"Individuals can receive the new COVID-19 booster two months after completing any primary series or any previous COVID-19 booster dose. The Pfizer bivalent booster is APPROVED for people who are 12 or older."
Approved? So I looked that up. It hasn't been approved by any agency that I can find in the Pfizer notice. It clearly says it's a permit for an unapproved product. And it also says this product is to prevent Covid-19, which the previous 4 shots haven't done, nor does the CDC say it prevents Covid.
Is this misinformation or mixed messaging or carefully worded warning not to sue?
"The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the UNAPPROVED PRODUCT, Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) for active immunization to prevent COVID-19 in individuals 12 years of age and older."
So I continued browsing and on p. 19 (about which OSU doesn't warn it's 50,000 students and probably that many staff and faculty)
"Postmarketing data with authorized or approved monovalent mRNA COVID-19 vaccines demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following receipt of the second primary series dose or first booster dose, with most booster doses likely administered at least 5 months after completing primary vaccination. For the Pfizer-BioNTech COVID-19 Vaccine, the observed risk is higher among adolescent males and adult males under 40 years of age than among females and older males, and the observed risk is highest in males 12 through 17 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical considerations/myocarditis.html).
Revised: 31 August 2022
Approved? So I looked that up. It hasn't been approved by any agency that I can find in the Pfizer notice. It clearly says it's a permit for an unapproved product. And it also says this product is to prevent Covid-19, which the previous 4 shots haven't done, nor does the CDC say it prevents Covid.
Is this misinformation or mixed messaging or carefully worded warning not to sue?
"The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the UNAPPROVED PRODUCT, Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) for active immunization to prevent COVID-19 in individuals 12 years of age and older."
So I continued browsing and on p. 19 (about which OSU doesn't warn it's 50,000 students and probably that many staff and faculty)
"Postmarketing data with authorized or approved monovalent mRNA COVID-19 vaccines demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following receipt of the second primary series dose or first booster dose, with most booster doses likely administered at least 5 months after completing primary vaccination. For the Pfizer-BioNTech COVID-19 Vaccine, the observed risk is higher among adolescent males and adult males under 40 years of age than among females and older males, and the observed risk is highest in males 12 through 17 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical considerations/myocarditis.html).
Revised: 31 August 2022
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