AstraZeneca cancels plan to file for US approval of COVID vaccine

[onthedarkside]

 

AstraZeneca (NASDAQ:AZN) said it will not submit an application seeking approval of its COVID vaccine Vaxzevria in the U.S.

 

The British pharma giant noted in its Q3 earnings release that as primary vaccination needs of the U.S. were being met already, it has decided not to submit a Biologics Licence Application (BLA) for Vaxzevria to the U.S. Food and Drug Administration.

 

The company added that it will continue to focus its efforts to make Vaxzevria available elsewhere in the world, including submissions for its use as a booster.

 

(more)

 

https://seekingalpha.com/news/3905400-astrazeneca-cancels-plan-to-file-for-us-approval-of-covid-vaccine

 

 

 

Also:

 

https://www.reuters.com/business/healthcare-pharmaceuticals/astrazeneca-withdraws-us-application-covid-vaccine-2022-11-10/

 

https://www.wsj.com/articles/astrazeneca-drops-plan-to-sell-covid-19-vaccine-in-u-s-11668076538

 

From the company's quarterly financial statement:

 

 

https://www.astrazeneca.com/content/dam/az/PDF/2022/Q3/Year-to-date_and_Q3_2022_results_announcement.pdf

 

 

[TorquayFan]

The market worldwide for Covid vaccines shrinks as the pandemic largely disappears and endemic status prevails.

 

AZ are probably fighting an uphill battle in the USA anyway, as mud sticks to perceptions about their original vaccine.

 

Bi-valent vaccines such as AZ 2 are being pushed for vulnerable groups but we need a genuine 2nd generation vaccine more of 'universal' nature, i.e. not just addressing existing variants.

 

AZ, BioNTech/Pfizer and Moderna face large drops in revenue in 2022/23 if the 'pandemic' stays quiet . . .

[TallGuyJohninBKK]

9 hours ago, TorquayFan said:

The market worldwide for Covid vaccines shrinks as the pandemic largely disappears and endemic status prevails.

 

Except, about  10,000 people per week are still dying of COVID around the world, including about 2,500 per week in the U.S. alone. And a lot more COVID hospitalizations on top of those fatality numbers.

 

https://covid19.who.int/?mapFilter=deaths

 

The pandemic isn't gone or finished. We're just benefiting, for the time being,  with Omicron variants that are overall milder than Delta before -- but still killing and sickening a lot of people.

 

As for the shots, I believe they're heading toward clinical trials of a combined flu and COVID vaccine that would become a seasonal standard for people in the higher risk groups, including the age 60+ folks.  Age alone is the single highest risk factor for bad COVID outcomes.

 

IMHO, AZ's vaccine, with its very rare but potentially serious blood clot issues, simply got beat out by the Moderna and Pfizer mRNA vaccines, and now has the added competition from the non-mRNA Novovax vaccine.

 

[TorquayFan]

TallGuy you say the pandemic isn't over and that's right -  also close to home, as my Wife tested positive today !! I'm OK so far . . .

 

Yes I've heard of a combined flu/covid vaccine many times before but the point is, they only cover known variants ! Of course it helps but could be better.

 

2nd Generation vaccines are needed of a more universal nature, probably addressing the nucleosid (core) of the protein (which doesn't mutate quickly) rather than the spikes, (which mutate constantly).

 

Something like this : "The Phase 1 trial is testing Scancell's two clinical candidates, SCOV1 and SCOV2 (COVIDITY), which in preclinical models have induced high titre antibodies and potent T cells against both the S and N antigens, including responses that cross-react with the Delta and Omicron variants. The objectives of the trial remain to assess the safety and immunogenicity of COVIDITY, with study data expected to be available in H2 2022. To date, 22 vaccine-naïve subjects have been enrolled and the COVIDITY immunisations have been well tolerated, with no safety concerns."

 

ATB