EU Medicines Agency hacked, BioNTech-Pfizer coronavirus vaccine paperwork stolen, probe launched

The EU Medicines Agency today revealed it was hacked, just a week after infosec eggheads said foreign state hackers have been targeting European institutions. In a notice to the media, the EMA said it had been "the subject of a cyberattack" and had "launched a full investigation, in close co-operation with law enforcement and …

[Anonymous Coward]

Other suspects?

According to the article, what was accessed was "some documents relating to the regulatory submission for Pfizer and BioNTech’s COVID-19 vaccine candidate...”

Presumably they weren't made public by the EMA because they contained trade secrets.

Thus, in addition to the usual suspects, in my cynical opinion, I would not rule out traditional industrial espionage.

[David 132]

Re: Other suspects?

Couldn't possibly be those nice Russians, they've had their own perfectly safe vaccine for months now.

Oh, who am I kidding. I won't be at all surprised if we now start to see "leaks" of carefully-out-of-context and distorted extracts from these Pfizer documents, spinning a story that the vaccine is unsafe, to sow doubt in target markets and discredit Pfizer, EMA, and the West in general.

[Jellied Eel]

Re: Other suspects?

Oh, who am I kidding. I won't be at all surprised if we now start to see "leaks" of carefully-out-of-context and distorted extracts from these Pfizer documents, spinning a story that the vaccine is unsafe, to sow doubt in target markets and discredit Pfizer, EMA, and the West in general.

One way to counter that would be to publish the documents that were submitted. This may have happened to an extent given Pfizer's submission to the US FDA has been published.. And makes for some interesting reading. Parts have already been spun, ie the risk of 'severe' adverse reactions after the second dose, which were more common in young subjects. Presumably that's due to having a stronger immune system, and 'severe' can just mean swollen lymph nodes.. So 'severe' in a strict, cautious medical sense, but not so bad in the practical.

For me, and with a hint of Russian, this is interesting-

https://www.rt.com/op-ed/509163-covid-19-test-flawed-withdrawn/

Last week I reported on an astonishing review conducted by a group of senior scientists on a paper on which most Covid testing is based. It comprehensively debunked the science behind the Corman-Drosten paper, which described a protocol for using the polymerase chain reaction (PCR) technique to detect Covid, finding 10 fatal flaws, including major failings in the operating procedure and potential conflicts of interest among its authors.

Which other scientists have also questioned. Along with IT types, eg Elon Musk having 4 tests with different results. Which doesn't really change the problem of COVID, or the benefits from working vaccines. Main effect would be on the constant score-keeping of 'cases', and potentially government responses to potential false positive results. I think there may also be other large benefits if mRNA vaccines are proven effective, ie potential to use those to prevent other diseases.

[katrinab]

Re: Other suspects?

False positives are a problem for the individual who receives the incorrect result.

They are not so much of a problem for public health surveillance, because they are looking at trends, and the trends will be correct even if some of the individual results are wrong.

[jmch]

Re: Other suspects?

"False positives are a problem for the individual who receives the incorrect result. They are not so much of a problem for public health surveillance"

Occasional false positives are only a problem for the individual. Huge numbers of false positives are a problem both for public health surveillance and for civil liberties (quarantine for a false positive is essentially house arrest without justification). I understand erring on the side of precaution but I think they're giving themselves too many haystacks to look into when there aren't that many needles

[jmch]

Re: Other suspects?

"One way to counter that would be to publish the documents that were submitted."

Absolutely. Keeping in mind that Pharma companies have benefited from financial incentives and cutting regulatory corners to develop the vaccines quickly, the least expectation in return is to waive trade secrecy and patent claims around the vaccines.

Absolutely COVID is a problem and it would be great to have working vaccines. But I don't believe it's that great a problem as is being made out, and I'd prefer if any vaccines went through the proper dev and test cycle to be sure they are safe and effective.

With respect to the PCR testing, there are papers showing that it should optimally be run for 30 cycles. Anything above 35 cycles gives 90%+ false positives. Many countries are recommending running these tests at 40 cycles, so a large percentage of the current wave of 'cases' is just people with trace elements of viral RNA who have no symptoms and are not carriers. So it's good to understand exactly what a 'case' means in the posted numbers. The real case numbers (ie symptomatic and/or carriers) are likely lower than the official counts by an order of magnitude.

[Anonymous Coward]

Re: Other suspects?

http://stoppfizer.org/

[Anonymous Coward]

Re: Other suspects?

