Euro Roundup: UK committee advises a mix of COVID boosters for autumn

| 18 August 2022 | By Jeff Craven 

The UK Joint Committee on Vaccination and Immunisation (JCVI) has recommended a mix of COVID-19 vaccines based on the original wild-type SARS-CoV-2 virus as well as Moderna’s bivalent COVID-19 vaccine that targets both the original virus and the B.1 Omicron variant for its autumn booster program.
JCVI advised the UK government to adopt Pfizer’s Comirnaty and Moderna’s Spikevax for the autumn booster program in addition to Moderna’s bivalent COVID-19 vaccine for adults, with Novavax’s recently approved vaccine recommended “when no alternative clinically suitable UK-approved COVID-19 vaccine is available.” For adolescents, JCVI recommends Cormirnaty, while children between 6-11 years old should receive the pediatric formulation of Comirnaty, the committee said.
The Medicines and Healthcare products Regulatory Agency (MHRA) recently approved the Moderna bivalent COVID-19 vaccine for use in adults (RELATED: UK MHRA is first to authorize Moderna’s bivalent COVID-19 booster, Regulatory Focus 12 August 2022). JCVI said they would evaluate other bivalent COVID-19 vaccines if approved by MHRA.
“All of the available booster vaccines offer very good protection against severe illness from COVID-19. As more vaccines continue to be developed and approved, the JCVI will consider the benefits of including them in the UK programme,” Wei Shen Lim, chair of COVID-19 immunization on the committee, said in a statement.
UK government opts not to purchase COVID PrEP therapy Evusheld
The UK government currently is not purchasing AstraZeneca’s COVID-19 pre-exposure prophylaxis Evusheld based on concerns about the therapy’s efficacy against SARS-CoV-2 variants and subvariants, according to a report from BMJ
“Following a robust review of the available data, our clinical experts advise there is currently insufficient data on the duration of protection offered by Evusheld in relation to the Omicron variant and the government will not be procuring any doses at this time. We will write to stakeholders with more information on the decision shortly,” a government spokesperson told Medscape UK.
This claim runs counter to some recent data suggesting Evusheld is protective against Omicron and its subvariants. Researchers at the University of Oxford wrote in a paper posted to the pre-print server bioRxiv that therapeutics like Evusheld and the monoclonal antibody sotrovimab “still show activity” against Omicron subvariants BA.4 and BA.5. A letter to the editor recently published in The New England Journal of Medicine showed Evusheld inhibited BA.2.12.1, BA.4, and BA.5 Omicron subvariants, according to an international team of researchers from the United States and Japan.
The National Institute for Health and Care Excellence (NICE) is currently determining the clinical value and cost effectiveness of Evusheld, but the expected publication date has not been listed.
Swissmedic releases benchmarking study showing faster authorization times over EMA
Time to authorization for new active pharmaceutical substances was shorter in Switzerland than it was in the EU in 2021, according to a new joint benchmarking study from Swissmedic and the pharmaceutical industry.  
The study looked at approval times for human medicines from 74 pharmaceutical companies, comprising 77% of the Swiss pharmaceutical market and 81% of the prescription drug market, and compared them with approval times under the European Medicines Agency (EMA) and US Food and Drug Administration (FDA).
In 2021, the median throughput time for new applications for new active substances was 391 days compared with 401 days under the EMA and 223 days under the FDA. Swissmedic said this was the first year that median their throughput times surpassed that of the EMA.
Swissmedic also found accelerated authorization procedures involving applications for new active substances were 25% lower in 2021 than in 2020, while applications via Project Orbis and the Access Consortium increased to 10% of all applications. Temporary authorization procedures also accounted for 10% of all applications, up from 4% in the previous year.
“Overall, we expect that application processing under international procedures (Orbis, Access) will play an increasingly important role in the authorisation of innovative medicinal products, which will in turn have a positive effect on submission gaps, throughput times and approval gaps,” the report stated.
Benchmarking study
EC seeks feedback on regulation to reclassify medical devices without an intended medical purpose
The European Commission (EC) announced this week it would like feedback on a recent draft act that would reclassify medical devices without an intended purpose to ensure they are meeting premarket and postmarket requirements as comparable medical devices.
Due to the potential for side effects associated with devices like high-intensity electromagnetic radiation emitting equipment used on the body for hair removal, the draft act states the devices should be classified as IIa, while high-intensity electromagnetic radiation emitting equipment used for skin treatment and “equipment intended to be used to reduce, remove or destroy adipose tissue” used on the human body without a specific medical purpose should be classified as class IIb medical devices.
“Such classification also corresponds to classification of active therapeutic devices whose functioning and risks profile are similar to those of the equipment without an intended medical purpose in question, intended to administer energy to or exchange energy with the human body or supply energy that will be absorbed by the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy,” the authors of the draft act wrote.
For devices “intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain” like in transcranial magnetic stimulation or transcranial electric stimulation, the draft act recommends they be classified as class III medical devices. “While such equipment is not surgically invasive, the electrical currents or magnetic or electromagnetic fields do penetrate the cranium to modify neuronal activity in the brain. Such modifications can have long-lasting effects and any unintended effects may be difficult to reverse,” the authors wrote.
The EC plans to adopt this initiative in the third quarter of 2022.
Draft act
EMA begins review of SK Chemicals COVID vaccine
The European Medicines Agency (EMA) on Thursday announced it has begun a review of South Korean firm SK Chemicals’ conditional marketing authorization application for its nanoparticle-based COVID-19 vaccine Skycovion.
EMA said the company has submitted data on the vaccine’s ability to promote an antibody response against the wild-type SARS-CoV-2 virus, as well as safety and quality information about the vaccine.
“The evaluation of Skycovion is one of the ongoing evaluations of data on COVID-19 vaccines. As the pandemic continues to evolve, it is important that the EU has a wide array of vaccines and treatments to enable Member States to combat the pandemic effectively,” EMA said.


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