Do you have a source for those senior FDA resignations? Here’s what I’m seeing,
The sudden departure of the two most significant vaccines leaders at the FDA in the middle of the COVID-19 crisis – and with the spread of the Delta variant in the US – has stirred conjecture that it was the Biden administration’s vaccine booster plan that prompted the move.
The FDA’s former acting chief scientist Luciana Borio said the pair were initially frustrated by the involvement of Centers for Disease Control and Prevention (CDC) and Advisory Committee on Immunization Practices (ACIP) in COVID-19-related decision-making, but it was the White House’s announcement to offer booster shots to people eight months after they received their second shot that proved to be the final straw.
“FDA is losing two giants who helped bring us many safe and effective vaccines over decades of public service. A huge global loss if they both leave,” said Borio.
It is reported that the two vaccine heads believed there was enough insufficient data to justify offering COVID-19 booster shots and that the announcement, amplified by President Biden, put too much pressure on the FDA to authorise them quickly.
MRNA makes their case for boosters. Not as strong as they want, but pointing that way.
Analysis of Open-Label Part of Phase 3 COVE Study
Today, Moderna is sharing a new analysis of the incidence of breakthrough COVID-19 cases among vaccinated participants in the open-label portion of the Phase 3 COVE study between 1-Jul-21 and 27-Aug-21.
The goal of the analysis is to quantify the impact of waning immunity in the face of the Delta surge in the United States.
In the analysis, 88 breakthrough cases of COVID-19 occurred in the more recently vaccinated group (49.0 cases per 1000 person-years) compared to 162 cases in the group vaccinated last year (77.1 cases per 1000 person-years).
The reduction in incidence rates for participants vaccinated more recently compared to participants vaccinated last year was 36% (95% CI: 17-52%).
A Cox proportional hazards model showed similar results after adjusting for age and risk factors for severe COVID-19. Fortunately, only 19 severe cases were observed.
While not significant, there was a numerical trend towards a lower rate of severe cases in the group vaccinated more recently (3.3 per 1000 person-years) compared to the group vaccinated last year (6.2 per 1000 person-years).
The increased risk of breakthrough in this analysis quantifies the impact of waning immunity in the COVE study between the median follow-up time of 8 months and 13 months since first dose.
The company believes this adds to evidence of potential benefit of a booster dose of mRNA-1273.
my read is their booster reduces the chance of a vaccinated-and-boosted person’s chance of getting symptomatic covid by about 1/3 compared to an un-boosted vaccinated person, but without good enough stats to say for sure.
From the intro/summary paragraph: “Even if boosting were eventually shown to decrease the medium-term risk of serious disease, current vaccine supplies could save more lives if used in previously unvaccinated populations than if used as boosters in vaccinated populations.”
They say pretty clearly what they see as higher value is no boosters until all unvaccinated around the world have initial vaccinations, and that they see it ethically wrong to further boost protection for people who have already obtained some protection before providing the universal access. Especially when the idiots in those privileged countries are refusing to get vaccinated and driving most local infections of both vaccinated and unvaccinated, which they also maintain in the paper. (but is not actually that clear with delta, especially in places where vaccination rates are higher than in the USA).
I’m not saying their stance is right or wrong. But it’s the WHO stance as well. They don’t care if they’re effective to boost back waning immunity, they want them to go to poorer regions without full access to the vaccine first. And they’re clear that that’s their main “disagreement”
I suspect there will always be a reduction. The question is what is low enough? Or do we just keep on boosting, even when the reduction is from a 1-in-a-million risk to a 1-in-two-million risk?
Why not? If free insurance for a million in 1 chance event was available, would you take it?
Or
If you could get a free option that pays out for black swan event, would you take it? (I’ll take as many as you have!)
Or
Free lottery tickets. Does it matter how much it pays or the chance of winning?
Sure, I took some free lottery tickets in the market the other day. Weird situations dunno if it’ll work out yet.
But vaccines do have rare health risks, like any medical procedure or product. Also, even if they’re free personally, they’re not free on a societal level ($20/shot or whatever these PFE/MRNA vaccines cost currently, plus the distribution and labor and delivery), so if the risk/reward doesn’t justify the cost, it’s not good public policy to subsidize them. You could always pay for one yourself out of pocket if your risk views were very different than the average.
I could make the argument that the monetary cost has already been authorized federally, and funds would likely be wasted reallocated somewhere else anyway.
