Is the COVID vaccine dangerous?

administering covid vaccine in arm

In the U.S., there are three COVID vaccines currently available (as of April 20): Pfizer, Moderna, and Johnson & Johnson. The Johnson & Johnson vaccine (which was halted) and the AstraZeneca vaccine (which is NOT being given in the U.S. right now), are making some worrying headlines. I'm going to focus on the Pfizer and Moderna vaccines (both mRNA vaccines) in this article.

As a retired doctor, I've been volunteering at local mass vaccination campaigns. We've hit a point where we've run out of people who really want the vaccines. Now, the patients are more hesitant. For those on the fence, I'd like to clear up some concerns.

"They developed it too fast."

bottle of mRNA vaccine The mRNA vaccine technology has been in development for the past 10 years. It is already being used to develop vaccines for rabies, Zika, HIV, the flu, and certain cancers. Even before this pandemic, scientists realized that this method of vaccine development could be much faster for a brand new infectious disease - which is exactly the situation we face.

For mRNA vaccines, developers only need to know the viral protein "key" that unlocks the human cell membrane "door". We had that as soon as the virus was "discovered" by the world back in January of 2020. We sequenced the genetic code of the virus immediately. Scientists then took the minuscule chunk of the code that makes the "key" spike protein and programmed it into the RNA printer. Then they wrapped the printed RNA in some grease, and voila! It's ready for injection. Pfizer's vaccine clinical trials started May 4, 2020, and we've been monitoring the trial participants since then.

The challenge with any clinical trial is making sure it's safe (Phase I), finding the right dosing (Phase II), and seeing how effective it is (Phase III). A trial requires a company to recruit researchers/doctors, train them, recruit volunteers, and administer the drug or vaccine tested. That process normally takes years because it's hard to find volunteers. For COVID-19, volunteers were scrambling to get the shots. Recruitment took no time at all.

For each phase, we have to wait for people to get sick. For some diseases, exposure rates are so low that you'd have to wait for years for natural infections. And if only 1% of the people normally get infected with whatever it is you are testing, then you have to have enough people infected in the treatment group versus the placebo group to show up statistically different. For diseases that don't happen often, it takes years to find out if something is working. For COVID-19, people were getting sick very quickly, and we had a good test to confirm disease. It didn't take long to see that the placebo group continued to get sick and die while the vaccine group almost stopped getting sick at all. So many people around the country were catching the disease that results were obvious within a month (but the researchers continued to study each patient for 3 months prior to releasing the results). Any vaccine trial requires waiting for patients to get sick naturally, which normally takes many years. We finished this part quickly because the country had a high rate of infection.

"They cut corners."

bottle of COVID-19 mRNA vaccine Not for the most important things. Three things were a bit different from the normal process.

  1. Some of the trial phases overlapped.

    We allowed this due to urgency. Normally, Phase I would need to be fully completed, reported to the scientific community, feedback gathered, then submitted to the FDA before the next phase could start. For COVID-19, phase I and Phase II started at the same time. Every step still happened, but the next phase was approved to start faster than normal. At this point, all followup periods have been met, and formal FDA approval will likely be issued in June.
  2. Emergency Use Authorization.

    There is a huge long process full of paperwork and lawyers to get things through the FDA normally. Scientists are busy, so it takes a long time to get them to come to the FDA and be part of an expert review panel. Then they have to write a report with their findings after the company's presentation. It's like calling your cable company and having to press 10 buttons in just the right order to talk to a live human being. Well, this time, everyone dropped everything else and focused on this. It's like you called your cable company and the CEO answered the call before the first ring even finished. We got our answer immediately, especially since the results were so spectacular - over 90% protective.
  3. Governments threw money and resources at this.

    Everything was streamlined and ready to go. Governments started paying for vaccines before they were even made. The labs making the vaccines were built before we even knew they worked. The vaccines doses were being mass produced before they were even approved by governments around the world.

In other words, the main things cut were financial constraints and bureaucracy.

"It hasn't been around for long enough."

May 4, 2020 was when the first and second phases of the Pfizer clinical trial started last year. That means that some people have had the shot for almost a year, and scientists have been able to monitor them throughout to make sure there are no bad long-term reactions. The ingredients of the Pfizer and Moderna vaccines (saline, fats, nucleic acids) all degrade very quickly (within hours to a few days) and stay in the injected muscle. In the US, of the 32,000,000 people infected with COVID-19, 565,000 died. Of the 77,000,000 people fully vaccinated with both doses, only 74 died from COVID-19. No (ZERO) deaths have been attributed to the mRNA vaccines.

"Not FDA approved, considered 'experimental.' Don't want to be a guinea pig."

The FDA did authorize the vaccines for emergency use. They are still going through the years-long "approval" process. 25% of the US population is fully vaccinated with both doses now, and nearly 50% of people have had at least one dose. It's only experimental in semantics. With so many people and doses given, it is far less experimental than many FDA approved medications. Six times as many people have had the vaccine than are prescribed Ambien. Ten times more people have had the vaccine than are taking insulin. Ten times more people have had the COVID-19 vaccines than the number of people who have taken the rabies vaccine - ever. When so many people have already gotten it, it's not much of an experiment anymore. It's basically proven safe and effective.

Pregnancy

35,000 women reported getting the vaccine while pregnant. The rate of problems (such as miscarriage, preterm birth, or preeclampsia) for vaccinated women is no different from normal. In fact, getting sick with COVID-19 while pregnant is especially dangerous, so vaccination with the mRNA vaccines (Pfizer and Moderna) is recommended.

V-Safe

If you do have any issues with the vaccines, please report it to V-Safe. They may contact you if you have severe symptoms.

IMHO

doctor putting bandaid on patients arm after covid shot The Pfizer and Moderna vaccines are safe and effective. I'm not a fan of the J&J vaccine, though it's still much better than nothing. If you have a choice between Pfizer and Moderna, Pfizer causes fewer side effects. Both are highly effective (>90% protective for at least 6 months). For >90% of the people I've given the second shot to, the first shot was not bad at all or just caused some mild arm discomfort for a few days. Generally, younger, smaller people tend to have slightly more discomfort. The second shot is worse than the first. Symptoms include injection site pain, fatigue, general achiness, mild fever, and headaches. If you have symptoms, they occur 12-60 hours after the second shot. If you already had COVID-19, then you can expect these symptoms with the first shot. Of the seven mass clinics I've worked at, no one had a bad reaction, not even fainting, and fainting is pretty much the worst of what the others have seen.

TL;DR

Vaccine development was fast because we cared about it, cut the red tape, and threw money at it. The Pfizer and Moderna vaccines are safe and effective.

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