Have any governments proposed relaxing drug/vaccine development requirements for the duration of the COVID-19 pandemic?

Question

Given that a vaccine or an effective treatment for COVID-19 is the best way out of the current crisis, it seems logical that governments would take a "no holds barred" approach to making it happen as soon as possible. Have any countries so far announced that they would abolish (or significantly relax) restrictions on drug/vaccine development for the duration of the pandemic?

Answer 1

I am totally sure there is a lot of relaxation going on already. For example, I believe the recent Seattle-based vaccine trial went straight to human volunteers, bypassing the animal testing stage. Note that this link criticizes that decision - I don't myself, but it's just the first link to this trial I found.

Thing is, and especially with a relatively low mortality disease like covid, you really don't want to make things worse than they by mass-treatment with the wrong approach. You do need to make sure it does what it supposed to do and that it doesn't hurt.

Here's a review of vaccine candidates, from Nature - at 78, it sounds like things are off to quick start. Note 1 item in this article: 90+% of vaccine candidates in normal times don't work out, for whatever reason. Or, to put things in a different perspective, how many times have you read about revolutionary cancer treatments in the last 2-3 decades? Sure, we are slowly beating cancer - which unlike covid is a bunch of diseases - but by now anyone paying attention knows that just because someone has found something interesting doesn't mean the work is done, no matter how appealing the headlines.

Even if safe, if it doesn't actually help, how are you ever going to convince "vaccinated" folk to observe social distance, if they are "immune"?

Now, I am totally with you that 12-18 months seems like a lot. Maybe some of it can be shaved off. But that should be driven by what experts in the field, with a strong mandate to limit red tape this one time can do.

Take our friend hydroxychloroquine. It is not a safe drug at any time and needs careful monitoring. Barging ahead and prescribing it, without showing that it works is something no one should do in this case. There's nothing wrong with testing hydroxychloroquine, and quickly, but the pros and cons need to assessed before large scale use. Right now, the pros are starting to look like the limits of doing cutting edge research very quickly, without sufficient time for assessment. It's not that it was wrong to think it might help, or pursuing accelerated tests, but it might end up being a dead end, using a drug with known serious side effects.

If hydroxychloroquine works, great. That's what 3-4 weeks of lockdown so far are buying us, the "luxury" of making rational choices and preparing to beat this, using the best experts in the field. And it's not like that's the only drug being looked at either - if Trump hadn't mouthed off about it, no one would even know it exists.

A bad vaccine may be worse than no vaccine

Edit: Since some people that are all gung-ho about full steam ahead, I'll add an extra bit of info re. vaccination risks that is getting mentioned wrt covid.

One of the ways covid seems to kill some people is overstimulation of the immune system (this was also the case in the 1918 Flu). And we know that some vaccines for some diseases can make this problem worse under some conditions. Probably because they've primed the immune system to overreact. This is the case with dengue fever. Imagine if we broadly vaccinated against covid, just to find out later that a non-negligible proportion of the population did worse because of untested vaccine effects?

Covid is a 1-5% death rate disease, at least when the local health system is not swamped. It is not rabies (100%) or Ebola (60%). That means we don't have the ethical right, or just the cold mathematical basis cost/benefit basis, to just barge in and hope for the best, based on our gut feelings.

We can, and should, take some shortcuts, but we have to do it intelligently, based on the knowledge of people who do this for a living. That doesn't mean we can't ask hard questions however.

I wouldn't tell my mechanic how to fix my car, I wonder why so many now claim to know better than vaccination and epidemiology experts.

Answer 2

China has also fast-tracked their own vaccine development, with testing in humans (news of March 18):

CanSino Bio and its collaborators at the Academy of Military Medical Sciences’ Institute of Biotechnology secured a quick Chinese regulatory go-ahead to start human testing of their recombinant coronavirus vaccine, the company said in a disclosure (PDF) to the Hong Kong Stock Exchange on Wednesday. [...]

The green light was doled out very quickly. It was only Tuesday when CanSino said it had filed the pre-IND review application for the vaccine to authorities and was in the process of a rolling submission of technical documents. [...]

Meanwhile, amid growing numbers of infections in the U.S., the FDA has allowed a phase 1 study of Moderna’s mRNA vaccine without animal data. On Monday, the biotech said researchers at the National Institutes of Health dosed the first subject. [...]

Besides CanSino and Moderna, many other companies are also working on vaccines for SARS-CoV-2. [...]

