Pfizer and other drug manufacturers have been given legal protection by the British government over its unlicensed vaccines, it has been revealed.

The legislative changes for the COVID-19 vaccine are largely due to the Human Medicines Regulations 2012 in relation to licencing medicines.

Changes to the regulation 174 of the Human Medicines Regulations, gives the MHRA scope to grant a temporary authorisation for the supply of an unlicensed medicinal product for use during pandemics.

What this means is that the product can be authorised by the MHRA despite not being licensed by the European Medicines Agency, which retains its powers over most UK medicines until January 2021. The MHRA still requires sufficient evidence of the safety, quality and efficacy of medicinal products to approve unlicensed use.

Kate Bingham, chair of the UK vaccine taskforce, summarised the position on the frontrunner vaccines at the time in an article for the Lancet. She said: “The most advanced vaccines, such as those developed by AstraZeneca and the University of Oxford, BioNTech and Pfizer, and Janssen, are based on novel formats for which we have little experience of their use as vaccines, although the initial immunogenicity and safety data are encouraging.”

In addition, the government has extended immunity from civil liability for some consequences resulting from the use of an unlicensed medicinal product, although there are still other liabilities and the exact scope of the immunity is complex.

There was already a degree of immunity from civil liability for products whose unlicensed use has been recommended by the state. Under the changes, those who are immune include companies placing an unlicensed medicine such as a vaccine on the market and the additional vaccinators for COVID-19 who are not registered healthcare professionals.

This was announced just weeks after it was revealed that the army will be deployed to distribute the coronavirus vaccine across the UK.

The immunity also applies to healthcare professionals, including pharmacists.

In a press conference with journalists on Wednesday, Ben Osborn, Pfizer’s UK managing director, refused to explain why the company needed indemnity from prosecution should any negative results arise from their vaccines.

He said: “We’re not actually disclosing any of the details around any of the aspects of that agreement and specifically around the liability clauses.”

Pfizer also refused to confirm exactly when the full data on the vaccine’s clinical trial would be published.

Read more about the legislative changes here.

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