SciCheck Digest

An international study of around 99 million people confirmed known serious side effects of COVID-19 vaccination. It also identified a possible relationship between the first dose of the Moderna vaccine and a small risk of a neurological condition. Social media posts about the study left out information on the vaccines’ benefits and the rarity of the side effects.

How safe are the COVID-19 vaccines?

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COVID-19 vaccines — like all vaccines and other medical products — come with side effects, including serious side effects in rare cases. The vaccines were rolled out to protect people from a novel virus that has killed millions of people globally and would likely have killed millions more without the arrival of the vaccines. There is a broad consensus from experts and governmental health agencies that the benefits of COVID-19 vaccination outweigh the risks.

Researchers have scrutinized the COVID-19 vaccines’ safety and continue to do so.

A study published Feb. 12 in the journal Vaccine reported on an international group of more than 99 million people who received COVID-19 vaccines, primarily finding links to known rare side effects.

The study largely focused on the Pfizer/BioNTech and Moderna vaccines, which have been widely given in the U.S., as well as the AstraZeneca vaccine, which was never authorized in the U.S.

“What we take away, is that the Covid-19 vaccination campaigns have been very effective in preventing severe disease,” study co-author Anders Hviid, head of the department of epidemiology research at the Statens Serum Institut in Denmark, told us in an email. “The few serious side effects that we have observed in this and other studies have been rare.”

Many popular posts on social media have shared results from the study, some lacking the context that the identified health problems are rare, that most aren’t new and that the vaccines have proven benefits.

Various posts made unfounded claims, stating or implying that people should not have received the vaccines, that the risks outweigh the benefits or that the risk of the rare side effects is greater than was reported in the study.

“Hundreds of millions of people were used as lab rats and now the truth that WE ALL ALREADY KNEW can no longer be denied,” said one popular  referring to the vaccines as “experimental” and “UNTESTED.”

“This thing was forced on people who faced almost no risk from Covid,” said another. “It is completely unacceptable.” The post shared statistics from the  (research) paper without making it clear that serious health problems after vaccination were rare and that risk varied by vaccine type and dose.

The Vaccine study confirmed that the Moderna and Pfizer/BioNTech vaccines are linked in rare cases to myocarditis and pericarditis, conditions involving inflammation of the heart muscle and lining.

The rate of myocarditis was most elevated after the second dose of the Moderna vaccine. Myocarditis risk — which is greatest in men in their late teens and early twenties — was identified via vaccine safety monitoring and first reported in 2021.

Based on the current evidence, the CDC says, the benefit of vaccination outweighs the risk of these conditions, which improve for most people after medical treatment and rest.

The study confirmed neurological and blood clotting conditions associated with the AstraZeneca vaccine. In the U.S., these problems were linked to the Johnson & Johnson vaccine, contributing to this vaccine no longer being recommended or available.

The study also identified a new possible safety signal indicating a potential link between the first dose of the Moderna and AstraZeneca vaccines and rare neurological conditions. This included an association between the first doses of the vaccines and acute disseminated encephalomyelitis, or ADEM, an autoimmune condition that causes inflammation of the brain and spinal cord.

Anders Hviid emphasized that the researchers only saw these neurological events after first doses of the two vaccines. “We did not see these signals following further doses of these two Covid-19 vaccines, nor did we see them after any dose of the Pfizer/BioNTech vaccine which has been more widely used,” he said.

“We are also talking about very rare events,” Hviid continued. “As an example, the association between the first dose of Moderna and acute inflammation of the brain and spine would, if causal, correspond to 1 case per 1.75 million vaccinated. It is only due to the sheer scale of our study, that we have been able to identify this minute potential risk.”

Study Bolsters the Evidence Serious COVID-19 Vaccine Side Effects Are Rare

The Vaccine study drew on national or regional health records from eight countries with institutions participating in the Global Vaccine Data Network, an international group that studies vaccine safety. The researchers analyzed health outcomes after around 184 million doses of the Pfizer/BioNTech vaccine, 36 million doses of the Moderna vaccine and 23 million doses of the AstraZeneca vaccine.

The researchers focused on 13 health problems that either had a known association with vaccination or for which there was some rationale to investigate whether there was an association. To determine whether the health problems were associated with vaccination, they compared the expected rates of the health problems — or the number of health events that should occur based on background rates in the regions studied — with the number of events they observed in the 42 days after vaccination.

“This study confirms the primary already detected and validated side effects established by previous literature,” Jeffrey S. Morris, director of the division of biostatistics at the University of Pennsylvania’s Perelman School of Medicine, told us via email, referring to the rare heart conditions associated with the Moderna and Pfizer/BioNTech vaccines, as well as the rare conditions associated with the AstraZeneca and Johnson & Johnson vaccines. 

Morris said that findings on ADEM — the rare autoimmune neurological condition linked to first doses of the Moderna and AstraZeneca vaccines — “might be a new safety signal.”

ADEM involves inflammation to the brain and spinal cord, arising most often in children following an infectious illness. It has a sudden onset and typically eventually improves, with a full recovery in many, although not all, cases.

After the first dose of the Moderna vaccine, researchers observed seven ADEM cases, when they expected two. As we’ve said, Hviid calculated the rate of this side effect — if ultimately shown to be related to vaccination — to be 1 in 1.75 million following the first dose of the Moderna vaccine. 

The data show “this was indeed an EXTREMELY rare adverse event,” Morris said, referring to ADEM. “It is understandable at this incidence rate why it may not have been detected before now, and why a study with 99 million participants like this is important to find even the most rare serious adverse events that are potential minority harm risks of these vaccines.”

The authors of the study wrote that more research is needed into ADEM following COVID-19 vaccination, saying that “the number of cases of this rare event were small and the confidence interval wide, so results should be interpreted with caution and confirmed in future studies.”

The authors also wrote that neurological events have been found to occur at a much higher rate after COVID-19 than after COVID-19 vaccination.

The study means that “early warning systems are solid,” said Marc Veldhoen, an immunologist at the Instituto de Medicina Molecular João Lobo Antunes in Portugal, in a post on X, formerly known as Twitter. “To avoid any adverse reaction is not possible, but, identifying those at higher risk may be possible.”

Identifying those at greater risk of side effects can help guide decisions on which vaccines to recommend and what problems doctors should watch for in their patients.