Clinical Update - COVID-19 Vaccination Program

Dear colleagues,

Thank you for your ongoing support with the COVID-19 vaccination program roll-out. The following Clinical Update on the COVID-19 Vaccination Program is provided by NSW Health and is current at the date of publication 20th September 2021.

Key messages:

• NSW Health encourages everyone 12 years and over in NSW to strongly consider getting their COVID-19 vaccination now, with any COVID-19 vaccine that is available (noting the AstraZeneca COVID-19 vaccine is only registered for use in those 18 years and over)
• There are still vulnerable and at-risk groups in the community that are unvaccinated. Please continue to prioritise these groups for vaccination where possible
• The Comirnaty (Pfizer) and Spikevax (Moderna) vaccines have been provisionally approved for use in children 12 years and over
• ATAGI advises that the benefits of offering COVID-19 vaccination to all adolescents aged 12-15 years outweigh the known or potential risks and recommends inclusion of this age group in the Australian COVID-19 vaccination program
• NSW Health advises use of a 4 to 8-week interval between doses of the Vaxzevria (AstraZeneca) vaccine, for all of NSW
• A second dose interval of 4 to 6 weeks for Spikevax (Moderna) vaccination is recommended
• A second dose interval of 3 to 6 weeks for Comirnaty (Pfizer) vaccination is recommended
• Ensure you download your COVID-19 vaccine digital certificate – information on how this can be completed is available here
• Information on vaccination of people with past SARS-CoV-2 infection – see below
• Ensure appropriate personal protective equipment is worn by all staff at all times when providing direct care to patients

Highlights and updates:

• To 14 September 2021, 80% of NSW residents aged 16 years and over have received at least one dose of COVID-19 vaccine, and 48.5% are fully vaccinated – here
• ATAGI update following weekly COVID-19 meeting – 15 September – here
• ATAGI recommendations on the use of COVID-19 vaccines in all young adolescents in Australia – 27 August – here
• COVID-19 vaccination decision guide for people who are pregnant, breastfeeding or planning pregnancy – updated 2 September – here

Key resources:

• Primary care guidance on the approach to suspected thrombosis with thrombocytopaenia syndrome (TTS) – 4 August – here
• COVID-19 vaccine clinical considerations update – 10 September - here
• The Thrombosis & Haemostasis Society of Australia and New Zealand (THANZ) COVID-19 resources & TTS blood test request form – here
• The Australasian College of Emergency Medicine (ACEM) guidelines – v2; June – here
• Information on informed consent and a discussion tool for weighing up the risks and benefits of COVID-19 AstraZeneca vaccine here
• Clinical Excellence Commission latest infection prevention and control resources are available – here

Currently, individuals are only able to access a COVID-19 Digital Certificate after they have received all required doses of a vaccine approved for use in Australia. The Australian Immunisation Register (AIR) system rules for determining an individual’s COVID-19 vaccination status are based on ATAGI clinical guidance. Enhancements to the AIR will be implemented in mid-September 2021 to ensure that individuals who have received a mixed vaccination schedule can access a COVID-19 Digital Certificate. In the interim, individuals can use their Immunisation History Statement (IHS) as proof of vaccination.

People with a past SARS-CoV-2 infection

Past confirmed infection with SARS-CoV-2 is not a contraindication to vaccination, however ATAGI recommends deferring COVID-19 vaccination for up to 6 months after PCR confirmed infection. Current evidence suggests that the risk of SARS-CoV-2 re-infection is low in the 6 months after initial infection but may increase with time due to waning immunity. There are some situations where it may be reasonable to be vaccinated earlier than 6 months following infection in consultation with a health practitioner, such as people working in a job with a high risk of exposure to SARS-CoV-2, or patients who are significantly immunocompromised and who may not have a strong immune response after being infected with the virus.

If a person is infected with SARS-CoV-2 and has had their first dose of COVID-19 vaccine, the second dose may be deferred for up to 6 months. In these situations, the person should consult their healthcare professional and their individual circumstances should be considered.

ATAGI clinical guidance on the use of COVID-19 vaccine in Australia – v 7.2 updated 9 Sept 2021 – here

Updates from the latest guidance:

