AstraZeneca Hits Another Bump in the Road to COVID-19 Vaccine Approval in the US – BioSpace

AstraZenecas COVID-19 vaccine road to approval has been anything but smooth.Announcingin Marchamid-Aprilsubmission for U.S. approval, that timeline has been pushed back to mid-May,with the company citing the massive dataset as the cause.

"There's a lot more data than just a Phase III study and so we're working as fast as we can to pull it all together and submit," said MenePangalos, executive vice president ofBioPharmaceuticalsR&D at AstraZeneca.

CEO PascalSoriotreassured in a first-quarter results briefing there is no issue with the data, its merely the size causing this speedbump.

From the beginning, AstraZeneca promised to sell its COVID-19 vaccine without profit. But sales havent kept up with the costs, resulting in a hit to earnings.Earnings from vaccine sales have been nowhere near the companys best-sellerTagrisso, acancerdrug, reported over $1.1 billion in sales for the same quarter.Vaccine sales for the first quarter came in at$275million, a paltry amount when comparedto the multibillion-dollar sales anticipated for Pfizer and Moderna.

Johnson& Johnson reported $100million in sales for its vaccine this quarter, having also pledged to sell its vaccine at cost. Pfizer and Moderna made no such forbearance of profit, expecting $15 billion and $18.4 billion in revenue, respectively, from sales of COVID-19 vaccines.

Developing a safe and effective vaccine at breakneck speed to stop a global pandemic is no small task. When the pandemic first began,over 100 vaccine candidates began the race to development.That list has been whittled downover the year as efforts have been abandoned.

Currently, just three COVID-19 vaccines are approved for use in the U.S., with AstraZeneca hoping to be the fourth.The vaccine is already approved for use in at least 78 countries.

With close to 240 million doses of eitherthe Pfizer-BioNTech, Moderna and J&J vaccines already administered in the U.S., itsbecoming likelythe AstraZenecashotsoriginallyintended tobe suppliedto the countryunder government contractare not needed. However, an approval by the FDAwould provide amuch-neededboost to confidence in the vaccine,as its faced multiplequestion-raisingsetbacks through the past months.

The Biden administration haspromisedto make the 60 million doses earmarked for the U.S. available to the rest of the world, pending a quality review.

Former Biden-team advisorEzekielEmanuel, oncologist and professor at the University of Pennsylvania, explained the importance of FDA approval for AstraZenecas vaccine, even if its not used in the U.S.

We need this vaccine out there helping the world, Emanuelsaid. If it were not authorized, that would be a blow to the whole world, not just the U.S.

The AstraZeneca shot is much cheaper than rival vaccines, as well as easier to transport and store. The companys initial pledge for three billion doses this year were primarily being supplied for poorer countries that cant transport or afford the pricier, cold storage vaccines.

The AstraZeneca shot reputation has taken a few hitswithreportsthat information provided by the company on its clinical trials was outdated and provided an incomplete view of efficacy data.

The biggest hit to confidence has been the suggested link between the AstraZenecavaccine and blood clots.Quebec just reportedCanadas firstblood clot death in a woman whohadreceived the vaccine.

"We just had our first patient who has died of a thrombosis, cerebral thrombosis, following vaccination from AstraZeneca," Dr. Horacio Arrudatolda news conference Tuesday."This is an event that is rare. We knew that it might happen.

Although the AstraZeneca vaccine has been linked to blood clot cases in the Europe and UK, the cases are still rare. Health authoritiesstillbelieve thebenefits of the vaccine far outweigh the lowrisk of blood clot.

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AstraZeneca Hits Another Bump in the Road to COVID-19 Vaccine Approval in the US - BioSpace