Is President Trump preparing to fast track the AstraZeneca COVID-19 vaccine known as AZD1222? According to a report in the Financial Times, this is exactly what is being contemplated as the administration would “bypass normal regulatory standards to fast-track” the experimental AZD1222 for use in America ahead of the November 3, 2020 election. One tool that is contemplated, according to these reports, is the use of the emergency use authorization (EUA) in October: this would certainly lead to an even wilder election. A UK study involving AZD1222 has enrolled 10,000 participants while U.S. government agencies established the bar at 30,000 volunteers. The White House has declined to comment on any fast-tracking of AZD1222. But should this investigational product, developed by University of Oxford and considered by some to be the leading COVID-19 vaccine candidate, be fast-tracked before the election that certainly could shake things up even more. Now AZD1222 has arrived in America for the Phase 3 pivotal study, which has an estimated start date of August 17, according to government disclosures. TrialSite identified a major anomaly worthy of discussion. It involves the study’s estimated primary completion date: unlike any other major COVID-19 Phase 3 vaccine study in the West or for that matter in the East. This study timeline is unbelievably compressed with the estimated start date of August 17 followed by the estimated primary completion date on December 2, 2020. Does this unprecedented timeline compression have a purpose above and beyond good science and public health?
Could politics somehow influence study design in a bid to position “emergency use authorization” by October? This could be a powerful booster to bolster a strong position right before the election. AstraZeneca, according to Reuters, of course has denied such discussions but this again fits into a powerful political narrative that intrigues at least a peer into more details.
Currentl,y AstraZeneca’s AZD1222 is in Phase 2 and 3 clinical trials in the UK. South Africa, Brazil, India and as noted below, now America. Although AZD1222 is considered a leading candidate, it would probably be premature to declare this vaccine was ready within a few months. But that’s exactly what has been set up!
AZD 1222 Phase 3 Clinical Trial Comes to America
This study literally just started last week, according to U.S. disclosure in Clinicaltrials.gov. Partnered with one of the world’s leading contract research organizations (CROs) called IQVIA, AstraZeneca has launched the Phase 3, double-blind, placebo-controlled study of AZD1222 for the possible prevention of COVID-19 in adults. With a formal start data of August 18, the study is not yet recruiting volunteers, according to the government website.
Targeting 30,000 volunteers, the mass scale study includes two arms and three primary outcomes measures and seven secondary outcomes measures viewable here.
The clinical trial will include at least 62 trial site locations with well-respected principal investigators out of University of Rochester and Columbia University. They include Ann Falsey, MD (Univ. of Rochester) and Magda Sobieszczyk, MD (Columbia University).
The Anomaly: Unprecedented Acceleration from Study Start Date to Estimated Primary Completion Date
Upon reviewing the AstraZeneca (AZD1222) start date of August 18, the study designers follow a very different pattern than precedent. In this case, it has appeared to be put on an incredibly intensive accelerated fast track with the estimated primary completion date on December 2, 2020! This is just about 3.5 months in an unprecedented move, materially deviating from peer trials from Pfizer, Moderna, and Johnson & Johnson (Janssen), not to mention the Chinese biotech’s Phase 3 studies.
Given the established target dates, it’s literally possible that if the study team can work tirelessly to enroll and treat the participants, they would be able to accumulate enough data for an assessment leading to potential emergency use authorization (EUA) before even the Nov 3 election.
A Review of Other Phase 3 COVID-19 Vaccine Trials
TrialSite reviewed the other two critical Phase 3 COVID-19 vaccine trials ongoing in the United States and beyond. Here the author sought to determine if the AstraZeneca study term between study start date and estimated primary completion date truly deviated markedly from comparable peers. This turns out to be the case.
In the case of the prominent Moderna (mRNA-1273) trial, the start date of the Phase 3 study was July 27, 2020. Now the estimated primary completion date is actually October 27, 2021, a little over a year from the start date. And the estimated final end date is the same.
