Research Roundup: Moderna will not enforce COVID-19 patents, rolling EMA approval for vaccine candidates, and monoclonal antibody treatment study results
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Moderna announced last week that it would “not enforce” its COVID-19–related patents against other vaccine makers and would be willing to license intellectual property for COVID-19 vaccines for the post-pandemic period. The company, which is currently developing one of the four front-running COVID-19 vaccine candidates, said in a statement that it feels a “special obligation under the current circumstances to use our resources to bring this pandemic to an end as quickly as possible.” Some advocates have responded with praise for Moderna being the only company working on a drug or vaccine to pledge open-sharing of its COVID-19 patents, while other advocates question the motivations behind the pledge, given Moderna’s pending intellectual property legal challenges as well as recent consumer and political pressures for access. Moderna plans to submit its vaccine candidate for US Food and Drug Administration (FDA) emergency use authorization by November 25 and later as a candidate for the general population by late January 2021, with the aim of having it available for widespread distribution by spring 2021.
BioNTech and Pfizer have begun a rolling submission of their COVID-19 vaccine candidate for review by the European Medicines Agency (EMA), a process that AstraZeneca’s vaccine candidate also began the previous week. The candidate, BNT162b2, was accepted for rolling review based on its strong preclinical and early clinical data, which showed antibody and T-cell responses in people dosed in early-phase trials. BioNTech and Pfizer subsequently launched a phase 3 clinical trial—so far enrolling 37,000 participants across several countries. EMA will start assessing data on the experimental candidate before all necessary evidence is available, allowing it to reduce time spent on a decision once pivotal clinical trial results are available.
A monoclonal antibody treatment developed by Eli Lilly appears to be effective in reducing virus levels and preventing hospital use in COVID-19 patients. The treatment, a combination of two monoclonal antibodies, was tested in non-hospitalized patients sick with COVID-19. Eli Lilly is also developing and had previously released results for a similar treatment using a single antibody, for which the company has filed for FDA emergency use authorization. Both antibody regimens have been well-tolerated, with no serious side effects, according to a company statement. Eli Lilly has said it expects to file for emergency use authorization for its combination therapy next month and anticipates having 1 million single-antibody treatment doses and 50,000 combination treatment doses available in the fourth quarter of 2020.