Notes for Lead Clinician / HCP operating under a PGD

The Health Care Professional carrying out the clinical assessment should be aware of the MHRA Conditions of authorisation, the vaccine’s contraindications together with the advice from JCVI.

Anaphylaxis

Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine.
For the Pfizer BioNTech Covid-19 mRNA Vaccine (Comirnaty®) and the COVID-19 Vaccine Moderna (Spikevax®) close observation for at least 15 minutes is recommended following vaccination. A second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of either mRNA vaccine.

This requirement is not specified for the Covid-19 Vaccine Vaxzevria (AstraZeneca) however recipients should be observed for any immediate adverse reactions post-immunisation, with supporting information and subsequent appointment provided if required.

If the recipient of a vaccine is the driver of a vehicle, they should be asked not to drive for 15 minutes to reduce the chance of vasovagal attack whilst driving.

*Contraindications

Hypersensitivity to any of the ingredients is a contraindication for all vaccines.

This would include an allergy to any of the following ingredientsfor the Comirnaty® (Pfizer BioNTech Covid-19 vaccine):
https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/summary-of-product-characteristics-for-covid-19-vaccine-pfizerbiontech

or heref or the Covid-19 Vaccine Vaxzevria (AstraZeneca):
https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca/information-for-healthcare-professionals-on-covid-19-vaccine-astrazeneca

or here for the Spikevax® (Covid-19 Vaccine Moderna):
https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna/information-for-healthcare-professionals-on-covid-19-vaccine-moderna

Contraindications to the Covid-19 Vaccine Vaxzevria (AstraZeneca) now include:

Patients with a history of heparin-induced thrombocytopenia and thrombosis (HITT or HIT type 2). Patients who have experienced major venous and/or arterial thrombosis occurring with thrombocytopenia following vaccination with any COVID-19 vaccine should not receive a second dose of COVID-19 Vaccine Vaxzevria (AstraZeneca).

This condition is rare, tends to present with unusual forms of clotting and the mechanism is believed to be an idiosyncratic reaction related to an immune response to the first dose of the COVID-19 Vaccine Vaxzevria (AstraZeneca). Because of this likely immune mechanism, there are no risk factors or a reason to believe that individuals with a past history of clots or of certain thrombophilic conditions would be at increased risk of this very rare condition. Please refer to the clinical lead if you are unsure.

As a precautionary measure, administration of the COVID-19 Vaccine Vaxzevria (AstraZeneca) in patients with a history of cerebral venous sinus thrombosis with thrombocytopenia or antiphospholipid syndrome should only be considered when the benefit outweighs any potential risks. This discussion must be carried out by a healthcare professional who is competent to explain and discuss the risks of covid-19 infection for that individual and the benefits that vaccination can offer.

Further information can be found in the updated chapter of the green book.

Frequently Asked Questions: MHRA and JCVI guidance on COVID-19 Vaccine Vaxzevria (AstraZeneca) and very rare clotting disorders are available here.

Further information for healthcare professionals is also available here.

Capillary Leak Syndrome

Very rare cases of capillary leak syndrome (CLS) have been reported in the first days after vaccination with Vaxzevria (AstraZeneca). A history of CLS was apparent in some of the cases. Fatal outcome has been reported. CLS is a rare disorder characterised by acute episodes of oedema mainly affecting the limbs, hypotension, haemoconcentration and hypoalbuminaemia. Patients with an acute episode of CLS following vaccination require prompt recognition and treatment. Intensive supportive therapy is usually warranted. Individuals with a known history of CLS should not be vaccinated with this vaccine.

¹People under the age of 18

Only Comirnaty® (PfizerBioNTech) vaccine is currently the preferred vaccine for people aged between 12 and 17.

²Drug Allergies

The Comirnaty® (Pfizer BioNTech) COVID-19 vaccine and the COVID-19 Vaccine Spikevax® (Moderna) both contain polyethylene glycol (PEG), a known allergen commonly found in medicines and also in household goods and cosmetics. Medicines containing PEG include some tablets, laxatives, depot steroid injections, and some bowel preparations used for colonoscopy. Antibiotics do not contain PEG. Public Health England’s Immunisation Against Infectious Disease (the Green Book) advises that a known allergy to PEG is extremely rare but would contraindicate receipt of this vaccine. Patients with undiagnosed PEG allergy may have a history of unexplained anaphylaxis or of anaphylaxis to multiple classes of drugs. Those with a PEG allergy can still receive the AZ vaccine.

The rate of anaphylaxis reported to date to the Vaxzevria (AstraZeneca) vaccine is in line with the expected rate of anaphylaxis to non-COVID vaccines.

The Vaxzevria (AstraZeneca) vaccine does not contain PEG but does contain a related compound called polysorbate 80. Some people with PEG allergy may also be allergic to polysorbate 80. However, polysorbate 80 is widely used in medicines and foods, and is present in many medicines including monoclonal antibody preparations. Some injected influenza vaccines (including the main vaccine used in over 65-year olds) contain polysorbate 80. Individuals who have tolerated injections that contain polysorbate 80 (such as certain influenza vaccines) are likely to tolerate the Vaxzevria (AstraZeneca) vaccine.

Pregnancy

The JCVI has advised that pregnant women should be offered the COVID-19 vaccine at the same time as the rest of the population, based on their age and clinical risk group. Data from the United States shows that around 90,000 pregnant women have been vaccinated, mainly with mRNA vaccines including Comirnaty® (PfizerBioNTech) and Spikevax® (Moderna), without any safety concerns being raised.

Based on this data, the Joint Committee on Vaccination and Immunisation (JCVI) advises that it’s preferable for pregnant women in the UK to be offered the Comirnaty® (PfizerBioNTech) or Spikevax® (Moderna) vaccines where available. There is no evidence to suggest that other vaccines are unsafe for pregnant women, but more research is needed.

There is also no evidence that pregnancy is a risk factor for vaccine induced thrombosis and thrombocytopenia (VITT) and there have been no reported cases after vaccination of pregnant women.