//Special note//---
Today, I have had a plan to share the contents
of the other article. However, the important articles which needs to urgently
communalize are published from Nature medicine and The New England Journal of
Medicine(1-4). Therefore, I change the original plan. I introduce a part of
contents about SARS-CoV-2 important reports(1-4) exclusively today.
//Background//---
Children and adolescent generally have milder
symptom for SARS-CoV-2, but they need to take mask and keep physical distance
in the school life in the un-vaccination condition. Therefore, at least
psychological condition is a concerned matter especially in the children. In
order to take back the normal (School) life in the children, they need to be
vaccinated even in low-risk for SARS-CoV-2 symptom progression. However, they
are in transient phase of immune function(5), so we need to carefully proceed
safety vaccination protocol.
Robert
W. Frenck, Jr., M.D., Nicola P. Klein, M.D., Ph.D., Nicholas Kitchin, M.D. et
al evaluate the efficacy of mRNA vaccine(BNT162b2) (already approved for the
adult) for 12 to 15 years children(1). I want to share a part of contents in
this important report.
//Condition(1)//---
Vaccine: BNT162b2 (Pfizer/BioNTech)
Place: The United States of America
Cutoff date: March 13, 2021.
Age: 12 to 15 years old
Participant number: 2260
//Result(1)//---
(The Adverse event) 12-15 Yr / 16-25 Yr
*Dose 1
Fever(10%/7%) / Fatigue(60%/60%),
Headache(55%/54%), Chills(28%/25%), Muscle pain (24%/27%) / Antipyretic
use(37%/32%)
*Dose 2
Fever(20%/17%) / Fatigue(66%/66%),
Headache(65%/61%), Chills(42%/40%), Muscle pain (32%/41%) / Antipyretic use(51%/46%)
*On fever, 12-15 years old is slightly
higher than 16-25 years old.
*These adverse events are resolved within 1
or 2 days.
*Lymphadonopathy was reported in 9 of 1131
BNT162b2 recipient which is higher than 16-25 years old (1 of 536).
*No thromboses or hepersensitivity adverse
events or vaccine-related anaphylaxis was seen.
*No deaths were reported.
---
(Vaccine efficacy for 12 to 15 years old
children)
*At least 7 days after dose 2
Vaccination group: 0 infection/1005
children - 16 /978 placebo
Efficacy 100%
---
(Neutralization titer)
12-15 years children 1239.5 for 705.1
(16-25 years old)
Therefore, immune function for SARS-CoV-2
is high.
//Discussion//---
*We need to commonly recognize the adverse
effect especially on fever (>38degC). Approximately 1 of 5 (20%) children are
affected with fever (>38degC). Therefore, this clinical fact needs to be
accepted by the parent and the teachers in advance. At the same time, when the
child is affected with fever, we say that “this is
normal response, and resolved within 1 or 2 days” and
we need to have them relieve. This painful experience leads to vaccine
hesitance of children for SARS-CoV-2 vaccine. Therefore, the parent and the
teacher need to explain about the risk and the benefit, and we need to provide
(social) benefit for them after vaccination.
//Support(1)//---
Supported by BioNTech and Pfizer.
//Acknowledgment(1)//
We thank Sheena Hunt, who wrote the first
draft of the manuscript under direction from the authors, and Tricia Newell and
Philippa Jack (all from ICON) for medical writing and editorial assistance with
an earlier version of the manuscript, which was funded by Pfizer; all the
participants who volunteered for this trial; the members of the data and safety
monitoring committee — Jonathan Zenilman, Kathryn Edwards, Lawrence Stanberry,
Robert Belshe, and Steven G. Self — who have been reviewing the trial safety
data on a weekly basis; Greg Adams, Negar Aliabadi, Mohanish Anand, Fred
Angulo, Ayman Ayoub, Melissa Bishop-Murphy, Mark Boaz, Christopher Bowen, Salim
Bouguermouh, Donna Boyce, Sarah Burden, Andrea Cawein, Patrick Caubel, Darren
Cowen, Kimberly Ann Cristall, Michael Cruz, Daniel Curcio, Carmel Devlin,
Niesha Foster, Luis Jodar, Stephen Kay, Esther Ladipo, Marie-Pierre Hellio Le
Graverand-Gastineau, Juleen Gayed, Jacqueline Lowenberg, Rod MacKenzie, Robert
Maroko, Jason McKinley, Tracey Mellelieu, Brendan O’Neill, Jason Painter, Sohil
Patel, Elizabeth Paulukonis, Allison Pfeffer, Katie Puig, Kimberly Rarrick,
Balaji Prabu Raja, Kellie Lynn Richardson, Elizabeth Rogers, Melinda Rottas,
Charulata Sabharwal, Vilas Satishchandran, Harpreet Seehra, Judy Sewards, Helen
Smith, Uzma Sarwar, David Swerdlow, Elisa Harkins Tull, Sarah Tweedy, Erica
Weaver, John Wegner, Jenah West, David C. Whritenour, Fae Wooding, Emily
Worobetz, Nita Zalavadia, Liping Zhang, and Lefteris Zolotas, all from Pfizer,
for their contributions to this work; the Pfizer Vaccines Clinical Assay Team,
the Pfizer Vaccines Assay Development Team, and all of the Pfizer colleagues
not named here who contributed to the success of this trial; Corinna Rosenbaum,
Christian Miculka, Andreas Kuhn, Ferdia Bates, Paul Strecker, Ruben Rizzi,
Martin Bexon, Eleni Lagkadinou, and Alexandra Kemmer-Brück (all from BioNTech);
and Dietmar Katinger and Andreas Wagner (both from Polymun).
