AstraZeneca's COVID-19 vaccine launch has been hit with safety concerns and supply shortfalls in Europe, and now the drugmaker is responding to yet another setback—this time in the U.S.
With the Biden administration ordering Johnson & Johnson to take over an error-prone Emergent BioSolutions plant in Baltimore, AstraZeneca needs to secure new manufacturing capacity. The United States will assist in that search.
AstraZeneca is working with the government's Biomedical Advanced Research and Development Authority to “maximize and accelerate US production of COVID-19 vaccines,” the company said in a statement.
AstraZeneca has yet to apply for emergency use authorization for its vaccine in the U.S., but it is expected to do so in the coming weeks. It isn't clear whether the U.S. will need AZ vaccine doses given the ongoing rollout of the Pfizer, Moderna and J&J shots.
Emergent’s Baltimore-Bayview facility had been helping with vaccine production for AstraZeneca. Another CDMO, Catalent, is helping to produce the shot for the British drugmaker at another plant in Baltimore.
AstraZeneca has agreed to supply the U.S. with 300 million vaccine doses, but last week NIAID Director Anthony Fauci said supply from the company may not be necessary to vaccinate the population.
It all adds up to more uncertainty for AstraZeneca. The company's launch is underway in Europe and many countries around the world, but it has run into safety concerns over rare blood clots. Meanwhile, AZ recently cut its first-half 2021 supply target for Europe by two-thirds to 100 million doses.