I cannot tell you how much "bending of the rules" this is in China, since I'm not familiar with their regulations. But the timing of the Chinese announcement was roughly two days later after the US announced the first Moderna vaccine dose having been injected into a human (on March 16). Interestingly perhaps, China is also developing a mRNA vaccine "jointly developed by the Chinese Centre for Disease Control and Prevention, Tongji University and Stermina in Shanghai", but this one is still undergoing animal testing in China, with human testing announced to begin mid-April.

So yeah, the US (NIAID/Moderna) and China (CanSino) are now basically in a "race for the [vaccine] cure". Others will probably join. I suspect they might also benefit from regulatory fast-tracks, possibly depending how well politically connected they are in their test jurisdictions. (The EU has given Curevac a grant to work on a mRNA vaccine similar to the Moderna one; however no human tests have begun with that--they've been announced for June. The WHO said that over 40 concrete vaccine candidates have been proposed, with at least a hundred in development.)

The WSJ reported (without a lot of specifics on the regulatory side that):

Counting drugs approved for other diseases, there are 254 clinical trials testing treatments or vaccines for the virus, many spearheaded by universities and government research agencies, with hundreds more trials planned. Researchers have squeezed timelines that usually total months into weeks or even days.

---

More recent news (Apr 14) regarding Covid-19 anti-bodies tests low standards:

On CNN Tuesday, senior medical correspondent Elizabeth Cohen warned that many of the antibody tests on the market for COVID-19 — the tests that show whether you are immune to the virus — are barely tested under the Food and Drug Administration’s new standards, and possibly ineffective. [...]

“The problem is, the FDA lowered the standards last month, and basically pretty much anyone can sell an antibody test,” continued Cohen. “They don’t even have to show that it works. All they have to do is say, hey, FDA, I want to sell this test and I validated it here in my city where I am. That’s all they have to do. They don’t have to show their data.”

And after the backlash, there's some sort of review announced:

[Scott Becker, CEO of the Association of Public Health Laboratories] said FDA Commissioner Stephen Hahn told him and members of his association that the National Cancer Institute (NCI) would start reviewing tests that are on the market to see if they obtain correct results. [...]

The FDA did not respond to questions for this story, referring CNN to the NCI.

A lot of the media has incorrectly headlined these news as the FDA tightening the (approval) standards, but that doesn't seem to be actually happening yet.

---

And (August edit) to add the latest story on the Russian vaccine developments:

Russia enacted a law in April which eliminated the requirement for crucial Phase 3 trials to be conducted before approval. This has allowed researchers to fast-track the vaccine development process.

Answer 3

August 2020 Update

In light of the severe impact of the pandemic, it is probably fair to say that every country is reassessing the approval process for new vaccines to a greater or lesser degree.

According to the WHO, as of 13th of August 2020, six vaccines are in Phase III trials, and 16 are between Phase I-II. Phase III trials are essential because they check for problems such as Antibody-dependent Enhancement(ADE), which is where a vaccine actually helps viruses infect host cells.

Phase III trials.

• The U.S.'s leading candidate is the vaccine from Moderna. President Trump launched Operation Warp Speed to fast-track the release of vaccine candidates, but regulatory approval from the F.D.A. is likely to require proof of success in Phase III trials. I can't find any evidence to suggest that the F.D.A. has relaxed the normal approval process, but they are likely to come under significant pressure from the Whitehouse to do so.

• The vaccine from the U.K.'s University of Oxford, is probably the front-runner both in terms of human trials and pre-orders. They have already received orders for at least 2 billion doses globally. Late-stage testing has commenced in at least three countries, and they are the only candidate vaccine to have published peer-reviewed results. In the UK, the Medicines and Healthcare products Regulatory Agency is the body that oversees the approval of new vaccines. They have released a set of guidelines explaining their approach to regulatory flexibilty in light of the COVID emergency. There are conditions under which vaccines can be fast-tracked for emergency use, but they will still have to prove success in Phase III trials first.

• Four vaccines in China are in Phase III trials, and at least two Phase I, and one Phase II reviews have been published. Probably the leading vaccine candidate was developed by Chen Wei's team at the the Beijing Institute of Biotechnology. Unconfirmed reports have claimed that some of these candidate vaccines are already being tested on employees of the companies involved, and other rumors have suggested that they are available for some employees of state-owned companies and the military. It appears therefore likely that China has potentially extended Phase III trials in a somewhat non-traditional way.

Notable Phase I-II trials

• The vaccine developed by the Gamaleya Research Institute has only announced the completion of Phase I trials, but President Putin has claimed that he has already inoculated one of his daughters. The results of the phase I trials haven't been publically peer reviewed. This suggests a severe relaxation of normal regulations. Indeed, on 14th August, top respiratory doctor Professor Alexander Chuchalin has quit the Russian health ministry, citing ethics violations concerning the registration of this new vaccine.