Emergency use authorization

ACIP COVID-19 vaccine priority proposal – healthcare workers first

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.

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.”

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

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

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

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.

1/13: New Thread: A dozen reasons why I'm worried about releasing a #COVID19 #vaccine through an emergency use authorization (EUA)

— Prof Peter Hotez MD PhD (@PeterHotez) September 2, 2020

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

Coronavirus vaccine EUA? Bad science from a desperate president

Because of recent emergency use authorizations (EUA) from the FDA, there is trepidation that they will approve a coronavirus vaccine EUA to make a big splash for a desperate Donald Trump. This is unsettling to those of us who are “pro-vaccine,” because it could cause hesitancy towards this vaccine, and frankly, all vaccines, to skyrocket.

Democrats in Congress are trying to make sure that a coronavirus vaccine EUA does not endanger the health of the country or cause Americans to become even more vaccine-hesitant. So, this article will examine what is and is not a part of an emergency use authorization. And what this all means for a potential coronavirus vaccine EUA.Read More »Coronavirus vaccine EUA? Bad science from a desperate president