COVID vaccine development process – how it compares to “normal”

Back before the world of the COVID-19 pandemic, the vaccine development process took a long time. Despite the nonsensical claims of the anti-vaccine zealots, the vaccine development process is robust and thorough. The safety and effectiveness of all of the pre-pandemic vaccines are settled science (read the article before you jump up and down screaming about “settled science”).  

However, the world of the COVID-19 pandemic meant that if we can save a few months or even years off the development timeline on a new COVID-19 vaccine, it could save hundreds of thousands, maybe millions, of lives.

Of course, much of the optimism comes from experts like Dr. Anthony Fauci, one of the few rational public health experts who are willing to speak up in Washington DC. Maybe he has seen some secret data only available only to him and Bill Gates that supports this optimism. Maybe he just is trying to be the national cheerleader for healthcare.

I don’t know the real answer, but a lot of vaccine experts who have spent their lifetime studying vaccines, like Dr. Peter Hotez, MD Ph.D., have expressed dismay at how politics may “trump” good science.

So, this article will try to lay out the COVID-19 vaccine development process, along with the independent controls that make sure that all vaccines are safe and effective.

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Vaccine development process – how it’s usually done

vaccine development process

Back before the world of the COVID-19 pandemic, the vaccine development process took a long time. Despite the nonsensical claims of the anti-vaccine zealots, the vaccine development process is robust and thorough. The safety and effectiveness of all of the pre-pandemic vaccines are settled science (read the article before you jump up and down screaming about “settled science”).  

However, the world of the COVID-19 pandemic meant that if we can save a few months or even years off the development timeline on a new COVID-19 vaccine, it could save hundreds of thousands, maybe millions, of lives.

Of course, much of the optimism comes from experts like Dr. Anthony Fauci, one of the few rational public health experts who are willing to speak up in Washington DC. Maybe he has seen some secret data only available only to him and Bill Gates that supports this optimism. Maybe he just is trying to be the national cheerleader for healthcare.

I don’t know the real answer, but a lot of vaccine experts who have spent their lifetime studying vaccines, like Dr. Peter Hotez, MD Ph.D., have expressed dismay at how politics may “trump” good science.

So, this article will try to lay out the development process, along with the independent controls that make sure that all vaccines are safe and effective.

Continue reading “Vaccine development process – how it’s usually done”

ICAN lawsuit against CDC statement that vaccines do not cause autism

vaccines autism

This article about another ICAN lawsuit disputing the CDC statement that vaccines do not cause autism was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.

On March 31, 2022, a federal district judge dismissed the Informed Consent Action Network‘s (ICAN) lawsuit demanding that CDC remove the statement that vaccines do not cause autism. The judge dismissed the lawsuit because ICAN failed to show that the alleged harms it claimed were caused by anything CDC did, or that removing the statement would fix the problem that they claim they identified. 

The claim never got to be examined on the merits, and for the purpose of dismissal at this early stage, the judge is required to treat ICAN’s claims as true. But it’s worth reminding readers that extensive data shows that vaccines do not cause autism.

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FDA responses to FOIA requests on COVID vaccines – not a conspiracy

FDA FOIA

This article about FDA responses to Freedom of Information Act (FOIA) requests by anti-vaccine activists was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease. She is also a member of the Vaccines Working Group on Ethics and Policy.

In contrast to anti-vaccine claims (and the headline that echoed them), the FDA responses to a broad Freedom of Information Act (FOIA) requests are not evidence of a conspiracy or some kind of unusual problem (though it may reflect some of the general issues with our FOIA system).

In a recent set of posts by anti-vaccine activists, they criticized FDA for, allegedly, wanting 55 years to process a FOIA request for vaccine data. Unfortunately, some media sources repeated the claim uncritically. 

The reality, unsurprisingly, is different. A group that includes several anti-vaccine activists and people who have had anti-vaccine support in the past submitted a very broad request for documents related to the Pfizer-BioNTech vaccine trial.

These documents need to be redacted before being released, to protect interests like patient privacy and trade secrets. The parties are wrangling about the rate at which FDA should process those documents, and the anti-vaccine talking point is basically a misrepresentation of the FDA’s position about the schedule. Here is the report of both parties’ positions to the courts.

FDA explained that this is a very large request, it is one of several hundred they are dealing with, and their FOIA office is small. It wants to provide it at a rate of 500 pages a month, a rate that, from cases cited by FDA, has been repeatedly accepted by courts as reasonable (reflecting standard practice) and has already started providing some of the data. The group is demanding all the information in the next four months. The court will have to decide what is the appropriate rate of release. 

To emphasize — at no point did FDA ask the plaintiffs to wait 55 years for documents. The FDA offered to start releasing documents immediately, and work at a rate of 500 pages a month after December 1, releasing 500 pages to the plaintiffs each month – in order of priorities set by the plaintiffs.

This post will examine numerous issues surrounding FOIA requests to the FDA, and whether the responses by the FDA are reasonable or not.

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Pfizer COVID-19 vaccine whistleblower – hand waving about clinical trials

laboratory test tubes

And here we go again – a so-called COVID-19 vaccine whistleblower makes vague claims about the Pfizer clinical trials. Predictably, the anti-vaccine world points a trembling, HPV-riddled finger at us, screaming “SHAME. SHAME. SHAME.”

