The Oxford and AstraZeneca co-developed COVID-19 vaccine could be one of the first vaccines submitted for regulatory approval, alongside Pfizer and BioNTech’s vaccine candidate BNT162b2.
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The University of Oxford says it hopes to present interim Phase III trial data of its COVID-19 vaccine candidate AZD1222 to regulators by as early as next month.
The Oxford and AstraZeneca co-developed COVID-19 vaccine could be one of the first vaccines submitted for regulatory approval, alongside Pfizer and BioNTech’s vaccine candidate BNT162b2.
If approved, the Oxford-AstraZeneca vaccine could possibly roll out by late December or early 2021, making it one of the first successful vaccines available for treating the disease. This prediction reflects one recently made by Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID), who recently said a COVID-19 vaccine could be available to high-risk Americans by the end of December or early January.
There are four potential COVID-19 vaccines currently in Phase III trials in the U.S., all of which are in the running for accelerated approval. Pfizer and Moderna represent the front runners in the race, both of which are expecting to have sufficient data available to file for an Emergency Use Authorization in late November. Last month, however, Moderna CEO Stéphane Bancel said the company’s vaccine won’t likely be available until January.
While the Phase III Oxford-AstraZeneca AZD1222 trial was first posted in ClinicalTrials.gov in mid-August, work on the vaccine began in January, making it one of the earliest developed vaccine candidates for COVID-19 infection. The developers made the viral vector vaccine from a weakened version of the common cold virus that leads to infections in chimpanzees.
Prior to approval, data from the Oxford-AstraZeneca 40,000-participant late-stage vaccine trial requires careful review by regulators. In a statement made to lawmakers by the chair of the UK Vaccine Taskforce, Kate Bingham, many affiliated and independent bodies are hoping the Oxford-AstraZeneca trial as well as the Pfizer-BioNTech trial will provide positive interim data by early December.
Clinical studies of AZD1222 have faced their share of challenges during the pandemic. In September, for instance, global trials of the candidate were put on pause after a single unexplained illness occurred in a trial participant. “It is not unusual that in large scale vaccine trials, some participants will become unwell, and every case has to be evaluated to ensure the careful assessment of safety,” AstraZeneca said in a statement. Following an expedited safety review by the U.S. Food and Drug Administration in conjunction with regulators in the UK, South Africa, Brazil and Japan, the global AZD1222 trials hit the restart button in late October.
Similarly, a phase III trial of Johnson & Johnson’s COVID-19 vaccine candidate, JNJ-78436735, was temporarily paused in mid-October, also due to an unexplained illness. The company announced quickly after the pause that it was preparing to resume recruitment for the trial in the United States, based on recommendations from an independent Data Safety and Monitoring Board.
Britain’s health regulator MHRA (Medicines and Healthcare Products Regulatory Agency) has already started an accelerated rolling review of Oxford and AstraZeneca’s vaccine candidate. According to a statement by Oxford Vaccine Trial Chief Investigator Andrew Pollard, approval of AZD1222 does not necessarily mean the world will immediately return back to “normal,” as it takes time for roll out the vaccines and not everyone will choose to take them.
AstraZeneca has said it plans to produce two billion doses of AZD1222 pending regulatory approval. Approximately 400 million doses are slated for the U.S. and UK, whereas one billion doses are being planned for production for low- and middle-income countries. In the United States, the vaccine candidate is being supported by a $1 billion investment from the government’s Operation Warp Speed program, an initiative aimed at rapidly producing a vaccine against the novel coronavirus.
But a decline in COVID-19 infections in the UK this summer has led AstraZeneca to delay vaccine deliveries to the UK government, at least until enough data from Phase III clinical trials become available. Initial delivery estimates for the UK was 30 million shots by Sept. 30, but now Britain’s vaccines chief says only 4 million doses will be delivered this year.
