COVID and Flu Vax Update - 17/2/21

Flu Vaccines:

At this stage, we have not had confirmation from the Government about Flu Vaccines and when they will become available for us to administer. As soon as we hear from the Government we will let our patients know. We expect there will be a delay in the 2021 Seasonal Flu Vaccines due to the rollout of the COVID Vaccines.

 

COVID Vaccines:

We have expressed our interest in becoming a COVID Vaccination Clinic. We have not had confirmation whether we have been successful or not.

If we are successful, we will be part of the Government's Phase 1b plan, which is scheduled at this stage to begin sometime in March (they may be delays). The vaccine applicable in Phase 1b is likely to be the University of Oxford/AstraZeneca Vaccine.

At this time there is limited information available but we have some information and links below regarding COVID Vaccines from the RACGP and the Department of Health:

 

 

 

 

Who will be eligible to receive the vaccine?

To check which phase you will likely be vaccinated in, click the following link from Australian Government: https://covid-vaccine.healthdirect.gov.au/eligibility

The Australian Government has announced that COVID-19 vaccination eligibility has been expanded, and will be available and free for all people living in Australia, including:

  • all Medicare-eligible Australians
  • all visa-holders, including refugees, asylum seekers, temporary protection visa holders, and those on bridging visas
  • people currently residing in detention facilities, including those whose visas have been cancelled. 

Due to the current funding model, people who are not eligible for Medicare will be unable to receive the vaccine through a general practice clinic. Access will be via state/territory managed vaccination clinics. Further details will be shared when available.

While the Australian Government strongly supports vaccination, it is not mandatory and individuals may choose not to vaccinate.

 

When will I get my vaccine?

To be confirmed (the planned Vaccine Rollout is copied in the table below). At this stage, we have not had confirmation from the Government if we will be involved in Phase 1b. If we are to be involved, we will receive additional information at that time from the Government which we will share with all our patients.

 

How can I book in for my vaccine?

There is talk about an online National Booking System being set up for vaccine appointments. At this stage, we are unsure how this will work but it is looking like patients will be able to book in online using this system, or by calling up COVID Vaccine clinics to make an appointment. More information on this should be released soon.

 

How will the vaccine be rolled out?

Vaccine administration for those most at risk is due to commence in mid-February 2021 after the Pfizer/BioNTech COVID-19 vaccine was granted provisional approval by the TGA. The vaccine roll-out will be via a phased approach, initially targeting high priority groups. 

 

Which vaccines will be available?

1. Pfizer/BioNTech Vaccine - The Therapeutic Goods Administration (TGA) has provisionally approved the Pfizer/BioNTech COVID-19 vaccine for use in Australia for people 16 years of age and over. The first priority groups in Australia will start receiving this vaccine in February 2021 as part of Phase 1a (not in General Practice).

2. University of Oxford/AstraZeneca Vaccine - If the vaccine is proven to be safe and effective, and is approved for use, it is likely to be available from March 2021 as part of Phase 1b (General Practices will be involved).

 

Vaccine Discussion Points:

  • Benefits of vaccination: The primary benefit of vaccination is protection against illness from COVID-19, and in particular protection against severe illness and death. The vaccine efficacy of Comirnaty in the phase II/III clinical trial was approximately 95% against symptomatic COVID-19 and was consistent across age groups.

  • It is possible that a vaccinated person may still become infected with SARS-CoV-2 and pass on the virus to someone else, regardless of whether they have any symptoms: It is currently unclear to what extent COVID-19 vaccines prevent asymptomatic infection or transmission of SARS-CoV-2 from a vaccinated person to others and in the population. This may also vary between different vaccines. Data on this will be gathered over time from additional clinical studies and as populations are vaccinated.

  • The need for a second dose of the same brand: Comirnaty requires two doses, as do the other COVID-19 vaccines anticipated to be available in Australia in 2021. The interval between doses may vary by brand. While the first dose will provide some protection, it may only be partial and may only last for the short-term. The second dose is needed to ensure optimal protection. The same vaccine brand should be used to complete the vaccination course. Vaccine recipients should be advised that they will need to make a booking for their second dose.

  • Continuation of other public health measures: Even after completing vaccination, all people must continue to practise public health measures to reduce their personal risk of infection with SARS-CoV-2 and of passing the virus to others, such as physical distancing, hand washing, wearing a face mask, COVID-19 testing and quarantine or isolation as required. As population-level immunity to the virus increases over time following widespread uptake of vaccination, these public health measures may be able to be eased, but only as advised by the local public health authorities.

  • Safety of COVID-19 vaccines: Comirnaty has been studied in tens of thousands of people, and is considered to be very safe. Tens of millions of people around the world have received a COVID-19 vaccine. Most side effects are mild and transient. Reactions at the injection site and some systemic reactions, like headaches, fever and fatigue, are very common within the first 48 hours. Very rarely, anaphylaxis has been reported after Comirnaty, occurring in the USA at a rate of about 5 cases per 1 million doses (as of January 2021). The potential for other rare or unanticipated side effects to emerge over time is low, but is being closely monitored, as for any vaccine or medicine.

  • Management of side effects: Most side effects start within 24 hours of vaccination and will resolve in 1–2 days on their own. To reduce discomfort, paracetamol or ibuprofen can be taken. Some of the expected vaccine side effects overlap with the symptoms of SARS-CoV-2 infection, such as fever. However, a key differentiating factor is that respiratory symptoms (e.g. cough, runny nose etc.) are not known to be associated with Comirnaty.

