Moderna To Ask FDA To Approve New COVID-19 Vaccine That’s 94% Effective | Talking Points Memo

I would take that 94.5% and 95% rating with a grain of salt. This is how drug companies arrive at their numbers:

Pharma marketing may be a slick, amoral enterprise, but you are doing an apples-to-oranges injustice to fundamental statistics in equating relative risk percentages with absolute figures like vaccine efficacy.

If a drug decreases your annual risk of some feared condition from 0.003% to 0.002%, calling it a “33% improvement” (0.001%/0.003% = 33%) is indeed hype, but that’s not what’s happening here.

That 95% number reflects the ratio of total infections in the control (placebo) group to those in the test group: For every positive COVID case among the vaccinated, there were 19 among the controls. That’s quite a powerful result, and it deserves the headlines it’s received.

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It will work this time because of two major innovations. 1. Natural mRNA is broken down quickly when injected into the body. By manufacturing the mRNA synthetically, the companies were able to include rare bases that stabilized the mRNA against breakdown. 2) The mRNAs are encapsulated into liposomes (small fat globules) that are specifically designed to protect the mRNA and deliver it to the cells that need to take it up. The composition of those liposomes is probably proprietary for each company but the nature of the lipids/phospholipids and their ratios is critical. These studies have been going on for decades and we are just now seeing the fruits of those labors.

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Yes. If that’s the case, I agree.
Where do you find these numbers with the breakdown between the two groups? With drug companies, they don’t publish the trial data anymore, just the results. I’d like to see the trial data numbers and check their math because over the years, I have become a little bit skeptical regarding companies who have hyped data to sell a drug in the past.

Precisely.
While 95% effectiveness is amazing, it’s still 5% ineffective.
Roll 1 on d20 and your comfort will have to be that you won’t get as sick as if you hadn’t been inoculated. Probably.

The numbers I tossed out are simply implicit in the reported efficacy, ie. 19 in 20 = 95%. I haven’t looked, but I’m not aware that the full phase 3 numbers are published yet, although they’ll certainly be central to the approval process.

With a phase 3 trial you basically have to wait for enough people to get sick so you have a statistically valid differential between the 2 study arms. What we read about in the recent breaking headlines were interim results, “un-blinded” by a special independent safety review board that can halt a trial if it’s harming people or showing no efficacy, OK it to continue, or recommend accelerated approval. I believe the Pfizer “90%” reveal was based on a review of 60 or so total positive cases (which were mostly in the placebo group)

I am also skeptical of drug co. pronouncements, and their marketing is often at odds with intellectual honesty. With gimmicks like the eternally abused relative risk-hyping, they have certainly led us all to distrust “lies, damned lies, and statistics” with good cause. Fortunately, these clinical trials do at least have some built-in guardrails (such as the independent review boards, and double-blind protocols) that media reports don’t always fully appreciate or convey.

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What I’d really like to know is if that unlucky roll is somehow innate to the individual, or if one can “roll again” with similar chance of success.

Of course, if we had enough global vaccination compliance to achieve anything like 95% immunity, we’d be well over the threshold to choke off the community spread & eradicate the damn thing…assuming it doesn’t mutate before we get there.

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It’s a common practice to salt some independent boards with industry insiders in other areas. How are these board members selected and from what industry? Do they have past or current ties to any drug companies? Are they allowed to own and invest in drug stocks?. There’s billions at stake in most drug roll outs. The drug companies like to increase their odds wherever possible because of the huge pile of money at stake. Class action lawsuits can have a dampening effect on their enthusiasm though.

I’d like to see the FDA also share some cost and blame for approving drugs that do more harm than good. And there have been a few they have approved in the past that fit that description. I’m not saying the vaccines will do so, I just want to check their math. When they hide their trial data from the public and rely on the integrity of a just a few people to check their data, I’m leery of the process.

Oh, wow, thanks for the answer. Kind of you to reply. I am sure everyone else will also appreciate your added information and background.

I will continue to keep my fingers crossed. Perhaps we are living at just the right time when a confluence of research and hard work are about to pay off at a most crucial time…:+1:

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Where are you getting this, because it’s not true. The effectiveness of vaccines is determined by the natural variability of the immune systems from person to person. Five percent of the people who get the vaccine are just not capable of responding to the vaccination in a manner that confers immunity. It certainly does not mean that everyone’s immune system reacts the same to some how randomly fail 5% of the time it’s exposed to the virus. If you have an adequate response to the vaccine, then you should have immunity no matter how many times you are exposed. Now, of course, how long that immunity will last is to be determined, but when you are immune, you are immune.

