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Product Development

COVID-19 Quick Takes: EMA to require more stringent safety monitoring for vaccines; plus J&J, Clover-Thousand Oaks, Medicago-GSK, Inovio and Synairgen

Nov 18, 2020 | 2:24 AM GMT

EMA details additional safety monitoring requirements for vaccines
EMA announced several additional safety monitoring activities it will require of COVID-19 vaccine manufacturers in addition to the normal pharmacovigilance requirements of all medicines. These include the submission of monthly safety reports, rather than the usual six-month safety reports; post-authorization observational safety studies; and enhanced monitoring of reported adverse events to more quickly detect any emerging safety signals. EMA will also increase its transparency by publishing the full risk management plan for each COVID-19 vaccine.

J&J starts second Phase III vaccine trial
Johnson & Johnson (NYSE:JNJ) said Monday it began evaluating prime-boost administration of JNJ-78436735 in the 30,000-subject Phase III ENSEMBLE 2 study. The pharma will run the new study in parallel with the 60,000-volunteer Phase III ENSEMBLE trial, which began in September, of one vaccination with the adenoviral vector vaccine. On Sunday, the company announced an expanded collaboration with the Biomedical Advanced Research and Development Authority (BARDA), under which the pharma will now commit $604 million and BARDA $454 million to conduct ENSEMBLE.

Clover partners with Thousand Oaks on vaccine
Sichuan Clover Biopharmaceuticals Inc. partnered with CDMO Thousand Oaks Biopharmaceuticals Inc. to package its COVID-19 vaccine candidate and support global Phase II/III testing and commercialization; financial terms were undisclosed. Earlier this month, the Coalition for Epidemic Preparedness Innovations (CEPI) said it would continue to support development of the vaccine, providing full funding for the pivotal trial, for a total investment of up to $328 million.

Medicago vaccine plus GSK adjuvant in Phase II/III
Medicago Inc. and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) started a Phase II/III trial testing prime-boost administration of 3.75 µg CoVLP, a recombinant spike virus-like particle produced in a tobacco plant, and the adjuvant AS03. Phase II will enroll over 300 volunteers ages 18-64 and over 300 people ages 65 and older; the 30,000-subject Phase III portion is expected to start before year-end.
The trial start comes less than a week after the Mitsubishi Tanabe Pharma Corp. (Tokyo:4508) subsidiary published in medRxiv Phase I data for 3.75, 7.5 or 15 µg CoVLP alone or in combination with Dynavax Technologies Corp. (NASDAQ:DVAX) adjuvant CpG 1018 or AS03CoVLP plus AS03 induced the strongest humoral and cellular responses.

Inovio vaccine begins Phase II
Inovio Pharmaceuticals Inc. (NASDAQ:INO) said it began the Phase II portion of the Phase II/III INNOVATE study, which will be funded by the U.S. Department of Defense, of DNA vaccine INO-4800. The planned Phase III portion will remain on a partial clinical hold until the company resolves FDA’s questions regarding the CELLETRA 2000 device for vaccine delivery.

Inhaled interferon benefits hospitalized patients
Synairgen plc (LSE:SNG) published Thursday in The Lancet Respiratory Medicine previously announced interim Phase II data showing hospitalized COVID-19 patients given SNG001 vs. placebo had greater chance of clinical improvement on an ordinal scale and of recovery as defined as no limitation of activities and no clinical or viral signs of infection. The inhaled IFN-β-1a is one of at least two type I interferon products to have shown signs of efficacy against COVID-19 in the clinic.

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