Plague Profits: Vaccines, Part 1

In the U.S. and Europe, basically five companies have successfully brought COVID-19 vaccines to market: Pfizer and BioNTech, AstraZeneca with the University of Oxford, Johnson & Johnson’s Janssen division, and Moderna. This is just a brief look at what happened to these company’s revenues from 2019, prior to the COVID-19 pandemic, and the following two years. Revenues are not necessarily profits. More analysis on profitability and where some of this money comes from will be included in future posts.

Pfizer and BioNTech have been broken out separately. For Johnson & Johnson, the numbers represent just one of the mammoth company’s units, Pharmaceuticals.

One thing becomes clearly obvious. COVID-19 vaccines have brought in an incredible amount of money for all of these companies. Pfizer’s sales basically doubled since 2019, BioTech’s went from only $117.53 million in 2019 to $20.52 billion in 2021. AstraZeneca went from $24.384 billion in 2019 to $37.417 billion in 2021, and J&J’s Pharma sales climbed from $42.198 billion to $52.080 billion. Moderna’s COVID-19 vaccine is the company’s first commercial product (same as BioNTech). As a result, sales went from $60 million in 2019, which is basically for licensing fees, to $18.471 billion in 2021.

Pfizer

Revenue

2019                                        2020                                        2021

$40.905 billion                        $41.651 billion                        $81.288 billion

BioNTech

2019                                        2020                                        2021

$117.53 million (U.S.)            $521.46 million (U.S.)            $20.52 billion (U.S.)

AstraZeneca

2019                                        2020                                        2021

$24.384 billion (U.S.)             $26.617 billion (U.S.)             $37.417 billion (U.S.

J&J (Pharmaceutical Only)

2019                                        2020                                        2021

$42.198 billion                        $45.572 billion                        $52.080 billion

Moderna

2019                                        2020                                        2021

$60 million                             $803 million                           $18.471 billion

Top Stories 5-5-21

Amryt and Chiasma Combine to Form Rare and Orphan Diseases Powerhouse

Amryt inked an all-stock acquisition deal with Chiasma. The combined company will focus on rare and orphan diseases with three marketed products and a strong development pipeline.

COVID-19 Pandemic Could Run Through 2022 or Longer

There has been a lot of news out of Pfizer-BioNTech about the COVID-19 vaccine, both in terms of additional trials, approvals in children, and the potential of booster shots. Novavax has also expanded its trials. Here’s a look.

Four New Biotechs to Watch: Esker, Mogrify, Isolere and BridGene

There’s money on the move and venture capital firms launch several biotech companies with hefty Series A financing rounds. Here’s a look.

Commentary

In the U.S., at least, there seems to be a slowing down of COVID-19 vaccine rollout, despite the big manufacturers, especially Moderna and Pfizer-BioNTech continuing to sign manufacturing deals. And Pfizer noted they’re on track to rake in $26 billion on the COVID-19 vaccine alone this year, while also suggesting it might be a yearly thing. Or at the very least require a booster.

That may be true, but it makes even my more rational biopharma defender side cringe. Of course they’d like that to happen from a business point of view, but do you have to be so apparently oblivious to the ammunition you’re feeding the anti-vaxxer crowd?

The CEOs are likely just speaking the truth, and who knows, probably aimed at their shareholders more than the general public. But still, a little bit of if-we’re-very-lucky-the-vaccines-will-eradicate-COVID-19-but-we’ll-follow-the-science scripting might go a long way.

You know, like in “Bull Durham”? Learn your cliches. They’re your friend. And God willing, things will work out.

1/2-Doses of Moderna Vaccine? Wait, what?

1/4/22

I wrote earlier today, reporting on the technical head of Operation Warp Speed, Dr. Moncef Slaoui, saying he or they are in talks with Moderna about giving people between the ages of 18 and 55 a half-dose of the COVID-19 vaccine. This was seemingly in response to the government’s pretty crappy roll-out of the vaccine distribution. I wrote, in part:

“What seems most puzzling about this approach isn’t whether it would be effective, but that actual vaccine production does not appear to be the reason why vaccinations are lagging. Slaoui indicated that 17.5 million does in the U.S. had been shipped as of yesterday, with 1.5 million people receiving the shots in the preceding 72 hours, which is about 500,000 per day. Although this appears to be an improvement over the first couple weeks, the bottleneck appears to be somewhere after the manufacturing process, not from the manufacturing process.”

I want to go back to this. I’m a medical writer and I have a degree in microbiology, but otherwise, I’m not an expert on vaccines or immunology. Still, my personal reaction to this is: WTF?

