HEALTH

COVID-19 vaccine manufacturer Pfizer has

made a big announcement — here's what to
make of it
ABC Health & Wellbeing / By health reporter Olivia Willis, science reporter Belinda Smith and Tegan Taylor
Posted Tue 10 Nov 2020 at 1:37pm , updated Wed 11 Nov 2020 at 12:25am

Pfizer says its coronavirus vaccine has 90 per cent efficacy, but what does that
mean? (AP: Siphiwe Sibeko)

Drug company Pfizer announced on Monday night that its COVID-19 vaccine may be 90 per cent effective
in stopping the virus — but it's not at the finish line yet.

The Pfizer trial is one of four potential vaccines the Australian Government has signed an agreement to
purchase, if it is successful.

Here are five things you need to know about this announcement.

LIVE UPDATES: Read our blog for the latest news on the COVID-19 pandemic.

What exactly have they announced?

Drug companies Pfizer and BioNTech announced their vaccine candidate was "more than 90 per cent
effective in preventing COVID-19" in people who, as far as they know, have not previously been infected
with the virus.

The vaccine, dubbed BNT162b2, involves two jabs, each three weeks apart.

In interim results from the companies' phase 3 clinical trial, which started in July and has more than
43,000 enrolled participants, they reported 94 lab-confirmed COVID-19 infections.

What does 90 per cent 'effective' mean?

It sounds pretty good, hey?

But the vaccine's 'efficacy' doesn't measure how well it stops the SARS-CoV-2 virus entering a vaccinated
person's body.

Instead, it's a measure of stopping — or at least reducing the severity of — COVID-19.

And this vaccine, apparently, lowers your chances of getting sick by 90 per cent, compared to someone
who hasn't been vaccinated.

Kylie Quinn, a vaccine expert at RMIT University, told ABC News: "If you had 10 people who you knew were
going to be infected ... and you vaccinated those people before they were exposed, nine out of those 10
people would not develop (COVID-19)."

If you want to get technical (and who doesn't?!), vaccine efficacy and vaccine effectiveness are slightly
different terms.

Vaccine efficacy is calculated through clinical trials, like the Pfizer/BioNTech trial. Vaccine effectiveness
is measured out in the real world, once the vaccine has been approved for use in the general population.

To calculate the more-than-90-per-cent efficacy figure for BNT162b2, an external committee examined
how many of the 94 infected individuals were vaccinated and how many received the placebo (a saline
injection).

But the published results are a little light on detail. The announcement was made via press release —
not a peer-reviewed journal paper — and it did not include the vaccine/placebo breakdown of infected
participants.

The efficacy of the vaccine may change over time, too.

Dr Quinn says there's still a little way to go before the trial wraps up.

"This is the interim analysis of 94 patients. The study closes out at 164 individuals
who have become symptomatic," Dr Quinn says.

"So we're not far enough."

Does this make it the vaccine front-runner?

It sure does — but others are likely to be hot on its tail.

There are currently 11 COVID-19 vaccines in phase 3 clinical trials, but Pfizer is the first company to
announce its results.

While Pfizer is still collecting safety data on the vaccine, it says so far no serious safety concerns have
been observed. It plans to apply for emergency authorisation from the US Food and Drug Administration
in late November.

The early trial results aren't just good news for

Pfizer either, according to Dr Richard Hatchett,
CEO of the Coalition for Epidemic Preparedness
Innovations (CEPI).
"We believe these interim results also increase
the probability of success of other COVID-19
candidate vaccines which use a similar
approach," Dr Hatchett said in a statement.
That approach is targeting the SARS-CoV-2's
spike protein, the pointy bits on the surface of
the virus that allow it to enter our cells.
Professor Terry Nolan, a vaccine expert from the
University of Melbourne's Doherty Institute, says
while scientists had been pretty sure the spike
protein was the right target for vaccines, these
results clinched it.
"While there was every reason to
Clinical trial stages
Pre-clinical: Testing in animals. Does
the vaccine produce antibodies? Does
it protect against illness? What dose is
necessary?
Phase I: Testing in a small number of
humans. This phase is about making
sure the vaccine is safe.
Phase II: More testing in humans —
does the vaccine actually work?
Phase III: Testing in a larger number of
humans to confirm its effectiveness.
Phase IV: After the vaccine has been
rolled out, ongoing surveillance to
make sure it's safe and doesn't have
long-term adverse effects.

believe… that it was the right target,

we were never going to know for sure
until we had this sort of human
response data.

