It is hoped the world’s first coronavirus vaccine could be rolled out by the end of the year after pharmaceutical giant Pfizer said its experimental jab was more than 90 per cent effective in preventing the disease.
In a major breakthrough, New York-based Pfizer and German partner BioNTech SE, who are developing an mRNA-based vaccine, said they have so far found no serious safety concerns and expect to seek US emergency use authorisation later this month.
The vaccine has been tested on 43,500 people in six countries.
Pfizer and BioNTech SE are the world’s first drug makers to show successful data from a large-scale clinical trial, a huge victory in the fight against the Covid-19 pandemic which has claimed more than one million lives worldwide.
The UK has ordered 40 million doses of the BNT162 coronavirus vaccine, and Downing Street said on Monday that 10 million doses – covering up to five million people – could be available by the end of the year if it is approved by regulators.
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Pfizer said the interim analysis was conducted after 94 participants in the trial developed Covid-19, examining how many of them received the vaccine versus a placebo.
The company did not break down exactly how many of those who fell ill received the vaccine.
Still, over 90 per cent effectiveness implies that no more than eight of the 94 people who caught Covid-19 had been given the vaccine, which was administered in two shots about three weeks apart.
The efficacy rate is well above the 50 per cent effectiveness required by the US Food and Drug Administration for a coronavirus vaccine.
To confirm its efficacy rate, Pfizer said it will continue the trial until there are 164 coronavirus cases among participants, a figure that could be met in December.
The data have yet to be peer-reviewed or published in a medical journal. Pfizer said it would do so once it has results from the entire trial.
Announcing the results of the phase three clinical study, Dr Albert Bourla, Pfizer chairman and CEO, said: “Today is a great day for science and humanity.
“The first set of results from our phase three Covid-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent Covid-19.
“We are reaching this critical milestone in our vaccine development programme at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen.
“With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis.
“We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.
“I want to thank the thousands of people who volunteered to participate in the clinical trial, our academic collaborators and investigators at the study sites, and our colleagues and collaborators around the world who are dedicating their time to this crucial endeavour.
“We could not have come this far without the tremendous commitment of everyone involved.”
When will a vaccine be ready for use?
Pfizer and BioNTech plan to apply to the US Food and Drug Administration – the US medicines regulator – by the end of the month for emergency approval to use the vaccine.
It is hoped that the vaccine will be ready for use by the end of 2020. If authorised, the number of vaccine doses will initially be limited.
Many questions also remain including how long the vaccine will provide protection. The news provides hope that other vaccines in development against the novel coronavirus may also prove effective.
About 12 Covid-19 vaccines around the world are currently in the final stages of testing, but Pfizer’s is the first to report any results.
The success of the latest coronavirus vaccine trials by Pfizer and BioNTech could pave the way for the rollout of a least one vaccine in the UK early in the new year, a scientist advising the UK Government has said.
Sir John Bell, regius professor of medicine at Oxford University and a member of the Government’s vaccine taskforce, said that other vaccines were now likely to become available in the near future.
“I am really delighted with this result – it shows that you can make a vaccine against this little critter. Ninety percent is an amazing level of efficacy,” he told BBC Radio 4’s The World at One.
“It rolls the pitch for other vaccines because I can’t see any reason now why we shouldn’t have a handful of good vaccines.”
Asked if people could look forward to a return to normal life by the spring, Sir John replied: “Yes, yes, yes, yes. I am probably the first guy to say that but I will say that with some confidence.”
A spokesman for UK Prime Minister Boris Johnson warned there was no final date and could not say how long the approval process would take.
Asked if it would be deployed by Christmas, the spokesman said: “The results are promising, but we have to remember there are no guarantees.”
Each person receiving the vaccine in trials has needed two doses, meaning the initial 10 million doses delivered to the UK could help up to five million people.
Care home residents and workers would be given first priority, followed by over-80s and health and social care workers.
Those over 50 would also be prioritised in decreasing order of age, alongside moderate- and high-risk people with medical conditions.
The head of the UK’s vaccine taskforce has previously said any final jab may only go to half of Brits in total.
Downing Street welcomed the results from Pfizer’s vaccine tests as “promising” and said the UK will have procured 10 million doses by the end of the year to be given out if it is approved.
The Prime Minister’s spokesman said: “The results are promising and while we are optimistic of a breakthrough, we must remember there are no guarantees.
“We will know whether the vaccine is both safe and effective once the safety data has been published and only then can licensing authorities consider making it available to the public.
“In the meantime, the NHS stands ready to begin a vaccination programme for those most at risk once a Covid-19 vaccine is available before being rolled out more widely.
“In total, we’ve procured 40 million doses of the Pfizer candidate vaccine, with 10 million of those doses being manufactured and available to the UK by the end of the year if the vaccine is approved by the regulators.”
In the US, president-elect Joe Biden greeted the experimental vaccine as excellent news, but warned that widespread vaccination remains months away and Americans need to continue wearing masks and maintain social distancing.
