An incredibly costly mistake will delay the Sanofi SA and GlaxoSmithKline PLC COVID-19 vaccine by several months, complicating plans by developed economies in America and Europe for greater numbers of inoculations. Due to mishaps with manufacturing processes, volunteers in studies were actually administered lower doses than the clinical trial protocol directed. Now, according to Sanofi, the teams will have to reformulate the vaccine and go through the process of needing to restart the clinical trials in February 2021. With an estimate of four to five months in the middle of a pandemic, this leads to an incredibly disappointing reality measured not only in enormous costs but also an adverse impact on the mission to combat COVID-19. Initially thinking the two companies could have a regulatory approved product by the first half of 2021, they now estimate the last quarter of 2021—about a year from now. Both of these European pharmaceutical companies received $2.1 billion of U.S. taxpayer money from Operation Warp Speed in a bid to accelerate the testing, production and ultimate distribution of this vaccine candidate.
The OWS Deal
In the Operation Warp Speed deal, the European pharma’s were awarded $2.1 billion back in July in exchange for the U.S. government securing 100 million future doses plus an option to acquire 500 million more doses. Moreover, the European Union has ordered up to 300 million doses. TrialSite notes that this is just the latest investigational product production mishap. AstraZeneca reported in November that their AZD1222 vaccine candidate (Oxford vaccine) was impacted when mistakes in manufacturing led to a lower dose than the protocol called for. This turned out to include some good news as the lower dose actually had a more positive impact (e.g., greater effectiveness), but the errors in the process raised significant questions about quality control. Could these companies be moving too fast?
The Rivals Team up
Typically competitors, Sanofi and GSK teamed up to co-develop the vaccine in a concerted effort to combine forces to accelerate the vaccine development. The parties brought together the Sanofi-based antigen, which is a protein derived from SARS-CoV-2 that serves to trigger immunity—and GSK-owned adjuvant, a molecule introduced to enhance the immune response.
Heart of the Problem
The core of the mishap involved reagents produced by a couple of suppliers. Reagents are substances or compounds added to a system to trigger a chemical reaction or added to test if a reaction will, in fact, occur.
Apparently, in this case, the team produced errors of faulty substances associated with two different reagent suppliers. As it turns out, both reagents, originating from third-party supplier manufacturers, involved inexact volumes of material in the actual reagent.
The industry sponsors had already treated volunteers with the investigational product. Again, unbeknownst to the pharmaceutical companies, volunteers were not receiving the appropriately manufactured vaccine. Interestingly, the candidate appeared to generate positive results for the age group of 18 to 49. However, for the vulnerable cohort aged 50 and above, the flawed investigational product led to an overall inadequate immune reaction.
It is important to note that mistakes such as this, that is, reagents with improper mixtures, for example, can lead to dangerous results. This shouldn’t happen.