Consultation on regulations for possible Covid vaccinations

The science and debate around vaccines.

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The government wants to allow for the speeding up of authorising any vaccine for Covid – and has opened a consultation for feedback:

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Distributing vaccines and treatments for COVID-19 and flu

Summary

We want your views on proposed changes to the Human Medicine Regulations to help with the safe and efficient distribution of a COVID-19 vaccine and expanded flu vaccine programme in the UK, along with treatments for COVID-19 and any other diseases that become pandemic.

This consultation closes at

Consultation description

The UK government, with the Minister of Health in Northern Ireland, is seeking views on proposed changes to the Human Medicine Regulations 2012.

The consultation covers:

  • authorising temporary supply of an unlicensed product
  • civil liability and immunity
  • expanding the workforce eligible to administer vaccinations
  • promoting vaccines
  • making provisions for wholesale dealing of vaccines

Consultation document: changes to Human Medicine Regulations to support the rollout of COVID-19 vaccines

Ways to respond

Distributing vaccines and treatments for COVID-19 and flu – GOV.UK

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Expert opinion is generally in favour:

“The government consultation released today shows some of the thought and preparation going into the deployment of a possible COVID-19 vaccine. Its main purpose is to give the government the option to authorise a vaccine before it is licensed by the European regulator (the EMA) and laying down some of the legal groundwork to do so. If the government chooses to exercise this option, it would help public confidence if the government commits to fully disclosing its reasons for regulatory divergence from the EMA’s decision-making, especially in its interpretation of safety and efficacy.”

expert reaction to government announcement of new measures to support deployment of COVID-19 vaccines | Science Media Centre

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The debate has become very politicised, especially in the States:

Robert F Kennedy – the man who became a conspiracy king | The New European

Anti-vaccination group sues Facebook over fact-checking program – The Verge

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And especially during these times:

Why is the ‘anti-vaxxer’ movement growing during a pandemic? | Free to read | Financial Times

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With a book just out:

Anti-vaxxers | The MIT Press

Jonathan Berman: Anti-Vaxxers and How to Challenge a Misinformed Movement – YouTube

Anti-vaxxers: How to Challenge a Misinformed Movement: Berman, Jonathan M: Amazon.com: Books

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And with the Lancet just publishing a study on “growing evidence of vaccine delays or refusals due to a lack of trust in the importance, safety, or effectiveness of vaccines, alongside persisting access issues”:

Mapping global trends in vaccine confidence and investigating barriers to vaccine uptake: a large-scale retrospective temporal modelling study – The Lancet

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It is nevertheless an important debate:

Anti Vaxxers: Understanding Opposition to Vaccines

Regarding the Use of the Term “Anti-Vaxxer” | The BMJ

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With a lot of opinion:

Coronavirus: ‘All these anti-vaxxers’ are ‘nuts’, Boris Johnson says, as he wants ‘everybody’ to get vaccinated | Politics News | Sky News

Anti-vaxxers who refuse to get a coronavirus jab could be banned from restaurants | Daily Mail Online

Anti-vaxxers: Half of parents ‘will not give kids coronavirus vaccine’ | Express.co.uk

Piers Morgan confronts ‘dangerous’ face of anti-vax movement – ‘will never defeat COVID’ | UK | News | Express.co.uk

The world needs to do more to improve confidence in vaccines | telegraph.co.uk (paywall)

Anti-vaxxers are biggest threat to our health | Comment | The Times (paywall)

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The problem is that a press release from a pharmaceutical CEO is not the same as a peer review on the safety and efficacy of any vaccine being registered and put on the market.

And there just isn’t enough data available on the current swathe of hopeful Covid vaccinations – with one trial in the Lancet covering only 76 patients:

Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia – The Lancet

expert reaction to a study looking at two open, non-randomised phase 1/2 clinical trials of the Russian rAd26 and rAd5 vector-based COVID-19 vaccine | Science Media Centre

Early-phase Russian trials reveal safety and immunogenicity of two formulations of a two-part vaccine

Note of concern

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And this is what the government’s consultation seeks to address.

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photo: Vaccine Injection Vaccination – Free vector graphic on Pixabay

   
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