What is the best argument against approving the AZ vaccine? Every argument I see against this position here is usually a vague notion that regulatory processes are Good or a reference to how the vaccine hasn't actually been submitted for approval. To me, it reads as a kind of knee-jerk "government agency good, pharma company bad" culture war, which is stupid when literally thousands and thousands of lives are at stake.
Is there an actual good argument on the merits opposing an immediate approval of the AZ vaccine?
I too am confused by the actions of the FDA. How about this explanation:
Vaccine skepticism for COVID is more widespread than the normal anti-vaxxer movement, especially for PoC. Estimates of this are up to 35% of the population that doesn’t currently want a vaccine. E.g., my friend works at a vaccine center in the Bronx that had hundreds of doses that were going to waste; they went out on the street to recruit locals but nobody wanted it.
When PoC are told they’re getting a different vaccine from the good one that white people get, that won’t inspire confidence.
Keeping everyone on the same product will alleviate these fears.
I generally agree but am concerned about decrease in efficacy of AZ against the South African variant. Similar findings with J & J and Novavax but still protective against severe illness. The mRNA vaccines seem to be better against SA variant but the only data is from lab experiments and not the real world.
"Unless someone at the FDA can explain to him in a compelling way that they have actual doubt about the safety and efficacy of the vaccine — as opposed to quibbles about the process or a scientific interest in seeing data from a better-designed trial ..."
Aren't the "quibbles about the process" and the issues with the trial design part of the reason for doubts about efficacy?
It's too bad that Republicans and libertarians have become so obsessed with their various culture war hang-ups that any useful good government ideas they may have contributed are squarely in the past at this point.
1) I will be a *lot* more confident that the AZ vaccine works after a panel of experts digs through the raw data and confirms the findings summarized in papers. I don’t fully trust a pharma company’s summary of their trial results. There are a lot of details and a pharma company’s job is to put the best possible light on their trial.
2) Yes, zero people died of covid in the vaccine arm. But only 1 person died in the control arm. Very small numbers here and not reliable to draw a solid conclusion about deaths. That said, it’s pretty clear from the trial that the vaccine is likely safe and effective.
3) I don’t think there’s a huge stockpile of the AZ vaccine simply waiting for Americans’ arms. Maybe I’m wrong, but presumably the current supply is being directed at European countries where it is already approved. If rushing the approval makes only a very small increase in US vaccination rate, then the benefits of rushing are small.
4) The drawbacks of rushing range from terrible (if the EUA eventually needs to be withdrawn) to bad (generally increasing vaccine hesitancy).
At the end of December, the US was averaging 250,000 vaccination shots per day. Currently we're at just under 1.9 million shots per day. In a few weeks, especially if J&J is approved, I would hardly be surprised if we're at 3 million per day. Back in December Biden aggressively called for a goal of 1 million per day, then had to scurry around to increase the bar to 1.5 million per day, obviously well below where we're at.
I'm not saying we shouldn't treat this as a great emergency and not consider all possible resources. I'm just saying we're currently well ahead of where anyone thought we'd be with likely more progress to come. It's possible that the situation will be resolved positively under current processes.
The current hypothesis on why the lower dose was more effective is that it was likely due to the time period between the two doses. Basically, the longer interval between two doses probably increases the efficacy.
There's another advantage to the AstraZeneca vaccine, and that's that one of their trials tested the subjects weekly and total infections (symptomatic and asymptomatic) dropped by about 2/3. That's something that's particularly important for a younger population that's more likely to be going to work or otherwise be unable to self-isolate
I think it is unfortunate that epidemiologists have not been more forthcoming about the disease-spread models and the objective function they are optimizing to formulate their predictions and recommendations. Their silence undermines trust that they actually know what they are talking about.
Related is the issue of why the US (and other countries) do not incorporate the decisions of other competent regulatory bodies in their decision-making. This would not mean automatic acceptance, but in a Bayesian sense, it ought to affect decisions.
I am writing to you as a concerned member of the public to ask you to approve the AstraZeneca Vaccine as soon as possible.
I know AstraZeneca messed up their trials and you want them to do a new one. However, the AstraZeneca vaccine has already been approved by the UK and EU regulators, a new trial will take months, the flawed data is enough to show safety and at least pretty good efficacy, and millions of doses of this vaccine are already being produced at a factory in Baltimore.
Please ask AstraZeneca to submit an application with the same info they gave the UK and EU regulators. Millions of Americans like me are desperate to get a vaccine to end this horrible pandemic before the more infectious variants spread. I won't be eligible for many months; even if the AstraZeneca vaccine is "worse" than the currently-approved ones, it's better than nothing, which is the alternative for me. In these extraordinary circumstances, where every day is a matter of life and death for thousands, I hope you can summon a renewed and forceful sense of urgency to get as many people as possible vaccinated as quickly as you possibly can.
I have no idea if this is the right venue for this kind of comment from the public. But I feel strongly on this issue and I have no idea what else to do. So I hope someone is reading this, and thank you for considering it.
