U.S., U.K. volume bets on AZD1222 come into question with vaccine efficacy data
As U.K.’s MHRA readies review of AZ’s COVID vaccine, company weighs additional trial
As the U.K.’s MHRA prepares to review AstraZeneca and Oxford’s COVID vaccine, AZ is weighing running an additional trial.
As the U.K. moves to review AZD1222 from AstraZeneca and Oxford, efficacy data from the three front-runner COVID-19 vaccines provides an opportunity to take stock of governments’ bets on which candidates warranted the most investment, and of how the landscape could shift if AZ opts for a second trial.
Both the U.S. and U.K. made AZD1222 their biggest investments by volume, largely due to its lower price. But as emerging data raises questions about its relative efficacy and optimal dosing regimen, the adenoviral vector vaccine could see its role in the COVID-19 response dwindling, with the possibility that it may never become available stateside.
The U.K.’s government Friday formally requested that MHRA start a review of AZD1222, making the country a clear front-runner to host the debut of the vaccine.
The news came on the heels of last week’s readout showing a full-dose regimen of AZD1222 performed worse than a partial-dose regimen, and raised the possibility of AstraZeneca plc (LSE:AZN; NASDAQ:AZN) needing to run another trial.
That data might affect the timing for Operation Warp Speed’s distribution of the vaccine in the U.S., if AZ waits to gather more data before filing for emergency use authorization (EUA) to FDA. But should higher performing vaccines become widely available during that time period, the candidate could miss the boat for a U.S. EUA entirely.
On Nov. 23, AZD1222 from AZ and partner University of Oxford became the third COVID-19 vaccine to meet FDA’s threshold for efficacy, behind mRNA-1273 from Moderna Inc. (NASDAQ:MRNA) and BNT162b2 from Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX).
A May deal with OWS secured 300 million doses of AZD1222, or about 37% of the total vaccine doses slated to be procured by the U.S. government, not including the exercise of any options.
But AZD1222’s performance fell short of the 95% efficacy demonstrated by mRNA-1273 and BNT162b2. (On Nov. 30, Moderna reported its vaccine had prevented 94.1% of symptomatic and 100% of severe cases of COVID-19.) Operation Warp Speed has procured 100 million doses of each of those vaccines.
The U.K. has ordered 100 million doses of AZD1222, out of a total of 357 million across seven manufacturers. AZ has said it may have 4 million doses available in the U.K. by year-end and 40 million by March.
The U.K. Department of Health has also called upon MHRA to review Pfizer and BioNTech’s BNT162b2, of which the country ordered 40 million doses; the mRNA vaccine could be available in the country as early as next month.
The U.K. also has an agreement to procure Moderna’s mRNA vaccine. On Nov. 16, the U.K. signed an agreement for 5 million doses of mRNA-1273, updated to 7 million on Nov. 29. The earliest delivery of that vaccine would be next spring.
Among vaccines without data on protection from infection, the U.S. has procured a total of 300 million doses from Novavax Inc. (NASDAQ:NVAX), Johnson & Johnson (NYSE:JNJ) and partners Sanofi (Euronext:SAN; NASDAQ:SNY) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). The U.K. has procured 210 million doses from the above plus Valneva SE (Euronext:VLA; VSE:VLA).