Baroness Joan Bakewell threatens Government with legal action over delays to second Pfizer vaccine jab

Baroness Dame Joan Bakewell has said the grounds to delay the second jab were unlawful
Ian Gavan/Getty
Luke O'Reilly12 January 2021

The Government has been threatened with legal action by Dame Joan Bakewell over delays to the second dose of the Pfizer/BioNTech vaccine.

Originally, Pfizer vaccine recipients were told their doses would be given 21 days apart but the Government has now stretched the timeline for the second dose to between three and 12 weeks.

It did this following a recommendation from the Joint Committee on Vaccinations and Immunisation (JCVI) to give more people a first dose of the vaccine.

Labour life peer Baroness Bakewell said there were grounds to show the decision taken by ministers to delay the second dose by up to 12 weeks was unlawful.

Baroness Bakewell, 87, has instructed the law firm Leigh Day to start proceedings in response to the new dosing policy, and names the respondent as Health Secretary Matt Hancock.

The Leigh Day letter, marked “Urgent: Proposed claim for judicial review”, says: “Our client is fully supportive of the national effort to meet the exceptional challenges posed by the pandemic.

“Our client is, however, concerned that the Government’s instruction to delay the provision of the second dose of the Pfizer vaccine is potentially unlawful and unsafe and would therefore impede rather than advance the pandemic response.”

The letter sets out three potential grounds for judicial review, including breach of the conditions of authorisation.

It says the move to delay doses appears to be “contrary to the instructions for use” that had been agreed between the regulator the Medicines and Healthcare products Regulatory Agency (MHRA) and Pfizer.

Britain's Prime Minister Boris Johnson visits a COVID-19 vaccination centre at Ashton Stadium in Bristol
The Government decided to delay the second dose 
REUTERS

A second potential breach is that it “does not appear there was a proper or lawful basis for the Government to depart” from the MHRA’s assessment of the vaccine.

A third issue is a “breach of legitimate expectations”, with patients consenting to a course of medical treatment on the understanding they would get a second dose after 21 days.

Baroness Bakewell, who received her first dose of the Pfizer vaccine in December, said: “Older people are in limbo: they need to know whether delaying the Pfizer vaccine is both safe and legal.

“I am bringing this case because I believe the Government needs to make this clear.”

Stanley Johnson has already received his second dose of the vaccine
AP

The move follows disquiet among some scientists about the 12-week delay, while Pfizer recommends the second dose of its jab is given after 21 days – as set out in its clinical trials.

Pfizer has said “the safety and efficacy of the vaccine has not been evaluated on different dosing schedules…there is no data to demonstrate that protection after the first dose is sustained after 21 days.”

Meanwhile, the World Health Organisation (WHO) said “there is very little empiric data from the trials that underpin this type of recommendation”.

Other scientists, writing in the British Medical Journal (BMJ), said the new policy is “not based on data from the trial, but on an assumption of what would have happened if the second dose hadn’t been given at 21 days”.

However, other experts have defended the policy, saying it will save the most lives from Covid-19.

England’s deputy chief medical officer, Professor Jonathan Van-Tam, said the data showed that patients got “almost complete protection” from their first dose of the Pfizer vaccine and could wait for their second dose.

He said JCVI analysis showed the vaccine was 89% effective against Covid-19 in the period of 15 to 21 days after the first dose, and it was unlikely that such protection would decline severely in the 12 weeks after the jab.

“Simply put, every time we vaccinate someone a second time, we are not vaccinating someone else for the first time,” he wrote in the Mail on Sunday.

“It means we are missing an opportunity to greatly reduce the chances of the most vulnerable people getting severely ill from Covid-19.”

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