FDA, CDC, and COVID-19 vaccines — who does what?

FDA CDC COVID-19 vaccines

This article about the role of the CDC and FDA concerning COVID-19 vaccines 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.

I write this right after the FDA expert advisory committee, Vaccines and Related Biological Products Advisory Committee (VRBPAC), voted unanimously that the benefits of both Moderna and Pfizer-BioNTech’s COVID-19 vaccines for children 6 months to 5 years of age outweigh their risks, clearing a smooth path for FDA to grant emergency use authorization (EUA) to these vaccines. I was asked about the division of labor between CDC and FDA on COVID-19 vaccines, and it seems like something worth setting out.

So this is a short post about the relative roles of the FDA and CDC in getting COVID-19 vaccines to people in the USA. It is not a full picture of how vaccines get to us; there is a lot more to that. I am not even going into the full requirement for approving or authorizing a vaccine; just who does what. But this piece of the puzzle can be useful by itself.

For those looking for a full description of the vaccine approval process, I recommend either the Skeptical Raptor’s post on that topic or the description by the Vaccine Education Center of the Children’s Hospital of Philadelphia.  

Continue reading “FDA, CDC, and COVID-19 vaccines — who does what?”

Pfizer and Moderna vaccines for COVID-19 – differences and similarities

If you are an American, you probably could not avoid noticing the news that the Pfizer and Moderna vaccines for COVID-19 have shown >90% effectiveness in preventing the disease over the short-term. And both companies would probably be seeking an Emergency Use Authorization (EUA) in the USA for use of their vaccines in groups who are most in need of protection from COVID-19.

Even though I’ve discussed the positive and negative points about the Pfizer and Moderna COVID-19 vaccines, I think it’s important to highlight the similarities and differences between the two vaccines. Also, please note that these vaccines probably will be released first in the USA, especially Moderna who received support from the Federal Government through Operation Warp Speed (Pfizer opted out of it). There are several other vaccines in phase 3 clinical trials that could be seeking a EUA sometime in the near future in the USA and Europe.

COVID-19 vaccine candidates in phase 3 clinical trials – the official list

Moreover, there are over 200 COVID-19 vaccine candidates in development, with dozens in phase 1 and phase 2 clinical trials. By early 2022, we could be comparing 10 or 15 vaccines that might be entering the market.

But this article is just going to focus on the Pfizer and Moderna COVID-19 vaccines. I’m going to hit the key similarities and differences between the two vaccines. I may conclude with my opinion on which one will be successful, but we might not know for years which of all of these vaccines are the “best.”

Continue reading “Pfizer and Moderna vaccines for COVID-19 – differences and similarities”

Create an independent FDA, CDC – new COVID-19 vaccines required it

independent CDC FDA

The COVID-19 pandemic and the subsequent rush for treatments and vaccines for the virus have renewed calls for a more independent FDA and CDC. Professor Dorit Rubinstein Reiss, who is a frequent contributor to this space, has written two powerful articles arguing for an independent CDC and FDA.

If you have followed the progression of the COVID-19 pandemic in the USA, the Centers for Disease Control and Prevention (CDC) and the United States Food and Drug Administration (FDA) responses have been politicized to the point that even those of us who have strongly supported those two agencies are appalled. 

The CDC has been pushed to scrub information and data to make the Trump administration look good. Recently, it was reported that one of Trump’s minions tried to pressure CDC regarding the transmission of the virus to kids to get it in line with the nonsense being pushed during Trump’s failed presidential campaign.

And then the FDA gave Emergency Use Authorizations (EUA) to hydroxychloroquine and remdesivir for treatment of COVID-19. Unfortunately, the data showed that hydroxychloroquine does not work and remdesivir has only a marginal effect on outcomes. In each case, it appears that the FDA was more interested in promoting these drugs to support President Trump’s wild claims that he was “doing something” about the pandemic, rather than relying upon robust science.

Professor Reiss has written two articles about how we might create a more powerful and independent FDA and CDC by utilizing the types of structures of actual independent agencies within the Federal Government. I want to quickly review what she proposes because I think it’s a conversation that we hope that President-elect Joe Biden might embrace during the next few years.

The problem is that 

Continue reading “Create an independent FDA, CDC – new COVID-19 vaccines required it”

Dorit Rubinstein Reiss – an index of her vaccine articles on this website

Dorit Rubinstein Reiss

Dorit Rubinstein Reiss – Professor of Law at the University of California Hastings College of the Law (San Francisco, CA) – is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines (generally, but sometimes moving to other areas of medicine), social policy and the law. Her articles usually unwind the complexities of legal issues with vaccinations and legal policies, such as mandatory vaccination and exemptions, with facts and citations.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination–she really is a well-published expert in this area of vaccine policy, and doesn’t stand on the pulpit with a veneer of Argument from Authority, but is actually an authority. 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 was also one of the many contributors to the book, “Pseudoscience – The Conspiracy Against Science.”

