Oxford/AstraZeneca COVID-19 Vaccine still targeted for September rollout - why is this not being covered?

Associate 2 in RE - Comm

Ya'll probably heard about the Phase 1/2 trial results released yesterday. If you are not following, an executive from AstraZeneca appeared before Congress this morning to discuss timing, pricing, distribution, etc.

Initial distribution of AZD1222 for the United States and U.K. is still on track for September of 2020. You heard that right, we will likely have a vaccine widely available this fall. This will likely end the pandemic (at least domestically). This - of course - assumes the third and final phase of trials is successful, but it seems there is no reason not be confident it will be (they've already tested hundreds of humans).

So...why are none of the major outlets covering this? This has major, major implications. It will likely end the public health crisis, enable our economy to reboot, have a huge impact on the November election. This is excellent news.

Comments (44)

  • Associate 2 in PE - Other
Jul 21, 2020

This is being covered, I've seen it on CNBC for two days now and there are countless articles mentioning it.

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Controversial
Jul 21, 2020

Yep. Potentially great news that has been covered extensively.

Not sure why someone not reading the news equates to the news not doing its job.

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Jul 21, 2020

Seems like a lot of the major outlets have kind of glossed over it. Bloomberg did an interview with Oxford directly and CNBC has been covering it in regard to it's impact on the markets. Besides that, not much coverage.

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Jul 21, 2020

You're using a lot of certain language around an entirely uncertain concept.

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Jul 21, 2020

The "concept" is becoming less and less uncertain as the trials unfold. I would wager this thing is widely distributed by end of 2020.

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  • Prospect in IB - Gen
Jul 21, 2020
:

This - of course - assumes the third and final phase of trials is successful, but it seems there is no reason not be confident it will be (they've already tested hundreds of humans).

And then, by testing the vaccine on a larger population, a horrible side effect is observed.

    • 1
Jul 21, 2020

None of this is definitive and while a great sign-- realistically the vaccine will be rolled out to only healthcare providers and the most at risk populations first. The general public probably won't see the vaccine until early-mid 2021, this stuff takes time.

Most Helpful
Jul 21, 2020

It seems like you're trying to spin this politically. Is that why you posted anon?

As others have said, this is being covered by the news. Maybe you're just not reading the right news.

edit: this has been covered by both parties' respective platforms, so can't see a political spin on it. Now I'm just confused as to why you think it's not being covered.

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  • Analyst 1 in RE - Other
Jul 21, 2020

not an anti-vax type or anything, but something about a vaccine being rolled out this quickly with so little time given to consider side effects in the name of massive profit going toward the "winning" company that can produce any sort of vaccine the fastest rubs me the wrong way

Jul 21, 2020
Analyst 1 in RE - Other:

something about a vaccine being rolled out this quickly with so little time given to consider side effects in the name of massive profit going toward the "winning" company that can produce any sort of vaccine the fastest rubs me the wrong way

This is also a problem. Mistakes bound to be made somewhere.

Jul 21, 2020

This vaccine builds on previous coronavirus vaccine efforts (MERS I believe). They didn't start entirely from scratch if that makes you feel any better about the timeline.

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Jul 21, 2020

Can guarantee your regular Joe who has average health will not get this vaccine in 2020. Healthy people like most of us (hopefully) won't see this until middle to late 2021. @liquidiot is right that the most at-risk populations will be given the vaccine first and foremost. And we don't even know the side effects either.

Jul 21, 2020

This

Also, never has there ever been a clinical stage candidate that killed it in healthy volunteers in Phase 2 and had shit bubble up in Phase 3. Because all biotech ER teams and healthcare funds have 100% calls and 3000% returns right

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Jul 21, 2020

Even "if" the vaccines prove successful, you can't just get 300 million doses overnight. There's still a long, long road ahead. I'm confident SA2021 will be virtual.

Edit: Not sure why I'm getting so much MS. It's important to be realistic with dates here.

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Jul 21, 2020

Not sure about this Oxford one but I think some of the vaccine companies have been manfacturing in tandem with testing, essentially making a huge gamble that their vaccine will pass approval (not so much a gamble when it's government grant $$).

