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Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation  jcm9144@gmail.com

SPECIAL REPORT #20.25

COVID Vaccine Development

We are all waiting with some kind of trepidation final results and positive outcomes from the various COVID vaccines currently in clinical development. Although it was expected that some early validated results would become available in October of this year, it is now most feasible that this will not be the case and that at, the very best, we will get the outcomes of some late stage clinical trial later in the year.

In the meantime, one will have to settle with partial and sometimes inconsistent data. This report is pinpointing at some of them.

In the New England Journal of Medicine, Moderna has reported data from elderly patients who received, mRNA-1273 its COVID-19 vaccine in a phase 1 trial. Age has been associated to poor outcomes in COVID-19 patients and vaccines sometimes fail to boost immunity in older patients. The trial enrolled 20 adults aged 56 to 70 years old and 20 adults aged 71 and older. Ten subjects in each group received a 25 µg dose and ten received a 100 µg dose, which is the dose Moderna currently tests in phase 3. After the second dose, levels of binding antibodies were substantially increased and are an encouraging sign of vaccine effectiveness. By day 43, levels of type 1 helper T cells had increased in all patients who received the 100 µg dose. Moderna CEO, Stéphane Bancel said on September 29, that mRNA-1273 would not be available for widespread distribution until at least spring 2021.

In a press release of September 29, Regeneron reported that REGN-COV2 antibody cocktail reduced viral levels and improved symptoms in non-hospitalized COVID-19 patients. In an adaptive phase 1/2/3, 275 patients received a high dose of 8 g or a low dose of 2.4 g of REGN-COV2 in a single infusion alongside of standard care versus placebo with standard care. “The greatest treatment benefit was in patients who had not mounted their own effective immune response, suggesting that REGN-COV2 could provide a therapeutic substitute for the naturally-occuring immune responses” said George Yancopoulos, Regeneron’s chief scientific officer. Of the 275 patients two patients suffered severe side effects. REGN-COV2 is a combination of two antibodies that target different areas of the receptor-binding domain on COVID-19’s spike protein. Regeneron hopes to confirm these findings from a group of patients who have already been enrolled.

On September 30, Blomberg reported that the European Medicines Agency (EMA) has agreed to a rolling review of the application for AstraZeneca and the University of Oxford’s AZD1222/ChAdOx1 their COVID-19 investigational vaccine. The expected timing of filling should be early 2021 when data from two pivotal-lage scale clinical studies will be available.

On the darker side of the current COVID-19 vaccine front, the US FDA has placed Inovio’s COVID-19 vaccine on hold after the health regulator raised questions. Inovio did not explicitly indicate the reasons of the setback except to say that the issue is related with the delivery device used for the study which was supposed to start in August. Inovio shares fell as much as 33% after the trial hold was announced. Innovio’s experimental vaccine is a synthetic DNA that codes for specific antibodies aimed at boosting the immune system. No DNA-based vaccine has ever been approved by any health authority.

Unformal reports from the all of the most advanced investigational COVID-19 vaccines are indicating that availability to a large public will not occur in the next three months.

Paris, October 1, 2020.

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