Manufacturers of COVID-19 vaccines typically start delivering in under six months after tech transfer

Based on press releases and additional publicly-available information, KEI is building a dataset with a non-exhaustive list of deals that involve technology transfer and outsourcing of COVID-19 vaccines manufacturing. As of February 19, 2021, the dataset includes observations for over 70 outsourcing and technology transfer deals done since the start of the pandemic until present. We will continue to add deals and data points.

The current version of this dataset, which is still a work in progress, is available here.

The dataset includes a diverse list of companies, platforms, and manufacturing steps. In most of the cases where information is publicly available, delivery of the first batches started in under six months after the technology transfer began. Our dataset shows that companies with pre-existing drug and vaccine manufacturing capabilities can start producing COVID-19 vaccines relatively quickly, if technology transfer is made.

Timing of delivery following the technology transfer

We reviewed the date when the outsourcing agreements were announced, which we see as a proxy for the date when the technology transfer started, and the estimated time it took the manufacturer to make their first delivery. In almost all of the cases where information is available the manufacturer said that they were going to make the first delivery, or actually started delivering, within six months from the deal announcement date. This is true across vaccine technology platforms, and for different types of manufacturing steps – regardless of whether the deal relates to the production of bulk active ingredients, fill and finish, or the complete product.

Viral vector vaccines

For instance, on August 17, 2020, mAbxience in Argentina announced that they had entered into a manufacturing and technology transfer agreement with AstraZeneca for their then vaccine candidate. mAbxience is a biologics and biosimilars manufacturing company that had just recently inaugurated a production plant in Garín, Argentina. Three months later Hugo Sigman, CEO of Grupo Insud, mAbxience’s parent company, announced that production of the AstraZeneca vaccine was going to start on November 23, 2020. Therefore, mAbxience started production of the AstraZeneca vaccine just over three months after the technology transfer presumably began.

Another example of technology transfer deals relating to the AstraZeneca viral vector vaccine are the ones signed with Emergent BioSolutions. On June 11, 2020, Emergent BioSolutions announced that they had entered into a manufacturing agreement with AstraZeneca relating to their COVID-19 vaccine. On July 27, 2020, Emergent BioSolutions announced that they had expanded their manufacturing agreement with AstraZeneca. Emergent BioSolutions’ CEO Bob Kramer said during a February 2, 2021 interview, less than seven months after the June 11, 2020 deal was announced, that they had already started manufacturing the AstraZeneca viral vector-based vaccine.

mRNA vaccines

We have identified over a dozen deals outsourcing steps for mRNA manufacture, which involve three vaccines using that technology platform. Our analysis of those deals also suggests that manufacturers committed to deliver the first batches in just a few months after the deal was signed and technology transfer presumably started.

For example, on May 1, 2020, Swiss multinational Lonza announced an agreement with Moderna to manufacture their COVID-19 vaccine mRNA-1273. According to the announcement, the companies planned to establish “manufacturing suites at Lonza’s facilities in the United States and Switzerland for the manufacture of mRNA-1273 at both sites.” They explained that “[t]echnology transfer [was] expected to begin in June 2020, and the companies intend to manufacture the first batches of mRNA-1273 at Lonza U.S. in July 2020.” In this case, Lonza and Moderna planned to start manufacturing the vaccines just within a month after they began the technology transfer process. Following the emergency use authorization in the United States, Lonza produced the first commercial batch of the Moderna vaccine in November 2020.

Similarly, in November 2020 contract developing and manufacturing company Rentschler Biopharma SE entered into an agreement with CureVac for the production of their COVID-19 vaccine. Rentschler agreed to “manufactur[e] active pharmaceutical ingredient, downstream processing and formulation of drug substance for the vaccine.” On February 1, 2021, Rentschler announced that they had “initiated the set-up of manufacturing capabilities for CureVac´s COVID-19 vaccine, CVnCoV.” This suggests that it took them around three months to set up the manufacturing capacity to produce this vaccine.

Several of the mRNA deals in our dataset relate only to the fill and finish step. Based on the cases where data is available, it appears that it typically takes between one to three months for contract manufacturers to start delivering filled and finished vaccines. For example, Recipharm AB agreed to perform that step for Moderna at their drug manufacturing facility located in France, according to a December 30, 2020 announcement. The press release said that “supply will commence in early 2021.”

Protein subunit vaccines

Our dataset includes over a dozen agreements for the manufacture of protein subunit vaccines, most of which involve Novavax. For example, in August 13, 2020, Novavax and SK Bioscience announced they had reached “a development and supply agreement for the antigen component of NVX-CoV2373.” SK Bioscience, which had “cell culture and recombinant protein capability,” said that they planned to “initiate the production of the NVX-CoV2373 antigen at its vaccine facility in Andong L-house, South Korea beginning in August 2020.” This suggests that the company believed it could start delivering vaccines within a month after the technology transfer process presumably started.

Types of facilities that can manufacture vaccines

Another insight that can be drawn from our outsourcing and technology transfer deals dataset relates to the type of facilities that can be used for the production of COVID-19 vaccines. Our review suggests that a variety of companies with different types of pre-existing capabilities could start manufacturing COVID-19 vaccines, if technology transfer is made. The list of contracted manufacturers include companies with previous experience in vaccine manufacturing, such as the Serum Institute; but also companies with recently built facilities, some of which were designed mostly for the production of drugs or biologics. For instance, the mAbxience facility in Argentina where the AstraZeneca vaccine is being manufactured was built primarily for the production of biologics and biosimilars.

Similarly, some companies agreed to manufacture multiple vaccines. For example, Emergent has entered into deals with Janssen and AstraZeneca. Rentschler Biopharma has agreements with Pfizer/BioNTech and CureVac. Serum Institute has agreements with AstraZeneca and Novavax. At least in the case of the Serum Institute agreements, the manufacture involves two different vaccine platforms: protein subunit and viral vectors.