COVID-19 vaccines and myocarditis – what are the facts

medical stethoscope and mask composed with red foiled chocolate hearts

Regulatory agencies, such as the FDA and CDC, are monitoring reports of myocarditis, a heart inflammation, after COVID-19 vaccines. Although if there is a link, it is exceedingly rare, anti-vaccine activists have already 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.

Continue reading “COVID-19 vaccines and myocarditis – what are the facts”

Myocarditis and COVID vaccine – a rare event that may not be linked

COVID-19 vaccine myocarditis

Regulatory agencies across the world, including the FDA and CDC, are monitoring COVID-19 vaccine adverse events including reports of myocarditis, a heart inflammation. Of course, the anti-vaccine squad will probably jump on this to make it appear that the vaccine is 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 this adverse event is 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.

Continue reading “Myocarditis and COVID vaccine – a rare event that may not be linked”

Pfizer COVID vaccine authorized for use in 12-15-year-olds

Pfizer COVID-19 vaccine

The FDA has expanded the emergency use authorization (EUA) for the Pfizer COVID-19 vaccine to now include 12-15-year-olds. The CDC’s Advisory Committee on Immunization Practices will meet soon to make the final recommendations on use of the vaccine in that age group in the USA.

This is an important step in putting the pandemic behind us and allows American families to begin to return to a normal life.

Even though parents have been able to easily get the vaccine, it was only available to adults (although the Pfizer COVID-19 vaccine was indicated for 16 years and up). This new authorization means that schools can consider opening up if this age group is vaccinated, and may allow teenagers to attend summer camps and get-togethers with friends.

This broadening of the age group resulted from a clinical trial which enrolled 2,260 participants between the ages of 12 and 15. The young teens were given either two doses of the vaccine (same dosage as adults) or a placebo three weeks apart.

Photo by Marisol Benitez on Unsplash

The researchers recorded 18 cases of symptomatic SARS-CoV-2 infection in the placebo group and none in the vaccine group. This showed it to be highly effective at preventing symptomatic illness.

Additionally, the vaccine was also very safe for these children, with similar minor side effects as those seen in the larger clinical trial participants, ages 16-25. Fevers were observed more frequently in the vaccinate 12- to 15-year-olds, about 20%, compared to 17% in the 16- to 25-year-olds.

As I wrote previously, we probably need to reach 80% vaccination rates to have full herd immunity, and we will need to include children in that number to even get close. So this is important good news to defeating this pandemic.

So, let me sum this up:

  • The Pfizer COVID vaccine was shown to be highly effective in preventing symptomatic disease in 12- to 15-year-olds.
  • The vaccine was shown to be extremely safe in the same age group.

There’s plenty of vaccines available in the USA. So once ACIP recommends it for this age group, take your kids down to your local vaccine hub and get it done!



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COVID-19 vaccine safety signals – ACIP reports good news so far

pexels-photo-5922099.jpeg

The CDC’s Advisory Committee on Immunization Practices (ACIP) has reported that there are no COVID-19 vaccine safety signals through 16 February 2021 for the two vaccines available at that time from Moderna and Pfizer. This is good news and should allay the fears of those who might be on the fence about the vaccines.

I want to briefly examine what ACIP discussed regarding the COVID-19 safety signals. In addition, they looked at any concerns with regards to the vaccine and pregnant women – also good news. So, just good news.

Continue reading “COVID-19 vaccine safety signals – ACIP reports good news so far”

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.

Continue reading “ACIP COVID-19 vaccine priority proposal – healthcare workers first”

Will the Pfizer Moderna AstraZeneca COVID-19 vaccines end the pandemic?

Pfizer Moderna AstraZeneca COVID-19 vaccines

There has been a lot of excitement lately with the Pfizer/BioNTech, Moderna, and AstraZeneca/Oxford COVID-19 vaccines lately, but I wanted to temper your enthusiasm thinking the pandemic is going to be over in a few weeks, and we can all hit the pub, drinking with our friends, family, and neighbors. 

If anything, I would strongly recommend wearing a face mask across the world until a substantial number of people are vaccinated, and that may take a lot longer than you thought. By the way, more recent scientific evidence supports the FACT that when both individuals are masked, there is almost no transmission of viruses. 

So, let me explain why, despite the good news, we still need to protect ourselves from the coronavirus. There is light at the end of the tunnel, but don’t be confused by the recent announcements by Pfizer, AstraZeneca, and Moderna regarding their COVID-19 vaccines – there is still a lot of hard work to be done.

Continue reading “Will the Pfizer Moderna AstraZeneca COVID-19 vaccines end the pandemic?”

COVID-19 vaccine recommendations being developed by CDC and ACIP

COVID-19 vaccine recommendations

On November 23, 2020, new Centers for Disease Control and Prevention (CDC) COVID-19 vaccine recommendations were discussed during an emergency meeting of the Advisory Committee on Immunization Practices (ACIP). As I discussed recently, Pfizer, Moderna, and AstraZeneca all have announced that their vaccines exhibited high effectiveness and safety during phase 3 clinical trials.

This is a brief review of what ACIP and CED are “thinking” regarding COVID-19 vaccine recommendations.

