Journalist and TV presenter Baroness Dame Joan Bakewell is threatening the Government with legal action over delays to the second dose of the Pfizer/BioNTech vaccine.
The Labour life peer said there were grounds to show the decision taken by ministers to delay the second dose by up to 12 weeks was unlawful.
Originally, those having the vaccine 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.
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.
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.”
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.”
The second dose of the vaccine from Oxford University and AstraZeneca will also be administered up to 12 weeks later under the new policy.
Its clinical trial data showed that many of those given the jab had their second dose in varying timeframes.
Stephanie Hill, solicitor at Leigh Day, said: “The Covid-19 pandemic has created exceptional challenges. Our client, like everybody, hopes that the vaccination programme will be rolled out as quickly as possible.
“It is crucial that any changes to the vaccination programme are made lawfully, in accordance with regulatory approval, and with the informed consent of patients.”
Baroness Bakewell is fundraising for the legal costs for the case.
David Taylor, emeritus professor of pharmaceutical and public health policy at University College London, speaking at the UCL School of Pharmacy and Royal Pharmaceutical Society 2021 lecture on Tuesday, said: “I strongly support the British approach to delaying booster doses of Covid-19 vaccines on public health grounds.
“The evidence is it will save lives. Despite past problems with Government pandemic control policies we can be confident they are world class with regard to immunisation.”
A Department of Health and Social Care spokesperson said: “Getting vaccines deployed as rapidly as possible to as many at risk older and clinically vulnerable people, as well as frontline health and social care workers, is our number one priority.
“The decision by the MHRA to change vaccine dosage intervals followed a thorough review of the data and was in line with the recommendations of the UK’s four chief medical officers.
“The Government is closely following the guidance of the Joint Committee on Vaccination and Immunisation (JCVI) which recommended we prioritise first doses of vaccine for as many people as possible initially.”
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