Hacker News Reader

Comment by dia80 | Hacker News Reader

Seemed to take a surprisingly long time. Let's hope the time had been well spent planning the roll out.

The reverse actually.

Whilst Oxford had the (generic) basis of the vaccine ready to go, prior to the COVID outbreak, it was the removal of all bureaucracy in this, and other, vaccine trials, that has allowed them to go from r&d to approved in 10 months or so.

Which is apparently what researchers will tell you is the 'real' time it takes to develop a vaccine. No time writing proposals and rewriting them when they get rejected, no awaiting someone to approve the proposal, no applications and waiting for grant money, no time spent waiting for volunteers for clinical trial groups, and so on.

Regarding the dosage, more information here: https://www.bbc.co.uk/news/health-55308216

(edit) and the time to develop here: https://www.bbc.co.uk/news/health-55041371

The biggest speedup factor was how easy it was to get people sick. A certain number of people had to get sick within the trial groups before results could be conclusive. With how widespread COVID is and how many people caught it, they hit that requirement significantly faster than they normally would.

Yes. Listened to one of the researchers talking about this. They said just that, this time difference here is almost all down to not waiting for funding or going through the usual grant process.

What was long about it? It only months instead of years, and for mRNA vaccines this whole time was spent on the validation and approval process while the vaccine design itself took only about ~2 days right after SARS-CoV-2 was sequenced.

From https://nymag.com/intelligencer/2020/12/moderna-covid-19-vac...:

> "Moderna’s mRNA-1273, which reported a 94.5 percent efficacy rate on November 16, had been designed by January 13. This was just two days after the genetic sequence had been made public"

I assume you are referring to the approval process. I've been thinking that too.

I don't want to be that person who thinks a really complicated thing should be trivial, so: Can anyone suggest why it would take weeks to approve these vaccines? What might the regulator actually be doing in this time?

They're clearly going to know that the request is urgent, and know when it's going to be arriving in their inbox; they could ask for anything apart from final data ahead of time to check everything is as they want it. I don't see why they can't have made sure they were happy with everything else ahead of receiving the final data.

Given the pace, and the lack of years-long trials, they perhaps brought in a lot of additional people to help analyse the methodology and data.

Both Pfizer and Moderna were approved within a week of request. So it's not expected for the approval process to be slow.

If you compare the data between Pfizer[1] and AstraZeneca[2]. The AZ trials were significantly more complicated, with variations in methodology between phases and locale and much smaller sample sizes. It looks like they had to massage data and combine phases and explain differences, why they were doing it, and why it should still be considered safe.

Pfizer just submitted a giant sample size homogeneous trial result.

I would imagine it's way easier explaining and approving the one methodology/result with a giant sample size from Pfizer than the four methodologies/trials with small sample sizes and different doses within those trials given by mistake from AZ.

[1] https://www.nejm.org/doi/10.1056/NEJMoa2034577 [2] https://www.thelancet.com/journals/lancet/article/PIIS0140-6...

in the findings for AZ, there is 1 reported death. So this means particapnt got the virus outside and vaccine didn't work right?

> From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death.

Means they didn't get the vaccine at all.

ahh ok all in the control arm

By what standard? The article says specifically:

    It has been developed at a pace that would have been unthinkable before the pandemic.

    The new vaccine approval comes after Public Health England said the country was facing "unprecedented" levels of infections

Reply on news.ycombinator.com