What’s new at this update
FDA authorizes Pfizer/BioNTech vaccine in adolescents 12 to 15 years of age
The US Food and Drug Administration has authorized the Pfizer/BioNTech vaccine for emergency use in adolescents ages 12 to 15 years. The agency amended the original emergency-use authorization from December 2020 that authorized use in individuals ≥16 years of age. Authorization was based on an ongoing randomized, placebo-controlled clinical trial of over 2000 participants in the US. More than half of the participants were followed for safety for at least 2 months following the second dose. See the Prevention section for more information.
JCVI recommends alternative to AstraZeneca vaccine in under 40s
The Joint Committee on Vaccination and Immunisation in the UK now advises that it is preferable for adults ages 30 to 39 years without underlying health conditions to receive an alternative to the AstraZeneca vaccine, where available, and only if this does not cause substantial delays in being vaccinated. The committee previously advised that it is preferable for adults ages <30 years without underlying health conditions that put them at higher risk of severe disease to be offered an alternative vaccine also. See the Prevention section for more information.
EMA assessing reports of Guillain-Barre syndrome and myocarditis after vaccination
The European Medicines Agency is assessing safety signals of Guillain-Barre syndrome with the AstraZeneca vaccine, and of myocarditis and pericarditis with the mRNA vaccines. The agency’s safety committee will continue its review and communicate further information when available. See the Prevention section for more information.
EMA concludes review of safety signal of facial swelling with Pfizer/BioNTech vaccine
The European Medicines Agency has recommended a change to the product information of the Pfizer/BioNTech vaccine to include a new side effect of facial swelling in people with a history of injections with dermal fillers. The agency’s safety committee found that there is a reasonable possibility of a causal association between the vaccine and the reported cases of facial swelling. See the Prevention section for more information.
WHO approves Covilo® vaccine for global use
The World Health Organization has authorized the Covilo® vaccine, an aluminium-hydroxide-adjuvanted, inactivated whole virus vaccine, for use globally. The vaccine, developed by Sinopharm/China National Biotec Group, was shown to be 79% against symptomatic infection 14 or more days after the second dose. See the Prevention section for more information.
Indian variant upgraded to variant of concern
The VOC-21APR-02 (or B.1.617.2) variant, first identified in India, has been upgraded from a variant under investigation to a variant of concern in the UK. Travel-associated and locally-acquired cases have been reported in many countries around the world, including the UK. Preliminary evidence suggests the variant is at least as transmissible as the UK B.1.1.7 variant, but there is insufficient evidence to indicate whether it can cause more severe disease or render vaccines less effective. See the Etiology section for more information.
Original source of updateexternal link opens in a new window
Coronavirus disease 2019 (COVID-19) is an infectious acute respiratory disease caused by a novel coronavirus. The World Health Organization (WHO) was informed of cases of pneumonia of unknown microbial etiology associated with Wuhan City, Hubei Province, China on 31 December 2019. The WHO later announced that a novel coronavirus had been detected in samples taken from these patients. Since then, the epidemic has escalated and rapidly spread around the world, with the WHO first declaring a public health emergency of international concern on 30 January 2020, and then formally declaring it a pandemic on 11 March 2020. Clinical trials and investigations to learn more about the virus, its origin, how it affects humans, and its management are ongoing. This topic is based on the best evidence currently available, but as this is a rapidly evolving situation, evidence is limited in some areas and some recommendations may be based on observational studies and retrospective analyses, as well as randomized controlled trials and guidelines.
A potentially severe acute respiratory infection caused by the novel coronavirus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The clinical presentation is generally that of a respiratory infection with a symptom severity ranging from a mild common cold-like illness, to a severe viral pneumonia leading to acute respiratory distress syndrome that is potentially fatal. Characteristic symptoms include fever, cough, dyspnea, and loss of taste/smell, although some patients may be asymptomatic. Complications of severe disease include, but are not limited to, multi-organ failure, septic shock, and venous thromboembolism. Symptoms may be persistent and continue for more than 12 weeks in some patients.