==========================================
Dear Mr. Paulson:
Thank you for your email to the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER). One of seven centers within FDA, CBER is responsible for the regulation of many biologically-derived products, including blood intended for transfusion, blood components and derivatives, vaccines, allergenic products, and cell, tissue and gene therapy products.
We appreciate your interest in this matter.
As you may be aware, FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on February 26, 2021, to discuss the request for Emergency Use Authorization (EUA) for a COVID-19 vaccine from Janssen Biotech Inc.
FDA regulates vaccines to ensure that they are safe and effective. Vaccines, like all biologic products regulated by FDA, undergo a rigorous review of laboratory, clinical and manufacturing information submitted by the product sponsor to help ensure the safety, purity, and potency of these products.
Please know that FDA has been preparing for the review of Emergency Use Authorizations (EUAs) for COVID-19 vaccines for several months and stands ready to do so as soon as an EUA request is submitted. While we cannot predict how long FDA’s review will take, we will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner, so that we can continue to make vaccines available to the American public.
FDA considers the totality of evidence when evaluating the safety and effectiveness of new vaccines and will continue to collaborate with our global regulatory counterparts and exchange information on the rapidly evolving scientific landscape of products and clinical trials and, as possible, discussing the interpretation of data supporting regulatory decisions.
We hope this information is helpful. If you have additional questions, please contact CBER’s Consumer Affairs Branch by email at ocod@fda.hhs.gov or by telephone at 1-800-835-4709.
My conclusion from both this article and the comments is that there is one thing worse than letting hidebound bureaucrats determine the process and that's letting internet take providers do it.
And on the libertarian front, I want to highlight Alex Tabborok and Arnold Kling who have both been using their platforms to repeatedly shout about this for awhile now.
It’s more than ok to blame the bureaucrats, no need for throat clearing (former government bureaucrat myself).
The amount of harm that has been done in the name of “following standard process” in this world is beyond measure. If you’re an FDA employee at any sort of senior level, you should be leaking the reasons for the delay to the press.
What is the best argument against approving the AZ vaccine? Every argument I see against this position here is usually a vague notion that regulatory processes are Good or a reference to how the vaccine hasn't actually been submitted for approval. To me, it reads as a kind of knee-jerk "government agency good, pharma company bad" culture war, which is stupid when literally thousands and thousands of lives are at stake.
Is there an actual good argument on the merits opposing an immediate approval of the AZ vaccine?
I too am confused by the actions of the FDA. How about this explanation:
Vaccine skepticism for COVID is more widespread than the normal anti-vaxxer movement, especially for PoC. Estimates of this are up to 35% of the population that doesn’t currently want a vaccine. E.g., my friend works at a vaccine center in the Bronx that had hundreds of doses that were going to waste; they went out on the street to recruit locals but nobody wanted it.
When PoC are told they’re getting a different vaccine from the good one that white people get, that won’t inspire confidence.
Keeping everyone on the same product will alleviate these fears.
Thoughts?
Do we know if the effectiveness of Pfizer and Moderna are impeded by a prior administration of AstraZeneca?
"“their failures to do the basics of drug research cannot be dismissed based on the whims of masturbating libertarians.”"
Man, why do people have to use such gross and revolting language?
I would *never* call someone a "libertarian" like that.
I generally agree but am concerned about decrease in efficacy of AZ against the South African variant. Similar findings with J & J and Novavax but still protective against severe illness. The mRNA vaccines seem to be better against SA variant but the only data is from lab experiments and not the real world.
"Unless someone at the FDA can explain to him in a compelling way that they have actual doubt about the safety and efficacy of the vaccine — as opposed to quibbles about the process or a scientific interest in seeing data from a better-designed trial ..."
Aren't the "quibbles about the process" and the issues with the trial design part of the reason for doubts about efficacy?
It's too bad that Republicans and libertarians have become so obsessed with their various culture war hang-ups that any useful good government ideas they may have contributed are squarely in the past at this point.
1) I will be a *lot* more confident that the AZ vaccine works after a panel of experts digs through the raw data and confirms the findings summarized in papers. I don’t fully trust a pharma company’s summary of their trial results. There are a lot of details and a pharma company’s job is to put the best possible light on their trial.
2) Yes, zero people died of covid in the vaccine arm. But only 1 person died in the control arm. Very small numbers here and not reliable to draw a solid conclusion about deaths. That said, it’s pretty clear from the trial that the vaccine is likely safe and effective.
3) I don’t think there’s a huge stockpile of the AZ vaccine simply waiting for Americans’ arms. Maybe I’m wrong, but presumably the current supply is being directed at European countries where it is already approved. If rushing the approval makes only a very small increase in US vaccination rate, then the benefits of rushing are small.
4) The drawbacks of rushing range from terrible (if the EUA eventually needs to be withdrawn) to bad (generally increasing vaccine hesitancy).
