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Pharmacists highlight concerns over needles and syringes supplied with the Spikevax® Bivalent vaccine

The PDA understands that UK Health Security Agency is monitoring feedback regarding the Spikevax® Bivalent needles and syringes, with new guidance expected to be developed.

Fri 23rd September 2022 The PDA

The PDA has learned of recent concerns about the needles and syringes supplied with the Moderna Spikevax® Bivalent vaccine. This includes reports of bending when vaccinators pierce the top of the vial containing the Covid-19 vaccine doses, needles falling out during manipulation and appearing to be bent even before removal from the packaging.

PDA members who are working in a Covid-19 vaccination role are advised to report any concerns via the Yellow Card medical device reporting system, and to keep up to date with NHS clinical updates for ongoing information and guidance.

Current advice from NHS sources includes the sharing of video and poster resources (available on FutureNHS) which have been produced by the supplier to support the introduction of the new administration needles and syringes for Spikevax® Bivalent. This is following a switch from BD Flu+ 23G x 25mm 1ml syringe combined needle and syringe (CNS) to the Owen Mumford Unifine Safety Retractable Needle 25G x 25mm & 1ml Syringe.

However, it should be noted that the video and poster produced by the supplier to support the introduction of new administration needles and syringes are generic for the product and not specific to the Covid-19 programme. Local procedures, including Infection Prevention and Control (IPC) and vaccine handling, may differ from that demonstrated. The NHS England Clinical Bulletin of 24 August 2022 (available on FutureNHS) reminds sites that they need to adhere to the specific procedures/guidance related to Covid-19 vaccination which are covered in the national and local Standard Operating Procedures (SOPs) and training. It highlights that, “a note has been added to the video to reflect the general usage instructions: The purpose of this video is to demonstrate the features of the needle/syringe. It is not intended as a training resource regarding other aspects of practice and, where those shown differ from national/ local guidance, current recommendations should be followed.

Some staff may have been advised to informally revert to the syringe type previously used in the interim period. PDA members should refer to clinical leads, and national and local protocols and SOPs must be adhered to.

Further information on this topic can be found on the Covid-19 Vaccination Programme FutureNHS site, registration required.

The PDA will continue to monitor the situation.

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