coronavirus

Vaccine development process – how it’s usually done

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.

COVID-19 first anniversary – the old raptor was wrong on vaccines and right on quackery

Today represents the first anniversary of the COVID-19 pandemic. Yes, it was around for a few months before this, but many of us heard the same thing about SARS and MERS, ironically, both related coronaviruses, Ebola, Zika, and other diseases over the past few decades. I think many of us just sighed, shrugged our shoulders, and repeated the mantra that the flu killed more people.

In the days that led up to March 11, 2020, I think we were becoming much warier, if not concerned. A few counties in California, probably the first in the USA, decided to shut down and limit gatherings to no more than 1000 people. Yes, 1000 people. Today, we think that’s outrageous and frightening.

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.”

Pfizer COVID-19 vaccine news – should we pump the brakes just a bit?

Recently, we saw a lot of news about the Pfizer COVID-19 vaccine – it seemed to show about a 90% effectiveness in preventing the disease. This is potentially good news in preventing the spread of this disease because alternatives like herd immunity is a disastrous form of genocide.

But, what does this news actually mean? Does it imply that the world is saved, and soon we can eschew masks and social distancing? Does that mean the pandemic will come to an end?

We need to know if the COVID-19 vaccine actually does what Pfizer claims. We need to know if it is safe. And we need to know when the vast majority of people can receive the vaccine. When we know all of that, we can then see the light at the end of the tunnel for this deadly pandemic.

Let’s take a skeptical look at the Pfizer COVID-19 vaccine along with what it may mean to the world. I’m writing this in the form of several questions that I have with the answers as I know them.

FDA approved remdesivir for coronavirus – what this means for a vaccine

On 22 October 2020, the FDA approved remdesivir from Gilead Sciences to treat COVID-19. Remdesivir is a broad-spectrum antiviral that has shown some effect in treating the novel coronavirus.

However, does this mean that the FDA approval of the drug is supported by good science? As I’ve written previously regarding rushed approvals of a potential COVID-19 vaccine, we should be concerned that the FDA has become politicized to approve COVID-19 drugs to make Donald Trump look good.

I think there’s evidence that the FDA-approved remdesivir was rushed and that the evidence supporting its use in COVID-19 treatment may be vastly overstated.Read More »FDA approved remdesivir for coronavirus – what this means for a vaccine

Governor Newsom’s COVID-19 emergency powers limited by California court

This article about a California court decision regarding Gov. Gavin Newsom’s COVID-19 emergency powers 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.

On November 2, 2020, Judge Sarah E. Heckman ruled that the Governor’s power under the California Emergency Services Act (CESA) only included the power to suspend statutes, not to change them via executive order. While the decision clearly limits the Governor’s power to act in an emergency and raises questions about the validity of some of the Governor’s COVID-19 orders, it does not affect his order about the election that was the basis for the lawsuit, nor would it, for example, overturn California’s face covering mandate and other restrictions not issued under CESA.

It is appropriate for the judiciary to address the constitutional limits on actions by the other branches, and it’s not a bad thing to limit the powers of the governor, even in an emergency. But the narrow construction of the Governor’s power to act in an emergency under the constitution is concerning.Read More »Governor Newsom’s COVID-19 emergency powers limited by California court

Connecticut court supports masks in schools – rejects emergency injunction

This article about a Connecticut court decision regarding masks in schools 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.

On November 2, 2020, Judge J. Moukawsher of the superior court in Hartford District, Connecticut denied the request that children do not wear masks while attending school. The Connecticut Freedom Alliance, LLC sought an emergency injunction stopping Connecticut’s Department of Education’s order that Connecticut school children wear masks.Read More »Connecticut court supports masks in schools – rejects emergency injunction

Pro-science Joe Biden – he deserves our support for President

In case you’re living under a rock and reading this, the United States will choose either pro-science Joe Biden or science-denying Donald Trump to be our next president. There are a lot of reasons to support former Vice President Biden over Trump, but the biggest one for me is that he’s pro-science.

Science matters. And it matters more than just climate change, vaccines, COVID-19 pandemic, and many other issues that are critical to the world these days. It is also relevant to healthcare, women’s health, abortion, and competitiveness in today’s world.

I know that none of you who read this blog will be surprised that I give my strongest endorsement of the pro-science Joe Biden over that Nazi Republican Donald Trump. But let me show where Biden and science are sympatico with mine. And hopefully, yours.Read More »Pro-science Joe Biden – he deserves our support for President

Flu vaccine and COVID-19 infections – some evidence it might lower risk

Recently, I have been discussing the flu vaccine and COVID-19 infections. First, I debunked anti-vaccine myths. Second, I explained that the seasonal flu vaccine might be helpful in improving outcomes for patients who contract the coronavirus.

However, at that time, I wanted to make it clear that:

Once again, I am not making any claim that the seasonal flu vaccine will prevent a coronavirus infection. It’s just about comorbidities, that is, other health conditions that increase one’s risk for dangerous outcomes from the disease.

Because COVID-19 is a respiratory disease, anything that weakens the respiratory system could (and again, we don’t have solid information on the pathophysiology and comorbidities for the disease) lead to a worse course for the disease. And that would include a higher risk of mortality.

The flu vaccine can reduce the risk of one coronavirus comorbidity since the flu is a respiratory disease. So, the flu vaccine isn’t going to help reduce your risk of coronavirus infection, but it will reduce your risk of complications, including death, from COVID-19.

In addition, preventing the flu may help to reduce hospitalizations and ICU admissions, allowing for more capacity for patients who have contracted COVID-19.

But again, I assumed that the flu vaccine would have little effectiveness against SARS-CoV-2, the virus that causes COVID-19. This seemed biologically plausible because, as opposed to what Donald Trump claims, the flu virus and coronavirus are vastly different organisms. The two viruses are actually in two different phyla, meaning that the influenza virus and coronavirus are as closely related as a human is to a lobster.

There appeared to be no scientifically supported reason to believe that the flu vaccine actually prevents COVID-19. However, there seems to be some intriguing, preliminary, and potentially convincing evidence that the flu vaccine may have some effect on the risk of COVID-19. Read More »Flu vaccine and COVID-19 infections – some evidence it might lower risk

Flu treatment quackery – it is all woo, so get your influenza vaccine

by Michael Simpson
2020-10-22
Flu vaccine, Immunology, Supplements, Vaccines

It’s that time of year when we are bombarded by flu treatment quackery from “immune-boosting” miracle supplements to junk that “cures” every single virus known to medical science. During this world of the coronavirus pandemic, it seems to be even louder.

This article will attempt to debunk the myths of flu treatments such as “boosting the immune system,” magical supplements, and other nonsense involved with the world of flu treatment pseudoscience.

The one way to prevent the flu, other than hiding in a bubble during the winter (which may be a good thing with the COVID-19 pandemic), is the seasonal flu vaccine. But that’s not a treatment, it prevents the flu.