Serious questions, because you've been vocal about this for awhile: 1) what dosing regime should we use? And 2) should we approve Russia's Sputnik V vaccine? That trial was far more sketchy than AZ's, subject to a wide range of vocal disapproval across the globe, and yet is now showing 92% efficacy. https://www.npr.org/sections/coronavirus-live-updates/2021/02/02/963166648/russias-sputnik-vaccine-is-reported-to-be-92-effective-against-covid-19
At the end of December, the US was averaging 250,000 vaccination shots per day. Currently we're at just under 1.9 million shots per day. In a few weeks, especially if J&J is approved, I would hardly be surprised if we're at 3 million per day. Back in December Biden aggressively called for a goal of 1 million per day, then had to scurry around to increase the bar to 1.5 million per day, obviously well below where we're at.
I'm not saying we shouldn't treat this as a great emergency and not consider all possible resources. I'm just saying we're currently well ahead of where anyone thought we'd be with likely more progress to come. It's possible that the situation will be resolved positively under current processes.
The current hypothesis on why the lower dose was more effective is that it was likely due to the time period between the two doses. Basically, the longer interval between two doses probably increases the efficacy.
https://www.bmj.com/content/372/bmj.n326
There's another advantage to the AstraZeneca vaccine, and that's that one of their trials tested the subjects weekly and total infections (symptomatic and asymptomatic) dropped by about 2/3. That's something that's particularly important for a younger population that's more likely to be going to work or otherwise be unable to self-isolate
I think it is unfortunate that epidemiologists have not been more forthcoming about the disease-spread models and the objective function they are optimizing to formulate their predictions and recommendations. Their silence undermines trust that they actually know what they are talking about.
Related is the issue of why the US (and other countries) do not incorporate the decisions of other competent regulatory bodies in their decision-making. This would not mean automatic acceptance, but in a Bayesian sense, it ought to affect decisions.
I sent an email to the FDA on this subject a few weeks ago. Probably not useful...but I don't know what is. Did get a reply, but it didn't say much.
=============================================
to: ocod@fda.hhs.gov
Subject: Please approve the AstraZeneca Vaccine
I am writing to you as a concerned member of the public to ask you to approve the AstraZeneca Vaccine as soon as possible.
I know AstraZeneca messed up their trials and you want them to do a new one. However, the AstraZeneca vaccine has already been approved by the UK and EU regulators, a new trial will take months, the flawed data is enough to show safety and at least pretty good efficacy, and millions of doses of this vaccine are already being produced at a factory in Baltimore.
Please ask AstraZeneca to submit an application with the same info they gave the UK and EU regulators. Millions of Americans like me are desperate to get a vaccine to end this horrible pandemic before the more infectious variants spread. I won't be eligible for many months; even if the AstraZeneca vaccine is "worse" than the currently-approved ones, it's better than nothing, which is the alternative for me. In these extraordinary circumstances, where every day is a matter of life and death for thousands, I hope you can summon a renewed and forceful sense of urgency to get as many people as possible vaccinated as quickly as you possibly can.
I have no idea if this is the right venue for this kind of comment from the public. But I feel strongly on this issue and I have no idea what else to do. So I hope someone is reading this, and thank you for considering it.
==========================================
Dear Mr. Paulson:
Thank you for your email to the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER). One of seven centers within FDA, CBER is responsible for the regulation of many biologically-derived products, including blood intended for transfusion, blood components and derivatives, vaccines, allergenic products, and cell, tissue and gene therapy products.
We appreciate your interest in this matter.
As you may be aware, FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on February 26, 2021, to discuss the request for Emergency Use Authorization (EUA) for a COVID-19 vaccine from Janssen Biotech Inc.
FDA regulates vaccines to ensure that they are safe and effective. Vaccines, like all biologic products regulated by FDA, undergo a rigorous review of laboratory, clinical and manufacturing information submitted by the product sponsor to help ensure the safety, purity, and potency of these products.
Please know that FDA has been preparing for the review of Emergency Use Authorizations (EUAs) for COVID-19 vaccines for several months and stands ready to do so as soon as an EUA request is submitted. While we cannot predict how long FDA’s review will take, we will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner, so that we can continue to make vaccines available to the American public.
FDA considers the totality of evidence when evaluating the safety and effectiveness of new vaccines and will continue to collaborate with our global regulatory counterparts and exchange information on the rapidly evolving scientific landscape of products and clinical trials and, as possible, discussing the interpretation of data supporting regulatory decisions.
If you would like to receive email updates, from CBER you may subscribe to our mailing list on our website at: https://www.fda.gov/vaccines.../resources-you-biologics....
We hope this information is helpful. If you have additional questions, please contact CBER’s Consumer Affairs Branch by email at ocod@fda.hhs.gov or by telephone at 1-800-835-4709.
My conclusion from both this article and the comments is that there is one thing worse than letting hidebound bureaucrats determine the process and that's letting internet take providers do it.
Bravo on this article.
And on the libertarian front, I want to highlight Alex Tabborok and Arnold Kling who have both been using their platforms to repeatedly shout about this for awhile now.
It’s more than ok to blame the bureaucrats, no need for throat clearing (former government bureaucrat myself).
The amount of harm that has been done in the name of “following standard process” in this world is beyond measure. If you’re an FDA employee at any sort of senior level, you should be leaking the reasons for the delay to the press.