COVID-19 News: CureVac Partners with Novartis and More
According to the U.S. Centers for Disease Control and Prevention (CDC)’s COVID Data Tracker, 107,028,890 total COVID-19 vaccine doses have been delivered and 80,540,474 administered. Of those, 26,957,804 have received two doses.
Distribution and administration of the Johnson & Johnson vaccine began this week, which will change the metric a bit, because it only requires a single shot. There is also additional COVID-19 news. Here’s a look.
CureVac and Novartis Partner on Manufacturing CureVac’s COVID-19 Vaccine
Germany’s CureVac NV inked a deal with Switzerland’s Novartis AG to manufacture CureVac’s COVID-19 vaccine candidate, CVnCoV. They have already begun work on it, including technology transfer and test runs. After the final agreement, Novartis plans to manufacture the mRNA and bulk drug product for the vaccine for up to 50 million doses by the end of this year and up to another 200 million doses in 2022. They expect delivery from their manufacturing location in Kundl, Austria to begin in the summer of this year.
CureVac’s integrated European vaccine manufacturing network includes Bayer, Fareva, Wacker and Rentschler.
“I am very pleased that with Novartis we have found another highly experienced partner to support the production of our vaccine candidate,” said Florian von der Mulbe, chief production officer of CureVac. “Together with Novartis we expect to increase significantly our manufacturing capacity and place our production network on an even broader base.”
Novavax Expects FDA Emergency Use Authorization for its COVID-19 Vaccine by May
Earlier this week, Novavax’s chief executive officer, Stanley Erck, said he expected the U.S. Food and Drug Administration (FDA) might grant the company’s COVID-19 vaccine emergency use authorization (EUA) by May. The company reported positive interim data from the Phase III trial in the UK in January, where the vaccine candidate demonstrated 89.3% efficacy. It included the most common wildtype Wuhan strain, as well as the UK and South African variants.
Novavax also signed a deal with Poland’s Mabion SA to possibly produce the COVID-19 vaccine. Mabion will initiate commercial-scale production trials of Novavax’s vaccine and the technology transfer will begin. The company would be part of Novavax’s plan to supply 1.5 billion doses of the vaccine already contracted globally. Novavax also believes the vaccine will be approved for use in Europe this quarter.
European Regulators Begin Rolling Review of Russia’s Sputnik V COVID-19 Vaccine
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) initiated a rolling review of Sputnik V (Gam-COVID-vac), Russia’s Gamaleya National Centre of Epidemiology and Microbiology’s COVID-19 vaccine. The rolling review launch was based on data from lab studies and clinical trials in adults. The data suggests that the vaccine triggers antibodies and immune cells that target SARS-COV-2 and may help protect against COVID-19.
EMA will determine if the benefits outweigh the risk and if the vaccine complies with the usual EU standards for effectiveness, safety and quality. They didn’t provide a timeline other than to say it should “take less time than normal to evaluate an eventual application because of the work done during the rolling review.”
Bharat Biotech’s COVID-19 Demonstrated 81% Efficacy
Bharat Biotech, based in India, reported interim vaccine efficacy of 81% for its COVID-19 vaccine. The interim data analysis was based on 43 recorded cases of the disease in the trial of 25,800 people. The Phase III trial was conducted in partnership with the Indian government’s medical research division. Of the 43 cases, 36 received a placebo, compared with seven who received the Bharat Biotech vaccine. The country approved the vaccine, COVAXIN, in January ahead of Phase III efficacy data. India has begun vaccinating its population using COVAXIN and the Oxford-AstraZeneca vaccine.
MediciNova Discontinues Development of its COVID-19 Vaccine
MediciNova, based in La Jolla, California, announced that after a careful review of its development programs, it was discontinuing development of its COVID-19 vaccine. The decision, they indicated was “to maintain adequate resources for its other development programs which have indications with larger unmet medical needs and market opportunities.”
The last time the company announced anything related to its COVID-19 vaccine was on November 24, 2020. At that time, MedicieNova announced that Good Manufacturing Practice (GMP)-based Master Virus Seed Stock (MVSS) production of the vaccine, using BC-PIV technology, was initiated at Millipore Sigma BioReliance Service, a group company of Merck KGaA, Darmstadt, Germany.