AstraZeneca Behind In Providing Necessary Data For FDA Vaccine Review
Sources tell The Wall Street Journal that the company missed its April target for filing for emergency use authorization and is now expecting to apply in mid-May. The company also revealed in financial reports that it has so far lost money with its covid vaccine.
The Wall Street Journal:
AstraZeneca Struggles With Data Needed For Covid-19 Vaccine’s Approval
AstraZeneca executives have struggled to pull together the full data necessary to apply for U.S. approval of its Covid-19 shot, according to people familiar with the matter, further delaying its efforts to secure the Food and Drug Administration’s go-ahead. The company said last month that it would apply for what is known as emergency use authorization for its vaccine by mid-April. It has recently told U.S. officials it might need until mid-May to finish its application for an FDA review, according to one of these people. (Strasburg and Burton, 4/29)
Bloomberg:
Astra to Seek U.S. Vaccine Clearance After Missing Target
AstraZeneca Plc confirmed it plans to apply for U.S. emergency authorization of its Covid-19 vaccine in the first half of 2021 after it missed an original target this month that raised questions over whether the company would pursue the clearance at all. The drugmaker, which has pledged not to profit from its Covid shot during the pandemic, said the product it developed with the University of Oxford recorded sales of $275 million in the first quarter, a fraction of its $7.3 billion in revenue. Astra’s results exceeded analyst estimates as the company benefited from strong growth in its cancer drugs portfolio. (Ring, 4/30)
The New York Times:
AstraZeneca’s Covid-19 Vaccine Has Generated $275 Million In Sales So Far This Year.
The Covid-19 vaccine developed by AstraZeneca and the University of Oxford brought in $275 million in sales from about 68 million doses delivered in the first three months of this year, AstraZeneca reported on Friday. AstraZeneca disclosed the figure, most of which came from sales in Europe, as it reported its first-quarter financial results. It offers the clearest view to date of how much money is being brought in by one of the leading Covid vaccines. (Robbins, 4/30)
The Guardian:
AstraZeneca CEO Hits Back At Covid Vaccine Supply Criticism
AstraZeneca’s chief executive, Pascal Soriot, has mounted a robust defence of the drugmaker’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 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. (Kollewe, 4/30)
And in updates on the Johnson & Johnson vaccine —
The New York Times:
Shake-Up At Covid Vaccine Manufacturer That Tossed Millions Of Doses
Executives of Emergent BioSolutions, the Covid-19 vaccine manufacturer that was forced to discard up to 15 million doses because of possible contamination, reported a shake-up in leadership on Thursday and offered the most fulsome defense yet of the company’s performance. While announcing the high-level personnel changes and taking responsibility for the ruined doses, executives nonetheless forecast record revenues this year of nearly $2 billion. (Stolberg and Hamby, 4/29)
The Baltimore Sun:
COVID Vaccine Maker Emergent Says It Has A Plan To Fix Baltimore Plant After Mistake
Emergent BioSolutions executives said Thursday that they expect to submit a plan in coming days to federal regulators outlining how they will clean up the Baltimore plant that had to dump 15 million doses of contaminated COVID vaccine. It will “meet or exceed” the requirements from the U.S. Food and Drug Administration, which outlined multiple failures in an inspection report released April 21, Emergent President and CEO Robert G. Kramer Sr. said. (Cohn, 4/29)
The Baltimore Sun:
Vice President Kamala Harris Visits Baltimore COVID Vaccine Site, Thanks Those Getting Shots
Declaring “Today is a good day, Baltimore,” Vice President Kamala Harris marked the 100th day of the Biden administration by visiting a bustling vaccination site and saying the nation is beginning to emerge from the coronavirus crisis, even as significant economic and health challenges remain. The Democratic vice president, joined Thursday by Republican Gov. Larry Hogan and Democratic Mayor Brandon Scott, toured the mass COVID-19 vaccination site at M&T Bank Stadium, where she celebrated the patients and vaccinators as “heroes.” (Barker, 4/29)