Here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3798059/

FTA: “Vaccine efficacy measures the protective effects of vaccination by the reduction in the infection risk of a vaccinated individual relative to that of a susceptible, unvaccinated individual.” A vaccine that’s 95% effective reduces your risk of infection by 95%. It doesn’t reduce your risk either by 100% or 0%, depending upon a roll of the dice, which is what some people on here have been saying.

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You don’t understand what they are saying. If I get the vaccine my risk is related to the fact that it is not known if I mounted an appropriate response to the vaccine. If I’m in a cohort of 100 people who were vaccinated with 95 being totally immune and 5 having the same lack of resistance as an unvaccinated person, then my personal risk is 5% because I don’t know if I’m one of the 5 or one of the 95. The protection afforded to individuals is not a role of the dice, but rather due to their individual immune health at the time of vaccination. When exposed to an antigen we all make slightly different antibodies and we make them in varying amounts. For some people the antibodies produced in response to the vaccine just are not that good enough or are not of sufficient quantity to work against the virus.

The paper is however interesting and I always love practical applications of differential equations, so thanks for bring it to my attention. [Also for clarity this paper deals primarily with the issue of infection rather than disease. The COVID trials only looked at risk of disease, not infection. It is possible -although unlikely- that the COVID vaccines work by turning symptomatic infections into asymptomatic infections which would have a big implication for those not vaccinated or immunodeficient. ]

@crewman6 Right? We have had whole RNA companies start up and fold within 5-6 years, as investors threw millions into this technology. At one conference, I heard a well-known industry leader, who at the time say on the boards of 4 RNA start ups, say that he banked his daughters cord blood based on the promise of this technology because it could be used to develop a personalized oncology treatment for her if she needed it, using RNA technology. I never forgot that and years later, I signed up to have my child’s cord blood banked. My daughter is 11 now.

These RNA companies and their investors gave been waiting for a health crises like this for over 15 years and here we are. And a RNA research company with zero products on the market, and no commercial experience, will be manufacturing a product that will be injected into tens of millions of people overboard the next 12 months?

The bright spot here is that life sciences funding will hopefully focus on these truly life-saving therapies, like fighting the next bacterial or viral infection. We have a lot of US companies dedicated to researching new antibiotics that are on life support themselves.

So, many people are remarking about the speed with which these categories of vaccines have come to market. Think of this like climbing Mount Everest and having already climbed to base camp (and not working out on a Stair Master in Chicago). You had to do a lot to get here. I suspect that most of the scientists working on the Pfizer and Moderna COVID-19 vaccines were still in grade school 15 years ago. The nature of science is to build upon the discoveries of those who preceded you. Moreover, the tools to do what Pfizer and Moderna have done are relatively new. I am glad for your daughter, but the Pfizer and Moderna are not the enemy; plus, Pfizer was founded in 1849 and they have a lot of experience bringing drugs to market. And while Moderna may be new, you should take consolation in the fact that their results - using the same technology but a different platform - are essentially the same as Pfizer’s. That said, vaccines are the ONE thing we do to otherwise healthy people; everything else is done because people have disease a;ready. Consequently, safety is always paramount.

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I saw where a roll out timeline is already in place.

Healthcare workers and nursing home residents are first in line. The first doses will number about 24 million, available by the end of December. They expect to have another 70 million doses over the next month or two. ETA: Found the article here:

CDC Panel Says Health Workers, Nursing Homes Will Get COVID-19 Vaccine First – NBC Connecticut

I’m seeing a lot of deniers out there saying they won’t take the vaccine because it hasn’t been proven enough.

I wrote the following:

For those who say no thanks, thank you.

More for me and for rational people who don’t want to have lifelong debilitating issues as a result of the virus. You go ahead and expose yourselves. The rest of us will get on with life.

Other countries are already distributing vaccines or preparing to do so. The US will be bringing up the rear again, because too many citizens are afraid of science and believe feelings over facts.

At least, once the vaccine is available, the hospitals will have enough room for the deniers.

ETA: I have two articles from Connecticut on FB that tell how the vaccine will be distributed there - one of the grocery store chains (Big Y) will distribute from their pharmacies and also Walgreens and CVS:

CVS, Walgreens preparing to be among first in US to administer coronavirus vaccines (kwwl.com)

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