Many bloggers and commenters on vaccine issues will link to one or more of her articles here as a primary source to counter an anti-vaccine claim. The purpose of this post is to give you a quick reference to find the right article to answer a question you might have.

Below is a list of articles that Dorit Rubinstein Reiss has written for this blog, organized into some arbitrary and somewhat broad categories for easy reference. This article will be updated as new articles from Professor Reiss are published here. We also may update and add categories as necessary.

Because she has written over 160 articles for this website, there is a vast amount of information about vaccines and the law, I have created a search engine that allows you to quickly find a specific article written by Professor Reiss on this website by using any keywords that you want. This should help speed up your search for just the right article that she has written.


Continue reading “Dorit Rubinstein Reiss – an index of her vaccine articles on this website”

ACIP COVID-19 vaccines meeting – summary of August 2020 discussions

This article about the August 2020 ACIP COVID-19 vaccines meeting 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.

On August 26, 2020, the Advisory Committee on Immunization Practices (ACIP) held an emergency meeting to discuss COVID-19 vaccines. This was an emergency meeting, as opposed to one of its three annual scheduled meetings, but it was not “emergency” in the sense of being unplanned – it was announced long in advance, and the announcement was repeated during the June and July emergency meetings.

The ACIP COVID-19 vaccines meeting consisted of four to five hours of presentations from the COVID-19 vaccines workgroup, convened in April, and one hour of public comments that included multiple pro-vaccine speakers and four anti-vaccine individuals.

The main takeaway most people would have from the meetings are, I expect, the same as mine – that COVID-19 vaccines safety is taken extremely seriously by the workgroup and the committee, that there is still a lot of uncertainty about which of the vaccine in the pipeline will be effective, and that there are thorny, hard questions in deciding how to allocate the first vaccine doses.

This will be a very short overview of the meeting. The next meeting is on September 22, and I encourage and urge people to listen and learn from it. The presentation slides for the previous meetings can be found here. Continue reading “ACIP COVID-19 vaccines meeting – summary of August 2020 discussions”

October 2019 ACIP public comments – anti-vaccine complaints, part 2

2019 ACIP public comments

This is part 2, the 2019 ACIP public comments, of Professor Dorit Rubinstein Reiss’ review of the recent Advisory Committee on Immunization Practices (ACIP) meeting. Part 1 can be found here.

There were 18 people slotted for the October 2019 ACIP public comments. Because more people signed up for comments than could fit in the hour allotted for it, they used a lottery to determine who will comment (note that in addition, the committee offered unlimited opportunity to comment in writing).

However, six of these people did not attend the meeting, so there were 12 commenters in all. Three of them were pro-vaccine, two members of the Immunization Action Coalition – LJ Tan and Julie Murphy – and one, a pediatrician from Oklahoma, Dr. Eve Switzer.

Nine of the 2019 ACIP public comments were from anti-vaccine individuals. Continue reading “October 2019 ACIP public comments – anti-vaccine complaints, part 2”

October 2019 ACIP meeting review – vaccine discussions, part 1

2019 ACIP meeting review

This article is my October 2019 ACIP meeting review. On October 23, 2019, I attended one out of two days of the meeting of the Advisory Committee on Immunization Practices (ACIP). 

Unfortunately, I could not stay both days, because I had to get back to teach on Thursday. But that one day was instructive. Like last time, this meeting was data-heavy and intensive, and the process was thorough.

While a number of anti-vaccine activists attended, there was no real indication that they followed the committee’s deliberations, tried to understand what was discussed, or learned from the information presented.

Their comments during and after the meeting did not contribute substantively to the discussion or offered anything that could lead to meaningful policy changes.

Because of the length of this review, it will be divided into two parts:

  • Part I describes the content of the meeting.
  • Part II addresses the public comments.

Continue reading “October 2019 ACIP meeting review – vaccine discussions, part 1”

Google University equals research for anti-vaccine pseudoscience

Google University

I’m sure everyone has run into the type – a science denier who thinks their two hours at Google University makes them as knowledgeable as a real physician or scientist. This arrogance manifests itself in ridiculous discussions with anti-vaccine religious nutjobs who claim to have “done the research,” and who believe their pseudoscientific research is more valuable than real scientific research.

This Google University education from vaccine deniers, really all science deniers, can be frustrating. I frequent a couple of large Facebook groups that try to help on-the-fence anti-vaxxers understand what constitutes evidence and what doesn’t with respect to vaccines. Recently, one of the anti-vaccine true believers kept saying she knew more than a nurse with a public health master’s degree. The arrogant anti-vaxxer kept claiming that she “did her research.”

Hang on. The old dinosaur needs to slam his head on the desk.