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Jul 21, 2020

They are having a lot of preliminary negotiations with large manufacturers who can help really scale this thing up quickly. Don't remember what AZs plan is but Moderna (who I don't have too much confidence in) struck a big agreement with Lonza a while back.

Jul 21, 2020

I could not agree more. I've been following this vaccine like a hawk since they announced they were targeting Q3 2020 back in April. Every single news publication said they were crazy and that it would take 2-3 years for a vaccine.

Well here we are, well into phase 3 trials with the first 2 phases passed with flying colors. Anyone I mention this to has never heard of the Oxford/azn partnership! It has been reported here and there but not getting the coverage it deserves.

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  • Intern in IB-M&A
Jul 21, 2020

Did you buy the stock back in April?

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Jul 22, 2020

No, and it's not even worth it since they pledged to roll it out on a nonprofit basis

Jul 21, 2020

Surprised this hasn't been brought up yet, but apparently the Oxford vaccine only gives you antibodies for 56 days, after that you need another dose.

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Jul 23, 2020

Recurring revenue stream, nice.

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Jul 21, 2020

There's more money to be made for media by continuing the fear mongering and news coverage of the rise of cases.

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Jul 21, 2020

It has been covered extensively. As has Moderna's candidate and the Pfizer/BioNTech one.

  • Prospect in S&T - Equities
Jul 22, 2020

how much is it going to be? will insurance cover it?

Jul 22, 2020

There is a fair degree of skepticism and I think the media has generally understood (for once) not to get over-hyped on all these vaccine promises.

The latest updated about this vaccine, from Monday, is that it did show an immune response but had been tested in a Phase I/II trial. The trial itself started in April 2020 and will end in May 2021 (on paper). These are interim results. Even if these were enough to get a Phase II/III rolling, it would likely start in August and you could get interim results by October/November. You then have to submit to regulatory agencies (the FDA and EMA) who could take 6 months to approve (and this would be considered insanely fast to review all the data and make a good decision). Realistically the earliest you can get a vaccine is Q2/Q3 2021. No one realistically expects one to be ready in September. You also have to consider time to ramp up production of the vaccine and fill orders. There is still so much to do.

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Jul 22, 2020

A Phase III trial already started in Brazil a few weeks ago.

AZ has said multiple times that they aim to have 1 billion doses available by the end of 2020 and are signing contracts w/ manufacturers all over the world.

The FDA has said multiple times that it will expedite vaccine approval assuming they can ensure its safety and efficacy.

This is not a typical situation and people should stop treating it as such. There's a very strong chance that there is a vaccine approved and available within 90 days from today.

(Also the May 2021 "end date" for phase 1/2 trial is when researchers plan to stop contacting participants. It's not meant to be the date final results are expected)

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Jul 22, 2020

Yes,
this
https://clinicaltrials.gov/ct2/show/NCT04456595?co... is the Brazil trial; the one that hasn't started recruited and on paper is starting in July. It will realistically be underway in August and you won't have interim results until October/November earliest. AZ can say whatever they want to secure orders, but that doesn't change the course of reality. Additionally, the FDA will certainly expedite the process but it won't become a matter of weeks or a couple of months, especially for companies that present Phase II evidence at best. Maybe 3-4 months if you have a robust interim readout from a Phase III but no quicker than that. Zika and Ebola vaccines also went through expedited processes but none were a matter of a couple of weeks. And this would still land you at the end of 2020, conservatively. To this, you still need to add time to ramp up production. Remember that any vaccine approved now in a hurry is likely to have conditional approval, meaning that they can be required to provide additional data as the trials continue.

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Jul 22, 2020

Not sure why you're getting downvoted but everyone is a clinical/ regulatory expert nowadays right

AZ is taking a risk by amping up manufacturing this early on but their preemptive scaling up of manufacturing isn't indicative of looming success - this is done with flu vaccines every year before the dominant circulating strains are confirmed just due to the fact that vaccine production is labor intensive and high quantities are needed

Vaccine procurement is also a weird process in that countries' health agencies don't just pay per unit at the point of sale. There's a whole bidding process involved where one manufacturer wins and supplies all, so it'll be interesting to see how that plays out with so many damn vaccines utilizing different technologies in the pipeline

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Jul 22, 2020

If these drugs are on Breakthrough Status or Expedited Review, the FDA will cut that review time down to... maybe 3 months. The thing with BReakthrough Status and Expedited Review is that the FDA is reviewing results on a near regular basis for any drug during these trials in order to get it to market faster. I think that a 12-month window is possible if the drug proves early on and at all phases that it can meet and exceed its endpoints. That said, it still takes a lot of time to get these drugs tested and to market. I still think Q420 is unrealistic but it is theoretically possible.

