AstraZeneca drops submission to US regulators for Covid-19 vaccine approval

AstraZeneca has abandoned its submission for US regulatory approval for the Covid-19 vaccine it developed with Oxford university, almost two years after it was initially approved in the UK and Europe.

Pascal Soriot, AstraZeneca’s chief executive, said the company had decided to focus its regulatory team’s efforts on areas with larger unmet medical need, pointing to 19 regulatory approvals since the last earnings call.

“We have decided to withdraw application in the United States simply because the US marketplace is well supplied and in fact, the demand for vaccine in the US and elsewhere in the world is declining,” he said.

He added that the submission in the US was growing “very complicated and very large”, as the company compiled vast amounts of data on the Vaxzevria vaccine from around the world. The vaccine received temporary approval in the UK in December 2020, and in the EU, in January 2021.

“To be honest, it didn’t make any sense for us to continue pursuing this application. We have many, many other things we can do that will have a much bigger impact on helping patients and creating value for the company,” he said.

AstraZeneca distributed the vaccine on a non-profit basis during the pandemic, and sold 3bn doses. But in the US, officials criticised the company over how it presented data on the efficacy of its vaccine. Now, the market has been saturated by the Pfizer and Moderna mRNA jabs.

In March, AstraZeneca’s head of research and development told the Financial Times that it would consider not submitting for approval in the US, if it found it was “banging its head against a brick wall indefinitely”.

Soriot said the company had not given up developing other vaccines.

Before the pandemic, AstraZeneca only had a nasal spray vaccine for flu but last year it formed a new unit that includes shots. He said internal discoveries gave the company “good hope” that it would invent new vaccines, but the proof would take three to five years.

“We are at the beginning of the journey. Just like 10 years ago, we were at the beginning of the oncology journey,” he said.

Ahead of the UK chancellor’s autumn statement next week, Soriot called on the government to protect spending on innovative drugs, which he said could reduce hospitalisations and costs.

“Unfortunately, the government, in the recent past, has been focused on massively reducing prices and investment in innovative medicine,” he said.

AstraZeneca raised its earnings guidance for the full year, after its margins were boosted by soaring sales of higher priced oncology and rare disease drugs and a drop in revenue from non-profit Covid-19 vaccine contracts.

The Anglo-Swedish drugmaker expected 2022 core earnings per share to increase by a high twenties to low thirties percentage, compared with previous guidance to expect a mid-to-high twenties rise.

The company reported $11bn in third-quarter revenue, up 19 per cent year on year at constant exchange rates, and higher than analysts’ forecasts of $10.8bn.

Sales of Vaxzevria declined as expected to $180mn from $1.1bn in the same quarter the year before.

Core earnings per share were $1.67, up 70 per cent year on year at constant exchange rates, and above the average analyst estimate for $1.54. The core gross margin was 81 per cent, up 6 percentage points.