zejef

Property	Value
?:abstract	BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently. METHODS: In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 µg per dose). BNT162b2 is a lipid nanoparticle-formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety. RESULTS: A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. CONCLUSIONS: A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.).
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?:creator	<https://research.tib.eu/covid-19/entity/Polack%2C_Fernando_P%3B_Thomas%2C_Stephen_J%3B_Kitchin%2C_Nicholas%3B_Absalon%2C_Judith%3B_Gurtman%2C_Alejandra%3B_Lockhart%2C_Stephen%3B_Perez%2C_John_L%3B_P%C3%A9rez_Marc%2C_Gonzalo%3B_Moreira%2C_Edson_D%3B_Zerbini%2C_Cristiano%3B_Bailey%2C_Ruth%3B_Swanson%2C_Kena_A%3B_Roychoudhury%2C_Satrajit%3B_Koury%2C_Kenneth%3B_Li%2C_Ping%3B_Kalina%2C_Warren_V%3B_Cooper%2C_David%3B_Frenck%2C_Robert_W%3B_Hammitt%2C_Laura_L%3B_T%C3%BCreci%2C_%C3%96zlem%3B_Nell%2C_Haylene%3B_Schaefer%2C_Axel%3B_%C3%9Cnal%2C_Serhat%3B_Tresnan%2C_Dina_B%3B_Mather%2C_Susan%3B_Dormitzer%2C_Philip_R%3B_Sahin%2C_Ugur%3B_Jansen%2C_Kathrin_U%3B_Gruber%2C_William_C>
?:journal	N._Engl._j._med
?:license	unk
?:publication_isRelatedTo_Disease	<https://research.tib.eu/covid-19/entity/COVID-19>
is ?:relation_isRelatedTo_publication of	<https://research.tib.eu/covid-19/entity/300zejef_HAS_C0015672_COEXISTS_WITH_C0679225> <https://research.tib.eu/covid-19/entity/300zejef_HAS_C0018681_COEXISTS_WITH_C0679225> <https://research.tib.eu/covid-19/entity/300zejef_HAS_C0030193_ASSOCIATED_WITH_C0679225>
?:source	WHO
?:title	Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
?:type	<https://research.tib.eu/covid-19/vocab/Publication>
?:who_covidence_id	#968768
?:year	2020

Property

Value

?:abstract

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently. METHODS: In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 µg per dose). BNT162b2 is a lipid nanoparticle-formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety. RESULTS: A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. CONCLUSIONS: A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.).

is ?:annotates of