In Russia we do not have COVID-19. We only have a few cases of lead poisoning where bad citizens claiming to have COVID-19 unfortunately shot themselves.

[Version 1.0]

Re: Other suspects?

While I wouldn't rule out industrial sabotage, the consequences of getting caught would make most manufacturers simply pay someone on the inside for the data, not hack in from the outside.

Look, we're seeing these sort of hacks everywhere - we need to simply disconnect all critical storage systems and access system from the Internet.

El Reg, I still want a pair of wire cutters icon for internet security comments!!!

[Doctor Syntax]

Re: Other suspects?

"we need to simply disconnect all critical storage systems and access system from the Internet."

In fact, disconnect them from other parts of the organisation that don't need access.

In due course we'll be told lessons have been learned.

[fajensen]

Re: Other suspects?

And of course the GCHQ, they have "form".

[Julz]

Re: Other suspects?

They have all the forms, the filled in ones.

[ITS Retired]

With something as bad as COCID-19,

why can't the various countries work together on several vaccines? Or is that too civilized?

[Mark Exclamation]

Re: With something as bad as COCID-19,

It's not about saving humanity, or working together for the benefit of mankind. It's all about money/profits (in the West), and political point scoring (in the East).

[sabroni]

It's all about money/profits and political point scoring.

FTFY

No need to pretend the East isn't run by money grabbing scum or that the west isn't allowing politics to drive it's vaccination efforts.

Did you see Matt Hancock "crying" on the tv? Or hear Williamson's "Best country in the world" bullshit? (Best guinea pigs in the world ITYM.....)

[Anonymous Coward]

Re: With something as bad as COCID-19,

> why can't the various countries work together on several vaccines?

They are.

The Pfizer vaccine is a US - DE joint project (Pfizer is a US-based company, BioNTech is a German company). The AstraZeneca vaccine is a US - UK joint project.

AstraZeneca received COVID grant money from the US Government. Pfizer didn't, they spent their own money on their COVID vaccine work.

Russia and China don't want to play. They'd much rather develop their own vaccines that don't work that well.

[Andy The Hat]

Re: With something as bad as COCID-19,

"Russia and China don't want to play. They'd much rather develop their own vaccines that don't work that well."

Or want to produce their own vaccine that works just as well but will cost them a fraction of the price ...?

Or want to produce their own vaccine that works just as well and don't want their countries to be bent over a Western political barrel ...?

Or want to produce their own vaccines that work much better and are cheaper because their development isn't linked to western capatilist economic interests and is medically driven?

Or are quite happy to have a safe 65% vaccine rather than an "up to 95%" vaccine that's potentially 50% ...?

Sweeping statements don't help. You have to look at this holistically ...

[Anonymous Coward]

Re: With something as bad as COCID-19,

> Or want to produce their own vaccine that works just as well but will cost them a fraction of the price

The Pfizer vaccine costs $19.95 per shot. Two shots are required.

We know that because the US Government bought 100 million doses. The Moderna vaccine is roughly around the same.

The Pfizer vaccine will be available for free in the US. Because it was bought for with US taxpayer money. Same for the Moderna and the AstraZeneca vaccines.

Is free too expensive for you?

Why don't you go to Russia - or China - and get vaccinated for COVID? Their "vaccine" is available right now. You don't have to wait for those stupid US or EU safety approvals.

Moronic statements don't help your agenda, you know.

[sabroni]

Re: Moronic statements don't help your agenda, you know.

"It's free because we paid for it before it was invented."

Does that not sound moronic to you?

[Anonymous Coward]

Re: Moronic statements don't help your agenda, you know.

> It's free because we paid for it before it was invented.

And that is precisely what happened. AstraZeneca and Moderna received grants from the US Government - Operation Warp Speed - for the explicit purpose of developing and testing a COVID vaccine.

Both AstraZeneca and Moderna fulfilled their contractual obligations. Both of them will be submitting their vaccines for FDA approval in a matter of days.

Pfizer didn't participate in Operation Warp Speed, so they didn't receive US Government grant money. That didn't prevent them from developing what appears to be a very safe and effective COVID vaccine.

Yes, the vaccines are free in the US because US taxpayers paid for their development and testing. The US Government bought several hundred million doses of these vaccines with US taxpayer money.

Sorry, that doesn't cover other countries.

