JNJ COVID-19 vaccine receives FDA emergency use authorization – great news

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On 26 February 2020, the Johnson and Johnson (JNJ) COVID-19 vaccine underwent an FDA expert review, similar to the ones for the Pfizer and Moderna COVID-19 vaccines. The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of the third vaccine in the USA to prevent COVID-19. On 27 February 2020, the USFDA gave clearance for an Emergency Use Authorization (EUA).

VRBPAC agreed that the vaccine was very effective, especially in preventing death and serious COVID-19 disease. They also found no serious safety signals, with the incidence serious adverse events were no higher compared to the placebo group or what would be expected in the general population.

The EUA approved the vaccine for use in adults 18 and older. Before JNJ can ship the vaccine, the CDC’s Advisory Committee on Immunization Practices (ACIP) will meet tomorrow to make recommendations on who can receive this vaccine.

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COVID-19 vaccines pipeline – potential next emergency use authorizations

COVID-19 vaccines pipeline

After the emergency use authorizations (EUA) were given for the Moderna and Pfizer COVID-19 vaccines, what is next in the pipeline? There are three vaccines that could be reviewed by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) during the next few weeks that would provide recommendations to the FDA (and other national drug regulatory bodies) for EUAs.

The three vaccines I’m going to discuss are ones that have a reasonable chance of getting approved for use in the USA or Europe. This excludes COVID-19 vaccines from Russia, China, and other countries that rarely, if ever, get FDA approval for vaccines (see Note 1).

So, let’s take a look at what are probably the next three COVID-19 vaccines in the pipeline.

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COVID-19 vaccine EUA prevented by hydroxychloroquine – myth busted

COVID-19 vaccine eua

This article about how “cures” should prevent a COVID-19 vaccine emergency use authorization (EUA) 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.

I have seen this myth around but haven’t had a chance to respond to it, so I will do it quickly here. No, there is no conspiracy to hide the benefits of things like hydroxychloroquine (HCQ) and vitamin D, and no, if they were shown effective, it would not prevent a COVID-19 vaccine EUA.

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Pfizer COVID-19 vaccine facts – scientific evidence to deal with misinformation

Pfizer COVID-19 vaccine facts

Because the Pfizer COVID-19 vaccine is ready to launch in many countries, it is time that we provide the facts about the vaccine. This will be different than my myth debunking article (which will be constantly updated as the anti-vaxxers get going with their lies and disinformation), as this article will try to make sure that everyone is on the same page with what this vaccine is. 

Almost all of the information will come from the Pfizer/BioNTech COVID-19 mRNA vaccine documents that were submitted for review by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) in advance of an emergency use authorization (EUA) that was issued by the FDA on the evening of 11 December 2020. I read through most of the material to save you all time during this holiday season (so please like this article and share it across the planet).

I’m going to just hit what I think will be the most important points about the vaccine’s safety, effectiveness, ingredients, and other related information. Because these Pfizer COVID-19 vaccine facts will be most useful in debunking wild claims that you might read on the internet. I am planning to do the same with the Moderna vaccine, so stay tuned once VRBPAC reviews their data and the FDA issues an EUA.

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Pfizer COVID-19 mRNA vaccine – FDA approves emergency use authorization

pfizer COVID-19 mRNA vaccine

On 10 December 2020, the Pfizer/BioNTech COVID-19 mRNA vaccine was reviewed by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) in advance of an emergency use authorization (EUA). Unless you were avoiding the internet (and hence, you wouldn’t be reading this), you would know that the review went well, and VRBPAC “approved” the vaccine. On the evening of 11 December, the FDA gave approval for the EUA, the first COVID-19 vaccine available in the USA.

This article will quickly review the major points about the VRBPAC discussion, a review of some of the data, and finally a summary of what we know and don’t know about the Pfizer COVID-19 mRNA vaccine. 

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ACIP COVID-19 vaccine priority proposal – healthcare workers first

ACIP COVID-19 vaccine priority

On 1 December 2020, the CDC’s Advisory Committee on Immunization Practices (ACIP) COVID-19 vaccine priority recommendations were discussed. As I have written recently, Pfizer, Moderna, and AstraZeneca all have announced that their vaccines exhibited high effectiveness and safety during phase 3 clinical trials, while both the Pfizer and Moderna vaccines are seeking emergency use authorizations (EUA) from the US Food and Drug Administration (FDA), so these vaccines may become available within a few weeks.

This is a brief review of the ACIP and CDC COVID-19 vaccine priority lists for the first tranches of vaccines.

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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.”

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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 

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Vaccine development process in the world of a coronavirus pandemic

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 was 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 coronavirus pandemic means 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 of lives. This does not mean those political agendas like we’ve seen Trump do with hydroxychloroquine and other things should take precedence over good science. 

So, this article is going to lay out how, in a world without a pandemic, the coronavirus vaccine development process should proceed while ignoring how the politically-driven FDA may subvert the process

Although I am very uncomfortable with the coronavirus vaccine development process over the past few months, it looks like, for better or worse, we’ll probably have one or two different vaccines in unknown quantities by early 2021. 

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., who has 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.
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Trump coronavirus vaccine – in this one specific case, I’m anti-vax

trump coronavirus vaccine

As I’ve discussed previously, the FDA may use its Emergency Use Authorization (EUA) powers to push the Trump coronavirus vaccine out on the citizens of the USA before it’s been fully tested. Using Vladimir Putin’s example of pushing out a vaccine before it’s fully tested, Donald Trump keeps insisting that we’ll get a new COVID-19 vaccine soon, well before phase 3 clinical trials are done.

All vaccines currently on the market have been tested thoroughly. And the science that these current vaccines are very safe and very effective is settled. I am thoroughly convinced of the evidence that we have excellent vaccines, so it is clear that I am thoroughly pro-vaccine – I do not have to convince anyone of that.

However, for the Trump coronavirus vaccine, I am anti-vaccine. But it is a very narrow, very unique situation. 

I have been troubled by the speed of the coronavirus vaccine research. I think it can lead to a bad vaccine on the market. Recently, Astra-Zeneca had to put a hold further testing of the so-called University of Oxford vaccine, because of a suspected serious adverse event in one individual. Astra-Zeneca will investigate the adverse event to determine if the vaccine caused it.

This is not uncommon in clinical trials – there is an abundance of caution while investigating new drugs, despite what people believe about how clinical trials are managed. That’s why vaccine research is difficult and not a slam dunk. 

On the other hand, there will be serious consequences to a rushed Trump coronavirus vaccine, because we might not get these safety signals that can appear in large clinical trials. And if we do this wrong by avoiding large phase 3 clinical trials, people who may be on the fence about vaccines become convinced by anti-vaxxers that this awful process was used by all other vaccines. It wasn’t.

Dr. Peter Hotez, MD Ph.D., one of the leading vaccine scientists in the world,  posted a Twitter thread where he discussed his concerns about a potential Trump coronavirus vaccine.

I want to review each of the 12 concerns he posted along with my own opinions on each. Continue reading “Trump coronavirus vaccine – in this one specific case, I’m anti-vax”