A document from the FDA Committee on Moderna’s COVID-19 vaccine states that “there are no specific safety concerns.”

A review by the Food and Drug Administration Committee of the Moderna Coronavirus Vaccine Emergency Use Authorization Application found that a subgroup analysis of age, race, ethnicity, comorbidities, or previous SARS-CoV-2 infection was “specific safety. It turns out that there is no concern about it, which may pave the way for a second entry into the scene with the COVID-19 Jab.

In a document posted prior to the Vaccine and Related Biologics Advisory Board meeting on Thursday, the panel also confirmed COVID-19 (including severe cases) in which the vaccine occurs at least 14 days after the second dose. I found that I reduced the risk of.

The Commission does not have sufficient data to assess vaccine-related protection periods, efficacy in certain high-risk populations such as immunocompromised individuals, and efficacy in individuals previously infected with SARS-CoV. Noted-effectiveness in 2 or pediatric populations. The Commission also said that future vaccines associated with viral alterations, efficacy against asymptomatic infections, efficacy against long-term effects of COVID-19, efficacy against mortality, or efficacy against transmission of SARS. There was not enough data to evaluate-CoV-2.

Allergic reactions to vaccines are rare and short-lived

Unlike Pfizer and BioNTech vaccines, Moderna Jab induced non-serious side effects such as injection site pain, malaise, headache, muscle aches, arthralgias and chills. The reaction was generally characterized as mild to moderate.

The FDA has considered three serious vaccine-related side effects, including nausea, vomiting, and swelling of the face. The Bell’s palsy case also occurred in vaccinated individuals who “at this time cannot conclude a causal link to vaccination.”

More than 300,000 deaths from coronavirus in the United States

Thirteen deaths were reported in the study cohort, six of which occurred in vaccinated participants and seven who received placebo. Two deaths in the vaccine group were found to be participants over the age of 75 with existing heart disease, and the other two were found to have died at home for unknown causes. Another death in the vaccine group occurred in participants with Crohn’s disease and short bowel syndrome who were hospitalized for thrombocytopenia due to obstructive nephrolithiasis and acute renal failure, with the sixth committing suicide 1 day and 21 days after dosing.

“Safety data from approximately 30,350 participants aged 18 years and older from the November 11, 2020 interim analysis were randomized 1: 1 to vaccine or placebo and followed up after the second dose. The median was 7 weeks. Certain safety concerns that prevent the issuance of the EUA, “the document said. “These safety data are the primary basis for FDA safety reviews.”

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If the Panel approves the Moderna vaccine on Thursday, the vote will take place in front of FDA personnel who will decide whether to grant an Emergency Use Authorization (EUA) based on the Commission’s findings. Such approval came about a week after regulators gave Pfizer’s COVID-19 vaccine to the EUA, and the state began rolling out to healthcare professionals.

A document from the FDA Committee on Moderna’s COVID-19 vaccine states that “there are no specific safety concerns.”

Source link A document from the FDA Committee on Moderna’s COVID-19 vaccine states that “there are no specific safety concerns.”

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