Yes, in case you didn't know: receiving government grants for financing the development of a new product - regardless of what that product is - is nothing new. At least not in the US.

Your point is? Did you have a point in the first place?

[sabroni]

Re: Your point is?

It's not free if you paid for it.

Sorry, didn't realise that needed explaining.

[Triggerfish]

Re: With something as bad as COCID-19,

There is the possibility of availability if you are not in the right gang, its possibly one of the reasons countries like Vietnam are working on developing their own.

https://www.europeanpharmaceuticalreview.com/news/136170/rich-countries-buy-up-majority-of-covid-19-vaccine-doses-peoples-vaccine-alliance-says/

https://www.reuters.com/article/uk-health-coronavirus-vaccines-alliance/poor-countries-seen-missing-out-as-rich-nations-hoard-covid-19-vaccines-idUSKBN28J04C

[Jellied Eel]

Re: With something as bad as COCID-19,

The Pfizer vaccine costs $19.95 per shot. Two shots are required.

I think you'll find that's the MRsP rather than cost.. So $39.90 per treatment. Which may then need to be repeated, depending on how long immunity lasts for, and how long COVID remains a risk..

The Pfizer vaccine will be available for free in the US. Because it was bought for with US taxpayer money. Same for the Moderna and the AstraZeneca vaccines.

Is free too expensive for you?

So not free, still $39.90, just purchased on behalf of all Americans by the US taxpayers.. Who may also have paid for a lot of the R&D via government grants. So basically socialising the costs, and privatising the profits. But that's a theme wrt COVID and responses. The US may hand out another $1tn in relief funds, which give or take the economics of money printing, isn't free. Same with any post-pandemic spending plans to 'Build Back Better'. Or Greener.

Why don't you go to Russia - or China - and get vaccinated for COVID? Their "vaccine" is available right now. You don't have to wait for those stupid US or EU safety approvals.

That highlights some interesting challenges wrt global pandemic management. So for a long time, we've had travel vaccinations, eg needing Yellow/Scarlet fever vaccination to travel to the swamps of Canvey Island. There's presumably some international agreement that recognises those vaccinations, so people are safe to travel, and return. Which presumably should be necessary with COVID vaccinations, especially if those become a requirement for travel. AFAIK the WHO is trying to wrangle that problem, so keeping a master list of vaguely functional vaccines.

Then there's 'patient choice'. So in the US, adverts bombard me with reasons to buy expensive, branded prescription drugs rather than cheap generic equivalents. Now, we have a slew of COVID vaccines ranging from traditional attenuated to ones based on the humble adenovirus, or the more novel mRNA versions.. Which I guess is good news given some vaccines may be more suitable for some patients than others. But patient choice potentially removed, ie you'll get Pfizer, and don't pull that face. But then the drug dealers would want exclusivity, because that means $$$, and trying to explain the pros/cons of different vaccines is non-trivial for both a GP and patient.

[Anonymous Coward]

Re: With something as bad as COCID-19,

> So in the US, adverts bombard me with reasons to buy expensive, branded prescription drugs rather than cheap generic equivalents.

You have no clue what you are talking about.

In the US, the pharmacy is required to fill the prescription with a generic, unless the doctor checked the DAW (Dispense As Written) box on the prescription and the doctor wrote a brand name drug on the prescription (as opposed to a generic) and no generic equivalent is available for the brand name drug.

No responsible doctor here will check the DAW box when a generic equivalent is available.

The health insurance policy won't cover the brand name drug if a generic equivalent exists. You are free to pay for the brand name with your own money.

Obviously you have no clue how things work in the US, so why don't you do everyone a solid and stop talking about stuff you have no clue about. Mmmmmkay?

[Jellied Eel]

Re: With something as bad as COCID-19,

You have no clue what you are talking about.

Here's one that was prepared earlier. For no reason other than it was the first ad that came up when I asked YT for 'US drug ads*'-

https://www.youtube.com/watch?v=xipiotOLGDY

Just ask your doctor (or psychiatrist)! Then ask why Eli Lilly made the ad, and then if they made the ad to help get the 2m prescriptions it's managed..

The health insurance policy won't cover the brand name drug if a generic equivalent exists. You are free to pay for the brand name with your own money.

So basically you're saying yes, you can ask your doc for the drug as seen on TV. While you're there, ask about the savings card!-

https://www.trulicity.com/hcp/savings/savings-card

Ok, so other medications are available and will be presented in an ad break soon.. They're empowering!

