A recent report by the United States’ National Academy of Sciences has concluded that COVID-19 vaccines provide safe and effective protection against the SARS-CoV-2 virus. In short, getting COVID-19 is far more harmful than getting a vaccine. Serious COVID-19 vaccine adverse events were rare and were less bad than the effects of COVID-19 overall. The SARS-CoV-2 virus is the coronavirus responsible for the COVID-19 disease.
A Comprehensive Report
TheApril 2024 report titled, ‘Evidence review of the adverse effects of COVID-19 vaccination and intramuscular vaccine administration,’ is the first comprehensive review of COVID-19 vaccine-related adverse events in the United States.
A committee formed by senior scientists from research centres across the US reviewed the available data about side effects and adverse events following vaccination for the top four vaccines used in the USA between 2021 and 2023. These vaccines were the Janssen adenovirus based shot, the novavax jab and the Pfizer and Moderna mRNA vaccines.
The committee members dug into hundreds of research papers from across the world to find out what the most common adverse events were. They also assessed how common these adverse events were and whether there was evidence that the adverse even was caused by the vaccine.
Common Events Were Mostly Harmless
The report’s overall finding was that the most common adverse events after getting any COVID-19 vaccine were temporary flu-like symptoms (a sign your immune system is at work) and/or soreness around the injection site (because you have a small injury in the muscle due to being jabbed).
Both of these are very common after effects associated with many vaccines.
Rigorous Investigation
Adverse medical events recorded within a week to a month of vaccination with a COVID-19 shot. The committee members surveyed the published data across all the research publications and reports. They totted up the totals for each claim and investigated whether there was evidence for a relationship between COVID-19 vaccine and the event.
They did this by calculating the existing risk that a person would develop a condition and then looked to see how many people reported the onset of that condition within a month of being vaccinated. The researchers used statistical tests to work out whether more people developed the illness after being vaccinated than otherwise would have done.
The NAS report presents the evidence that they found for the incidence of each event, providing the numbers of people they found who developed each condition and how many people were vaccinated.
They then show the comparison between how many people would be expected to get that illness and whether or not there was evidence that a COVID-19 shot had made it more likely.
Adverse Events
The team examined eight types of possible adverse events and explained whether or not a COVID shot might have increased the odds of having each one:
- Shoulder injuries – this was explained as the painful upper arm area after an injection. A very common reaction after getting a COVID shot and one that resolved itself very quickly. All the vaccines were likely to cause a shoulder injury because they were all delivered by injection.
- Neurologic conditions – this included Bells’ palsy, Guillain-Barré Syndrome, chronic head aches, POTS transverse myelitis and chronic inflammatory demyelinating polyneuropathy. The committee failed to find evidence of a causal relationship for any of these other than Guiallain-Barré Syndrome. There was some evidence that the adenovirus based COVID -19 vaccines could increase a person’s risk of developing this condition. According to the CDC, there have previously been reports that 1–2 people in a million go on to develop this syndrome after receiving a flu shot.
- Hearing loss and tinnitus – the committee’s review of the evidence found that there were so few cases of hearing loss or tinnitus reported soon after vaccination that there was insufficient evidence to try to test a relationship.
- Blood clotting disorders, including thrombosis, immune thrombocytopenia syndrome and capillary leak syndrome. The researchers were able to gather enough data to conclude that while the mRNA vaccines did not trigger thrombosis the Janssen adenovirus based vaccine did seem to have a causative effect. There were too few cases of the other conditions to draw any conclusions.
- Vascular conditions including heart attacks, stroke, haemorrhagic stroke, embolism, deep vein thrombosis. The team found that deep vein thrombosis and pulmonary embolisms were so rare they couldn’t tell whether or not they were caused by the vaccine. Enough people had heart attacks that they were able to see that neither of the mRNA vaccines made a person more likely to have one. Too few people who got the adenovirus or Novavax shot suffered a heart attack or stroke for them to tell either way.
- Myocarditis and pericarditis were linked to vaccination with mRNA vaccines but not the Janssen or Novavax shots.
- Female infertility. The committee found no evidence that any of the vaccines caused infertility in women.
- Sudden death. The evidence showed that the mRNA vaccines did not increase a person’s likelihood of dying within a month or two of getting the shot. So few people died suddenly after receiving an adenovirus or novavax shot that it was impossible to make any conclusions either way.
Is It Safe? Yes.
Overall, there were very few people who reported serious adverse events after vaccination that it was difficult for the committee to make conclusions. However, they did report the apparent causal relationship between the mRNA vaccines and myocarditis and pericarditis and the Janssen adenovirus vaccine with Guillain-Barré Syndrome and thrombosis.
Reassuringly although there were enough of these cases for the report’s authors to perform statistical tests to assess the relationships, they were still very rare. The most common adverse event by far being a sore shoulder or temporary flu-like symptoms.
None of the vaccines posed a greater risk to an individual than contracting COVID-19 would have done.
REFERENCES
National Academies of Sciences, Engineering, and Medicine. 2024. Evidence review of the adverse effects of COVID-19 vaccination and intramuscular vaccine administration. Washington, DC: The National Academies Press. https://doi.org/10.17226/27746.
GBS (Guillain-Barré Syndrome) and Vaccines | Vaccine Safety | CDC. Published February 6, 2023. Accessed August 1, 2024. https://www.cdc.gov/vaccinesafety/concerns/guillain-barre-syndrome.html
Popular press stories have suggested that vaccine-induced myocarditis or pericarditis cases DO happen, but these are likely far less severe than the same diseases after naïve COVID cases
Did any of the articles or this review discuss the relative severity?
That’s a lot of papers to trawl through, if you’d like to look at the report Myocarditis is on page 199, there should be a live link in the article to take you to a PDF. They focus mostly on the causality, so does getting a vaccine raise the probability that you will get myocarditis? It was someing like 1-2 cases per million, so already very small increase in risk. The tricky element of your question is how do you rate severe? So I looked into the death rates for you. Accordinfg to this paper, https://link.springer.com/article/10.1007/s00392-022-02141-9 from 2022, if you are hospitalised with myocarditis, normally you have a roughly 2% chance of dying. COVID-19 infection raises your risk of dying to 13%. In contrast according to this study and some others https://onlinelibrary.wiley.com/doi/10.1002/jmv.29693 mortality from vaccine induced myocarditis was 0.44%. If you think about it, most people who developed myocarditis bad enough to see a doc after a vaccine were teen boys, so I think that already makes mortality less likely! It couyld be that a lot more people had it but didn’t notice anything bad enough to visit a doc so were never diagnosed. So my guess is that the severity of the condition is far lower from vaccines than from getting COVID19. 0.44% mortality from myocraditis triggered by a vaccine, vs 2.3% mortality normally, vs 13.6% mortality of myocarditis plus COVID19 inbfection.
Hi Walt,
Thank you for your question. The largest trial I found was done in India which reported approximately 2 cases of myocarditis per 10 million vaccine doses.
As noted above, this was much lower than cases from the virus itself.
Regards
Cliff
Jaiswal V, Mukherjee D, Peng Ang S, et al. COVID-19 vaccine-associated myocarditis: Analysis of the suspected cases reported to the EudraVigilance and a systematic review of the published literature. Int J Cardiol Heart Vasc. 2023;49:101280. Published 2023 Dec 3. doi:10.1016/j.ijcha.2023.101280