EU regulator: mRNA coronavirus vaccines possibly linked to heart swelling


POLITICO Europe 09 July, 2021 - 08:17am 55 views

“Our vision is to develop an mRNA combination vaccine so that people can get one shot each fall for high efficacy protection against the most problematic respiratory viruses,” Moderna CEO Stéphane Bancel said in the company’s announcement.

Read full article at POLITICO Europe

Is Moderna’s leap with mRNA jabs really worth $100 billion?

Mint 09 July, 2021 - 10:26am

The covid assumptions that justify its market value are too dicey

Just 18 months ago, Moderna Inc was an early-stage biotech firm working on a new way of making vaccines worth $6.5 billion. Today, having developed and delivered one of the fastest-arriving and most effective covid shots, its market value is approaching $100 billion. Some of the stock’s 1,000% gain is clearly warranted. Wall Street analysts expect its vaccine, which uses new messenger-RNA technology, to net a historic $17.6 billion in revenue this year. But its valuation is now in the same league as drugmakers that, unlike Moderna with its one vaccine, have multiple marketed medicines. Holding the stock at this level requires particular assumptions about the pandemic’s future and a heroic tolerance for risk concentration.

The big question for Moderna investors is how long covid vaccine sales will last. The market for first and second doses is shrinking each day and is starting to concentrate around developing nations, where prices are lower. The company’s prospects rely heavily on booster shots aimed at providing extra protection should immunity from the initial round of vaccinations fade, as many expect. While mRNA vaccines will likely be the boosters of choice because of their efficacy and safety, it’s unclear how many people will get a Moderna top-up. Pfizer and BioNTech also make a highly effective mRNA vaccine. That helps explain why Wall Street estimates for Moderna’s 2021 sales range widely, from $13 billion—which would represent a decline from this year’s consensus forecast—to $22.2 billion.

One can make a case for the higher range. Countries that use AstraZeneca’s vaccine or others that offer less protection may offer boosters just to be safe. The potentially dangerous combination of waning vaccine immunity and variant spread could lead to even broader uptake. Booster demand will be concentrated in wealthier nations, letting Moderna charge more and compensate for declining volume. And there would be an additional upside if variant-specific shots are required because Moderna’s adaptable technology and established manufacturing should give it an advantage in rolling out second-generation vaccines.

But, at least for now, two mRNA doses appear to hold up against bad outcomes from the highly infectious delta variant first identified in India. So does Johnson & Johnson’s single-shot vaccine, according to recently released data. Delta is driving a wave of infections in the heavily-vaccinated UK but relatively few hospitalizations so far, even with significant use of AstraZeneca’s shot. In addition, a recently published study suggests that mRNA vaccines generate a broad immune response that may last for years. So boosters could very well be delayed or limited to people who have weaker immune systems. A longer interval will allow potential competitors such as Novavax, Sanofi and GlaxoSmithKline to catch up. Given all this, the lower revenue scenario is a distinct possibility.

Even if Moderna’s covid vaccine sales do not peak until next year, a decline is inevitable, and it could be steep. The company’s lack of other revenue sources will magnify the reaction to any covid disappointment. Expectations for its drug pipeline are justifiably high after the success of its vaccine, but you can only hang so much of a $95 billion valuation on distant and unproven products. Moderna’s most advanced non-covid project, a cytomegalovirus vaccine (to protect against a virus that’s harmless to most but can cause birth defects if passed from a mother to her unborn child), will only begin a final-stage trial this year.

Recent pharma history shows what can happen to rich valuations when a golden goose runs out of eggs. Here, Gilead Sciences Inc offers an instructive example. The company launched a path-breaking hepatitis C drug in late 2013. Sales spiked to an astonishing $19.1 billion in 2015, but then plunged as competitors arrived. Gilead’s value followed suit, dropping as much as $100 billion from its peak of almost $180 billion. Of course, the comparison isn’t perfect. Gilead had a reliably growing multibillion-dollar HIV drug franchise to provide a floor.

In Moderna’s case, a key unknown is how well mRNA technology will work to prevent other diseases. This new technology’s adaptability may be most beneficial in an epidemic or against viruses like influenza that change frequently, and that’s not generally a valuable niche. The company hopes to use mRNA to treat cancer and some rare diseases, but those early efforts are particularly uncertain. Either way, while Moderna will retain a first-mover advantage in mRNA and unique expertise, the field will get more crowded as other drugmakers invest heavily in the technology. I’ve been wrong about Moderna’s valuation before, calling it rich after its 2018 initial public offer. But even in the rosiest of scenarios, it seems stretched now. This time, if there is a reckoning, it has a lot further to fall.

