Australia has welcomed news that a COVID-19 vaccine it’s signed up for is 90 per cent effective, based on early test results.
The federal government has ordered 10 million doses of the Pfizer and BioNTech vaccine, which has exceeded the US manufacturer’s expectations and has been hailed as a game changer.
The pandemic has claimed more than 1.2 million lives worldwide, including more than 900 Australians.
‘The data on our vaccine candidates continues to be positive. We will examine the evidence carefully but the latest results are heartening news,’ health minister Greg Hunt told News Corp.
Australian health experts have cautiously welcomed the vaccine’s early success but want to see further details and results.
More than 43,000 voluntarily participated in the Pfizer trial and were jabbed with either the vaccine or the placebo.
Pfizer, which developed the vaccine with German drugmaker BioNTech, are the first to release successful data from an interim analysis of a large-scale clinical trial
From the trial, 94 people have so far tested positive for Covid-19, and more than 90 per cent of those did not receive the real vaccine.
‘Any news is good news,’ Australian National University infectious disease specialist Sanjaya Senanayake told Sunrise on Tuesday.
‘After 94 people in that trial in that phase 3 trial of about 40,000 who have been given placebo, 90 per cent effectiveness has been shown.’
‘Many of us were thinking that if we had a good COVID-19 vaccine then it would be about 55 to 60 per cent effective. 90 per cent is great.’
‘We need to also see that data in a medical peer- reviewed journal to really analyse it closely… And of course, even if it holds up now, will it still hold up in six months or 12 months? We will never know that until that time and those milestones pass.’
He estimates a vaccine to be available to the Australian public in the second quarter of 2021.
Victoria’s Deputy Chief Health Officer Dr Allen Cheng described the news as positive but wanted to see further detail.
‘Promising early results for the Pfizer mRNA vaccine, but would like to see full details of safety and efficacy,’ he tweeted.
‘This vaccine currently requires storage at -70C which will be challenging to distribute.’
Pfizer, which developed the vaccine with the German drugmaker BioNTech, are the first drugmakers to release successful data from a large-scale clinical trial of a coronavirus vaccine
Opposition leader Bill Shorten also welcomed the news.
‘I think if we want to see international travel again at a serious level, I think the vaccine is important,’ he told the Today show.
‘Australia’s done well. Eventually we’d like to see international visitors come here and us travel overseas.
‘I think the vaccine is an important missing link. I’m not going to put down the binoculars and say the race is over yet.’
Pfizer is on track to apply later this month for emergency-use approval from the U.S. Food and Drug Administration.
‘We´re in a position potentially to be able to offer some hope,’ Dr Bill Gruber, Pfizer´s senior vice president of clinical development told The Associated Press.
‘We´re very encouraged.’
But even if all goes well, authorities have stressed it is unlikely any vaccine will arrive much before the end of the year, and the limited initial supplies will be rationed.
Global markets, already buoyed by the US election win of President-elect Joe Biden, rocketed on the news from Pfizer.
The S&P 500 was up 3.3% in afternoon trading, while the Dow Jones Industrial Average gained more than 1,300 points. Pfizer jumped more than 11%. Other vaccine stocks were up as well.
However, the announcement doesn’t mean for certain that a vaccine is imminent: This interim analysis, from an independent data monitoring board, looked at 94 infections recorded so far in a study that has enrolled nearly 44,000 people in the U.S. and five other countries.
Australian National University infectious disease specialist Sanjaya Senanayak (pictured) has welcomed the early success rate of the Pfizer and BioNTech COVID-19 vaccine
Some participants got the vaccine, while others got dummy shots.
Pfizer released no specific breakdowns, but for the vaccine to be 90% effective, nearly all the infections must have occurred in placebo recipients.
The study is continuing, and Pfizer cautioned the protection rate might change as more COVID-19 cases are added to the calculations.
Pfizer has estimated it could have 50 million doses available globally by the end of 2020, enough for 25 million people
WHAT DO THE NEW TRIAL RESULTS SHOW?
