AstraZeneca struggles to get vaccine data together for US approval

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AstraZeneca executives have struggled to pull together the full data necessary to apply for US approval of its COVID-19 shot. The Wall Street Journal reports that according to people familiar with the matter, this is further delaying its efforts to secure the US Food and Drug Administration’s go-ahead.

The company said last month that it would apply for what is known as emergency use authorisation for its vaccine by mid-April. It has recently told US officials it might need until mid-May to finish its application for an FDA review, The WSJ reports.

One especially time-consuming task has been compiling British data from almost four months of vaccinations in the UK, including efficacy, virus-transmission and safety statistics. That has added to the complexity of AstraZeneca’s submission and is expected to lengthen any FDA review.
The WSJ reports that other shots that the FDA has authorised had large-scale human trial data but little or none from real-world rollouts outside of controlled studies. The AstraZeneca shot, meanwhile, is approved and being used in large numbers around the globe, including across much of Europe, Asia and Latin America. It hasn’t been cleared for use in the US, unlike COVID-19 vaccines from Pfizer Inc, Moderna Inc and Johnson & Johnson.

AstraZeneca is struggling to fix high-profile production problems in Europe and has grappled with hundreds of incidents of rare but serious blood-clotting among people who have received its vaccine. European regulators and the drug-maker are studying those cases but say that for most adults, and especially older people, the risks of COVID-19 are much greater than those of blood clotting from vaccinations.

The WSJ reports that AstraZeneca and partners have been making doses in the US ahead of its FDA application. The White House said last week that it would share as many as 60m of those doses with the rest of the world, pending a product-quality review, as part of efforts to support countries crippled by COVID-19 infections. That audit is separate from the FDA emergency-use authorisation process.

 

AstraZeneca’s CEO Pascal Soriot has, meanwhile, mounted a robust defence of the drug-maker’s COVID-19 vaccine efforts, and said the business should be proud of what it has done for the world and is doing its “very best” to produce more, as the company faces legal action from the EU over delivery shortfalls, and shipments to poorer countries have also been delayed.

The Guardian reports that the company generated $275m in revenues from the COVID vaccine it developed with Oxford University in the first three months of the year and shipped 48m doses to 120 countries through the global vaccine-sharing initiative COVAX, 80% of which went to low and middle-income countries. In total, it has supplied more than 300m vaccine doses to more than 165 countries so far this year.

“We never pretended we were going to be perfect and certainly, we’ve learned a few things along the way. We don’t regret anything because we look forward, not backward,” Soriot said. “We did our very best to help the world, and overall the team should be very proud of the difference we’ve made and lives we’ve saved.” He added the company was on track to produce 200m doses ready for distribution every month from May.

In India, where COVID cases have soared in a catastrophic second wave, more than 90% of vaccinations are made using the AstraZeneca jab. “Imagine what India would look like if we had not stepped up?” Soriot said. “The world needs this vaccine.”

AstraZeneca’s vaccine is seen as a lifeline for poorer countries, as it is cheaper and easier to store and transport than some of the other coronavirus vaccines being produced.

However, The Guardian reports, far fewer doses than expected have been delivered through COVAX, which is led by organisations including the World Health Organisation, as a result of export bans, hoarding and supply shortages. The Indian government has restricted exports from its largest vaccine manufacturer, the Serum Institute, which produces the AstraZeneca jab.

Soriot said he understood the Indian government’s decision to prioritise its own population. He said: “This pandemic in India has really exploded and it’s something that has caught many by surprise. It’s not clear yet when it will be possible to export again [from India].”

He said AstraZeneca was doing its “very best to produce as much as we can” but added that this depended on how much the cell cultures in its factories yielded. “We can’t tell the cells in the bioreactors to produce more. The cycle to make the vaccine is a very long one, so that’s the limitation.”

 

Full Wall Street Journal report (Restricted access)

Full report in The Guardian (Open access)

 

See also MedicalBrief archives:

Unpacking the lingering questions over AstraZeneca’s vaccine

AstraZeneca shoots itself in the foot, again

AstraZeneca claims 79% prevention efficacy in US vaccine trial

Political blows to AstraZeneca vaccine may boost vax hesitancy


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