mRNA

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

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.

Myocarditis and COVID mRNA vaccines – very rare adverse event

Regulatory agencies, such as the FDA and CDC, are monitoring reports of myocarditis, a heart inflammation, after COVID-19 mRNA vaccines from Moderna and Pfizer. Although myocarditis after these vaccines are exceedingly rare, anti-vaccine activists have already jumped on this issue to make it appear that COVID-19 vaccines are dangerous.

My job is to look at this data and give you a scientific analysis of the observations and whether they are actually related to the vaccine.

Like with reports of other conditions, such as blood clots, after receiving COVID-19 vaccines, we need to examine whether myocarditis is actually related to the vaccine or just random events in which the incidence is no different than what would be predicted in a similar group of unvaccinated people. And if it is linked, we need to look at the potential risk and compare it to the risks of COVID-19 itself.

Why can’t we get a cancer vaccine as fast as one for COVID-19?

by Michael Simpson
2021-06-13
Cancer, COVID-19, HPV vaccine, JNJ, Moderna, Pfizer, Vaccines

I keep reading memes and other nonsense that if scientists are so smart why can’t we have a cancer vaccine as fast as we did for COVID-19? It’s not a serious question, it’s actually pejorative – it’s meant to imply that we’ve been looking for years for a cancer vaccine without success, yet we were able to get a COVID-19 vaccine within a few months, so obviously it was rushed.

Fortunately for us on the side of science, this is one of the silliest and most desperate myths being pushed by our favorite anti-vaxxers.

Busting cancer myths is one of my favorite activities – my non-statistical analysis of medical pseudoscience puts cancer slightly above vaccines on the stupidity of the tropes. Combining vaccine nonsense with cancer is right up my bailiwick. Let’s have some tearing apart this trope.

COVID-19 vaccine shedding – another anti-vaccine myth to scare people

by Michael Simpson
2021-05-02
AstraZeneca, COVID-19, JNJ, Moderna, Pfizer, Vaccines

Here we go again – an expensive, privileged Miami private school has banned teachers who received the COVID-19 vaccine because of “shedding” concerns. Yes, you read that right, the school wrote to teachers that “we cannot allow recently vaccinated people to be near our students until more information is known.”

The school’s co-founder, Leila Centner, claimed that those people who had received the COVID-19 vaccine can somehow shed the spike protein, which in turn can cause menstrual cycle irregularities, miscarriages, and sterility in other women just by being in close proximity to vaccinated people who are shedding something.

Centner wrote, “we cannot allow recently vaccinated people to be near our students until more information is known.” She must get this nonsense from Kelly Brogan, anti-vaccine quack, who seems to have something with Centner and this school

Centner cited debunked claims that the vaccine causes infertility based on “reports have surfaced recently of non-vaccinated people being negatively impacted by interacting with people who have been vaccinated. Let’s be clear that that the scientific consensus about this vaccine is that is very effective and carries few risks.

Simply put, COVID-19 vaccine shedding does not exist, but I will spend a few moments debunking it again.

COVID-19 vaccine during pregnancy – the CDC now recommends it

by Michael Simpson
2021-04-25
COVID-19, Moderna, Pfizer, Pregnancy, Vaccines

The CDC just announced that it recommends the COVID-19 vaccine during pregnancy to protect the health of the mother and the developing fetus. The CDC stated that there are “no safety concerns” among women in their third trimester and for their newborn babies.

Despite the claims of COVID-19 deniers everywhere, the disease is dangerous and can cause both short- and long-term harm to anyone, and that means pregnant persons and their newborn babies. That’s why the COVID-19 vaccine is so important.

Let’s take a look at what the CDC said and why pregnant persons should get the COVID-19 vaccine.

COVID-19 vaccines herd immunity – ignore anti-vaxxer disinformation

by Michael Simpson
2021-04-22
AstraZeneca, COVID-19, JNJ, Moderna, Pfizer, Vaccines

The only way to herd immunity to this pandemic is with COVID-19 vaccines, but still, people are refusing the vaccine, not only in the USA but also throughout the world. But the anti-vaccine world is doing everything it can to sow fear, uncertainty, and doubt about these vaccines.

