So the way I read this statement, they explicitly say state "Pfizer has not conducted gain of function."
Then they later admit, " In a limited number of cases when a full virus does not contain any known gain of function mutations, such virus may be engineered to enable the assessment of antiviral activity in cells." (I'm not exactly clear what that means, but it reads like they do gain-of-function to me. I've learned that when people are usually unclear on very important statements it's often the worse interpretation that's true, otherwise they'd have a reason to be clear).
Then they quickly defend "It is important to note that these studies are required by U.S. and global regulators for all antiviral products and are carried out by many companies and academic institutions in the U.S. and around the world."
So I'd take this to mean one of two things:
1) Gain of function research is required & happening everywhere and they just stopped telling everyone because it's so political so we now weasel-word around it; if you were technical you'd understand
or
2) They are twisting words very hard in this press statement about what is "required"
Engineering the virus doesn’t mean making gain-of-function mutations. “Function” has a specific meaning and it’s not a synonym for “does anything.” Instead, in broad strokes, think of “function” as referring to biological activities that give the virus some advantage over its host.
To make a simplistic analogy (necessarily imperfect but sufficient for these purposes), consider instead a computer virus. If an antivirus company patches the binary in order to make it easier to study its behavior (for example, in order to make it more debuggable), that’s “engineering” the virus but it’s not “gain-of-function.” If the company instead patches the virus so that it can take advantage of a new 0-day exploit and spread further, that’s “gain-of-function.”
Whether gain-of-function research is capable of revealing new insight into transmissible diseases not obtainable elsewhere is a point of debate among biologists, but one can be well assured that a for-profit operation isn’t going to touch it with a ten-foot pole. Engineering the virus on the other hand, or in other words making mutations in viral components, is basically a description of “doing basic molecular biology” and is non-optional.
The sort of allegation that Pfizer is responding to is more or less the equivalent of someone recording an engineer calling themselves “hackers,” visiting “Hacker News,” then writing an exposé claiming that this proves Company X is in the business of computer crime.
The activity mentioned in the Pfizer press release that skirts closest to “gain-of-function” is actually a bit you didn’t mention at all, where they’re required by regulatory bodies to determine how the virus might resist an antiviral. Unlike computer viruses, biological ones mutate under treatment pressure. The closest analogy for a computer virus might be if it phones home and downloads a new payload to modify its behavior when it detects the presence of some antivirus software. For obvious reasons, studying how a pandemic virus would mutate in response to approved drugs is both necessary and icky, hence why Pfizer discussed its biosecurity measures. The distinction they make (rightly) between this research and a “directed evolution” or “gain-of-function” experiment, is that they’re reading out an answer to the question “Does the virus mutate when we treat with this antiviral drug, and if so, how?”, not culturing viruses iteratively in the presence of drug until they obtain an optimized treatment-resistant virus.
One interesting thing to note is another weasel word "In a limited number of cases when a full virus does not contain any known gain of function mutations, such virus may be engineered to enable the assessment of antiviral activity in cells." It sounds like they're saying "We might do gain of function without knowing it."
Obviously this shouldn't be interpreted as some tinfoil-hat "making a supervirus." But given lableaks have happened 50 or so recorded times[1], scrutiny is obviously warranted. I'd be cucious exactly what the oversight is at such labs, and whether there are whistle-blower protections/policies should anybody witness anything dangerous (be it deliberate or simply failing to follow safety procedures).
> Then they quickly defend "It is important to note that these studies are required by U.S. and global regulators"
Right before that claim, they mention another set of studies that don't require gain-of-function engineering. The regulations probably refer to those, and Pfizer is hoping we'll misinterpret their statement and think the regulations demand gain-of-function.
I would be very surprised if regulations required genetically engineering more dangerous virus strains.
Then they later admit, " In a limited number of cases when a full virus does not contain any known gain of function mutations, such virus may be engineered to enable the assessment of antiviral activity in cells." (I'm not exactly clear what that means, but it reads like they do gain-of-function to me. I've learned that when people are usually unclear on very important statements it's often the worse interpretation that's true, otherwise they'd have a reason to be clear).
Then they quickly defend "It is important to note that these studies are required by U.S. and global regulators for all antiviral products and are carried out by many companies and academic institutions in the U.S. and around the world."
So I'd take this to mean one of two things:
1) Gain of function research is required & happening everywhere and they just stopped telling everyone because it's so political so we now weasel-word around it; if you were technical you'd understand
or
2) They are twisting words very hard in this press statement about what is "required"