Except, like a lot of these stories, the anti-vaxxers overstate anything critical about the COVID-19 vaccines, while ignoring the vast majority of evidence that support the overwhelming safety and effectiveness of these vaccines. Their confirmation bias is amazing.

Anyway, let’s take a look at this COVID-19 vaccine whistleblower and see if anything they say passes the smell test.

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FDA rejects ICAN petition to revoke of EUAs issued for COVID vaccines

ICAN COVID-19 vaccines

This article about the FDA’s actions on a petition from ICAN to revoke EUAs for COVID-19 vaccines was written by Viridiana Ordonez. Ms. Ordonez has contributed other articles to this website and is aJ.D. candidate at the University of California, Hastings College of Law.

Del Bigtree‘s Informed Consent Action Network (ICAN) submitted a Citizen Petition to the Food and Drug Administration (FDA) on September 27, 2021. In its petition, ICAN requested that the FDA revoke the Emergency Use Authorization (EUA) granted to ModernaTX, Inc. (Moderna) and JNJ Jansen Biotech, Inc. (Janssen) for their COVID-19 vaccines.

ICAN argued that because the FDA has now approved Comirnaty – the COVID-19 vaccine created by Pfizer-BioNTech – the requirements for issuance of the EUA for the other vaccines are no longer met.

The FDA replied to the petition on October 20, 2021, and rejected the request, explaining that ICAN’s petition did not contain facts demonstrating any reasonable grounds for its request. This post summarizes FDA’s response. 

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Vaccine licensing primer – correcting anti-vaccine misinformation

vaccine licensing

This article about vaccine licensing was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease. She is also a member of the Vaccines Working Group on Ethics and Policy.

Anti-vaccine activists want to claim the Pfizer vaccine is still experimental despite FDA licensing.  They base that claim on a footnote in a document reauthorizing Pfizer’s Emergency Use Authorization (EUA).  FDA is clear that the now fully-licensed vaccine is identical to the EUA vaccine (except of course for the labeling: the EUA vaccine still bears its EUA label), and that both can legally be marketed.  The anti-vaccine claim is being made because the full licensure of the Pfizer vaccine renders moot their claim (not yet decided by a court) that you cannot mandate a vaccine licensed under the EUA. 

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FDA approval of Pfizer COVID vaccine – why did it take so long?

FDA approval pfizer COVID-19 vaccine

One of the questions I keep seeing is why did it take so long for FDA approval of the Pfizer/BioNTech COVID-19 vaccine, Comirnaty? The answer is complicated, but the basic issue is that the FDA is very conservative in approving drugs – I bet that will surprise everyone.

I’m going to delve into a couple of issues with the FDA and its approval of the Pfizer COVID-19 vaccine. Even though some people argue that it took too long to go from the Emergency Use Authorization (EUA) to full approval, it was, in fact, fairly rapid. Remember, clinical trials only commenced maybe 15 months ago, so this is warp speed compared to the usual vaccine timeline that may be nearly 10 years.

Many of us thought that it would take up to three years before we had COVID-19 vaccines available – I’m willing to eat humble pie on blowing that prediction, but it’s amazing what happens when governments, scientists, and pharmaceutical companies can do when they are all focused on a common goal. Not for nothing, but why can’t we do the same thing with climate change – a lot more of us are at risk of that than COVID-19, but I’ll leave that for another day.

Let’s take a brief look at why some of you are wondering why it took so long for the FDA approval of the Pfizer COVID-19 vaccine.

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Pfizer COVID vaccine received full FDA approval – expect new mandates

pfizer COVID-19 vaccine FDA

Today, 23 August 2021, the Pfizer/BioNTech COVID-19 mRNA vaccine received full FDA approval for individuals 16 years and older. This should stop the claim by anti-vaxxers claimed that these vaccines were “experimental,” because they had an  Emergency Use Authorization (EUA) in the USA and other countries, despite the fact that the EUAs required just as rigorous analysis as a typical New Drug Application.

Let’s examine what this Pfizer COVID-19 vaccine FDA approval means practically.

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Experimental COVID vaccines? Another anti-vaxxer trope to be debunked

pexels-photo-5863391.jpeg

And here we go with another one of those silly anti-vaxxers tropes – the COVID-19 vaccines are experimental, and the government/Big Pharma/Bill Gates are conspiring to test the vaccine on innocent people. Nothing could be further from the truth.

The claim that the COVID-19 vaccines are experimental probably arises from the fact that most of them received anEmergency Use Authorization (EUA) in the USA and other countries. The anti-vaxxers what to use the EUA to make a strawman argument that EUA is equivalent to “a risky, experimental drug that will cause great harm to you.”

But if these anti-vaccine activists spent just a little bit of time to understand the high-quality science behind these vaccines and the Emergency Use Authorizations, they might move on to some other topic. But in case someone finds this article among all of the nonsense on the internet, looking to find out if COVID-19 vaccines are, in fact, experimental, let’s debunk that with actual facts.

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