Comirnaty COVID-19 vaccine approved by EMA for children aged 5 – 11

30th November 2021

Comirnaty has now been granted a license extension and approved by the EMA for COVID-19 vaccination in children aged 5 to 11 years of age

Comirnaty is the COVID-19 vaccine made by Pfizer-BioNTech and has now been approved by the EMA for use in children aged between 5 and 11 years of age given as two doses, three weeks apart. The vaccine was previously approved for use in adults and children from the age of 12.

Although a study published in Nature Medicine in November 2021, reported that the majority of children and young people infected with COVID-19 survive, the analysis was based on the wild-type and alpha variant only. However, more recent data from the US, shows that once the delta variant became the dominant COVID-19 strain in circulation, weekly COVID-19–associated hospitalisation rates among children and adolescents rose nearly five-fold during late June–mid-August 2021.

Based on these findings, the Centers for Disease Control in the US considered that ‘preventive measures to reduce transmission and severe outcomes in children and adolescents are critical, including vaccination, universal masking in schools, and masking by persons aged ≥2 years in other indoor public spaces and child care centers.’

Clinical efficacy in younger children

The EMA approval of comirnaty in children from the age of 5 was based on a single study of the vaccine in those aged 5 to 11 years. The study itself was undertaken in two stages; an initial phase 1 dosing-finding trial, in which a total of 48 children 5 to 11 years of age, received two 10-μg doses of BNT162b2 administered 21 days apart (which was a third of the dose given for 12 to 15 year olds), after which, the participants were randomised in a 2:1 ratio and given two 10 μg doses BNT162b2 or saline placebo.

The study examined the immunogenicity of the 10-μg dose but also the vaccine efficacy against confirmed COVID-19 infection which had an onset at least 7 days after the second dose. For the phase 2 arm of the study, 2268 children with a mean age of 8.2 years (52.1% male) were randomised to BNT162b2 or placebo. The immunogenicity showed a similar geometric mean ratio to that achieved from a 30-μg dose given to older children.

In terms of vaccine efficacy, there were three cases of COVID-19, with an onset 7 or more days after the second vaccination dose in the BNT162b2 group and 16 among placebo recipients, giving a vaccine efficacy of 90.7% (95% CI, 67.7 to 98.3). 

While the EMA has approved comirnaty in younger children, this has not occurred in the UK, with the MHRA only approving vaccination for those aged 12 – 15 years.

Source. EMA News 25th November 2021

FDA approves remdesivir for COVID-19

30th October 2020

The US Food and Drug Administration (FDA) approved remdesivir (brand name Veklury) on 22 October 2020 for use in adults and paediatric patients aged 12 years and over and weighing at least 40kg for the treatment of COVID-19 in patients requiring hospitalisation.

The approval requires that remdesivir is only used in a hospital or healthcare setting capable or providing acute care which is comparable to hospital care. This new approval does not however, include the entire population that was originally included via the emergency use authorisation (EUA) issued on 1 May 2020. In order to allow continued use in paediatric patients the EUA was amended for use only in laboratory confirmed COVID-19 cases for patients weighing 3.5 to less than 40kg less or hospitalised children under 12 years of age weighing at least 3.5kg. However, the FDA makes clear that this is NOT an approved use of the drug and that this authorisation is only temporary and could be revoked.

The approval in adults was based on three randomised clinical trials which showed that treatment with remdesivir lead to clinically meaningful improvements across multiple outcomes compared to placebo. For instance, in the most recent ACTT-1 trial, published in the New England Journal of Medicine, remdesivir significantly improved time to recovery by 5 days and reduced disease progression among patients requiring oxygen. It also showed an improved time to recovery among patients not requiring oxygen in the SIMPLE-Moderate trial conducted in hospitalised patients. Moreover, adverse effects with remdesivir were similar to placebo.
Remdesivir was approved under the early access to medicines scheme in the UK in May 2020.

Reference
FDA News release. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19