At the end of last year, the Government announced that the second doses of the Covid-19 vaccines were to be administered up to 12 weeks after the first dose rather than after the initially stated three to four weeks from the first dose.
The Negligence Claimline experts examine the implications of this decision for patients – and the possible fallout for the Government.
Vaccine shortages were given as a major reason for the shift in approach. The chief medical officers made a statement that optimal efficacy was achieved through two doses. However, both vaccines – the Pfizer and BioNTech one and that of Oxford University and AstraZeneca – ‘offer considerable protection after a single dose, at least in the short term’.
In taking the decision to delay the second dose, the Government has effectively decided that it was better to provide more people with limited protection in the shortest possible time and thus help protect the NHS from being overrun, than offer fewer people the maximum possible protection.
Pfizer and BioNTech have said, however, that ‘there is no data to demonstrate that protection after the first dose is sustained after 21 days’, and the European Medicines Agency has said that the gap between the first and second doses of the Pfizer-BioNTech vaccine should not exceed 42 days.
The decision to delay has caused a furore across the medical profession and beyond, with the British Medical Association calling the Government’s decision ‘unreasonable and totally unfair’ and saying it could cause ‘huge logistical problems’ for general practices and vaccination centres.
A petition seeking to challenge the second dose delay has garnered more than 282,000 signatures, and London paediatrician Dr Michael Markiewicz has launched a crowdfunding appeal to take out an injunction against the Government to ‘stop them delaying giving the second dose of the Pfizer vaccine’. He has so far raised more than £25,000 of his £50,000 target.
Labour peer and former government voice of older people, Baroness Dame Joan Bakewell, has also instructed lawyers to challenge the delay. They have written a letter to Health Secretary Matt Hancock questioning the lawfulness of the decision to change the national Covid-19 vaccination policy.
The letter outlines three potential grounds for a judicial review into the vaccination policy:
- breach of the conditions of authorisation;
- breach of legitimate expectation; and
- the unlawfulness of departing from the Medicines and Healthcare products Regulatory Agency’s assessment that the second dose should be given within 21 or at most 28 days.
Dr Markiewicz and Lady Bakewell are reportedly in talks about combining their legal actions.
The UK Government has introduced regulations designed to reduce legal protection for anyone injured by a Covid-19 vaccine approved for emergency use, but it is not yet clear whether an individual could mount a legal case if they caught Covid-19 because of the Government-mandated delay between their first and second vaccinations.
To succeed in such a case, the person would have to show that the Government was negligent, which means proving that it owed a duty of care, that it breached that duty of care and that injury resulted.
Sounds easy enough on paper, but courts would no doubt take into consideration the public policy defence that the Government would inevitably present: that it was acting in the public interest by affording as many people protection from Covid-19 in as short a time as possible.
For confidential legal advice on this or any other medical negligence issue, contact us today for a free initial consultation with one of our specialist medical negligence solicitors on 01245 253214 or email [email protected]
This article is for general information only and does not constitute legal or professional advice. Please note that the law may have changed since this article was published.