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Covid-19 vaccines: an injection of politics

07 January 2021. Published by Peter Rudd-Clarke, Legal Director

The approval and roll out of the vaccines to combat Covid-19 in the UK has been administered with a large dose of political involvement. This has long term implications for the life sciences sector.

Before the pandemic, the law regulating the approval and use of life sciences products was not the stuff of mainstream politics. Covid-19 changed that. The regulation of personal protective equipment, manufacture of ventilators or the repurposing of drugs like Dexamethasone, to name just three examples, have featured heavily in the news as politicians struggled for a strategy to deal with the virus.

Political involvement in life sciences products reached a new level over Christmas and the New Year with the approval in the UK of the Pfizer/BioNtech (Pfizer) and the Oxford/AstraZeneca (AstraZeneca) vaccines.

A shot in the arm for innovation

In pre-pandemic days, the industry accepted (sometimes with frustration) the time required to run clinical trials, and the necessary caution shown by regulators in approving innovative products.

The process for developing and approving the Pfizer and AstraZeneca vaccines relied upon expedited clinical trials and a swifter regulatory approval process, as well as a regulation which allows for a "medicinal product" to be authorised "on a temporary basis" in response to the spread of an agent, including a pathogen, "which may cause harm to human beings". This is Regulation 174 of the Human Medicine Regulations 2012 (Regulation 174)

The Medicines and Healthcare products Regulatory Agency (MHRA) authorised the vaccines under Regulation 174 in response to the pandemic.  The MHRA is independent but its decision to use Regulation 174 is just the break-through that politicians were desperate for.

The use of Regulation 174, and the MHRA's approach which involved reviewing clinical trials data on a rolling basis, have been in the context of a global emergency. However, any individual suffering from a disease must cope with their own emergency – that, in many cases, will involve higher stakes for them personally than the pandemic. Charities, and other groups that advocate for innovative drugs to be brought to the market more quickly and efficiently, have taken an interest in the speed with which these new medicines have been approved.

The UK BioIndustry Association has argued that the experience of the pandemic ought to shorten the time it ordinally takes for a new medicine to go from an innovative idea to a treatment for patients.

Needling Pfizer and the BMA

The licence granted to Pfizer by the MHRA requires that the vaccine doses should be administered three to four weeks apart. However, to vaccinate as many people as possible, the government has extended the interval between the first and second jabs to up to 12 weeks. The government argues that this will provide broader protection to society as a whole.

In response, Pfizer has warned that there is "no data" to support plans to delay the second dose of its vaccine. The British Medical Association (BMA) has said the government's preferred timetable is unreasonable and unfair. The BMA has questioned the science behind the government's initiative.

By issuing new guidelines, the government has made the vaccine roll out an enormous exercise in administering medicines 'off licence' and has effectively pitted itself against the manufacturers and the Regulators. The approach is a stark example of expediency winning over the time-consuming process of varying a licence.

The US Food and Drug Administration has stated that the timeframes involved in the Pfizer vaccination programme should not be changed without another clinical trial, which also suggests that, in the UK, political factors, as much as scientific ones, are involved in decisions on how best to roll out the vaccine. 

Brexit booster

Gavin Williamson, the UK's Education Secretary, has been pilloried for boasting that the UK was the first to approve a Covid-19 vaccine "because we're a much better country than every single one of them". However, the UK has made a significant contribution in developing the AstraZeneca vaccine, being the first country to approve both the Pfizer and AstraZeneca vaccines and in leading the way in sequencing the genome of the virus's mutations.

According to Pfizer, other countries' regulators took their cue from the MHRA to see if they could also speed up their regulatory processes to approve its vaccine. The MHRA has also supported the World Health Organisation in working with other countries to approve the vaccines. 

Following Brexit, the MHRA has a chance to enhance its own reputation independently of the EU system. The UK government has announced that pharmaceutical companies will be offered fast-track approvals for innovative medicines, as the UK builds on the MHRA's role during the pandemic. This is part of a broader government initiative to attract life sciences companies to invest in the UK. Companies will be offered the same rolling review of data that speeded up approval of the Pfizer vaccine.

Who will call the shots?

The use of Regulation 174, decisions to administer the vaccines 'off label' and the novel approach taken towards clinical trials have all, to a greater or lesser degree, come about through political pressure exerted during an emergency. This is a change from the pre-pandemic position where progress was controlled by regulators and scientists.

A legacy of the pandemic will be greater interest in, and knowledge about, how life sciences products are brought to the market. Will scientists and regulators retain the upper hand, or will that role now fall to politicians?

In future, there will be more informed debate about how quickly innovative products can get from the laboratory to hospitals, whether temporary authorisation of medicines should occur more often and whether the regulatory system should be changed to boost industry in the UK following Brexit. Handled well, the legal and regulatory changes brought about by the pandemic could prove to be of lasting benefit for industry.

Politics has entered the bloodstream of the life sciences industry. Companies will hope that the effect will be revitalising.