Obviously you have no clue how things work in the US, so why don't you do everyone a solid and stop talking about stuff you have no clue about. Mmmmmkay?

Et tu, Brute. Meanwhile, howsabout explaining how $39.90 is 'free'?

*US TV is weird. See also-

https://www.youtube.com/watch?v=_5jnn1AIt7Q

[onemark03]

"Russia and China don't want to play."

Russia and China don't want to cooperate or be seen to be cooperating with "opponents" (I won't say "enemies"). It could be a bit embarassing.

[whoseyourdaddy]

Re: With something as bad as COCID-19,

Astra is UK, Zeneca is Swiss. They may have a US division as the US Medicare system is the world's single largest buyer of pharma ..in..the..world.

I'm up on this because I used to be obese and Prilosec kept my nighttime heartburn/gastro-reflux managed until I could drop 70 pound thus wean myself off a $10/day prescription until the patents ran out and it's OTC now.

I will be on my deathbed before I ever take another AstraZeneca prescription ever again.

"Hey, our new drug Prevacid works even better!"

Fuck off, scammers.

[Mikko]

Re: With something as bad as COCID-19,

OTOH one day later there is the news that UK and Russian scientists are cooperating to trial a combination of the AstraZeneca and Sputnik V vaccines

https://www.bbc.com/news/health-55273907

[Potemkine!]

Don't patent COVID-19 vaccines

Make all the data available to anyone for free, FFS.

[ElPedro100]

Re: Don't patent COVID-19 vaccines

Open source the vaccine so we can all make some. Would solve the distribution issues. Just need to buy a colder freezer.

[StrangerHereMyself]

Re: Don't patent COVID-19 vaccines

Ain't never gonna happen. Also, I'm vehemently against it.

If China or Russia want safe and effective vaccines they'll have to buy them from us. Also, we should ban all vaccines from those countries and make their sale illegal in the Western world.

The same holds for India which is ignoring patents on our medicines with the cover story that their poor people can't afford them, only to sell them here.

[Snake]

Re: ban non-Western vaccines

And what positive results will that bring, exactly?

Except more suffering. As long as it's not us doing the suffering (because we'll have our vaccine) that'll be OK?

[Androgynous Cupboard]

Re: Don't patent COVID-19 vaccines

You sound like a wonderful human being.

[heyrick]

Re: Don't patent COVID-19 vaccines

"Also, I'm vehemently against it."

Twat.

So the virus that we could have stood a chance at dealing with will linger on and on in places that don't have the resources to cough up money for a large populace or refuse to send for bullshit political reasons, until the point where it mutates (again) and comes and bites us all on the arse.

How does that help anybody? The virus doesn't care about the colour of your skin, how you vote, or what religion you believe in.

Make the vaccine available to everybody and then we'll only need to worry about those bloody anti-vaxxers.

[Triggerfish]

Re: Don't patent COVID-19 vaccines

That seems a great way to help world peace along, lets build up some real resentment in the middle of a pandemic, help still keep the world economy shut down, cause suffering and death for profit.

I bet you think insulin should be at water charge the company can get away with also.

[IGotOut]

Re: Don't patent COVID-19 vaccines

@stranger.....

You know many of the generic out if patent drugs come from India.

So feel free if you want you £5 a pack magic period pain Ibuprofen. Everyone else will stick to the identical 50p a pack, does everything without the marketing variety.

[Korev]

Re: Don't patent COVID-19 vaccines

I work for a Big Pharma that makes the bulk of its money from branded on-patent drugs - when I buy Ibuprofen or whatever "over the counter" I make sure it's the generic version :-)

[StrangerHereMyself]

Recipe

I wonder if the recipe for producing the vaccine is part of the evaluation process, since it's known that both the Russians and the Chinese want to obtain it.

No doubt they'll start producing an identical vaccine as soon as they obtain it.

Mark my words that if Russia steals it the Sputnik-V vaccine will suddenly be altered to become an identical copy of the Pfizer vaccine.

[I ain't Spartacus]

Re: Recipe

The recipe:

Soften finely chopped onions, carrots and celery in a 50/50 mix of olive oil and butter for half an hour to create a sofrito. Add some virus and brown on a high heat for a few minutes. Adding salt and pepper to taste. Then simmer gently with tomatoes, beef stock and white wine until you have achieved a thick consistency and perfect flavour. Serve on a sugar lump, on a spoon of liquid nitrogen - et voila.

