He was similarly unenthused about a decision by the biotech company Moderna to issue snippets of early data from the vaccine trial his agency has been conducting — without waiting for fuller results.

response to the coronavirus pandemic, the NIAID director also acknowledged the world will have limited data on the new vaccines when they are deployed, and may have to balance the need to save lives with the possibility of some adverse events.

Merck has a ton of experience developing vaccines.

The general trend on the part of the pharmaceutical companies, because of the enormous investment that goes into the development of a vaccine, is that you don’t go to the next step until you’re fairly certain that the step you’re in is going to be successful.

But what we’re doing is something that’s called developing “at risk.”.

What it means is that at the same time you’re finishing your Phase 1 trial, you’re preparing your Phase 3 trial sites, which is very expensive, and then you’re starting to manufacture the vaccine even before you know it works.

We’re now completing the Phase 1 [with the Moderna vaccine].

Not only with the Moderna vaccine, but also very likely with the AstraZeneca vaccine.

If you do and you’re already manufacturing doses, by December and January, if you’re lucky and if in fact it is effective, you can have a significant number of doses available by the end of the year, the beginning of 2021.

The only thing that’s the big unknown to me is that, is it going to be effective?

But there’s no guarantee that it’s going to be effective.

When Moderna recently released some the information on the vaccine they are developing with NIAID, they showed neutralizing antibodies in eight people.

What about what you’re seeing about the other vaccines in the clinic already.

Well, the Oxford University vaccine [developed in partnership with AstraZeneca], the data in the animals, you know, some of the animals got infected.

But then again, it depends on what you’re looking for with the vaccine.

That vaccine doesn’t look like it’s a knockout for protecting against infection, but it might be really very good at protecting against disease.

It’s an mRNA vaccine?

I’m sure that Pfizer is going to get results that are as good as the Moderna vaccine.

It just feels good to be directly or indirectly involved in four or five candidates, to do it in a way that I refer to as sort of harmonized, where you come to an agreement, which we did, that we’re going to do things where the trial protocols will be quite similar, where the laboratory tests that we’re going to ask for are going to be quite similar, so that you can extrapolate results from one study to another.

If one vaccine proves efficacy in a clinical trial and another vaccine is behind it but it’s getting the same correlate of immunity you could bridge data and facilitate the approval of the second and the third one based on the efficacy of the first one.

With such a compressed timeline for testing the vaccines, how much do you think we’re actually going to know about them before we start to deploy them.

If you’re only getting a few months worth of data, we won’t know much, if anything, about the durability of the protection.

So when you design a clinical trial, there are a certain number of events that will give you a definitive answer as to whether or not your vaccine is effective?

So we’re not going to declare efficacy or even begin to think about efficacy or not until we reach that predetermine statistically sound number of infections that either occurred and/or were prevented.

But we’re going to have to live with that.

The first thing we’re interested in is: If we vaccinate you in the late summer, early fall, are you protected through that fall, that winter and then going into the spring?

I mean, obviously, the concern with a vaccine, with a virus like this, is what are you going to get enhancing effect, [where the vaccine actually makes some recipients develop worse illness if they contract the infection].

Fact is Moderna s vaccine, as well as other companies vaccines, have a real chance to work well

The team behind the Oxford vaccine is going to be testing it on older people this summer as well as children