BioNTech, the German company developing the first widely used vaccine together with US partner Pfizer, is busy starting up a production facility that it says could produce up to one billion doses this year alone. The estimate was raised from the original expectation of 700 million.
The company, which has never brought a pharmaceutical product to market before, wowed the world last year when it got the authorization to sell a completely new line of vaccines in the UK, United States and Europe – three highly regulated markets for medical products.
The active ingredient in the injection is messenger RNA, or mRNA, which contains instructions for human cells to build harmless portions of the coronavirus called spike proteins. The human immune system recognizes the spike protein as foreign, enabling it to increase its response to the virus after infection.
Scientists have known how to make mRNA for some time, but not for commercial mass production.
“This is what makes it attractive from a scientific perspective, but also from a manufacturing perspective, to do it on a large scale, in a short amount of time,” said Valeska Skilling, head of production at the plant.
BioNTech only received approval Friday from the European Medicines Agency for the manufacture of the vaccine on the Marburg site, which was purchased from Novartis last year. The site is located within a pharmaceutical industry cluster with roots dating back more than a century to Nobel Prize winner Emil von Behring, who developed an antitoxin for diphtheria and tetanus.
Globally, BioNTech and Pfizer now estimate they could produce 2.5 billion doses by 2021, half a billion more than expected in February.
To make this happen, some 400 employees face large-scale production challenges involving some 50,000 separate steps, some of which require months of training. A crucial concern in dealing with mRNA, which is notoriously fragile, is to strictly avoid external contamination. Workers, who usually have degrees in disciplines such as biology or pharmacy, must wear two protective suits, boots and a full head covering which takes 20 minutes to put on.
Last week the company showed reporters some of its production equipment, including a bioreactor, a metal drum in which mRNA is produced from raw materials fed by tubes and closely monitored. One batch can contain enough mRNA for 8 million doses in a bag no bigger than a large sack of rice. Then it is filtered and coupled with lipids, or fat molecules, which form tiny particles that envelop the mRNA and protect it after injection into the human body. The final step is to fill the bottles, carried out by an external partner.
Stung by criticism, and aware of Germany’s upcoming national elections, Berlin has supported the Marburg factory, helping to push the necessary documents through the German bureaucracy.
Christoph Krupp, king of government vaccine production, said companies are increasing their capacity, buying new equipment and hiring more staff. Meanwhile, the government is trying to convince them that the investment will not be in vain.
“We want to prepare ourselves to maintain the production structure we are building now in the medium term, because we don’t know how the pandemic is developing,” said Krupp. “We don’t know how the virus mutates … we don’t know if there will be another pandemic.”
In an interview with the daily Frankfurter Allgemeine Zeitung, Krupp said this would require state assistance, and the government was considering a vaccine production reserve of 500 million doses per quarter, or about 2 billion a year.
The government may hope that its investment will pay off. According to economists cited by Germany’s IFO-Institute, providing a vaccine in such a short period of time could yield each German a net profit of up to $ 1,750 a year.
Jordans reported from Berlin.
Follow all AP pandemic coverage at https://apnews.com/hub/coronavirus-pandemic, https://apnews.com/hub/coronavirus-vaccine and https://apnews.com/UnderstandingtheOutbreak