"So clearly, the spike protein is the right target, and that means it's more likely than not that there will be
several successful vaccines."

Moderna is also working on an mRNA vaccine and should be releasing efficacy results "in the next
couple of weeks", according to Professor Nolan.

The Oxford/AstraZeneca vaccine, which Australia also has an agreement to distribute if it proves safe
and effective, will also be close to revealing results by then.

In September the Oxford/AstraZeneca trial was paused when some participants had adverse events, but
it's since resumed.
What's everyone saying about it?
The data, while preliminary, has been enthusiastically welcomed by infectious disease and public health
experts around the world, including White House coronavirus adviser Dr Anthony Fauci, who said the 90
per cent effectiveness result was "just extraordinary".

"Not very many people expected it would be as high as that," he said.

"It's going to have a major impact on everything we do with respect to COVID."

Dr Bruce Aylward, the World Health Organization's senior adviser, said Pfizer's vaccine could
"fundamentally change the direction of this crisis" by March, when the UN agency hopes to start
vaccinating high-risk groups.

How fast is coronavirus growing around the world?

Cumulative known cases

since 100th case
US
10M
India
Brazil

Russia
UK
1M Mexico

Sweden
Japan
100k China

S. Korea
Australia

10k
 10k
But independent scientists, including leading vaccine developer Dr Stanley Plotkin, have cautioned
against banking on the results too soon, noting that the data are incomplete and that many questions
still remain.
NZ

At this
1k stage, no long-term safety and efficacy data has been collected, and it will take months — if not

years — to understand how long immunity (generated by the vaccine)Talasts.

iwan

"That there is early efficacy of 90 per cent is great, but ... we don't know whether the vaccine protects
against
100
infection, so that individuals who are vaccinated won't be able to excrete the virus and infect
other people,"
0 Dr Plotkin,
50 emeritus
100 professor of paediatrics
150 200 at the University
250 of Pennsylvania,
300 told RN
Breakfast. Days since 100th case

"We don't know whether

Data it protects
sources: Johns the elderly
Hopkins Coronavirus as well
Resource Center,as
Ourthe young.
World in Data, The COVID Tracking Project, ABC

"As a scientist I would have to wait for those other data before I could decide
whether or not this is really as promising as it sounds."

There is also concern the vaccine will present significant manufacturing and logistical challenges, says
Professor Nolan.

Like other vaccines made with mRNA — which carry instructions to the body using genetic material —
the vaccine needs to be stored at ultra-cold temperatures, in this case, below minus 80 degrees Celsius.

"They're thawed before they're given, of course, but they're not stable for a long period of time at
refrigerator temperature," Professor Nolan said.

"The distribution between the warehouse and then a clinic or a GP surgery, or wherever else it's going to
be given, and how it's stored — that's going to be the hard bit.

"I suspect the [Australian] Government won't be announcing that just yet, I suspect they'll be working on
a solution to make sure that is going to work."

Read more about coronavirus:

Could higher-paid quarantine workers better protect us?
Can I walk to the shops? SA lockdown questions answered

When will we get it in Australia?

The Pfizer trial vaccine is one of four potential vaccines the Australian Government has signed an
agreement to purchase, if it is successful, and Federal Health Minister Greg Hunt says the Government is
continuing to monitor results.

"The data on our vaccine candidates continues to be positive. We will examine the evidence carefully,
but the latest results are heartening news," he said.
Last week, Department of Health Secretary
Brendan Murphy said that because the vaccine
involved complicated technology (an mRNA
vaccine has never been successfully manufactured and distributed anywhere in the world), the
Australian Government had decided to buy a small number of doses as a first option.

"If this turns out to be the most successful vaccine, obviously there's a capacity
to buy more," he said.

"And there is the capacity, we are exploring the potential, of whether we could set up local
manufacturing. But that isn't a prospect at the moment."

As for when Australians can expect to be rolling up their sleeves to get a COVID-19 jab, Mr Hunt has
previously said the goal and expectation is that "Australians who sought vaccination will be vaccinated
within 2021".

If Pfizer's trial vaccine is approved, the company says it aims to supply 1.3 billion doses of the vaccine by
the end of 2021.

What you need to know about coronavirus:

Who needs to wear a face mask in Victoria and when
The symptoms
The number of cases in Australia
Global cases, deaths and testing rates
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