Astrazeneca plc is the first company to sign an agreement with the European Commission to supply a COVID-19 vaccine.
The company agreed to provide the commission with up to 400 million doses of AZD-1222, which produces a surface spike protein prompting the immune system to attack the SARS-CoV-2 virus should it infect a body. The first delivery is expected by the end of 2020.
The agreement gives all EU members optional access to a vaccine at no profit. Those members could also redirect the doses to other European countries.
Other companies currently talking with the commission to supply vaccines are Sanofi SA-Glaxosmithkline plc for 300 million doses, Pfizer Inc., Moderna Inc., Johnson and Johnson, Biontech SE and Curevac BV.
In late July, Astrazeneca posted interim data from AZD-1222’s phase I/II blinded, multicenter, randomized, controlled clinical trial of 1,077 healthy adults showing the vaccine was tolerated and generated a robust immune response against the virus. The data showed a fourfold increase in antibodies to the virus spike protein in 95% of the patients a month after injection. A T-cell response, peaking by day 14, was also induced and maintained for two months afterward.
The vaccine is in phase II/III studies in the U.K., Brazil and South America, with data expected before the end of 2020. The studies will begin in the U.S. this year.
In mid-June, Astrazeneca agreed to supply up to 400 million doses of the vaccine with Europe’s Inclusive Vaccines Alliance, which includes Germany, France, Italy and the Netherlands.
Astrazeneca is receiving big backing in the form of $1.2 billion from the U.S. government as part of Operation Warp Speed to produce 300 million doses of AXD-1222, which is being developed by the University of Oxford in the U.K. and is licensed to Astrazeneca.
Novavax’s U.K. vaccine deal
Novavax Inc. said it signed an agreement to supply the U.K. government with 60 million doses of NVX-CoV2373, its vaccine engineered from SARS-CoV-2’s genetic sequence, in the first quarter of 2021. The agreement also includes a phase III study to asses the vaccine’s efficacy in the U.K. population.
Fujifilm Diosynth Biotechnologies will manufacture the antigens in the U.K., North Carolina and Texas. The U.K. site is expected to produce 180 million doses annually.
The agreement with Gaithersburg, Md.-based Novavax follows U.K. vaccine agreements already made with Astrazeneca, Valneva SE, Wockhardt Ltd., Sanofi and Glaxosmithkline.
The Novavax deal prompted the company stock (NASDAG:NVAX) to rise 9.9% Aug. 14, with shares closing at $146.51. The past 12 months have seen a dramatic rise in Novavax stock. On Aug. 14, 2019, shares went for a mere $6.04 each and peaked at $178.51 each on Aug. 10.
Shares wobbled about from Aug. 10 to 12. J.P. Morgan analyst Eric Joseph wrote that reaction to Russia’s approval of a vaccine may have played a part, as well as an Operation Warp Speed award to Moderna and Biontech’s positive incremental phase I data of BNT-162b1 that perhaps also contributed to the weakness. Joseph wrote that “we would be buyers into the recent weakness, maintaining our view of NVX-CoV2373 having a best-in-class benefit/risk profile” heading into phase III development.
Like Moderna and Astrazeneca, Novavax also has an Operation Warp Speed deal in the U.S. On July 7, it signed on to provide 100 million doses for $1.6 billion.
Preclinical data showed NVX-CoV2373 demonstrated an indication of antibodies to block binding of spike protein to receptors that are targeted by the virus.
Novavax has its phase I/II trial of NVX-CoV2373 going in Australia. The U.K.-based phase III, a randomized, double-blind, placebo-controlled study of 9,000 adults, is anticipated to begin in the third quarter of 2020. The clinical trial is designed to evaluate antibody and T-cell responses.