History and exam
- myalgia or arthralgia
- sputum production/expectoration
- chest tightness
- gastrointestinal symptoms
- sore throat
- neurologic symptoms
- ocular symptoms
- rhinorrhea/nasal congestion
- audio-vestibular symptoms
- chest pain
- cutaneous symptoms
- lower urinary tract symptoms
- bronchial breath sounds
- crackles/rales on auscultation
- contact with probable or confirmed case
- residence/work/travel in location with high risk of transmission
- older age
- male sex
- residence in a long-term care facility
- presence of comorbidities
- cardiovascular disease
- chronic respiratory disease
- chronic kidney disease
- cerebrovascular disease
- solid organ or blood stem cell transplant
- Down syndrome
- hemoglobin disorders
- HIV infection
- substance use disorders
- children with certain underlying conditions
- chronic liver disease
- vitamin D deficiency
- proton-pump inhibitor use
- autoimmune disease
- Parkinson disease
- physical inactivity
- blood groups A and B
- gut dysbiosis
- environmental factors
- real-time reverse transcription polymerase chain reaction (RT-PCR)
- pulse oximetry
- comprehensive metabolic panel
- blood glucose level
- coagulation screen
- cardiac biomarkers
- serum C-reactive protein
- serum erythrocyte sedimentation rate
- serum lactate dehydrogenase
- serum interleukin-6 level
- serum procalcitonin
- serum ferritin level
- serum amyloid A level
- serum creatine kinase and myoglobin
- blood and sputum cultures
- chest x-ray
Consultant and Emeritus Professor of Tropical and Infectious Diseases
Royal Liverpool University Hospital and Liverpool School of Tropical Medicine
NJB is partially supported by the National Institute of Health Research Health Protection Unit (NIHR HPRU) in Emerging and Zoonotic Infections at University of Liverpool in partnership with Public Health England (PHE), in collaboration with Liverpool School of Tropical Medicine. He is affiliated with Liverpool School of Tropical Medicine. The views expressed are those of the author and not necessarily those of the NHS, the NIHR, the Department of Health, or PHE.
Senior Clinical Lecturer and Defence Consultant in Infectious Diseases
Royal Liverpool University Hospital and Liverpool School of Tropical Medicine
TEF is a consultant/expert panel member to the World Health Organization, and is funded by the UK Surgeon General, the NHS, and Liverpool School of Tropical Medicine. TEF is partially supported by the National Institute of Health Research Health Protection Unit (NIHR HPRU) in Emerging and Zoonotic Infections at University of Liverpool in partnership with Public Health England (PHE), in collaboration with Liverpool School of Tropical Medicine. He is affiliated with Liverpool School of Tropical Medicine. He has received research grants from the Wellcome Trust, Medical Research Council, and the UK Public Health Rapid Support Team (UK-PHRST). The views expressed are those of the author and not necessarily those of the NHS, the NIHR, the Department of Health, or PHE.
H. Barrie Fairley Professor of Critical Care
University Health Network and Interdepartmental Division of Critical Care Medicine
Clinical Epidemiology and Health Care Research
Institute of Health Policy, Management and Evaluation
Dalla Lana School of Public Health
University of Toronto
Tory Trauma Program
RF declares that he has no competing interests.
Division of Infectious Diseases and International Health
University of Virginia
WAP declares that he has no competing interests.
The Fifth Medical Center of PLA General Hospital
Clinical Division and Research Center of Infectious Disease
XZ declares that he has no competing interests.
Associate Professor in Medicine
Department of Clinical Microbiology and Infectious Diseases
Hadassah Hebrew University Medical Center
RNP has received research grants from US-Israel Binational Science Foundation, Hebrew University, Rosetrees Trust, and SpeeDx. He is chair of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Study Group for Mycoplasma and Chlamydia Infections (ESGMAC). RNP is a consultant for and has stocks in eDAS Healthcare. He is also chairperson of the Israeli Society for Infectious Diseases guidelines committee.
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