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Covid-19 was discovered/named in December, 2019. By November, 2020, we have preliminary data from Phase III clinical trials for two vaccines. The previous record for vaccine development was 4 years.
Ok, let's get into it:
Like the Pfizer vaccine, we have a novel mRNA vaccine (more on that some other time) developed from a young, new biotech company that is reporting via press release the topline results of their study - though this one did not https://www.cnn.com/2020/11/16/health/moderna-vaccine-results-coronavirus/index.html?utm_medium=social&utm_content=2020-11-16T12%3A04%3A51&utm_source=twcnnbrk&utm_term=link
Like the Pfizer vaccine, we have a novel mRNA vaccine (more on that some other time) developed from a young, new biotech company that is reporting via press release the topline results of their study - though this one did not https://www.cnn.com/2020/11/16/health/moderna-vaccine-results-coronavirus/index.html?utm_medium=social&utm_content=2020-11-16T12%3A04%3A51&utm_source=twcnnbrk&utm_term=link
partner with a large Pharma and instead tested it on their own. In both cases, they pre-specified the outcomes they would look for: when total cases in both arms (placebo and vaccine) hit 90, they would analyze the data and see if more cases were in one arm or not.
Note: The FDA's baseline for an Emergency Use Authorization is based on flu vaccine efficacy of 50% (with confidence interval saying it's at least 30% effective).
While we hoped for more, the baseline expectation is that early vaccines would be focused
https://www.fda.gov/media/142749/download
While we hoped for more, the baseline expectation is that early vaccines would be focused
https://www.fda.gov/media/142749/download
on speed over efficacy, and that it would take a series of vaccines to go from flu territory (~50%) to the efficacy seen for the best, childhood staples (polio, etc). This is what it looked like for the current record holder: mumps. https://historyofvaccines.blog/2020/06/22/a-covid-19-vaccine-in-record-time-is-going-to-require-a-lot-of-knowledge-of-history-and-a-lot-of-cooperation-and-much-more-patience/
So now we have two reports of Phase III results showing >90% efficacy over a large - and in Moderna's case at least - diverse patient population. Moderna noted that in addition to being pretty effective (though not perfect) at preventing infection entirely, none of the severe
infections happened in the vaccine arm. This part, if it holds up, is what turns Covid19 from pandemic virus capable of destroying economies and health care systems into something closer to the common cold.
If peer review confirms, this is better than we could have hoped for.
If peer review confirms, this is better than we could have hoped for.
So, what comes next?
They will submit for peer review (guessing New England Journal of Medicine) and FDA EUA in the coming weeks. Part of that is at least 2 months of safety data, which they're just meeting now from Phase III data, but they'll have Phase I & II data as well.
They will submit for peer review (guessing New England Journal of Medicine) and FDA EUA in the coming weeks. Part of that is at least 2 months of safety data, which they're just meeting now from Phase III data, but they'll have Phase I & II data as well.
We don't know how long the FDA will take to review. It's tricky given that this is a totally new vaccine class, but that delays also have a cost in lives as well.
Both Pfizer and Moderna say they'll have 10 million doses ready by the end of the year, both targeting over
Both Pfizer and Moderna say they'll have 10 million doses ready by the end of the year, both targeting over
500 million by the end of 2021. Moderna's vaccine notably does not require transport/storage in deep deep freeze.
Healthcare workers will get it first. The more that get it, the less we'll have to worry about staff shortages (unclear what this will mean for PPE).
Healthcare workers will get it first. The more that get it, the less we'll have to worry about staff shortages (unclear what this will mean for PPE).
Next will come at risk folks, likely defined by national guidelines & state/local deployment strategies. This will include people who are older (>60), have health conditions (diabetes, hypertension, organ transplant, etc) that put them at risk, and hopefully "essential" workers.
Finally, I said a while ago that part of the problem for this Covid19 pandemic is that we are victims of our own health science success. Medicine has consistently pushed forward the average lifespan despite frankly worse lifestyle choices.
But we're victims of our own success.
But we're victims of our own success.
We have become dependent on technology and science to 'save us' with an easy option instead of doing the hard work building systems to take care of ourselves and each other.
Hundreds of thousands of Americans have died from this, and hundreds of thousands more will die before
Hundreds of thousands of Americans have died from this, and hundreds of thousands more will die before
the vaccine is widely deployed.
Science may save us in the end, but we're failing each other in the interim. The finish line is in sight, but how we do in this race is not determined by who gets across first - it's how many we get across with us.
Make the sacrifice. Please.
Science may save us in the end, but we're failing each other in the interim. The finish line is in sight, but how we do in this race is not determined by who gets across first - it's how many we get across with us.
Make the sacrifice. Please.
