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A third COVID-19 vaccine could enter the fight against the new virus in the coming days. But what does its security profile look like?
As a group of independent experts deliberate on the vaccine’s approval on Friday, Food and Drug Administration staff released documents earlier this week, finding the vaccine had a “favorable safety profile without any specific concerns. identified that would prevent the issuance of an EUA. “
Briefing documents did not note any COVID-19-related deaths in the vaccinated test group as of February 5, suggesting the vaccine is reducing COVID-19-related mortality. There were seven coronavirus-related deaths in the placebo group.
HOW DO WE KNOW COVID-19 VACCINES ARE SAFE?
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 within two days of vaccination. Participants aged 18 to 59 had reactions occurring soon after vaccination more often than those over 60 years old.
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“There were no specific safety concerns identified in analyzes of subgroups by age, race, ethnicity, medical co-morbidities or previous infection with SARS-CoV-2,” according to the documents. The committee noted five cases of hives, or red swelling, among the vaccinated participants, compared to one in the placebo group. The committee said the non-serious event was “possibly vaccine-related”. In addition, insufficient data on blood clots and tinnitus could not establish a “causal relationship between these events and the vaccine”.
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