Coronavirus disease 2019 (COVID-19)

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.

[Figure caption and citation for the preceding image starts]: Number of COVID-19 cases reported weekly by WHO Region, and global deaths, as of 9 May 2021World Health Organization [Citation ends].

See Epidemiology

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