(Reference)
(1)
Robert W. Frenck, Jr., M.D., Nicola P.
Klein, M.D., Ph.D., Nicholas Kitchin, M.D., Alejandra Gurtman, M.D., Judith
Absalon, M.D., Stephen Lockhart, D.M., John L. Perez, M.D., Emmanuel B. Walter,
M.D., Shelly Senders, M.D., Ruth Bailey, B.Sc., Kena A. Swanson, Ph.D., Hua Ma,
Ph.D., Xia Xu, Ph.D., Kenneth Koury, Ph.D., Warren V. Kalina, Ph.D., David
Cooper, Ph.D., Timothy Jennings, D.O., Donald M. Brandon, M.D., Stephen J.
Thomas, M.D., Özlem Türeci, M.D., Dina B. Tresnan, D.V.M., Ph.D., Susan Mather,
M.D., Philip R. Dormitzer, M.D., Ph.D., Uğur Şahin, M.D., Kathrin U. Jansen,
Ph.D., and William C. Gruber, M.D. for the C4591001 Clinical Trial Group*
Safety, Immunogenicity, and Efficacy of the
BNT162b2 Covid-19 Vaccine in Adolescents
The New England Journal of Medicine 2021;
385:239-250
---
Author Affiliations
From Cincinnati Children’s Hospital,
Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.),
and the California Research Foundation, San Diego (D.M.B.) — both in
California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom
(N.K., S.L., R.B.); Vaccine Research and Development, Pfizer, Pearl River
(A.G., J.A., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.), and SUNY
Upstate Medical University, Syracuse (S.J.T.) — both in New York; Vaccine
Research and Development (J.L.P., H.M., X.X.) and Worldwide Safety, Safety
Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Duke Human
Vaccine Institute, Durham, NC (E.B.W.); Senders Pediatrics, South Euclid, OH
(S.S.); Clinical Research Professionals, Chesterfield, MO (T.J.); BioNTech,
Mainz, Germany (Ö.T., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk
Management, Pfizer, Groton, CT (D.B.T.).
(2)
Johan Normark, M.D., Ph.D., Linnea Vikström,
B.Sc., Yong-Dae Gwon, Ph.D., Ida-Lisa Persson, B.Sc. Alicia Edin, M.D., Ph.D.,
Tove Björsell, M.Sc., Andy Dernstedt, M.Sc., Wanda Christ, M.Sc., Staffan
Tevell, M.D., Ph.D., Magnus Evander, Ph.D., Jonas Klingström, Ph.D., Clas Ahlm,
M.D., Ph.D., Mattias Forsell, Ph.D.
Heterologous ChAdOx1 nCoV-19 and mRNA-1273
Vaccination
The New England Journal of Medicine July
14, 2021
---
Affiliation
Umeå University, Umeå, Sweden
Karolinska Institutet, Stockholm, Sweden
Region Värmland, Karlstad, Sweden
Umeå University, Umeå, Sweden
Karolinska Institutet, Stockholm, Sweden
Umeå University, Umeå, Sweden
(3)
Michael Dougan, M.D., Ph.D., Ajay Nirula,
M.D., Ph.D., Masoud Azizad, M.D., Bharat Mocherla, M.D., Robert L. Gottlieb,
M.D., Ph.D., Peter Chen, M.D., Corey Hebert, M.D., Russell Perry, M.D., Joseph
Boscia, M.D., Barry Heller, M.D., Jason Morris, M.D., Chad Crystal, M.D., Awawu
Igbinadolor, M.D., Gregory Huhn, M.D., M.P.H.T.M., Jose Cardona, M.D., Imad
Shawa, M.D., Princy Kumar, M.D., Andrew C. Adams, Ph.D., Jacob Van Naarden,
B.S., Kenneth L. Custer, Ph.D., M.B.A., Michael Durante, M.S., Gerard Oakley,
M.D., Andrew E. Schade, M.D., Ph.D., Timothy R. Holzer, Ph.D., Philip J. Ebert,
Ph.D., Richard E. Higgs, M.S., Nicole L. Kallewaard, Ph.D., Janelle Sabo,
Pharm.D., Dipak R. Patel, M.D., Ph.D., Matan C. Dabora, M.D., M.B.A., Paul
Klekotka, M.D., Ph.D., Lei Shen, Ph.D., and Daniel M. Skovronsky, M.D., Ph.D.
for the BLAZE-1 Investigators*
Bamlanivimab plus Etesevimab in Mild or
Moderate Covid-19
The New England Journal of Medicine July
14, 2021
---
Drs. Dougan and Nirula contributed equally
to this article.
