Dive Brief:
- German drug conglomerate Bayer will help CureVac manufacture tens of millions more doses of the biotech's experimental coronavirus vaccine beginning as soon as the end of this year, company executives said in a Monday briefing with the German health minister.
- Bayer and CureVac are already co-developing the vaccine, with the large pharma providing support for clinical testing and regulatory discussions in other countries. Now, after discussions with the German government, Bayer has also agreed to make 160 million doses of CureVac's shot in 2022
- CureVac recently began a Phase 2/3 study testing whether its vaccine prevents COVID-19. The company aims to enroll into the trial some 36,000 volunteers in Europe and South America. Early results could be available by the end of March, CureVac's CFO Pierre Kemula recently told BioPharma Dive.
Dive Insight:
A shaky start to immunization campaigns in the U.S., U.K., and Europe, as well as the emergence for more virulent coronavirus strains, have drawn attention to limited vaccine supplies. While the makers of currently authorized shots, such as Pfizer and Moderna, expect production to steadily ramp up over the course of the year, more doses are desperately needed.
The supply crunch has already led to unusual partnerships, with Sanofi and Novartis last week pledging to lend extra production capacity to Pfizer and partner BioNTech.
The world will also need additional vaccines to be proven effective. CureVac, a German drug developer, is among those now in late-stage testing with an experimental candidate. Its target supply for 2021 — about 300 million doses — is significantly less than what other large pharmaceutical companies expect to produce for their respective shots.
Bayer, which does not make vaccines, will help boost CureVac's manufacturing capacity, but the production help likely won't arrive until 2022 or, at the earliest, late this year.
"Following discussions with the German government it has become clear that current manufacturing capacities for vaccines need to be increased, particularly for potential variants of the SARS-CoV-2 virus," said Stefan Oelrich, head of Bayer's pharmaceuticals division, at the Feb. 1 briefing.
Oelrich said Bayer will use its manufacturing network, including a large site in Wuppertal, Germany, to add 160 million more doses to CureVac's target supply in 2022.
CureVac's Kemula told BioPharma Dive the company expects to produce about 600 million doses in 2022. It's not clear whether the 160 million doses would be in addition to that total.
Incidentally, Bayer recently agreed to sell a plant within the Wuppertal site to China's WuXi Biologics, which intended to use the factory for coronavirus vaccine production. The agreement, worth about 150 million euros, included a long-term lease and services.
Also on Monday, CureVac announced its contract manufacturing partner Rentschler Biopharma had begun setting up manufacturing and optimizing production processes for the company's shot.
CureVac's vaccine, like ones developed by Moderna and BioNTech, uses messenger RNA to train the body's immune system to defend against coronavirus infection.
The dose picked by CureVac is about a third of BioNTech's and a tenth of Moderna's, potentially allowing CureVac to stretch supply of its drug product further. It's not clear, however, whether a smaller dose will correlate with strong efficacy. Early study results showed CureVac's vaccine spurred immune responses matching levels seen in the blood of recovered patients, but scientists are not yet certain what levels are required for a vaccine to be protective.