[heyrick]

Re: Recipe

Oh, if only medicines actually tasted of something other than being vaguely and strangely akin to the sensation of sucking on a PP3 battery.

[I ain't Spartacus]

Re: Recipe

Well the polio vaccine is pretty tasty. In the sense that I still had the horrible taste in my mouth an hour later.

And cough medicines are OK. If you like Red Bull.

When I was a kid we used to have pink, artificial strawberry flavour, antibiotics. I used to like them - but now they've taken all the sugar out and look to taste horrible (from children's reactions). Calpol is apparently nice though, I must try some.

[fajensen]

Re: Recipe

Dog medicine taste like bacon.

[six_tymes]

using people as guinea pigs.

[Korev]

How else do you propose finding if medication actually works? Computer models are nowhere near there yet (and may never get there).

[fajensen]

How do you think they figured out which mushrooms and berries to eat? Somebody's gotta do it!

[Long John Silver]

Submissions to regulators must be public domain

All submissions placed before regulators of pharmaceutical products ought become public domain immediately upon receipt. Following the deadline for manufacturers/distributors there ought be an interval during which other parties may submit comment and/or additional evidence; this too entering the public domain at the time the regulator publishes its decisions.

Pharmaceutical products are of special public interest. All submitted information regarding drug/vaccine efficacy, effectiveness at population level, adverse effects, and cost-utility, must be open to general scrutiny. There must be no excuse for withholding information under pretext of it being proprietorial trade secrets.

Pharmaceuticals are due for massive shakeup now that malpractice, inefficiencies, stiffing effects of patents, and price gouging on large scale have become evident. Hitherto excuses by the industry for exceptional treatment in the market no longer wash. High prices have been 'justified' on basis of immense R&D costs with many lines for inquiry being abandoned. Forgotten is that most of the research underlying development takes place in universities and other public institutions; it is funded by the state, by philanthropic institutions, and charitable donations; in so far as the concept of 'intellectual property' has any meaning ownership rests with the public. Much of what is written off as development is, particularly in the USA, aggressive marketing.

Bear in mind too that most clinical trials, particularly phases II and III, take place in healthcare facilities. The UK and some other socialised national health services offer an ideal setting for this. Their services from primary through to tertiary care tend to be integrated and to share comprehensive information systems. Pharmaceutical trials in the UK NHS receive considerable hidden subsidy because true costs of services in which they are embedded are not recouped either at trial stage or when production goes into profit. Fragmented health services in the USA offer sterile ground for large well-organised clinical trials.

The industry has been pushing its luck for many years. Technological advance has made it more easy than ever for independent manufacturers to step in and offer generic products efficiently. Highly priced patented preparations are under suspicion. It requires but one reasonably advanced economy, one out of reach from US Marines, to renege on the international 'intellectual property' scam for the whole rotten edifice to collapse; any such nation will find that increased vibrancy of its economy shall far outweigh loses resulting from other nations 'stealing' its supposed 'property'.

[Sgt_Oddball]

Re: Submissions to regulators must be public domain

Which is a terribly nice thing to do... But then who's going to pay for the researchers? If time and money spent developing a new treatment didn't earn a profit and was going to be straight up copied by a competitor who didn't pay a penny towards it, then why bother?

Goodwill doesn't keep people in jobs (at least it shouldn't do - there *should* be no need for charities. That they exist shows governments globally aren't able to provide for everyone).

At the end of the day for all their sins the pharmaceutical industry is a nessisary evil. They just need to be better regulated to prevent exploitation and extortion.

As for implying that the US just threaten anyone who makes stolen drug designs with the Marines.. How's that other war on drugs going?

[Korev]

Re: Submissions to regulators must be public domain

Forgotten is that most of the research underlying development takes place in universities and other public institutions; it is funded by the state, by philanthropic institutions, and charitable donations; in so far as the concept of 'intellectual property' has any meaning ownership rests with the public. Much of what is written off as development is, particularly in the USA, aggressive marketing.

Many, but not all targets are found by public institutions; but the molecules that target them are usually invented by pharma/biotech (Academic labs do license molecules and then receive royalties eg Abiraterone). The real work is finding if the said molecules work in the test tube, then animals and finally in humans. The vast bulk of cost is incurred later in the process and I can't see many government wanting to pay a billion or so for developing a drug that the laws of probability say will fail...