And you’re right. Side effects is 1 thing to weigh against the reduction of risk. Quite different if one were high risk, say continually exposed by virtue of working in a covid unit vs. stay at home all day with little social interaction.
Personal out of pocket cost could be evaluated similarly. If one were travelling, even an otherwise undetected asymptomatic infection would ruin your trip and be quite costly, due to quarantine or other requirements in many countries. On the other hand, a hermit would see the $20 or so cost to be unnecessary. When entering, some jurisdictions (eg. Canada, U.S.) even exempt testing with proof of recovery - could be an incentive to get that status with regular testing.
you will need to get a viral test no more than 3 days before you travel by air into the United States (US) and show your negative result to the airline before you board your flight, or be prepared to show documentation of recovery (proof of a recent positive viral test and a letter from your healthcare provider or a public health official stating that you were cleared to travel). https://www.cdc.gov/coronavirus/2019-ncov/travelers/testing-international-air-travelers.html
An asymptomatic infection would likely fit the bill.
Hopefully someday a majority of the public will recognize this belief as scientifically valid. Or better yet, hopefully someday, a majority of the public will recognize that the vaccination status of their fellow citizens is of no concern to them.
I have no idea what vaccines other than covid any of my fellow citizens have received. Do you?
As usual, completely misrepresenting my viewpoint in order to discredit me. Thankfully, even the people that agree politically with you more than me on this board can see through your feeble attempts.
Yes. We do. And it’s not looking great for many disease fighting fronts against other things we’ve been successfully fending off for years, thanks to the new maga anti-vaccine, anti-public-health push.
The CDC has data on the vaccination statistics for fellow citizens and you can go look up the data from the CDC site.
It’s not new and well predates Trump. California was a hot bed of anti vaxxers and they’re not exactly hard core MAGA territory. From their own favorite news source,
In California, the anti-vaccine movement has been popular for decades among Hollywood celebrities and wealthy parents, gaining momentum as state lawmakers passed one of the nation’s toughest mandatory vaccination laws for children in 2015. Previously, parents had opted out of vaccinations by seeking exemptions claiming that vaccines conflicted with their personal beliefs, but the law eliminated that option. The popularity of those exemptions led to immunization rates that dropped to 80 percent or lower at public and private schools and preschools in Beverly Hills, Santa Monica and other affluent Los Angeles area communities.
You’re not being a jerk like @bender, so I will grant you the premise. Yes, it is my concern if people don’t vaccinate their kids against pertussis (for instance). Since, at one time, my newborn baby wasn’t old enough for the vaccine yet, and he could have caught it from an unvaccinated 5 year old, it matters. I would, therefore, like it if everyone vaccinated their kid. But, even though that is what we think is best, we didn’t go around asking who at our church was anti-vax before putting our son in the nursery (we could have done this and briefly considered it - so I’m not offering a made up scenario). My wife just decided to be paranoid and didn’t put him in the nursery for several months. So even though we were concerned about unvaccinated kids, we didn’t concern ourselves with our fellow citizens and their decisions that they have a right to make. We adjusted our own decisions to account for the minute risk a potentially unvaccinated child could represent.
In the case of COVID, if you are eligible for the vaccine, there is literally a miniscule risk to you if you were to hang out with an unvaccinated person. You don’t even have to adjust your decisions. But you can if you want to. No one is saying you aren’t allowed to wear a N95 mask. No one is forcing you to eat in restaurants. . Those that aren’t eligible for the vaccine are under 12 and there was already a miniscule covid risk to them.
Are the unvaccinated kids not your fellow citizens? Cause it sounds to me like you were concerned about the vaccination status of your fellow citizens. And because of those concerns, you adjusted your decisions to account for the risk by waiting several months before putting your own child in the nursery.
I suppose nurseries can’t require vaccinations because it’s too soon, but every preschool (2 and up) around here requires vaccinations. So in a way we are all concerned about the vaccination status of our fellow citizens (the children). We are less concerned about adults because the adults were children once, and very likely already have their required shots.
But I think I get your point, you’re just not as concerned about COVID as you are about other diseases against which we vaccinate our children, like pertussis.
I asked the question. It was meant in the exact way @glitch99 interpreted it - Vaccination status of individual citizens - not the overall vaccine adoption rate. As far as I know, before covid people didn’t go around asking everyone for their vaccination status. And the efficacy of the covid vaccine currently doesn’t suggest we need to start asking. Yet that is exactly where we are.