Author Affiliations
From Massachusetts General Hospital and
Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N.,
K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P.,
M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) — both in
Indianapolis; Valley Clinical Trials–Northridge, Northridge (M.A.), the
Department of Medicine, Women’s Guild Lung Institute, Cedars–Sinai Medical Center,
Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) — all in
California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor
University Medical Center and Baylor Scott and White Research Institute, Dallas
(R.L.G.), and Gadolin Research, Beaumont (R.P.) — both in Texas; NOLA Research
Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake
Charles (J.M.) — both in Louisiana; Vitalink Research, Union, SC (J.B.);
Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research,
Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and
Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC
(P. Kumar).
(4)
Joana Barros-Martins, Swantje I.
Hammerschmidt, Anne Cossmann, Ivan Odak, Metodi V. Stankov, Gema Morillas
Ramos, Alexandra Dopfer-Jablonka, Annika Heidemann, Christiane Ritter, Michaela
Friedrichsen, Christian Schultze-Florey, Inga Ravens, Stefanie Willenzon, Anja
Bubke, Jasmin Ristenpart, Anika Janssen, George Ssebyatika, Günter Bernhardt,
Jan Münch, Markus Hoffmann, Stefan Pöhlmann, Thomas Krey, Berislav Bošnjak,
Reinhold Förster & Georg M. N. Behrens
Immune responses against SARS-CoV-2
variants after heterologous and homologous ChAdOx1 nCoV-19/BNT162b2 vaccination
Nature Medicine (2021)
---
Author information
Author notes
These authors contributed equally: Joana
Barros-Martins, Swantje I. Hammerschmidt, Anne Cossmann.
Affiliations
Institute of Immunology, Hannover Medical
School, Hannover, Germany
Joana Barros-Martins, Swantje I.
Hammerschmidt, Ivan Odak, Christiane Ritter, Michaela Friedrichsen, Christian
Schultze-Florey, Inga Ravens, Stefanie Willenzon, Anja Bubke, Jasmin
Ristenpart, Anika Janssen, Günter Bernhardt, Berislav Bošnjak & Reinhold Förster
Department for Rheumatology and Immunology,
Hannover Medical School, Hannover, Germany
Anne Cossmann, Metodi V. Stankov, Gema
Morillas Ramos, Alexandra Dopfer-Jablonka, Annika Heidemann & Georg M. N.
Behrens
German Center for Infection Research
(DZIF), Partner Site Hannover-Braunschweig, Hannover, Germany
Alexandra Dopfer-Jablonka, Reinhold Förster
& Georg M. N. Behrens
Department of Hematology, Hemostasis,
Oncology and Stem-Cell Transplantation, Hannover Medical School, Hannover,
Germany
Christian Schultze-Florey
Institute of Biochemistry, University of Lübeck,
Lübeck, Germany
George Ssebyatika & Thomas Krey
Ulm University Medical Center, Institute of
Molecular Virology, Ulm, Germany
Jan Münch
Infection Biology Unit, German Primate
Center, Göttingen, Germany
Markus Hoffmann & Stefan Pöhlmann
Faculty of Biology and Psychology, Georg-August-University
Göttingen, Göttingen, Germany
Markus Hoffmann & Stefan Pöhlmann
German Center for Infection Research
(DZIF), Partner Site Hannover-Braunschweig and Partner Site Hamburg-Lübeck-Borstel-Riems,
Hamburg, Germany
Thomas Krey
Cluster of Excellence RESIST (EXC 2155),
Hannover Medical School, Hannover, Germany
Reinhold Förster
CiiM, Centre for Individualised Infection
Medicine, Hannover, Germany
Georg M. N. Behrens
(5)
Jennifer Bermick & Matthew Schaller
Epigenetic regulation of pediatric and
neonatal immune responses
Pediatric Research (2021)
---
Author information
Affiliations
Department of Pediatrics, Division of
Neonatology, University of Iowa, Iowa City, IA, USA
Jennifer Bermick
Iowa Inflammation Program, University of
Iowa, Iowa City, IA, USA
Jennifer Bermick
Department of Pulmonary, Critical Care
& Sleep Medicine, University of Florida, Gainesville, FL, USA
Matthew Schaller
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