Though the product is authorized more than 70 countries, there is currently no reported US trial data, nor application for authorization to the FDA.
Amid scrutiny of safety outcomes contrasted against limited efficacy data relative to circulating SARS-CoV-2 variants, AstraZeneca COVID-19 vaccine doses are ready and available at the millions for the US population without signs of resolution toward authorization nor distribution.
In a report from The New York Times, AstraZeneca vaccine doses prepared for the US population—as part of a $1.2 billion development and manufacture agreement through Operation Warp Speed last summer—currently surpass 30 million.
A spokesman for the company, which developed its adenovirus-based two-dose vaccine in collaboration with Oxford University investigators, said discussion with the federal government on rollout of the vaccines is minimal, and the company is expressing interest in those ready doses be sent to at-need countries.
The AstraZeneca COVID-19 vaccine is currently authorized in 70-plus countries. However, data from its US-based clinical trial has not yet been published nor reported, and no application for Emergency Use Authorization (EUA) has been sent to the US Food and Drug Administration (FDA).
The vaccine—originally among the first products to report promising phase 1 results in early summer 2020—has been snake-bitten by unprecedented setbacks. In September last year, the US trial was paused for 7 weeks to assess a pair of neurological adverse events which hospitalized treated trial participants.
Last month, South Africa health authorities announced plans to withhold AstraZeneca vaccines from its frontline caregivers, instead waiting a full week to be able to provide them the single-shot Johnson & Johnson product. A preprint from the same week showed the vaccine was only 21.9% efficacious in preventing COVID-19 in seronegative patients from the region, showing its shortcomings in mitigating spread of the region’s prevalent B.1.351 variant.
And now, Denmark, Norway and Iceland health authorities have suspended use of the vaccine following reports of severe blood clot occurrence among vaccinated persons—though a causal link to the vaccine has not been established.
Without distribution of the AstraZeneca doses, the US currently has provided at least 1 COVID-19 vaccine dose to nearly 20% of its population, and has fully vaccinated 10%, per NPR.