Head of US FDA’s advisory group: ‘We never expected Covid vaccines to be so good, so effective’

Dr Arnold Monto says he watched as a vaccine was developed both faster and more effectively than any dared to hope – but says it’s unlikely to give ‘permanent protection’

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Early results from the clinical trials and observational studies of mRNA vaccines against SARS-CoV-2 indicated that not only were they highly effective at preventing symptomatic infection, but they were also effective in preventing asymptomatic infection and therefore transmission.2 (NEJM)

Guardian: It is likely that in the “before times”, few Americans knew that independent experts advised the US Food and Drug Administration (FDA) on the safety and efficacy of vaccines, and that the FDA usually took their advice.

Less than a year into the Covid-19 pandemic, that quickly changed.

The Vaccines and Related Biological Products Advisory Committee became arguably the most closely watched group of experts in America’s federal government. The media followed hearings, and thousands of Americans tuned in live to see whether these scientists considered Covid vaccines safe and effective.

“It’s really difficult, given the fact we never thought this [pandemic] was going to happen in this way … it’s all been a revelation,” said Monto. “And the revelation is also how societal beliefs would affect what we are seeing in terms of the continuation of severe disease.”

Ultimately, experts and Monto did say vaccines were safe and effective, and the FDA authorized Covid-19 vaccines for emergency use shortly thereafter. More than 237 million Americans have since received a vaccine. Through several more hearings, VRPAC has recommended vaccines to everyone older than five and booster doses to everyone older than 18.

Now, Monto is the author of a recent article in the New England Journal of Medicine, in which he considers the long-term future of the pandemic, and whether scientists can learn from another disease that was once pandemic – influenza.  Read more..

https://www.theguardian.com/society/2021/dec/25/us-fda-vaccine-advisory-group-covid-vaccines-flu


The Future of SARS-CoV-2 Vaccination — Lessons from Influenza

…by Arnold S. Monto, M.D.

After a period of falling Covid-19 illness rates, the recent spread of the delta variant of SARS-CoV-2 was a major disappointment and necessitated a reexamination of some previous assumptions.

This reconsideration may, at least in part, be a correction to overly optimistic views of what highly effective SARS-CoV-2 vaccines could accomplish. Some observers had hoped the vaccines could eliminate transmission of the virus, the ultimate goal of reaching herd immunity.1

A more likely picture of our future with this virus comes into focus if we examine the well-known infection patterns of another respiratory virus, influenza, both in and outside pandemics. That experience can help us reset expectations and modify goals for dealing with SARS-CoV-2 as it further adapts in global spread.

Early results from the clinical trials and observational studies of mRNA vaccines against SARS-CoV-2 indicated that not only were they highly effective at preventing symptomatic infection, but they were also effective in preventing asymptomatic infection and therefore transmission.2

The basic criterion used for emergency use authorization by the Food and Drug Administration was a standard one: prevention of laboratory-confirmed clinical infection meeting a case definition.

The effect on asymptomatic infections was a welcome surprise, because it has been thought that most vaccines for respiratory illnesses, including influenza, are “leaky” — that is, they allow some degree of asymptomatic infection and are better at preventing symptomatic infection.  Read more…

https://www.nejm.org/doi/full/10.1056/NEJMp2113403

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5 COMMENTS

  1. Reading through the VT intro to the NEJM article, the title gives impression the vaccines are and were stupendous, much better than expected.
    OK thats great to know, so I read through the VT intro, and there was actually great dissapointment because the vaccines didnt prevent the “delta” from infecting and killing a hundred thousand more in the USA, or whatever it was.
    So I wonder what the “better than expected’ is being talked about, so last paragraph I see they are talking about only the “early results” (not delta) where the vaccines not only prevented those with symptoms, but those infected without symptoms, so that is great thing to see since the Covid 19 had the “transmission” feature of no symptoms for up to 14 days but very contagious during that time. (indication of lab concocted genetically modified bioweapon but wont go into that now)
    So what the intro article says in nutshell II think) is vaccines worked better than expected for that first round of pandemic, before delta mutation/variant appeared, and now it was “dissapointing” in stopping the spread of delta….now comes omnicron

    • There have always been anti-vaxers, and pro-vaxers, and probably always will be. So why would VT want to ‘parrot something’? Why do you preclude us making our own choice when everyone else is doing so? Why would you care? Where are all the court case won lawsuits for deffective or lied about vaccines, when we live in an era where entities sue at the drop of a hat? Welcome to living in a world of controversies.

    • Come on Jim. You know why there are no vaccine court cases. Some of us actually know the dirty history of vaccines and the complicity of the US government. I can cite the complete history here, but you guys aren’t listening. No, Jim, there is no Santa Claus and all your vaccine obfuscation won’t change that.