Pfizer and German partner BioNTech said that 94 people in a trial of more than 43,000 have so far tested positive for Covid-19, and that over 90 per cent of those did not receive the real vaccine.
This suggests the vaccine is 90 per cent effective and that no more than eight out of those 94 people actually received the real jab.
Most of the people who tested positive were in the placebo group, where people are given a fake vaccine so that what happens to them can be compared with those who get the real thing.
The companies did not reveal the exact split of how many people had had the vaccine and how many had not.
The results were revealed in a corporate press release, which is not considered transparent enough for independent review, but they will be published in full later this year when the study is more complete.
This phase of the trial will continue until at least 164 participants have tested positive, the researchers said.
WHAT DOES THAT MEAN FOR ME?
The general public will not benefit from the vaccine – if it is approved – for weeks or months to come, but today’s results mean there is a ray of hope that the pandemic could end.
Coronavirus cannot yet be stopped without a vaccine, and one that prevents infections or at least reduces the risk of death could spell the end of social distancing.
The Australian federal government has bought 10 million doses of the Pfizer vaccine and they could be available to the most vulnerable people within months if the study ends well.
The Australian government has ordered 10 million doses of the Pfizer COVID-19 vaccine
WHEN COULD IT BE READY TO GIVE TO THE PUBLIC?
Pfizer and BioNTech have said they will try to apply to the Food and Drug Administration in the US for approval within the next month, provided their final results are as positive as today’s announcement suggests.
This is because Pfizer is an American company, based in New York. BioNTech is a German company so it is likely the same procedure will be followed in the European Union.
It will then be a question of how long it takes regulators to decide, and of how long delivering all the doses takes if it is approved, but it could be just weeks into December.
HOW DOES THE VACCINE WORK?
The jab is known as a messenger RNA (mRNA) vaccine, which uses genetic code from the virus to provoke the immune system.
Traditional vaccines tend to use damaged or destroyed versions of the real virus to achieve the same effect – if this one works, it will be the first mRNA jab ever to be proven in humans.
The vaccine is made of lab-generated genetic material which is created to imitate what scientists have found inside the coronavirus.
The genetic material (mRNA) is then injected into the body inside a fatty molecule.
The genes are specifically chosen to code for the ‘spike’ protein on the outside of the coronavirus, which are what the virus uses to bind to human cells and infect them.
When the molecules get into the body, they deliver the mRNA into living cells and trick the body into making its own copies of the spike protein.
When these appear in the bloodstream they trigger the immune system in the same way that the real virus would, although the effects are milder because there are no actual viruses driving the infections, so the situation is under the body’s control.
In the process, the immune system learns how to recognise and destroy the spikes so that when it encounters them for real it can kill the virus before it causes Covid-19.
IS IT SAFE?
Pfizer and BioNTech say they have not encountered any safety issues during their trials so far, which have been going on for six months.
This suggests with a good degree of confidence that the vaccine is safe for humans at least in the short term.
Long-term safety can only be proven when huge numbers of people have had the vaccine and had their health tracked for years or even decades afterwards, so scientists cannot yet be 100 per cent sure that no side effects will ever appear.
However, the current phase three trial includes more than 43,000 people from different backgrounds all over the world, all of whom are being closely monitored after having the vaccine.
If people suffer side effects of the vaccine that are more common or more severe than in the placebo group – who received a fake vaccine for comparison – this will be investigated in detail by the researchers.
Pfizer and BioNTech will not be given permission to distribute the jab without showing independent regulators that they have concrete data to prove the jab is as safe as possible.
WHAT ARE SCIENTISTS STILL TESTING FOR?
The trial is still going and will likely not end completely for years to come, because the more data scientists have, the more confident they can be about their results.
In the short term, the researchers must continue to gather safety data and proof that the vaccine is actually working.
The team said they will keep the current phase of the trial open until at least 164 people have been infected with the coronavirus.
They will then compare the infection rate in the vaccine group to that of the placebo group, who got a fake vaccine, to see how much of a difference the jab makes.
They will want to see that significantly fewer people got sick after having the jab, compared to people who had the fake one. Early data suggests this is the case.