Thread by @JuanGrvas

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#vaccine #covid19 @Pfizer and BioNTech
REG 174 INFORMATION FOR UK HEALTHCARE PROFESSIONALS
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SUMMARY:
The safety and efficacy of COVID-19 mRNA Vaccine BNT162b2in children under 16 years of age have not yet been established.

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Individuals receiving anticoagulant therapy or those with a bleeding disorder that would contraindicate intramuscular injection, should not be given the vaccine unless the potential benefit clearly outweighs the risk of administration.

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Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine. No data are available about concomitant use of immunosuppressants.

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There is no or limited amount of data from the use of COVID-19 mRNA Vaccine BNT162b2 in persons that have previously received a full or partial vaccine series with another COVID-19 vaccine.

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There is no data available on the interchangeability of COVID-19 mRNA Vaccine BNT162b2 with other COVID-19 vaccines to complete the vaccination series.
Animal reproductive toxicity studies have not been completed. COVID-19 mRNA

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Vaccine BNT162b2 is not recommended during pregnancy.
For women of childbearing age, pregnancy should be excluded before vaccination.
In addition, women of childbearing age should be advised to avoid pregnancy for at least 2 months after their second dose.

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COVID-19 mRNA Vaccine BNT162b2 should not be used during breast-feeding.
It is unknown whether COVID-19 mRNA Vaccine BNT162b2 has an impact on fertility.

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There were no meaningful clinical differences in overall vaccine efficacy in participants who were at risk of severe COVID-19 disease including those with one or more comorbidities that increase the risk of severe COVID-19 disease (eg asthma, BMI ≥ 30 kg / m2, COPD, diabetes)

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Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 disease.

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Case definition (at least 1 of): fever, new or increased cough, new or increased shortness of breath; chills, new or increased muscle pain, new loss of taste or smell, sore throat, diarrhea or vomiting.

AAR 0.84
NNT 119
The vaccine prevents 1 mild case in 119 vaccinated. Therefore, 118 vaccinated suffer the possible adverse effects without any benefit.

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There is no data on the effect on the transmission of the disease.
Apparently 7,379 patients were "lost" (efficacy data are given for 36,621 out of 44,000)
Safety data are given for only 19,067 patients (not 36,621)

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Healthy individuals over 12 years old were included, but the results are only given in those over 16 years old.
There is no efficacy data in the prevention of serious disease (hospitalizations, ICU admission) or mortality
#vaccine #covid19 @pfizer
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