AstraZeneca’s head of research and development has said the UK drugmaker would consider not submitting its Covid-19 vaccine for approval in the US if it finds it is “banging its head against a brick wall indefinitely” with regulators.
Sir Mene Pangalos said AstraZeneca would instead focus its attention on selling the vaccine it developed with Oxford university in other countries, though it will continue to talk to the Food and Drug Administration, the US regulator.
AstraZeneca has still not submitted the vaccine for approval after months of talks. Pascal Soriot, chief executive, said last April that the drugmaker planned to file within weeks.
“We don’t need to push it in places we are not needed or wanted,” Pangalos told the Financial Times on Thursday. “If we don’t end up submitting it for a BLA [biologics licence application], I don’t think it will have an impact around the world.”
Roughly 2.6bn doses of AstraZeneca’s cheap and easy to deliver Covid vaccine have been administered globally. But the company has suffered setbacks including being sued by the European Commission over delays in delivery, a case that was later settled, and concerns about a rare side effect.
US officials have expressed irritation with the company during the past two years over how it presented data on the efficacy of its vaccine. In March 2021, AstraZeneca released initial data from its vaccine trials, only for the US National Institute of Allergy and Infectious Diseases to question that data publicly just hours later.
Since then, US drugmakers Pfizer and Moderna have been able to produce enough vaccines for the entire US adult population to have access to three doses, with millions of extra doses having been shipped to developing countries.
In recent months, senior officials have stopped talking about the possibility of AstraZeneca’s Covid vaccine hitting the US market. “That product has fallen off my radar,” one told the Financial Times.
Another said: “Astra is not going to get approved here — we don’t need it.”
The White House, however, is still relying on the company to continue supplying its long-acting antibody treatment known as Evusheld. The US has bought more than a million doses of the treatment, and was hoping to purchase more, but warned earlier this week it might not have money to do so after Congress failed to approve a new pandemic funding package.
The UK on Thursday approved Evusheld, which helps protect the immunocompromised who do not respond to Covid vaccines. Pangalos praised the UK regulator for doing a “fantastic job” during the pandemic but said he wished it had moved faster on Evusheld. He urged Westminster to order the treatment.
“It is a very important therapy for the immunosuppressed who have been even more locked down than they have ever been. The virus is very prevalent and people are not as cautious about mask-wearing or keeping their distance,” he said.
Pangalos was speaking at the Dubai Expo 2020, where AstraZeneca is launching a scheme to fund postgraduate scientists who can bring new ideas to the company.
“It is lovely to be a little bit cool again and for society to realise we can have a really positive impact on wellbeing,” he said.
Source: Financial Times