Description | Moreira Junior, Edson Duarte. Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil. Fundacion INFANT (F.P.P.) and iTrials-Hospital Militar Central (G.P.M.), Buenos Aires; State
University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A.,
A.G., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.) — both in New York; Vaccine Research and Development, Pfizer, Hurley,
United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., P.L.) and Worldwide Safety, Safety Surveillance and Risk
Management (S.M.), Pfizer, Collegeville, PA; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and
Centro Paulista de Investigação Clinica, São Paulo (C.Z.) — both in Brazil; Global Product Development, Pfizer, Peapack, NJ (S.R.);
Cincinnati Children’s Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech,
Mainz (ÖT., U.Ş.), and Medizentrum Essen Borbeck, Essen (A.S.) — both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape
Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance and Risk Management,
Pfizer, Groton, CT (D.B.T.). | pt_BR |
Abstract | 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 fulllength
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. | pt_BR |