Pharmaceutical Industry - Why Vaccine Deliveries Are Delayed

Every dose counts. Every stitch in the upper arm saves lives. Every range of Covid-19 vaccines brings us a little closer to normal. After a slow start, the vaccination campaign in Austria is slowly picking up speed. Around a fifth of the population 1,5 million Austrians have received a partial vaccination to date. 633.000 people are already fully immunized (As of April 14.04th)

But the progress of vaccination is slowed down again and again. Manufacturers are reducing promised delivery quantities (AstraZeneca) or postponing, as recently Johnson & Johnson, delivery to Europe due to possible side effects. As a result, vaccination plans have to be reversed and vaccinations are delayed.

The procurement of the vaccine runs on several levels. The European Union concludes supply contracts with manufacturers. The EU member states then buy directly from the producers. The amount that each individual member country receives depends on the size of the population. So far, the EU has secured 2,6 billion cans from six manufacturers. Exploratory talks have been concluded with Valneva and Novavax, but no contracts have been finalized.

EU prepares for the future

But that is by no means the end of the story. As EU Commission President Ursula von der Leyen announced on Wednesday, the EU wants to negotiate with BioNTech / Pfizer about the delivery of another 1,8 billion vaccine doses for the period from 2021 to 2023. These should be used for refresher courses and vaccinations for children. Von der Leyen not only wants to locate the manufacture of vaccines, but also the production of all essential components in the EU.

However, manufacturers do not always keep their delivery promises. In the first quarter, the Union should have received 90 million cans from AstraZeneca. Then it was said that the company was only delivering 40 million. In the end, only a third, 30 million cans, was delivered. BioNTech / Pfizer and Moderna, however, kept their delivery commitments.

In the second quarter, AstraZeneca plans to deliver only around 70 million cans - instead of the contractually promised 180 million cans. Von der Leyen was angry about this and threatened the British-Swedish pharmaceutical company: "The message to the company is clear: first you keep your contract before you export," she said in mid-March. BioNTech / Pfizer, on the other hand, want to deliver 50 million additional cans to the EU by the end of June. The cans are brought forward from the fourth to the second quarter.

For Austria this means one million additional cans in the second quarter. "We can vaccinate faster," says Vice Chancellor Werner Kogler (Greens). The vaccination rollout will be adapted. As of April 14th, 2,34 million vaccine doses were delivered to Austria. However, the authorities cannot count on the same amounts every week. "There can be over-fulfillments as well as fewer deliveries than expected," says the Ministry of Health. So there are delays, but overall manufacturers have to meet their delivery obligations.

Weekly fluctuations

How many cans come to Austria per week depends on the manufacturer. BioNTech / Pfizer and Moderna deliver reliably, they say. At AstraZeneca this is not always the case, says Major General Andreas Pernsteiner from the Armed Forces Logistics Group. "At AstraZeneca there have been a number of changes in the delivery quantities since the start of deliveries in February, more than five times already," he says. According to Pernsteiner, the scheme is always the same. AstraZeneca gives a non-binding preview without a specific delivery promise a few weeks before the delivery date. In the week before delivery, there are then short-term changes in quantity. “That makes planning difficult,” says Pernsteiner. But why are there always delivery problems with the Covid-19 vaccines?

The causes are manifold. First of all, all countries face the same problem that there are (still) too few vaccines for everyone. The demand currently far exceeds the supply. According to London-based analytics firm Airfinity, which analyzes data on the pharmaceutical industry, produced around 413 million vaccine doses worldwide by the beginning of March. For this year, Airfinity expects around 9,5 billion cans to be produced. For comparison: Before the pandemic, around five billion doses of all other vaccines were made together worldwide.

“Fluctuations in the supply of cans, as frustrating as they may be, are a characteristic of the manufacture of complex organic products,” AstraZeneca said on request. According to its own statements, the British-Swedish pharmaceutical company has a network of 20 supply partners in more than 15 countries. The company emphasizes the speed at which vaccines are produced. The production takes about "only three to four months", according to AstraZeneca.

High demand with enormous time pressure: The upscaling of production quantities poses challenges for pharmaceutical companies. “Vaccines are complex to manufacture. For pharmaceutical companies this is much more time-consuming than normal drugs, ”says Alexander Herzog, Secretary General of the Austrian Association of the Pharmaceutical Industry (Pharmig). "Production runs in real time, there is no buffer, no storage capacity," says Herzog. Everything that is ready, go to the pharmaceutical wholesaler immediately.

Hundreds of individual components

Also at AstraZeneca. “We have to operate without stocks, which would give us the leeway to compensate for small unforeseen events,” the company says. There was also unexpectedly lower income at some of the newer AstraZeneca locations. "But we are still trying and confident that we will continuously increase the volumes by continuously perfecting the manufacturing process," said the vaccine manufacturer.

Vaccines consist of hundreds of individual components such as glass vials, filters or disposable bags. AstraZeneca assures that the supply of vials and closures is assured. BioNtech / Pfizer's vaccine consists of 280 ingredients from 16 different countries from 69 different manufacturers. "We guarantee 99 percent delivery security," says Reneé Gallo-Daniel, company spokeswoman for Pfizer Austria.

Safety comes first in production. "70 percent of the entire production is quality checks and batch tests," says Herzog. If there is a security problem, an entire batch can be discarded. In order to meet the gigantic demand, the manufacturers enter into cooperations. Competitors provide factories and staff. The supply of vaccines is improving from week to week, says Herzog. The next vaccines are already in the starting blocks.