News

HDA UK Media and Political Bulletin – 03 February 2021

Media Summary

GSK and CureVac to develop vaccines to tackle COVID variants
Financial Times, Donato Paolo Mancini & Joe Miller, 03 February

The Financial Times reports that the UK’s GlaxoSmithKline and Germany’s CureVac will work together on a new generation of COVID-19 vaccines to tackle emerging variants of the virus that have shown some resistance to existing ones.

The two companies have agreed a €150m deal to jointly develop a product using mRNA technology that would work on multiple variants of the Sars-Cov-2 virus and could be ready for use in 2022, subject to approval.

GlaxoSmithKline will also help manufacture up to 100m doses of CureVac’s mRNA vaccine candidate at its plant in Belgium. The CureVac vaccine, the only mRNA shot that is stable at conventional fridge temperatures, is in the final phases of testing.

CureVac has said it can manufacture 300m doses of its vaccine this year, and at least 600m next year. It has signed a deal to deliver 400m doses to the EU, and has said it will no longer pursue authorisation of the shot in the US, citing market saturation.

 

Bill that could allow wider hub-and-spoke dispensing expected to become law in February
The Pharmaceutical Journal, Carolyn Wickware, 02 February

The Pharmaceutical Journal reports that legislation paving the way for wider use of hub-and-spoke dispensing is expected to receive royal assent this month.

The Medicines and Medical Devices Bill will also lay the first steps towards building a replacement for the EU’s Falsified Medicines Directive (FMD) and supporting a wider range of professions to prescribe certain medicines.

The bill’s impact assessment set out the implications “for how powers may be used in the future” following secondary legislation, which included “enabling hub-and-spoke arrangements across legal entities.” This would mean that smaller pharmacies would be able to access dispensing hubs run by larger multiple pharmacies, for instance.

The DHSC confirmed to The Pharmaceutical Journal this week that the proposed changes to the regulation of pharmacies, which would also enable hub-and-spoke dispensing, have not changed.

 

Parliamentary Coverage

House of Lords, Written Answer, 02 February

Lord Scriven (Liberal Democrat): To ask Her Majesty’s Government what is the average waiting time to receive COVID-19 vaccinations in (1) mass vaccination hubs, (2) GP surgeries, and (3) community pharmacies.

Lord Bethell (Conservative): Waiting times at individual vaccination sites are not collected centrally by NHS England and NHS Improvement. However, it is important to keep waiting times to a minimum. To support this, the national vaccination booking system has been set up so that specific time slots can be booked in advance based on a site’s capacity.

 

Oxford Coronavirus vaccine shows sustained protection of 76% during the 3-month interval until the second dose
Oxford University, 02 February

Researchers at the University of Oxford have published an analysis of further data from the ongoing trials of the vaccine. The data reveals that the vaccine efficacy is higher at longer boost intervals, and that a single dose of the vaccine is 76% effective up to 90-days post vaccination.

They report that the effect of dosing interval on efficacy is pronounced, with vaccine efficacy rising from 54.9% with an interval of less than six weeks to 82.4% when spaced 12 or more weeks apart. They also detail that a single standard dose of the vaccine is 76% effective at protecting from primary symptomatic COVID-19 for the first 90 days post vaccination, once the immune system has built this protection 22 days after the vaccination.

Professor Andrew Pollard, Chief Investigator of the Oxford Vaccine Trial said: “These new data provide an important verification of the interim data that was used by more than 25 regulators including the MHRA and EMA. It also supports the policy recommendation made by the Joint Committee on Vaccination and Immunisation (JCVI) for a 12-week prime-boost interval, as they look for the optimal approach to roll out, and reassures us that people are protected from 22 days after a single dose of the vaccine.”

You can read the full press release here.

 

Full Coverage

GSK and CureVac to develop vaccines to tackle COVID variants
Financial Times, Donato Paolo Mancini & Joe Miller, 03 February

This article is subject to copyright terms & conditions. Please access the full article here.

 

Bill that could allow wider hub-and-spoke dispensing expected to become law in February
The Pharmaceutical Journal, Carolyn Wickware, 02 February

Legislation paving the way for wider use of hub-and-spoke dispensing is expected to receive royal assent in February 2021, the Department of Health and Social Care (DHSC) has said.

The Medicines and Medical Devices Bill will also lay the first steps towards building a replacement for the EU’s Falsified Medicines Directive (FMD) and supporting a wider range of professions to prescribe certain medicines.

The bill will provide the primary legislation needed to amend a variety of legislative frameworks, including the Human Medicines Regulations 2012 (HMRs).

These frameworks were previously amended through legislation that has since been repealed under the EU (Withdrawal) Act 2018.

The bill’s impact assessment set out the legislation’s implications “for how the powers may be used in the future” following secondary legislation, including “enabling hub-and-spoke arrangements across legal entities”, which will ultimately require a change to the HMRs.

This would mean that smaller pharmacies would be able to access dispensing hubs run by larger multiple pharmacies, for instance.

The DHSC confirmed to The Pharmaceutical Journal on 1 February 2021 that, despite amendments to the bill since it was laid before parliament in February 2020, the powers enabling changes to the regulation of pharmacies to be kept up to date, which would also enable hub-and-spoke dispensing, have not changed.

It added that the bill is in its final stages and the DHSC hopes it will achieve royal assent in February 2021.

Speaking during a debate on 27 January 2021, Pharmacy Minister Jo Churchill said the government plans to hold “a full public consultation” on broadening hub-and-spoke dispensing.

“The government will then report to parliament and include a summary of the concerns raised in the public consultation,” she said.

“To ensure that we get the right model to assist pharmacy going forward, we intend to be totally transparent.”

This comes after the government also committed to consulting the public on a new national scheme to detect falsified medicines in the supply chain within 12 months of the Medicines and Medical Devices Bill receiving royal assent.

The national scheme would replace the FMD, which was introduced across the EU in February 2019 and ceased to apply in Great Britain when the Brexit transition period ended on 31 December 2020.

The bill’s impact assessment listed “introducing a scheme to combat falsified medicine products” among a range of examples of how the powers may be used in the future following secondary legislation.

The bill could also enable hospitals to use patient tissue and DNA samples to tailor treatments for individual patients and allow hospitals, in their existing facilities, to develop drugs that have a shelf life of minutes and would otherwise be unavailable to them.

Medicine manufacturers may also be required to signpost patients to “up-to-date statutory information about certain medicines on a variety of digital platforms”, rather than include hard copy patient information leaflets in packaging, under proposals permitted by the bill.

The Medicines and Medical Devices Bill was first announced in the Queen’s Speech in December 2019 amid plans to introduce legislation to allow a wider range of healthcare professionals — potentially including pharmacists — in the NHS to prescribe ‘low-risk’ medicines.

Changes enabled by the powers in the bill will be made using secondary legislation at a later date, and any proposed legislative changes arising from the provisions in the bill will be subject to consultation, the DHSC said.

HDA UK Media and Political Bulletin – 03 February 2021

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