Australia’s vaccine rollout: How it affects you

 

It took Australia's medical regulator a record 54 days to approve Pfizer's COVID-19 vaccine, four times faster than normal, but the watchdog is assuring Australians safety was not sacrificed for speed. Here we answer questions about how the Pfizer vaccine was approved so quickly and what it means for Australians.

HOW DOES A MEDICINE GAIN APPROVAL FOR USE IN AUSTRALIA?

Before a medicine or vaccine can be used in Australia is has to be assessed as safe and efficacious by the Therapeutic Goods Administration (TGA).

Pharmaceutical companies that wish to market a product here must submit evidence including the results of large scale clinical trials to the TGA to prove their medicine is safe to use in humans and that it works to prevent disease or improve a health condition.

HOW LONG DOES THIS PROCESS NORMALLY TAKE?

Normally this process takes around 255 days but because of the urgent need to combat the COVID-19 pandemic it was sped up for COVID-19 vaccines.

HOW WAS IT SPED UP?

Normally the TGA waits until the pharmaceutical company seeking approval submits all its evidence in a single submission before it considers whether to approve it for use.

Traditionally this is after the clinical trials on the medicine or vaccine are complete and have been reported and peer reviewed.

In the case of COVID-19 vaccines the TGA granted Pfizer, AstraZeneca and Johnson and Johnson a special "provisional" designations.

This meant experts at the TGA began reviewing clinical trial results as they came in rather than waiting for the final report giving the process a head start when the final trial results arrived.

WHEN DID PFIZER GAIN PROVISIONAL STATUS?

Pfizer's COVID-19 vaccine was granted provisional designation on October 14. This was more than a month before its large scale Phase 3 clinical trial had been completed.


WHEN DID PFIZER SUBMIT ITS FIRST EVIDENCE TO THE TGA?

Pfizer's provided its first submission of evidence backing its vaccine to the TGA on November 2 2020.

WHEN DID PFIZER COMPLETE ITS PHASE 3 CLINICAL TRIAL?

Pfizer announced the results of its large scale clinical trial in over 43,000 people On November 18 2020. This trial showed it was 95 per cent effective at preventing COVID-19.

When did other countries approve the Pfizer vaccine?

The UK medical regulator approved the Pfizer vaccine on December 2 2020, the US Food and Drug Administration approved the vaccine for emergency use on December 12 2020 and the EU approved it on December 21 2020.

WHEN DID THE TGA COMPLETE ITS EVALUATION OF THE VACCINE?

The TGA completed its evaluation of the Pfizer vaccine on January 8 2021 and then asked an expert committee the Advisory Committee on Vaccines for its views on the vaccine. This independent ten member group includes academics and physicians with expertise in scientific, medical and clinical fields it is chaired by Monash University infectious diseases expert Professor Allen Cheng.

After receiving advice from this group the TGA held a meeting to formally consider the vaccine for approval on January 15 and a decision to register it was made on January 24.

WHAT HAPPENS NEXT?

The TGA says it will actively monitor the safety of the Pfizer vaccine both in Australia and overseas and "will not hesitate to take action if safety concerns are identified".

"As an extra check, the TGA laboratories will undertake batch assessment of each batch of the vaccine before it can be supplied in Australia," the regulator said.

IS THE PFIZER VACCINE APPROVED FOR USE IN EVERYONE?

No. The TGA has only approved the vaccine for use in people aged over 16.

CAN EVERYONE WHO WANTS TO GET THE PFIZER VACCINE?

No. The government has only secured 10 million doses of the vaccine, enough to vaccinate just 5 million Australians. Frontline health care workers, residents in aged care facilities and the elderly will get first priority.

ARE THERE ANY SIDE EFFECTS?

Yes. Many people who received the vaccine reported sore arms, headaches, minor fever and mild flu like symptoms. These show the vaccine is working to stimulate the immune system.

A small number of people who suffered from severe allergies experienced anaphylactic responses after being injected with the vaccine. They recovered after adrenaline was administered.

Around 23 frail elderly patients in Norway died after receiving the Pfizer jab but a World Health Organisation and an investigation by Norway's medical regulator found there was no certain connection between the deaths and the vaccine. The number of deaths were similar to what would normally be expected for people in that age demographic.

HOW MANY SHOTS OF THE VACCINE ARE NEEDED?

You need two jabs of the Pfizer vaccine 21 days apart to be fully protected from COVID-19.

DO YOU NEED TWO SHOTS OF THE SAME VACCINE?

With multiple vaccines available it is vital people who are vaccinated ensure they receive two shots of the same vaccine to be protected. Patients may not be properly protected if they get one shot of the Pfizer vaccine followed by a shot of the AstraZeneca vaccine.

The Australian Government is planning to record the bar code of every vaccine injected against the patients name on a vaccination record to ensure they get two vaccines from the same manufacturer. This record system will also be used to monitor any adverse events.

CAN PREGNANT WOMEN USE THE PFIZER VACCINE?

The TGA says there is limited experience with the use of the vaccine in pregnant women and animal studies showed it did not produce direct or indirect effects on the pregnancy or embryo development or post natal development.