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), seemingly in response to Slaoui’s comment on a Sunday morning talk show, at a different talk show, said, “We know what the science tells us. So my feeling … is let’s do it the way the clinical trials have instructed us to do it. But let’s get more efficient into getting it into people’s arms.”

Not to put words in Tony Fauci’s mouth, but I think “WTF?” might have been in the back of his mind.

If there’s evidence that the Moderna vaccine was going to be as effective with a half a dose, it really hasn’t been reported anywhere by Moderna. Same goes for Pfizer and BioNTech. And if it was, why not do it that way to begin with?

Of course, AstraZeneca and the University of Oxford, on the other hand, did report something along those lines, although one might reasonably say WTF? to that report. To reiterate for anyone who hasn’t been following this: in about 1800 patients in a clinical trial, they received a half-dose of the first shot of the Astra-Oxford vaccine by accident. Oops! But weirdly, that cohort had an efficacy rate of about 90% compared to about 62% in the full-dose-first-shot cohorts.

I haven’t heard of many vaccine experts or immunologists who are particularly excited about that data. Confused, yeah. Concerned, sure. And I heard of at least one biostatistician who wondered if it wasn’t just a statistical blip.

It makes one wonder if Warp Speed is trying to extrapolate from one clinical trial to another. It also makes one–okay, me!–wonder if Slaoui and/or Operation Warp Speed and/or Trump, are trying to divert attention away from the clusterf#$# that the initial rollout of this vaccine has been. After all, about the only person taking the blame is General Gustave Perna, who’s heading Warp Speed’s logistics operation. Give him credit for that.

And on a personal level, I’m not terribly surprised by the slow rollout. What they’re trying to do is completely unprecedented. And how it’s going so far rather closely resembles the Trump admin’s PPP efforts last March and April, and their COVID-19 testing efforts since, well, forever. I actually have quite a bit of faith in Slaoui and Perna, although more in Fauci, while I have little or none in the Trump admin. About the only thing they’ve done right is throw money at vaccine development. They probably should have thrown more money at the distribution problem at the state levels and done so earlier.

Personally, I’ll think it’ll scale up as states get on terms with Warp Speed and some very smart people at state and regional health systems finally stand up and say, “Y’know, let us handle it, we know what we’re doing.”

Meanwhile, my Spidey-Sense is tingling at Slaoui’s comment. I’d prefer the full dose, thanks.

COVID-19 Vaccines: 1st US Patient Dosed & Continuing Trials

By Mark Terry

December 14, 2020

1^st Patient Receives Pfizer-BioNTech COVID-19 Vaccine in the U.S.

Sandra Lindsay, a nurse at Long Island Jewish Medical Center is the first U.S. patient to receive the COVID-19 vaccine created by Germany’s BioNTech and U.S.-based Pfizer. Lindsay is a critical care nurse at the hospital in Queens, New York City.

She told CNN, “I feel hopeful today, relieved. I feel like healing is coming. This marks the beginning of the end of a very painful time in our country.”

Moderna

Moderna’s vaccine is up next, with the FDA’s vaccine adcom meeting on Thursday, December 17. If it moves like the Pfizer-BioNTech vaccine last week—and there’s no particular reason to believe it will be otherwise at this point—the vaccine will receive Emergency Use Authorization (EUA) sometime on Friday, December 18 or possibly Saturday the 19^th, and distribution will begin over the weekend and someone somewhere in the U.S. will receive the first of the Moderna shots sometime on Monday, December 21.

So Then What?

The Pfizer-BioNTech and Moderna vaccines, both mRNA vaccines, require two doses about 28 days apart. It seems to take a couple weeks to build up some immunity—typical of most vaccines—and although the second shot is needed to grant the full potential of the vaccine, both of which in clinical trials demonstrated about 95% efficacy, the clinical trials have suggested that some immunity begins in a week or so of the first injection. So people receiving the shot should still continue wearing masks, practice social distancing, and wash their hands thoroughly and regulatory.

CureVac Launches Phase IIb/III Trial of its Own COVID-19 Vaccine

Germany’s CureVac announced it has enrolled the first volunteer in the pivotal Phase IIb/III trial of its own mRNA vaccine candidate, CVnCoV against COVID-19. In early-stage trials, the vaccine was generally well-tolerated at all doses and induced strong antibody responses as well as the first indication of T-cell activation. The immune response was similar to that observed in recovered COVID-19 patients. The trial will utilize a 12-microgram dose.