• Vaccination against COVID-19 is recommended for all individuals from 12 years of age
• People with a history of congenital heart disease, cardiac transplant or cardiomyopathy can receive an mRNA COVID-19 vaccine without any precautions
• A second dose of a COVID-19 vaccine administered <14 days after the first dose is considered an invalid dose and an additional COVID-19 vaccine dose should be administered as a replacement dose
• Comirnaty (Pfizer) is provisionally registered by the TGA in people aged ≥12 years and is given in a two-dose schedule. Short-term efficacy against symptomatic COVID-19 is about 95% from seven days after the second dose in people aged ≥12 years
• Spikevax (Moderna Australia) is provisionally registered in people aged ≥12 years and is given in a two-dose schedule. Short-term efficacy against symptomatic COVID-19 is approximately 94% from two weeks after the second dose in people aged ≥18 years, and similar in adolescents aged 12–17 years
• Vaxzevria (AstraZeneca) is provisionally registered in people aged ≥18 years and is given in a two-dose schedule. Short-term efficacy against symptomatic COVID-19 ranges from about 62% to 73%, with the higher efficacy seen after a longer interval (12 weeks) between doses. Efficacy from day 22 after the first dose up until 12 weeks is about 73%
• The effectiveness of all 3 vaccines against symptomatic infection with the Delta strain of SARS-CoV-2 is reduced compared with earlier variants and the original virus, however protection against hospitalisation is maintained
• ATAGI recommends completing the vaccination course with the same vaccine. Mixed (heterologous) schedules using 2 different vaccines to complete the primary vaccination course are only recommended in special circumstances such as for those with serious vaccine-attributed adverse events after the first dose and in those who were partially vaccinated overseas with a brand not available in Australia
• Updated summary information on adverse events following COVID-19 vaccines.

ATAGI recommendations on the use of COVID-19 vaccines in all young adolescents in Australia – here

ATAGI has reviewed relevant benefits, risks and uncertainties of emerging information from overseas vaccination, and have recommended vaccination against COVID-19 for all individuals from 12 years of age. ATAGI recommends that the following groups of children aged 12-15 years be prioritised for vaccination:

• Children with specified medical conditions (immunocompromising conditions, other underlying conditions including chronic renal and lung disease) that increase their risk of severe COVID-19, including NDIS participants
• Aboriginal and Torres Strait Islander children aged 12–15 years
• All children aged 12–15 years in remote communities, as part of broader community outreach vaccination programs that provide vaccines for all ages (≥12 years).

COVID-19 vaccine claims scheme announced by the Australian Government – here

The Australian Government is developing a claims scheme to reimburse people who suffer a moderate to significant impact following an adverse reaction to an approved COVID-19 vaccine. Information about how to lodge a claim can be found here.

COVID-19 vaccination decision guide for people who are pregnant, breastfeeding or planning pregnancy – updated on 2 September – here

• The newly registered Spikevax (Moderna) COVID-19 vaccine is included in this advice
• If Pfizer or Moderna are not available, Vaxzevria (AstraZeneca) can be considered if the benefits to the individual outweigh the potential risk
• Pregnant people are a priority group for COVID-19 vaccination and should be routinely offered Comirnaty (Pfizer) or Spikevax (Moderna) vaccine at any stage of pregnancy
• There are no theoretical safety concerns regarding use of the Vaxzevria (AstraZeneca) in breastfeeding women, or women planning pregnancy
• Those who are trying to become pregnant do not need to delay vaccination or avoid becoming pregnant after vaccination
• Pregnant women have a higher risk of severe illness from COVID-19, and premature birth occurs more commonly
• COVID-19 vaccination may provide indirect protection to babies by placental antibody transfer or through breastmilk.

ATAGI and CSANZ guidance on myocarditis and pericarditis following mRNA vaccination

• People with a history of myocarditis or pericarditis more than 6 months previously can be vaccinated without additional precautions
• People who have precautions to vaccination can consult a GP, immunisation specialist or cardiologist before vaccination for advice
• Most pre-existing cardiac conditions are not regarded as contraindications to vaccination. Comirnaty (Pfizer) vaccine can be administered to people with a history of heart conditions: this includes coronary artery disease, myocardial infarction, stable heart failure, arrhythmias, rheumatic fever, rheumatic heart disease (RHD), Kawasaki Disease, most congenital heart disease and people with an implantable cardiac device.

A risk of myocarditis and pericarditis has been observed in people who have received mRNA COVID-19 vaccines in overseas studies, particularly in males under 30 years of age after the second vaccine dose. Symptoms typically appear within 1-5 days of vaccination and include chest pain, palpitations (irregular heartbeat), syncope (fainting) or shortness of breath. People who experience any of these symptoms after having an mRNA COVID-19 vaccine should seek prompt medical attention. Initial investigations for people presenting with symptoms or signs of myocarditis or pericarditis should include an ECG, troponin, chest X-ray, and investigations for differential diagnoses as clinically indicated (e.g. viral or autoimmune screens).

People who develop myocarditis or pericarditis attributed to their first dose of Comirnaty (Pfizer) are advised to defer further doses of an mRNA COVID-19 vaccine and to discuss this with their treating doctor.

Second dose COVID-19 AstraZeneca vaccine in the setting of a precautionary condition – here

People who are diagnosed with a precautionary condition (including CVST, HIT, splanchnic vein thrombosis, antiphospholipid syndrome with thrombosis and/or miscarriage or capillary leak syndrome) after receiving a first dose of Vaxzevria (AstraZeneca) vaccine are recommended to receive an alternative vaccine (currently Comirnaty (Pfizer)) as their second dose. In these instances, Comirnaty (Pfizer) should be given within a period of 4-12 weeks following dose one of Vaxzevria (AstraZeneca) vaccine.