Continue reading “COVID-19 vaccine recommendations being developed by CDC and ACIP”

Coronavirus vaccine priority list – if I were elected the Emperor of Vaccines

coronavirus vaccine priority list

Despite the wild claims that a COVID-19 vaccine will be available real soon now, the initial limited supply would require a coronavirus vaccine priority list. Despite what Donald Trump says, and his veracity is limited, the supply of the vaccine will be limited for many months after approval, whether that approval is legitimate or not

The supply of a new COVID-19 vaccine is limited by many factors – regulatory review (yes, the FDA and other regulatory agencies must approve the manufacturing facilities for new drugs after the company receives approval to market their drugs), manufacturing bottlenecks, the number of doses required for “immunity,” and distributions problems, especially the need to store these vaccines at extremely low temperatures (no, your home refrigerator won’t get that cold).

In fact, that last point is something that everyone overlooks – your average physician does not have the ultra-low temperature freezers, usually only hospitals and major health departments. And they aren’t cheap. Furthermore, vaccines just don’t show up at a physician’s office or hospital directly from Big Pharma – they are delivered by a massive distributor network that may not have delivery vehicles that can properly store the vaccines as they drive their trucks across the deserts of Arizona in October.

This isn’t just an issue in the USA, it’s across the world. People magically believe that once a vaccine is approved it will suddenly be available to hundreds of millions of people. Nothing could be further from the truth.

Because the Big and Little Pharma companies are being much less transparent than they should, we have really no clue how many doses may be available soon after they get the go-ahead. 

Using the USA as an example, we’ll need around 750 million doses for every individual (assuming that two doses will be necessary and everyone gets the vaccine, which won’t happen). Overlooking the fact that the USA probably has a total vaccine manufacturing capacity of 200 doses at best (most of our current 300 million a year of vaccines are manufactured not only in the USA, but also in Canada, Belgium, Germany, France, and Japan), it’s highly improbable if not impossible to have 750 million doses on day 1. It may take years to manufacture that many.

If there are only 10-20 million doses available on day 1 (I’m highly skeptical of even that), you have to assume that there will be a coronavirus priority list. 

Now, there is a group that will be developing a coronavirus vaccine priority list (they’ll probably give it a better name) – the CDC’s Advisory Committee on Immunization Practices (ACIP). Dorit Rubinstein Reiss reported on a recent ACIP meeting which reviewed the ongoing efforts with the COVID-19 vaccine, but they did not make any recommendations on who should get the vaccine.

In light of that,  if I were elected Emperor of Vaccines, then I would have to create an official coronavirus vaccine priority list so that the right people get the vaccination. Spoiler alert – most of us aren’t on that list. Continue reading “Coronavirus vaccine priority list – if I were elected the Emperor of Vaccines”

June 2020 ACIP meeting – meningococcal, influenza, COVID-19 vaccines

June 2020 ACIP meeting

This article about the June 2020 ACIP 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.

During June 2020, the Advisory Committee on Immunization Practices (ACIP) held its second annual meeting for the year. Because we are in the middle of the COVID-19 pandemic, and traveling is challenging for many – including, I suspect, for several of the Committee members, not all of which live near Georgia – the meeting, like most conferences this year (those which were not canceled) was held virtually. The CDC still provided an opportunity for oral comment, though there were some logistical challenges with their new system.

The June 2020 ACIP meeting discussed meningococcal vaccines, influenza vaccines, and then had the opportunity for public comment. The entire afternoon was devoted to COVID-19 and COVID-19 vaccines.

As with previous meetings, ACIP is a geek’s dream meeting and everyone else’s – except the experts, and I suspect – hope – most experts are geeks –  boredom feast. I learned a lot.

One of the most important lessons is that the committee takes vaccine safety very, very seriously. The other is that decisions on vaccines – like most policy decisions – are always made on incomplete knowledge. We never know everything. That is where expert judgment comes in. Incomplete knowledge does not mean there is not enough knowledge to assess benefits/risks, though any such assessment should be reassessed when new knowledge comes in.

Finally, it’s important to remember – and something the anti-vaccine observers of these meetings seem unaware of, but that doctors treating patients likely are not – that a decision not to use a vaccine is a decision with costs and risks – the costs and risks of the disease the vaccine prevents.

The choice is never between no risk and the vaccine because we don’t have vaccines unless a disease causes substantial mortality and morbidity. The choice is always whether, given the information, an informed decision can be made and which risks that information suggests are higher – those of the vaccine or those of not vaccinating.

Finally, my notes are over 14 pages of text for the June 2020 ACIP meeting, and that’s because my computer crashed at the end and I lost my last two pages of notes, which is really frustrating – and I have 153 screenshots of slides (yes, I am surprised too). I really want this post to be shorter. So I’m going to try and be very brief, and I’m happy to share my full notes, just email me at [email protected] Continue reading “June 2020 ACIP meeting – meningococcal, influenza, COVID-19 vaccines”

February 2020 ACIP Meeting review – Ebola, influenza, and coronavirus

february 2020 acip meeting

This article about the February 2020 ACIP 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.

I attended a large part of the February 2020 ACIP meeting (Advisory Committee of Immunization Practices) in Atlanta, GA. I had planned to stay throughout, but my airline changed my return flight and I had to leave before the end on the second day. I did, however, watch the first day and the first two parts of the second.

The coronavirus crisis changed some things. For example, there were multiple international groups visiting the CDC (there was also at least one group that was there for other reasons and sat on part of the meeting). And we had a presentation on the topic from Dr. Nancy Messonnier.

I will describe the meeting in the order it happened, though this is the very abbreviated version. As I said before, an ACIP meeting is a geek’s dream – there’s a lot of data provided and in-depth discussions of details. The committee has a heavy and important responsibility, and since it was targeted by anti-vaccine activists is carrying it out under tricky circumstances. Continue reading “February 2020 ACIP Meeting review – Ebola, influenza, and coronavirus”