A third COVID-19 vaccine could join the fight against the new virus in the coming days. But what is your security profile like?
While a panel of independent experts is deliberating the endorsement for the vaccine on Friday, the Food and Drug Administration team released documents earlier this week, finding that the vaccine had a “favorable safety profile with no specific concerns identified that would prevent issue of a USA. “
The information documents found no COVID-19-related deaths in the vaccinated trial group on February 5, suggesting that the vaccine reduces COVID-19-related mortality. There were seven coronavirus-related deaths in the placebo group.
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The most common reactions associated with the vaccine included pain at the injection site, headache, fatigue and myalgia, which were mostly “mild and moderate”, resolving two days after vaccination. Participants aged 18-59 had reactions that occurred soon after vaccination more frequently than those over the age of 60.
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“There were no specific safety issues identified in the subgroup analyzes by age, race, ethnicity, medical comorbidities or previous SARS-CoV-2 infection,” according to the documents. The committee observed five cases of hives, or red swelling, among the vaccinated participants, compared with one in the placebo group. The committee said that this non-serious event was “possibly related to the vaccine”. In addition, insufficient data on blood clots and tinnitus cannot establish a “causal relationship between these events and the vaccine.”