Wednesday, December 07, 2022

Third dose of COVID-19 vaccines not associated with increase in reports of serious adverse events: Study

Third dose of COVID-19 vaccines not associated with increase in reports of serious adverse events: Study

A new study looking at data from nearly 48,000 people in the US finds that the third dose of an mRNA vaccine, such as Pfizer or Moderna, is safe and did not increase the reporting of serious adverse events.

The study, published Thursday in the JAMA Network Open journal, found that the third dose did not result in an increase in serious adverse events compared to the first dose, but did increase in less-serious adverse events, such as fatigue and nausea.

“The results of this cohort study suggest that a third dose of the same type of vaccination after the BNT162b2 or mRNA-1273 primary series is associated with safe outcomes,” the study said.

The COVID-19 vaccines, manufactured by Pfizer-BioNtech and Moderna, were originally designed as a two-dose regimen backed by extensive clinical trials. As studies showed evidence of reduced immunity to the vaccine, health experts began to suggest booster shots, which were found to be safe and effective. But there is still less data on these third doses than on the first and second doses, a gap in knowledge that the researchers were hoping to close in this new study.

Researchers accessed electronic medical records provided by 47,999 adults within the Mayo Clinic Enterprise, a non-profit hospital system in the US, all of whom received three doses of the same mRNA COVID-19 vaccine between December 2020 and October 17. The dose was vaccinated with. 2021.

About 38,000 participants received the Pfizer-BioNTech vaccine for their three doses, while about 9,900 received Moderna Vaccine.

There were more than twice as many immunosuppressed individuals in the group receiving Moderna compared to the group receiving Pfizer. No adverse events specific to a certain brand were reported in the study.

The most common adverse events after receiving the third dose were fatigue, temporary swelling of lymph nodes, nausea and headache, with these symptoms reported by approximately two to five percent of participants.

Less than two percent of participants reported other common side effects such as joint pain, muscle aches, diarrhea and fever.

These numbers, while still small, represented a significant increase in how often these same participants reported these side effects after their first or second dose.

After the third dose, two patients had anaphylaxis, four patients had inflammation of the tissue around the heart called pericarditis and one patient reported myocarditis, meaning that only 0.01 percent of participants had one of these serious adverse events. gave information.

“Reporting of serious adverse events after the third dose was rare and did not increase significantly compared to the frequency of reporting after the second dose,” the study said.

Researchers monitored emergency department visits for participants within two days of receiving each dose of the vaccine, and found that there was an increase in emergency department visits after the third dose of Pfizer vaccine compared to the second. Overall, 0.29 percent of people visited the emergency department after the third dose, compared to 0.2 percent of those who visited the emergency department after the second dose.

There was no difference in ER visits for the different doses for those receiving Moderna.

The researchers said the overall results suggest that the third dose is indeed safe, as they do not come with an increase in serious adverse events. They said the third dose had a better safety profile than the one dose received in this study.

“Persons who actually received [one] mRNA-based COVID-19 vaccine doses have a greater increase in the incidence of adverse events after dosing [one]compared with baseline, which was observed [three]-dose cohort,” said the study.

The researchers noted that the study has limitations, such as the fact that people receiving the mixed brand were not included and that those receiving the third dose are more likely to be older and immunosuppressed, thus potentially providing vaccines. There is a lower immune response to drugs that may show fewer adverse effects.

Further studies in the third dose will provide more information on the safety profile of the mixture of vaccine brands, the study said, to determine how often adverse events occur.

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