Administering COVID-19 vaccines before or after anaesthesia or surgery – here & ACI rapid evidence check on this topic – here

Recent or imminent surgery is not a contraindication to vaccination; however, it is recommended to schedule COVID-19 vaccination more than one week before or after surgery. This will reduce the chance that adverse events following the vaccination, such as fever, are attributed as a complication of surgery, such as a surgical wound infection.

If you suspect possible TTS in the 42 days after vaccination (e.g. thrombocytopenia on pre-operative screening bloods), you should perform investigations for TTS. You should defer surgery until TTS is ruled out, or if TTS is confirmed, until full recovery.

TGA weekly safety report – 16 September 2021 – here

Thrombosis with thrombocytopaenia syndrome (TTS)

Since the last TGA safety notice, there have been a further 5 reports of low platelets and blood clots assessed as confirmed or probable TTS likely to be linked to Vaxzevria (AstraZeneca). This takes the total Australian reports assessed as TTS following the Vaxzevria (AstraZeneca) vaccine to 134 cases (75 confirmed, 59 probable) from approximately 10.8 million vaccine doses. Although estimates of risk based on small numbers of cases are imprecise, the risk of TTS in Australia is estimated by ATAGI to be around 2.4 per 100,000 in those < 60 years and 1.8 per 100, 000 in those ≥ 60 years.

In Australia, severe cases of TTS appear to be more common in women in younger age groups who seem to be slightly more likely to develop clots in unusual locations, such as the brain or abdomen, which have more serious outcomes.

Cases have most often occurred about 2 weeks after vaccination, although the time to onset (or diagnosis) has ranged from one to 83 days.

Myocarditis and pericarditis

The TGA and ATAGI continue to monitor reports of myocarditis and pericarditis. Symptoms that could suggest myocarditis or pericarditis include chest pain (including pressure), palpitations or shortness of breath, particularly if they occur within 1-5 days. As of 12 September 2021, the TGA has received 457 reports of suspected myocarditis and/or pericarditis following vaccination with Comirnaty (Pfizer). Myocarditis and pericarditis can occur due to other causes, including common viral infections, so it is expected that many reported cases may not be related to vaccination. Of the reports received, 128 reported suspected myocarditis, of which 90 were classified as likely to be myocarditis, 11 were deemed unlikely to be myocarditis, and 27 could not be classified because they did not contain enough information. For the cases classified as likely to be myocarditis patients were between 16 and 60 years old. When reported, most of the patients experienced symptoms within 3-4 days of vaccination. Over half of the patients required treatment in hospital, with 5 patients requiring treatment in intensive care.

Of note, in data from the US, where many more Comirnaty (Pfizer) vaccine doses have been given to individuals aged 12–17 years, the rates of myocarditis/pericarditis reported in males were 10 cases per million first doses and 67 cases per million second doses. Most of these cases were mild, and the patients recovered quickly following supportive care.

Myocarditis and pericarditis are much more common with COVID-19 infection and the cardiac risk can be more severe in this context. ATAGI has emphasised that the benefits of protection with vaccination against COVID-19 far outweigh these rare side effects.

Guillain-Barré Syndrome (GBS)

The TGA has been closely monitoring reports of GBS following Vaxzevria (AstraZeneca) since the start of the COVID-19 vaccine rollout. As of 12 September 2021, the TGA has received 115 reports of suspected GBS in people who have received the Vaxzevria (AstraZeneca) vaccine. It is expected that some suspected cases may not be related to vaccination, as GBS can also be caused by other conditions, such as a viral infection or some types of gastroenteritis.

Following an investigation, the TGA, along with other international drug regulators, have so far been unable to establish a clear link between GBS and Vaxzevria. As a precautionary measure, a warning statement about GBS has been added to the Product Information. This is in response to rare cases following vaccination in Australia and internationally. Symptoms that could suggest GBS include weakness and paralysis in the hands or feet that can progress to the chest and face over a few days or weeks and tend to affect both sides of the body.

Immune thrombocytopenia (ITP)

As of 12 September 2021, the TGA has received 71 reports of suspected ITP following vaccination. These patients had an extremely low platelet count, and signs of thrombocytopenia which may include unusual bruising, a nosebleed and/or blood blisters in the mouth. These symptoms occurred in a timeframe that suggested they could be linked to vaccination, and no other obvious cause was identified based on the information provided to TGA. However, apart from one fatal case that was assessed by an expert Vaccine Safety Investigation Group as being likely to be vaccine related, these cases have not been definitively linked to vaccination.

Reminder – reporting adverse events following immunisation (AEFI)

An adverse event following immunisation (AEFI) is a notifiable condition under the NSW Public Health Act (2010). All uncommon, unexpected or serious AEFIs must be notified by health professionals to the local Public Health Unit (PHU) on 1300 066 055. This includes suspected cases.