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Baroness Dame Joan Bakewell raises concerns about decision to delay second COVID-19 vaccine

The journalist and television presenter, Baroness Dame Joan Bakewell is questioning the UK government’s decision to delay the second dose of the Pfizer-BioNTech vaccine, affecting many thousands of people most at risk from COVID-19.

Dame Joan Bakewell

12 January 2021

A letter has been sent, on behalf of journalist and television presenter Baroness Dame Joan Bakewell, to the Secretary of State for Health and Social Care about the lawfulness of the decision to change the national COVID-19 vaccination policy and the issuing of an NHS letter which instructed that the second dose of the Pfizer-BioNTech vaccine will now be administered up to three months after the first dose, rather than in 21 days. 
Baroness Bakewell, like many thousands of others, received her first dose of the vaccine in December 2020 with an appointment for the second dose confirmed for 21 days later. The announcements on 30 December left her in limbo, without any clarity or reassurance. 
Leigh Day has sent a letter to Secretary of State for Health and Social Care, Matt Hancock, who instructed vaccination sites to reschedule second dose appointments and prioritise delivering as many first doses of the vaccine as possible.
The original vaccination programme had received regulatory approval and was supported by scientific trials on which regulatory approval was based. The status of the new programme is less clear.
The letter outlines three potential grounds for a judicial review into the vaccination policy:
  • Breach of the conditions of authorisation: the NHS Letter instructed health care professionals to act in a manner that appears to be contrary to the instructions for use that had been agreed between the MHRA and Pfizer.
  • Unlawful to depart from MHRA’s assessment: the evidence in granting temporary approval to the vaccine was sufficient in establishing effectiveness for 21 days (or at most 28 days). The MHRA is the body designated by law to determine such issues and it does not appear there was a proper or lawful basis for the government to depart from its assessment.  
  • Breach of legitimate expectations: it was clear from published documents and publicly made statements that the second dose would be administered 21 days after the first dose. Patients consented to a course of medical treatment on that understanding. The instruction contained in the NHS Letter breached these expectations and undermined their informed consent to the first dose.
Manufacturers BioNTech and Pfizer have warned against delaying the second dose and we are not aware of any evidence that the vaccine will protect against COVID-19 if the second dose is given later than it was tested in trials. 
The Secretary of State has been asked to respond to the letter sent by Leigh Day by today, Tuesday, 12 January 2021. 
Baroness Dame Joan Bakewell 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.”
Stephanie Hill, solicitor at Leigh Day, said: 
“We have sent a pre-action protocol letter to the Secretary of State for Health and Social Care following his decision to delay the second dose of the Pfizer COVID-19 vaccine. 
“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. 
“We urgently request for the Secretary of State to respond and provide a full account of the circumstances in which any changes to the programme were made.” 

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