Herd immunity is a form of indirect protection from infectious diseases that can occur when a sufficient percentage of a population has become immune to an infection, by vaccines or infection, which reduces the risk of infection by members of the community who lack that immunity. Although we don’t have a solid estimate for herd immunity levels for COVID-19, it is estimated to be between 60 and 75%.

Without herd immunity, there are a number of consequences. People who cannot get vaccinated or are immunocompromised will always be at risk of contracting the disease. The virus will continue to be transmitted, which will lead to more dangerous mutations. And there are local outbreaks of COVID-19 across the world that could bring the disease back to the USA and many other countries where we don’t reach herd immunity.

A large group of COVID-19 deniers and anti-vaxxers want to create herd immunity “naturally” instead of using vaccines – that is essentially genocide since so many people will die or suffer long-term consequences.

We need to get the COVID-19 vaccines into as many people as we can so that we can reach herd immunity. Right now, about 25% of Americans may refuse to get the vaccine, and that means we probably cannot reach herd immunity.

mbedThis article is just a list of my articles that can be useful in your arguments with the anti-vaxxers and individuals who are “on-the-fence.”

COVID-19 mRNA vaccines “hack the software of life” – anti-vaxxers new myth

In case you weren’t watching, anti-vaxxers are now proclaiming that COVID-19 mRNA vaccines “hack the software of life.” This results from the early hype about the Moderna vaccine when a Moderna executive proclaimed that their vaccines will “hack the software of life.”

Despite my having received the Moderna vaccine, I have found their hype machine to be quite annoying in the past. Worse, they decided to file documents proclaiming that the FDA will regulate their vaccine as “gene therapy.” Thank you, Moderna for making my life difficult in refuting nonsense about these COVID-19 mRNA vaccines and hacking the software of life.

Many of us have spent a considerable amount of time debunking the myth that the COVID-19 mRNA vaccine, from either Moderna or Pfizer, is gene therapy and does not hack the software of life. Whoever thought this was a good idea at the Moderna hype machine factory ought to find a new job.

So, once again, this article will debunk the myth about the Moderna COVID-19 mRNA vaccine having anything to do with “hacking the software of life.”

Adenovirus vaccines for COVID-19 – scientific facts vs anti-vax nonsense

The new COVID-19 vaccines from Johnson and Johnson (JNJ) and AstraZeneca utilize an adenovirus-vector to prevent the SARS-CoV-2 virus that causes COVID-19. Of course, this being a new vaccine technology, like the mRNA vaccines used by Pfizer and Moderna, we will be hearing all kinds of false claims about the new adenovirus vaccine.

So, this article will just try to explain what an adenovirus is, how it works in vaccines, and why it is safe. There’s going to be a lot of science here, so I’ll do my best to link you to good articles that explain some of it.

The anti-vaccine squad used an ignorance of basic cell biology to make all kinds of odd claims about the mRNA vaccines such as claiming that it would change the DNA of the vaccine recipient. It can’t.

COVID-19 vaccine choices – which one should you get?

There are now three COVID-19 vaccine choices that have been given clearance under Emergency Use Authorization (EUA) in the USA. The one question I keep getting from friends and strangers is – which of the COVID-19 vaccines should they get?

The three vaccines which have the EUA in the USA, from Pfizer, Moderna, and Johnson & Johnson (JNJ), are very safe and very effective, so my simple answer to the question is succinct – get whichever vaccine is available to you. It probably does not matter in the long run which will be better than the other, they all prevent SARS-CoV-2, the virus that causes COVID-19.

All three of the vaccines, plus additional COVID-19 vaccines from AstraZeneca and Novavax (neither of which have submitted EUAs to the FDA as of this date), will be available in the developed world, that is, the European Union, USA, Japan, Canada, Australia, and New Zealand. Each country will have slightly different combinations of these vaccines available, but this discussion should be germane to anyone asking about which to get.

COVID-19 vaccine and pregnancy – expert recommendations on safety

by Michael Simpson
2021-02-17
COVID-19, Moderna, Pfizer, Pregnancy, Vaccines

One of the questions that keep entering the discourse on the COVID-19 vaccine is whether it should be given during pregnancy. There’s not a definitive answer, but there is some good advice based on evidence from leading infectious disease experts.

I’m not here to make a recommendation one way or another regarding whether the COVID-19 vaccine should be given during pregnancy. My job is to provide the evidence and the recommendations so that every woman can be armed with this when speaking to their healthcare provider.