The Phase IIb/III trial, dubbed HERALD, will include more than 35,000 volunteers in Europe and Latin America. The HERALD trial will begin with the Phase IIb section, which is expected to merge directly into the Phase III efficacy portion. Participants 18 years or older will receive a two-dose regiment of either the vaccine or a placebo.

Leading Vaccines

Although so much attention has been paid to Pfizer-BioNTech, Moderna and the AstraZeneca-University of Oxford COVID-19 vaccines, they are not the only ones in late-stage trials. Although it’s hard to say what will happen to some of the later-developing vaccines as the frontrunners are rolled out and the pandemic begins to ebb, but many that will have vaccines available in 2021 will presumably help with limited manufacturing of the Pfizer-BioNTech, Moderna and AstraZeneca-Oxford vaccines. Here’s a few others:

CanSino—In limited use in China.

Gamaleya—Russia’s Sputnik V vaccine, which has also begun early use in Russia. AstraZeneca is also going to test their own vaccine in combination with Sputnik V.

Johnson & Johnson—Currently in Phase III trials, with interim data expected sometime in March.

NovaVax—Phase III

Vector Institute—In limited use in Russia, but is otherwise in Phase I and II trials.

Sinopharm-Beijing—Approved in the United Arab Emirate (UAE), Bahrain, and limited use in China.

Sinopharm-Wuhan‑Limited use in China and the UAE.

Sinovac—Limited use in China.

AnGes—This Japanese company is currently running Phase II/III trials with Osaka University and Takara Bio.

Medicago & GlaxoSmithKline—Canada-based Medicago, partially funded by cigarette maker Philip Morris, grows vaccines in a wild species of tobacco, Nicotiana benthamiana. It is currently in a Phase II/III clinical trial.

Anhuei Zhifei Longcom and the Chinese Academy of Medical Sciences—Currently in Phase III.

Bharat Biotech—In collaboration with the Indian Council of Medical Research and the National Institute of Virology, the Indian company’s Cvaxin is in Phase III trials.

Weekend Update

By Mark Terry

December 13, 2020

Sometimes the biopharma industry takes a break on the weekend, but apparently not during the pandemic. Here’s a peek at 3 stories from the weekend.

Pfizer-BioNTech COVID-19 Vaccine Rolls Out—Literally

After the FDA granted the Pfizer-BioNTech COVID-19 vaccine Emergency Use Authorization (EUA) on Friday night, December 11, the vaccine roll-out began—literally—on Sunday. Semi-trucks left the loading dock at Pfizer’s manufacturing facility in Kalamazoo, Michigan, on Sunday to deliver the vaccine in its specialized cold-temp storage containers, to head to airports and distribution centers.

TCR² Therapeutics’ T-cell Receptor Fusion Construct Promising in Solid Tumors, Including Ovarian

TCR² Therapeutics, which is yet another Cambridge, Mass. biotech company, announced positive interim data from their ongoing Phase I portion of TC-210 (gavacabtogene autoleucel—“gavo-cel”) Phase I/II trial for mesothelin-expressing solid tumors. As of the Nov. 24, 2020 data cutoff, 3 partial responses (PR) were recorded according to RECIST 1.1 criteria in the first 8 patients; and the first ovarian cancer patient achieved a confirmed PR up to month 6.

Gavo-cel is what they’re calling a T-cell receptor fusion construct. What this means in slightly more clear English, is that the company is fusing tumor antigen recognition domains to T-cell receptors. This basically creates immune cells more finely tuned to attack specific cancers. They’re also believed to be safer than, say, CAR-T therapies, because they shouldn’t create cytokine release syndrome.

AstraZeneca’s Dropping $39 Billion to Buy Alexion

The UK’s AstraZeneca is buying Boston’s Alexion Pharmaceuticals for a tasty $39 billion, which comes to $175 per share. Alexion shareholders will be able to bank $60 in cash per share and 2.1243 AstraZeneca American Depositary Shares (ADSs), which are equivalent on half of one ordinary AstraZeneca share, for each Alexion share.

Pascal Soriot, the AstraZeneca chief exe, stated, “Alexion has established itself as a leader in complement biology, bringing life-changing benefits to patients with rare diseases. This acquisition allows us to enhance our presence in immunology.”

It also pretty much doubles down on rare diseases, a profitable corner of biopharma. AstraZeneca’s focus these days is in oncology, cardiovascular, renal and metabolism, and respiratory diseases. They’ve been getting a rather lot of coverage for their COVID-19 vaccine that they’ve partnered with the University of Oxford on, and which might be submitted to the FDA and other regulators for emergency use authorization before the end of the year or shortly afterwards.