Jul 22, 2020

Well the FDA lag will be condensed as part of Trump's "Warp Speed" effort.

Funniest
Jul 22, 2020

I'm cool with the Brits colonizing us again if the boys come through and save football season.

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Jul 22, 2020

It won't be the football you're looking for

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Jul 22, 2020

I read the AstraZeneca release and am astonished their lawyers cleared it. It's misleading, to say the least.

Yes they have the distribution agreements in place and manufacturing capacity available, but a September rollout would require all of the following:

1) Evidence from the trials that the vaccine actually works. The release does mention there is no assurance it works.

2) Completion of Phase III trial (not yet begun) and FDA review of results

3) FDA approval

Anybody who thinks all this can happen in the next 5 weeks, even in super-duper emergency mode, is smoking dope.

Meanwhile, AZN stock price is up almost 50% from its March bottom, as the company prepares to attempt the Gilead acquisition. I think I've figured out what's going on here.

Pharma companies have become increasingly brazen in pushing optimistic announcements. To be sure, a lot of good stuff is happening, but obscured by a cascade of fake news.

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Jul 23, 2020

You misunderstand a couple of things:

The Phase III trials have already begun.

FDA approval will be expedited as part of the "Warp Speed" program.

It's not unrealistic to think they can start distributing this thing in September.

As far as their stock value, it's irrelevant as they are rolling this out on a nonprofit basis.

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Jul 23, 2020

Not sure I follow your points. They cannot claim the vaccine prevents the virus because they ethically cannot "challenge" vaccinated individuals w/ the virus. Hence they look for and report on immune response.

Phase III studies will determine if the vaccine prevents infection.

How would this content be too permissive from the lawyers' perspective? This is exactly by the book. If they said that the vaccine prevents the disease before doing phase 3, then they would be in hot water, but they did the exact opposite here.

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Jul 22, 2020

For what it's worth, the Pfizer/BioNTech candidate is seen as better from one leading commentator/scientist.

https://blogs.sciencemag.org/pipeline/archives/202...
The immune response from Oxford's is good, but worse than convalescent patients (from what I understand).

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Jul 23, 2020

JPM AM primer on the state of vaccines, published this Tuesday (July 21).

Highly recommend browsing through for everyone in this thread. Here's their take on Oxford/AZ:

Oxford University and AstraZeneca announced an aggressive timetable for development of an
adenovirus "vector" vaccine. It's based on a chimpanzee virus that is altered to be harmless to humans,
and for which humans have no antibodies. The virus is altered to include genetic components coding for
the SARS-CoV-2 spike proteins, which are expected to provoke the body's immune system into generating
necessary antibodies. The group hopes to produce one million doses by the fall if current clinical trials are
successful (6,100 volunteers have been recruited into a randomized trial). Some recent news:

  • Phase I results were quite positive: over 1,000 patients enrolled (compared to just 45 for Moderna). Of the 35 participants whose antibody responses were fully analyzed in a paper released on July 20, 90% produced neutralizing antibodies after a single shot (compared to other vaccine candidates which required second booster shots). The presence of neutralizing antibodies rose to 100% after a second shot. T-cell responses were confirmed, and side effects were not alarming (some fever and headache). No red flags and enough grounds for cautious optimism as large Phase III trials begin in the remaining global hotspots (US, South Africa, Brazil)
  • The US Biomedical Advanced Research and Development Authority (BARDA) agreed to provide $1.2 billion to AstraZeneca (the company developing and distributing the Oxford vaccine) to support clinical studies, vaccine manufacturing technology transfer, scaled-up manufacturing, etc. The funding will allow AstraZeneca to begin Phase II/III clinical studies this summer. In return, 400 million doses will be secured for the US/UK, with the first doses delivered as early as October if trials are successful

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  • Associate 2 in Consulting
Jul 31, 2020
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Jul 31, 2020
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