"Administration of COMIRNATY in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and fetus." it advises.

Can breast feeding mothers get the vaccine?

The TGA said it is unknown whether the vaccine is excreted in human milk. A combined fertility and developmental toxicity study in rats did not show harmful effects on offspring development before weaning.

CAN CANCER PATIENTS OR OTHER IMMUNOSUPPRESSED PATIENTS USE THE VACCINE?

The efficacy of COMIRNATY may be lower in immunosuppressed individuals, the TGA said.

ARE YOU IMMEDIATELY PROTECTED AFTER THE VACCINE?

Individuals may not be fully protected until 7 days after their second dose of the Pfizer vaccine the TGA said.

DOES THE VACCINE WORK IN PEOPLE AGED OVER 85?

The TGA said data for use in the frail elderly people aged over 85 years is limited.

"The potential benefits of vaccination versus the potential risk and clinical impact of even relatively mild systemic adverse events in the frail elderly should be carefully assessed on a case-by-case basis," the TGA said.

DOES THE VACCINE INTERACT WITH OTHER MEDICINES?

The answer to this question is not yet known because no interaction studies have been performed, the TGA said.

What are the most common adverse reactions?

The most frequent adverse reactions were:

* injection site pain (>80per cent),

* fatigue (>60 per cent),

*headache (>50per cent),

*muscle pain and chills (>30per cent),

*joint pain (>20per cent)

Fever and injection site swelling (>10per cent) and were usually mild or moderate in intensity and resolved within a few days after vaccination.

Older people were less likely to suffer side effects.


IS THE VACCINE EFFECTIVE IN ALL AGE GROUPS?

The TGA said the clinical trials showed the vaccine was slightly less effective in the elderly. Overall the Pfizer vaccine is 95 per cent effective but in those aged 65-74 is it only 92.9 per cent effective.

WHAT CHEMICALS ARE IN THE VACCINE?

*(4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315) 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159)

*Distearoylphosphatidylcholine (DSPC)

*Cholesterol

*Potassium chloride

*Monobasic potassium phosphate

*Sodium chloride

*Dibasic sodium phosphate dihydrate

*Sucrose

*Water for injections

The vaccine contains less than 1 mmol potassium (39 mg) per dose, that is to say essentially 'potassium-free'.

This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium‑free'

HOW DOES THE VACCINE NEED TO BE STORED?

The Pfizer vaccine must be stored at super cold temperatures of below -60 degrees Celsius. It can be held at room temperature (< 25 °C) for up to 5 minutes when transferring it between ultra-low-temperature environments.

Once removed from the freezer, the unopened vaccine can be stored for up to 5 days at 2 °C to 8 °C, and up to 2 hours at temperatures up to 30 °C, prior to use.

Once thawed, it should not be re-frozen.

THE VACCINE IS DELIVERED IN MULTI-DOSE VIALS WHAT DOES THIS MEAN?

The vaccine is delivered in multi-dose vials each containing 6 doses of the vaccine and it must be diluted with salt water before use

It remains stable for 6 hours at 2 ºC to 30 ºC after dilution but the TGA advises it be used immediately after it is diluted.

WILL YOU NEED TO HAVE REGULAR COVID-19 VACCINES?

It is not known how long the COVID-19 vaccine will protect people and it is possible an annual vaccination will be needed similar to the flu vaccination.

WHAT OTHER VACCINES WILL BE AVAILABLE IN AUSTRALIA?

Australia had agreements to purchase four COVID-19 vaccines but these options shrank to just three after the University of Queensland vaccine was cancelled last year.

The government increased its order for the Oxford/AstraZeneca vaccine to 53 million doses. This vaccine is being produced in Melbourne by CSL.

Orders for the Novavax vaccine were also increased to 51 million doses after the University of Queensland vaccine was stopped. This vaccine is still undergoing clinical trials.

We are also part of an international vaccine partnership called Covax which aims to distribute multiple vaccine supplies around the world.


WILL VACCINATION BE COMPULSORY?

No. The vaccine will be free and available to everyone but the government will not force Australians to have it. The government's vaccine policy states:

"While the Australian Government strongly supports immunisation and will run a strong campaign to encourage vaccination, it is not mandatory and individuals may choose not to vaccinate."

WILL YOU NEED TO BE VACCINATED TO TRAVEL OVERSEAS?

People wishing to travel overseas may need to be vaccinated.

"There may however, be circumstances where the Australian Government and other governments may introduce border entry or re-entry requirements that are conditional on proof of vaccination," the government's vaccination policy states.

Qantas CEO Alan Joyce recently signalled international travellers will have to have COVID-19 vaccine to get on a flight.

It is unclear at this stage whether the government will be satisfied a person is safe to enter Australia if they received a COVID-19 vaccine made in China or Russia.

HOW MANY COUNTRIES HAVE APPROVED THE PFIZER VACCINE?

The vaccine has now been granted a conditional marketing authorization, emergency use authorization, temporary authorization or provisional approval in a total of more than 50 countries, Pfizer said.

Originally published as Australia's vaccine rollout: How it affects you



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