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Male Fertility and COVID-19

News4JAX 09 July, 2021 - 10:26am

Pfizer sees waning immunity from its COVID-19 vaccine

CBS46 Atlanta 09 July, 2021 - 10:26am

EU regulator finds link between heart inflammation and mRNA COVID vaccines

Yahoo News 09 July, 2021 - 06:32am

Heart conditions myocarditis and pericarditis must be listed as possible side effects of the two mRNA vaccines, the safety committee of the European Medicines Agency (EMA) said on Friday.

Such cases primarily occurred within 14 days from vaccination, more often after the second dose and in younger adult men, the EMA said. This is in line with findings from U.S. health officials last month.

The EMA panel also recommended that people who have a history of capillary leak syndrome (CLS) must not be vaccinated with J&J's single-shot vaccine. The watchdog in June asked CLS to be added as a side effect from AstraZeneca's shot.

Both AstraZeneca and J&J vaccines use different versions of a cold virus to deliver instructions for making coronavirus proteins to produce an immune response.

(Reporting by Pushkala Aripaka in Bengaluru; Editing by Arun Koyyur)

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As the push to get people vaccinated against COVID-19 continues, you may have seen alarming reports about a new possible side effect of the COVID vaccine: heart inflammation. Experts are investigating a link between the vaccine and cases of myocarditis or pericarditis, an inflammation of the heart muscle itself or the outer lining of the heart, which is typically triggered by the body's immune response.

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One dose of the Pfizer or AstraZeneca coronavirus vaccine "barely" protects against the Delta variant of the virus, because of mutations the variant has developed, according to a new study published in the journal Nature Thursday.Why it matters: The study found that two doses of those vaccines generated a neutralizing response to the variant in 95% of people, highlighting the importance of full vaccination against COVID-19.Stay on top of the latest market trends and economic insights with Axios

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You've probably seen the headlines about people who were fully vaccinated but still contracted COVID-19: in my hometown of St. Louis, a woman contracted COVID a month after receiving her second dose of the vaccine, and a New York City man tested positive two weeks after getting the Johnson & Johnson vaccine. Can You Still Get COVID-19 If You're Fully Vaccinated?

Bill Gates makes his first in-person event appearance since news of his divorce. He'll reportedly make a speech about climate change.

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Could Pfizer and Moderna Be in Trouble After the Latest COVID Vaccine Findings? | The Motley Fool

Motley Fool 09 July, 2021 - 05:08am

Founded in 1993 by brothers Tom and David Gardner, The Motley Fool helps millions of people attain financial freedom through our website, podcasts, books, newspaper column, radio show, and premium investing services.

Long-lasting COVID-19 vaccines? That could be the case based on some recent research that shows messenger RNA (mRNA) vaccines could provide protection against the coronavirus that causes COVID-19 for years. In this Motley Fool Live video recorded on June 30, 2021, Motley Fool contributors Keith Speights and Brian Orelli discuss whether this is good news or bad news for Pfizer (NYSE:PFE), BioNTech (NASDAQ:BNTX), and Moderna (NASDAQ:MRNA).

Keith Speights: Some findings were recently published in Nature magazine that indicate that the Pfizer-BioNTech and the Moderna vaccines may provide protection for years.

Many investors are and were hoping for annual recurring revenue from these companies' vaccines. Brian, how troublesome is this latest data for the prospects for Pfizer, BioNTech, and Moderna?

Brian Orelli: There's a bit of an extrapolation going on here. The researchers looked at memory B cells, which tend to provide more long-term protection than, let's say, antibodies. They looked at those in the lymph nodes and found the cells were there as long as 15 weeks.

Typically, they'd mostly be gone by four to six weeks. So that's the basis of this claim that it could offer protection for years. If true, that will be a big blow obviously to vaccine makers, at least for Moderna and BioNTech.

Pfizer would be fine because it's so diversified. It's really hard to make an argument for the valuations of Moderna and BioNTech right now if these vaccines are one and done over a couple of years. They really need to have ongoing sales until they can get growth from other drugs in their pipelines.

Speights: Brian, when I first saw the story, I went to check out to see how the stocks were performing, and Moderna is up, BioNTech was barely changed, Pfizer barely changed. It seems to me that investors really aren't making much of this news. Do you think that's the right take at this point?

Orelli: I think it's still too early to be able to conclude that it's definitely going to work for years. The other issue is that we're looking at, will those B cells actually protect against the variants?

If they don't protect against the variants, then it doesn't really matter if you have B cells in your lymph nodes. If they're not going to protect against the variants then we're going to have to get a booster shot anyway.

Speights: Right. Obviously, if these vaccines provide immunity for multiple years, these companies aren't going to make nearly as much money as they expect and a lot of investors expect. So this is a big story to watch, but like you said, really, really early right now and too soon to maybe go drawing any conclusions at this point.

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