  • Isolation or testing after vaccination: Local public health guidance on criteria for SARS-CoV-2 testing should always be followed. People who have typical non-respiratory side effects (e.g. injection side pain, fever, lethargy) within the first 48 hours after vaccination with a complete absence of any respiratory symptoms may not need to get a COVID-19 test or isolate. Comirnaty is not known to cause respiratory symptoms such as rhinorrhoea or cough, and people with respiratory symptoms should be tested for SARS-CoV-2 as per local testing criteria.

  • Seeking medical attention after vaccination: Vaccine recipients should be advised to seek medical attention if they are concerned about a symptom, have new or unexpected symptoms, or if they have symptoms which have not resolved after several days. Vaccine recipients with any suggestion of an allergic reaction to vaccination within the first 1–2 days should also seek care, noting that the great majority of (rare) serious allergic reactions present within the first 15–30 minutes after vaccination.

  • Vaccine safety monitoring: Vaccine recipients may be contacted in the week after vaccination via SMS with a brief survey to collect data on any adverse events following the vaccine. This is part of a national adverse events surveillance system called AusVaxSafety. Adverse events can also be reported by the recipient or by the immunisation provider to their state or territory health department or to the Therapeutic Goods Administration (TGA). Refer to Question 13 below for further information.

  • Reporting of vaccinations: All COVID-19 vaccinations must be recorded on the Australian Immunisation Register (AIR). This will be a mandatory requirement under national legislation. Vaccine recipients can obtain a copy of their immunisation history statement online via their Medicare Online account through myGov.

  • Personal details collection: Please notify patients on how their personal details are collected, stored and used. For more information visit: https://www.health.gov.au/covid19-vaccines

 

Frequently Asked Questions:

  • Is it mandatory to get a COVID-19 vaccine?

No, it is not mandatory to get a COVID-19 vaccine. While the Australian Government strongly recommends COVID-19 vaccination, individuals can choose not to be vaccinated.It is possible that in the future, vaccination against COVID-19 might become a requirement for travel to certain destinations or for people working in or visiting certain high-risk workplaces or facilities, such as aged care facilities. If this becomes the case, there will be exemptions in place for people who are unable to be vaccinated.

  • How much does it cost to get a COVID-19 vaccine?

People residing in the Australian community, including visa holders, will be eligible for the COVID-19 vaccine national rollout according to priority groups. The COVID-19 vaccine will be voluntary, universal and free. The Government aims to have as many Australians as possible choose to be vaccinated for COVID-19. More information can be found in: Australia’s COVID-19 Vaccine and Treatment Strategy.

  • How long does it take for Comirnaty to work after receiving it?

Comirnaty may provide partial protection against COVID-19 as soon as 12 days after the first dose. However, this protection is likely to be short lived unless a second dose is given, and all people are recommended to receive the second dose to provide optimal protection.

  • What if a person does not get the second dose of Comirnaty?

A single dose of Comirnaty will provide only partial protection against COVID-19 and this protection is likely to be of shorter duration unless the second dose is given. For optimal protection against COVID-19, two doses are required.

  • What are the side effects of Comirnaty?

The side effects from Comirnaty are generally mild and short-lived, with onset mostly within 1 day after vaccination and duration of approximately 1–2 days.

In clinical trials, the most commonly reported adverse events in the first week after vaccination were:

  • Injection site pain (84.1%)
  • Fatigue (62.9%)
  • Headache (55.1%)
  • Muscle pain (38.3%)
  • Chills (31.9%)
  • Joint pain (23.6)
  • Fever (14.2%)
  • Injection site swelling (10.5%)

Clinical trial participants also rarely (0.3%) reported mild and transient lymphadenopathy (predominantly axillary or cervical) following vaccination, which may be related to the immune response to the vaccine.

Adverse events such as respiratory symptoms, vomiting and diarrhoea were no more common in the first week after vaccination in vaccine as compared with placebo recipients, meaning such symptoms are unlikely to be attributable to vaccination.

The adverse events described above were slightly more common after the second dose, and slightly less common in people over 55 years of age than in younger adults.

  • Are there any serious safety risks associated with Comirnaty?

The only known vaccine-related serious risk from Comirnaty is anaphylaxis. Anaphylaxis (a severe allergic reaction) is known to occur rarely after any type of vaccine.

No cases of anaphylaxis were seen in the phase II/III study of Comirnaty. However, anaphylaxis has been very rarely reported in US recipients of Comirnaty at a rate of around 5 cases per million doses administered (as of January 2021). Most of the recipients who experienced anaphylaxis had symptom onset within 30 minutes (90%). The majority had a past history of a known allergy, and 24% had a past history of anaphylaxis. The exact cause of anaphylaxis in these patients (e.g. if it was a particular component of the vaccine, such as polyethylene glycol) is still being investigated. No other serious adverse events have been confirmed to be directly linked to Comirnaty.

In the phase II/III clinical trial of Comirnaty there were four cases of Bell’s palsy (idiopathic lower motor neuron seventh nerve palsy, leading to weakness of one side of the face) in the vaccine group compared to zero cases in the control group. This was still very rare and occurred at a rate consistent with the expected background rate of Bell’s palsy. Therefore, the numerical imbalance in the trial may have been coincidental. This and a range of other adverse events of special interest are being monitored in post-market vaccine safety surveillance to determine, although very unlikely, if vaccination is linked with any unwanted rare or unexpected health outcomes.

 

More information can be found at the following websites: