Moderna set to deliver COVID-19 jab to the EU

The EU is continuing its COVID-19 vaccine shopping spree to supply member states with enough doses to vaccinate its entire population with a potential immunisation against the novel coronavirus SARS-CoV-2. After having signed options on a certain amount of the vaccines of AstraZeneca/Unversity Oxford, CureVac, Sanofi/GlaxoSmithKline, Janssen Pharmaceutica, it is now discussing another agreement with US company Moderna, the most advanced western developer of a potential COVID-19 vaccine.

Under the deal, the European Commission would have the option to purchase up to 160 million doses of Moderna’s vaccine candidate mRNA-1273 against the viral Spike protein, which is believed to provide immunisation against SARS-CoV-2 for at least 3 months.

Moderna kicked off Phase III study of mRNA-1273 on July 27 and enrollment of approximately 30,000 participants is on track to complete in September. The second mRNA vaccine supplier, Germany’s BioNTech, which has recruited 11,000 from 30,000 healthy volunteers at the end of June for a Phase III trial has not yet a deal with the Commission, which prefered to make an option agreement with the company‘s competitor CureVac AG, whose mRNA jab candidate has recently finished Phase I trials and in which the German EU presidency invested €300m at a price of €10 per share before the company’s recent Nasdaq IPO boosted the share value from €16 to currently €62.65 per share.

While nobody currently knows, if there will be a safe and effective vaccine against coronaviruses, which will not trigger antibody-directed enhancement (ADE), as there are only vaccines against 17 of roughly 100 human-pathogenic viruses, developers of COVID-19 therapeutics press for adequate public funding of treatments. Proctection, vaccines and therapeutics must be the 3 pillars of a rational strategy to fight the burden of the COVID-19 pandemic, a coalition of drug and antibody makers argues. People are dying until we will have an effective mass vaccination to protect young people as well as the immuno-senescent group of older high-risk patients.

Vaccine makers, such as Moderna, are building production capacities for mass vaccination with help of upfront payments provided by the governments. Moderna said, its goal was to be able to deliver up to  approximately 500 million doses in 2020 and possibly up to 1 billion doses per year, beginning in 2021. In Europe, the company is working with the CDMO Lonza and ROVI  for manufacturing and fill-finish outside of the United States.

According to Reuters, yesterday, the first documented instance of human re-infection with the new coronavirus was reported by researchers from the University of Hong Kong. A 33-year-old man, reinfected four-and-a-halft months after he had recovered from an infection with SARS-CoV-2. The impact on the finding is not yet clear. WHO officials downplayed any impact on current strategies to fight the COVID-19 pandemic. Researchers, however, told European Biotechnology that "we all know the frequent re-infections with other, not life-threatening coronaviruses (seasonal cold) – this is especially known with the virus family. As there are no vaccinations yet, we urgently need an effective means to prevent the deadly course of COVID-19."

The Hong Kong research group stated that vaccine-induced immunity may differ from naturally occurring immune reactions. Though, one has to wait for the outcomes of pivotal vaccine studies.