JOURNAL ARTICLE

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

Fernando P Polack, Stephen J Thomas, Nicholas Kitchin, Judith Absalon, Alejandra Gurtman, Stephen Lockhart, John L Perez, Gonzalo Pérez Marc, Edson D Moreira, Cristiano Zerbini, Ruth Bailey, Kena A Swanson, Satrajit Roychoudhury, Kenneth Koury, Ping Li, Warren V Kalina, David Cooper, Robert W Frenck, Laura L Hammitt, Özlem Türeci, Haylene Nell, Axel Schaefer, Serhat Ünal, Dina B Tresnan, Susan Mather, Philip R Dormitzer, Uğur Şahin, Kathrin U Jansen, William C Gruber
New England Journal of Medicine 2020 December 10
33301246

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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Becky Bellak

It is my understanding that Covid19 Vaccine has not been studied in patients that are immunocompromised and on Biologics do to autoimmune diseases. am I correct? when can we expect a clearance for this group to be deemed safe to receive such vaccine?

1

Kai-Gunnar Lillefosse

Regarding Beckys question are there safety features related to immunosuppresive patients how has underwent organ transplantation (s)

0

fahrul wakil

Do the health workers who treat covid’s patients in hospital need vaccine ?even they have an anibody yet ?
Do we have had extracted covid virus from the patient covid so we know genetic material as raw material to develop vacine?

-1

John Welden

Claiming 95% efficacy after ONE WEEK! Are you kidding me?

-2

Kathan Parikh

What is the reason behind specific gap of 21 days between two dosages ?

-3

Muhammad Shaikh

Ok. The placebo group had 162 "victims".. out of 21,728 people.... That is 0.7 percent... I mean this placebo is so good that it literally makes the vaccine obsolete.
And if you consider the adverse effects of the mRNA vaccine, if commonsense would prevail then any person would refuse to get this shot.

-5

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