Because of this absurd overvaluing of their Google University research, I want to review a handful of points that every science denier seems to use that makes us laugh. All but one applies to any type of science denial, but we’re sticking with vaccines. Because we can. Continue reading “Google University equals research for anti-vaccine pseudoscience”

Maine anti-vaccine legislation appears again – flawed and misleading

On 4 January 2019, the Maine Coalition for Vaccine Choice – a Maine anti-vaccine organization – posted an article about a proposed bill that they called “The Maine Vaccine Consumer Protection Program.” As with the coalition’s previous attempt to pass such a bill, in 2015, the proposal is ill-founded. The premises it is based on are flawed, and the proposals themselves range from directly misleading to not very meaningful. Continue reading “Maine anti-vaccine legislation appears again – flawed and misleading”

Getting the adult HPV vaccine – Dorit Rubinstein Reiss’ story

adult-hpv-vaccine

On 5 October 2018, the FDA expanded the licensing Gardasil 9 – currently the only HPV vaccine marketed in the United States – to men and women up to the age of 45. If up till now getting the adult HPV vaccine was not a realistic option for me, now it was. But at this point, the vaccine is not yet recommended for my age group – the Advisory Committee on Immunization Practices has not made any additional recommendations after licensing. Which raised the question: should I get it?

On one hand, I am in a committed monogamous relationship. I am a married mother of two young children, I have no plans of changing partners, and I’ve already probably been exposed to anything my husband had. I have never had an abnormal pap smear. That means that I am likely pretty low risk for getting a new HPV infection and that I have cleared any I ever had (almost all sexually active people in the United States have had HPV). If you are in a relationship, including marriage, and if you had children, you likely had sex at some point.

So the benefits of the adult HPV vaccine for me are low – but not non-existent. You never know what will happen, and while I hope to stay with my partner forever, bad things can happen – like death or sexual assault. One hopes for the best, but it’s reasonable to also plan for the worst (for example, while we do not plan to die, we have a will written out with provisions for caring for our kids if we do) – and the vaccine is age-limited. There are nine cancer-causing HPV strains in the vaccine, and I am fairly certain that I have not been exposed to all of them. 

The risks of the adult HPV vaccine are extremely minor. I’m likely to get a sore arm, may get other mild reaction like fever, and have a theoretical reaction of an allergic reaction (or fainting, though not being a teen, I think that’s unlikely). Studies pretty much rule out other risks.

In spite of anti-vaccine claims, getting the vaccine after being exposed to HPV does not increase your risk of cancer (but the vaccine won’t protect you against strains you were already exposed to).

So the adult HPV vaccine has low benefits but minuscule risks, at least for me. Still, it seemed to me to make sense to go for it, if possible. Especially because I speak up about HPV vaccines and encourage others to go for them, I thought it’s fair to get them myself, too. Show I mean it when I say that they are safe. 

To be sure, I emailed Dr. Paul Offit, who I trust completely on vaccines. He recommended going for it. 

I did not know, however, if my provider will give me the vaccine or if my healthcare insurance will cover it at my age (most health insurance in the USA does cover all vaccines, including the HPV vaccine, for children). In spite of what anti-vaccine people believe, I do not have secret ties to pharma or special access to vaccines. 

So I emailed my doctor:

Dear Dr. X,

Since the FDA approved HPV vaccines for people up to 45, I would like to get the vaccine, if possible.

I emailed Dr. Paul Offit, a vaccine expert,  for his opinion, and he recommended getting it.

Can you help me do that?

Best,
Dorit.

My doctor said: “Sure, let me see what our protocol is here and get back to you.”

After I did not hear back for over a week, I emailed again. My doctor answered:

Sorry that I could not repond in a timely manner.
I had forwarded your request to Dr. Y [details omitted to preserve my providers’ – and my own – privacy] but did not hear from them. I have ordered the shots. You can call your … health plan to see if it will be covered just to be sure.

You can go to ### injection clinic Mon-Fri 9am-12pm, 1:30-4:30 pm for the shot (ordered already).

Okay. All that was left was to actually get the vaccine. I wanted a picture – so I asked my eight-year-old son if he will act as photographer and come with me. He agreed. We went together, waited, and went in. I told him to take a lot of pictures all through, and he did. 

Dorit adult HPV vaccine

The nurse asked if I was feeling okay, if I ever had a reaction to a vaccine, if I was allergic to latex or anything else I knew of (yes, no, no). She explained what the shot was, and gave me the Vaccine Information Statement. We also wrote out the schedule for the next two doses. Then she cleaned the area, told me to take a deep breath and let it out, and done. I barely felt the needle. 

She told me my arm will hurt for a day or two. It didn’t, actually. Not complaining. I’m okay with less pain. But I would have been okay (not happy, but okay) with a sore arm for a few days, too. 

My son did a great job taking a lot of pictures. I posted several of those pictures on Facebook and Twitter, because, again, I think it’s important to make it clear I stand behind what I say on HPV vaccines specifically, and vaccines generally. 

So that’s my adult HPV vaccine story. One dose down, two to go. Maybe my arm will hurt next time.