AstraZeneca Says Modified COVID-19 Vaccine Could Take Half a Year or More

Efforts to reach large-scale production of a COVID-19 vaccine modified to address new viral variants could take AstraZeneca (AZ) at least six months to achieve, according to company documents.

The drugmaker is working in collaboration with the University of Oxford to modify its adenovirus-vector vaccine to adequately protect against fast-spreading UK and South African viral variants. The pair of strains have put the world on edge, raising concerns that they could render existing vaccines less effective or entirely useless. They have also prompted vaccine makers and researchers to monitor and prepare for future coronavirus mutations that could impact inoculations.

In a document detailing its 2020 performance, AZ said it “is focused on adapting [its vaccine] to new disease strains if required and hopes to reduce the time needed to reach production at scale to between six to nine months,” adding that it will use existing trial data and optimize its already established supply chain to enable that timeframe.

Despite new findings that the AZ/Oxford vaccine only afforded “minimal protection” against mild-to-moderate COVID-19 infection, the World Health Organization and Western governments have voiced their continued support for the two-dose shot, contending that it still appears to fully prevent severe infection, hospitalization and death (DID, Feb. 9). The new findings, however, led South Africa to put its AZ vaccine inoculation program on the backburner and move forward with Johnson & Johnson’s single-dose vaccine instead.

AZ, whose vaccine has still not received FDA Emergency Use Authorization (EUA), anticipates seeing results from its phase 3 U.S. trial around the middle of March, and it is expected to file for an EUA for its current vaccine shortly thereafter. The vaccine is currently being rolled out in the UK and EU, where it has received conditional authorization.

The FDA is currently working on developing guidance that will spell out the data it needs to see for vaccines rejiggered against viral variants, according to Acting FDA Commissioner Janet Woodcock. The agency chief said that the FDA plans to include how sponsors can show their vaccines generate immune responses to new variants through “streamlined clinical programs” that can be conducted quickly but still generate important efficacy data (DID, Feb. 8). — James Miessler