Side effects of bivalent Covid vaccines: Swissmedic presents first findings

Since the start of the Covid vaccinations, the drug authority Swissmedic has been collecting reports of undesirable side effects, evaluating them and taking stock after a few months. Between January 1, 2021 and today, a total of 16,212 suspected adverse event cases have been reported by doctors, pharmacies and individuals. During this time, 16.7 million doses were vaccinated. In other words, side effects were reported in less than one percent of vaccine doses.

Of the 16,000 reports since the start of vaccination, about 10,000 were reported as “not serious” and about 6,000 as “serious”. If those affected described the side effects as “severe”, the most common complaints were fever, headache, fatigue, chills, nausea and dizziness.

However, these side effects of vaccination predominate even in the reported non-severe cases. The vaccinated persons make their own assessment of the severity.

There were also reports for the first time about the two bivalent vaccines from Moderna and Pfizer/Biontech. “Only a few reports have been received so far,” says Lukas Jaggi, spokesperson for Swissmedic. Strictly speaking, there have been 55 reports so far of a total of about 600,000 booster vaccinations with bivalent vaccines. According to Swissmedic, 18 were classified as serious, so about a third.

“Currently, there is no concrete evidence of special side effects from the bivalent mRNA vaccines,” says Jaggi. The most commonly reported adverse reactions were headache, fever, arthralgia and nausea.

There were no fundamental changes in the safety profile of the vaccines. The protein vaccine Nuvaxovid from Novavax, which was very rarely vaccinated, does not play a role in this. Only 2335 doses vaccinated compared to 16.7 million mRNA vaccinations.

Compared to the latest balance of side effects reports, it should be noted “that relatively few reports have been received in the past two months,” says Jaggi. In addition to the 15,781 reports since August, only 431 have been added. More and more reports are being made by those affected or their relatives using the new web tool at Swissmedic.

Not much has changed in the reports of inflammation of the heart muscle or pericardium after a vaccination either. Since its inception, 416 suspected cases of myocarditis and/or pericarditis have been reported in Switzerland following vaccination of the 16.7 million doses. Of these, 94 cases were temporally related to Pfizer’s Comirnaty, of which 18 were after the third vaccination. There were 306 with Spikevax, 25 of them after the third vaccination. However, this vaccine from Moderna was vaccinated significantly more, namely 63 percent, than that from Pfizer. Four cases were reported after Janssen’s Covid vaccine.

Several studies show that inflammation of the heart muscle and pericardium was observed more often in people under 30 years after vaccination with the Moderna vaccine than after the Pfizer vaccine. However, that is also very rare.

Since the start of vaccination, 227 deaths in a temporal relationship to vaccination have been reported among serious cases. The average age of the deceased was 78.8 years. “As for the 227 deaths reported to Swissmedic, each report is checked by medical professionals trained in pharmacovigilance for a possible connection to the vaccine,” says Jaggi. “In the in-depth analysis of these cases, there were other more likely causes that could explain the event, despite a temporal association.”

Since the start of vaccinations against Covid-19, Swissmedic has received about 600 reports of various forms of menstrual disorders, the most common of which are increased bleeding. According to Jaggi of Swissmedic, further studies are now available and it is being considered whether heavy menstrual bleeding is included in the product information as a possible side effect.

Reported menstrual bleeding is usually minor and transient. The frequency is unknown. “However, there is no evidence from international data that Covid-19 vaccines negatively impact fertility,” says Jaggi.

Swissmedic writes that the evaluation of all side effects reports shows that the risk-benefit ratio of the vaccines used remains positive overall. According to Swissmedic, the next update on the suspected adverse effects of the Covid-19 vaccinations is likely to be published at the end of February 2023. (aargauerzeitung.ch)