GPs may be able to get an extra dose of the Pfizer/BioNTech Covid-19 vaccine out of some vials, according to new guidance from NHS England.
GPs were told during a webinar yesterday evening that the advice had been to use 1.8ml in diluting each vial but then to only draw five 0.3ml doses.
Concerns had been raised that with this approach some vials may contain another full dose that was being wasted.
GPs were advised that they were permitted to use a sixth full dose from the vial if in their professional judgment they could draw up the full 0.3ml.
But vaccinators should not mix residue from one vial with residue from another to make full dose, she told the webinar.
The Medicines and Healthcare products Regulatory Agency later said it had been consulted on the surplus dose and had ‘raised no objections’.
Webinar host Dr Nikki Kanani, primary care medical director at NHS England, also told attendees that she has not had, or been offered, a vaccine yet.
A message circulated today by NHS England’s Covid-19 Incident Coordination Centre for the East of England, seen by Pulse, stated: ‘Healthcare professionals must always use the correct volume of diluent, and after dilution must aim to secure five full 0.3ml doses of this Pfizer-BioNTech Covid vaccine in line with the manufacturer’s instructions and as outlined in the Information for Healthcare Professionals.
‘After that has been done, there may be potential for a sixth full dose with some vials due to variances in fill volume and the syringe /needle hold up volume combinations used. This should be subject to health care professional judgement on a case by case basis. The manufacturer has stressed care should be taken to ensure a full 0.3 mL dose will be administered to the patient from the same vial. Where a full 0.3 mL dose cannot be extracted the contents should be discarded.
‘The vaccine does not contain a preservative so it is best practice for all doses to be used as soon as possible after dilution, although all doses from a single prepared vial must be administered within 6 hours of the time of dilution. If further advice is required, in hospitals and vaccination centres please discuss with your Chief Pharmacist, and in local vaccination services, your Lead Responsible CCG Chief Pharmacist and Lead GP.’
Meanwhile, the national protocol for administering the Covid-19 vaccine has been published. It features a list of those who should not be given the vaccine, including those who have had a confirmed Covid-19 infection in the four weeks before.
The protocol – which is an alternative legal mechanism to the recently published patient group direction for giving the vaccine – lays out what registered and unregistered practitioners are allowed to do at different stages of delivering the vaccine.
It confirmed patients are excluded from vaccination if they:
- are less than 16 years of age
- have had a confirmed anaphylactic reaction to a previous dose of a Covid-19 vaccine
- have had a confirmed anaphylactic reaction to any component of the vaccine or residues from the manufacturing process
- are pregnant, think they may be pregnant, are planning to get pregnant or are breastfeeding
- are suffering from acute severe febrile illness (the presence of a minor infection is not a contraindication for vaccination)
- have had confirmed Covid-19 infection in the preceding 4 weeks
- are participating in a clinical trial of Covid-19 vaccines
- have received a dose of Covid-19 vaccine in the preceding 21 days
- have completed a course of Covid-19 vaccination
- are advised by the MHRA not to received Covid-19 mRNA vaccine BNT162b2
The Government reported that 137,000 people in the UK have received the first dose of the Pfizer/BioNTech Covid-19 vaccine in the first week of the vaccination programme.
The provisional figures show 137,897 people received the first of the two doses – which must be given 21 days apart – between 8 and 15 December, with 108,000 vaccinated in England.
Most of the vaccines have been administered to the over-80s, care home workers and NHS staff, the Government said.
Some GPs had reported issues with delivery of vaccine stock leading to delays in roll out.
Around 100 GP sites were set to receive Covid vaccine stock on Monday, with ‘at least another 100’ to receive theirs on Tuesday and more planned for later this week, NHS England said.
An MHRA spokesperson said: ‘The Pfizer/BioNTech vaccine is approved for supply in vials that contain five doses. The manufacturer has designed the fill volume to make sure the full five doses of product can be extracted from all vials. A small amount of liquid will generally be retained in the vial after five doses have been extracted.
‘We are aware of NHSE’s advice regarding the use of any surplus, and we have raised no objections.’