halle, 220 vials might be stuffed and capped each minute. Earlier than they’re labeled, the stuffed vials undergo one last inspection.

BioNTech presently produces 8 million doses of its vaccine each three to seven days on the new Marburg facility that the corporate bought from Novartis final fall. (Many lab technicians, most of whom transferred to BioNTech, nonetheless put on their previous lab coats with the Novartis emblem, as there hasn’t been time to order new ones.) In the end, the plant will churn out 1 billion doses a 12 months, and BioNTech is working with Pfizer, which oversaw the ultimate human testing that resulted within the vaccine’s authorization within the U.Okay., the U.S. and elsewhere, to ramp up manufacturing to supply the two.5 billion doses it dedicated to offering the world in 2021.

Each firms are fast to level out that their work is just not executed. Sahin and his workforce are additionally maintaining a tally of new variants of the virus beginning to take maintain around the globe, and have already developed one other vaccine to focus on these viral variations, and so they plan to start out testing it quickly.

Once bottled, the Pfizer-BioNTech vaccine is stored at -82°C (-116°F) at a filling and labeling facility in Halle.
Luca Locatelli for TIMEAs soon as bottled, the Pfizer-BioNTech vaccine is saved at -82°C (-116°F) at a filling and labeling facility in Halle.

With the success of the COVID-19 mRNA vaccine, Sahin and Tureci see mRNA know-how as enjoying a extra dominant position in treating different illnesses as properly, and are making ready to choose up the work on flu and most cancers vaccines that was interrupted by the pandemic. For now, the workforce is rightfully happy with what it’s achieved in a really busy 12 months.

“This can be a once-in-a-lifetime venture,” says Alexander Muik, director of immunomodulators on the firm, who was concerned within the early phases of creating the vaccine. “Who can say that they’re a part of the answer for a pandemic? Only some folks can say that.”

With reporting by Julia Zorthian/New York

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