But what about the promising BNT162 trial? Interestingly, TrialSite also reviewed the BioNTech/Pfizer (BNT162) Phase 3 clinical trial. In that case, the study start date was April 29, 2020 with an estimated primary completion date of April 16, 2021, a year later and a final estimated completion date of November 11, 2022.
In both the case of Moderna and Pfizer, at least a year passes between the Phase 3 COVID-19 vaccine start date and the estimated primary completion date. This falls in line with more historical precedent.
But what about Other Phase 3 Studies around the world?
TrialSite starts with the massive Janssen (J&J) sponsored Phase 3 clinical trial testing its experimental vaccine called Ad26.COV2.S on 60,000 participants around the world. With a start date of September 5, 2020, the study’s estimated primary completion date, fitting the norm for such a large study, is March 10, 2023 (2.5 year after start date).
In the UK, the University of Oxford leads the study of the same study drug (also calledChAdOx1 nCoV-19) that involves AZD1222, and TrialSite uncovered that the study start date was May 28, 2020 with an estimated primary completion date of August 2021 (1.3 year after start date) and an estimated study completion date during the same time.
On to the Chinese biotech vaccine makers and a similar pattern was observed.
China National Biotech now conducts its Phase 3 study for its inactivated COVID-19 vaccine. Targeting 45,000 participants, the start date was July 16, while the estimated primary completion date is March 16, 2021 (7 months after start) and estimated study completion date September 2021.
Chinese biotech Sinovac is also conducting a Phase 3 COVID-19 trial, which commenced July 21, 2020 and has a scheduled estimated primary completion date over a year later on September 21, 2020 with an estimated study completion date of October 2021.
What follows is a summary of the COVID-19 vaccine studies to date with start date and estimated primary completion date.
|Pharma Phase 3 COVID-19 Vaccine Study||Duration (Start date to Est. Primary Completion)|
|Moderna (mRNA-1273)||15 months|
|Pfizer/BioNTech (BNT162)||12 months|
|J&J (Janssen) (Ad26.COV2.S)||30 months|
|China National Biotech (inactivated vaccine)||7 months|
|Sinovac (CoronaVac)||14 months|
|University of Oxford (same as AZ)||15 months|
|AstraZeneca (AZD1222) in USA||3.5 months|
As is seen in the table above, AstraZeneca has dramatically deviated from any of its peers in the Western World, including the maker of the same vaccine candidate, University of Oxford. In one case, the duration between start date and estimated primary completion date is under a year—and that’s with China National Biotech. In this way, the AZD1222 trial in the USA takes on a compressed timeline similar to another major study: the Gamaleya study in Russia.
Big Stage for IQVIA
Clinical research organization (CRO) giant IQVIA was selected as the key collaborator and service provider of this pivotal study. One of the largest (if not the largest) and most sophisticated clinical trial services firms in the world, IQVIA has been considering virtual clinical trials for a long time and is perhaps a leader in assembling various technologies to accelerate studies, where and when feasible. This study becomes, perhaps, one of the most important in IQVIA’s history (the company is the result of a merger between CRO Quintiles and pharmaceutical information firm IMS).
Again, rumors and rumblings of an “October Surprise,” that is, an October emergency use authorization are just that, rumors captured in the press that don’t necessarily represent the truth. Based on all precedent, announcing an October emergency use authorization option for the AZD1222 COVID-19 vaccine would be premature but, as TrialSite has identified, perhaps conceivable based on how the study is designed; the study protocol has established an incredibly aggressive estimated primary completion date timeline.
The study design, involving 30,000 volunteers, includes an estimated primary completion date that’s literally just a few months from the start date. This kind of design assumes an intense amount of upfront activity; that is, the front-loading of enormous amounts of data collection in just over 90 days. This very well could lead to the opportunity for the sponsor to meet the December estimated primary completion date. If this assumption were to materialize, by October of this year, the sponsor will have accumulated enough data that potentially, a call could be made by the U.S. Food and Drug Administration (FDA) for an emergency use authorization, hence confirming the rumors heard today and reported in the Financial Times.