“Today’s news is great news, but it doesn’t change that fact. Today’s announcement promises the chance to change that next year, but the tasks before us now remain the same.”
The US quest for a vaccine has been President Donald Trump’s central response to the pandemic. He repeatedly assured the public that his administration would likely identify a successful vaccine in time for last Tuesday’s election, which he lost to Biden.
Pfizer expects to seek broad US emergency use authorization of the vaccine for people aged 16 to 85. To do so, it will need to have collected two months of safety data on around half of the study’s roughly 44,000 participants, expected in late November.
Bill Gruber, one of Pfizer’s top vaccine scientists said: “I’m near ecstatic. This is a great day for public health and for the potential to get us all out of the circumstances we’re now in.”
Pfizer and BioNTech have a $1.95 billion (£1.4 billion) contract with the US government to deliver 100 million vaccine doses beginning this year.
They have also reached supply agreements with the European Union, the UK, Canada and Japan.
To save time, the companies began manufacturing the vaccine before they knew whether it would be effective.
They now expect to produce up to 50 million doses or enough vaccine to protect 25 million people this year.
Pfizer said it expects to produce up to 1.3 billion doses of the vaccine in 2021.
What are the experts saying?
Medical experts were elated by the news and said the results looked promising, but warned that the announcement from Pfizer should be met with caution as further study is required.
Ian Jones, professor of virology at the University of Reading, said the Pfizer trial data shows “really impressive protection and no reported adverse events”.
He said: “Of all the current vaccines currently in development the BioNtech product always looked like the most bang-per-buck as it is entirely focused on the part of the virus that binds to the human cell, the receptor binding domain.
“The questions around its use were about the ability to manufacture at scale and the possible toxicity associated with a directly injected RNA product.
“The trial data show excellent results in both of those areas, really impressive protection and no reported adverse events.
“The only things we will not know for some time is the longevity of the response in all age groups, but assuming antibody titres are high that should be at least as good as any other vaccine currently in trial.”
Danny Altmann, professor of immunology at Imperial College London, said in terms of the impact on the Covid-19 pandemic “it’s good news, but it’s not ‘overnight success’ good news”.
Professor Altmann cautioned that this and other potentially successful vaccines would still need to be approved and delivered to people across the world, and this will still take many months.
He added, however: “I always felt optimistic, and my optimism remains strong.”
Michael Head, senior research fellow in global health at the University of Southampton, said: “This cautiously sounds like an excellent result from the phase three trials, but we should remain a little cautious.
“The provisional findings are made available in a press release, and the study is ongoing.
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“However, if the final results show an effectiveness of anywhere near 90 per cent with response in elderly and ethnic minority populations, that is an excellent result for a first generation vaccine.
“This has been seen before – the rapidly-produced ebola vaccine generated very high levels of effectiveness and exceeded all expectations. Equally, billions of dollars and numerous clinical trials have struggled to produce any form of vaccination against HIV. Science can be unpredictable.”
Peter Horby, professor of emerging infectious diseases and global health in the Nuffield Department of Medicine at the University of Oxford, said the Pfizer results “bode well for Covid vaccines in general”.
“This news made me smile from ear to ear,” said the scientist.
“It is a relief to see such positive results on this vaccine and bodes well for Covid-19 vaccines in general.
“Of course we need to see more detail and await the final results, and there is a long, long way to go before vaccines will start to make a real difference, but this feels to me like a watershed moment.”
Florian Krammer, a microbiology professor at the Icahn School of Medicine at Mount Sinai in New York, said: “These are fantastic results. The efficacy could be higher than expected, and this probably means that – at least in the US – there will be an application for approval very soon.
“Of course, it would be better to see age-specific data, but I suspect that these will be published soon. Frankly, this is the best news I have received since January 10.”
Marylyn Addo, head of tropical medicine at the University Medical Center Hamburg-Eppendorf in Germany, added: “These are interesting first signals, but again they are only communicated in press releases. Primary data are not yet available and a peer-reviewed publication is still pending.
“We still have to wait for the exact data before we can make a final assessment. At present, there are still few details about the exact data, for example regarding different age groups and in which groups the 94 cases occurred exactly.”
Bernd Salzberger, head of infectiology at University Hospital Regensburg in Germany, predicted that the drug will be granted early approval in the US.
He said: “Although only a few events – a total of 94 cases – have been observed in the study so far, this is a very good result. No serious side effects have been reported – overall a very positive result, which will probably lead to an early approval.”
How did the markets react?
Financial markets were given a boost by the announcement.
The FTSE 100 jumped more than 5.5 per cent, adding £82 billion to the value of its shares in the market’s best day since March, following news from Pfizer that the Covid-19 vaccine trial exceeded experts’ expectations.
In the US, futures tracking the S&P 500 hit a record high of 3,586.25 points.
Carsten Brzeski, global head of Macro, ING, said: “The bigger driver of the economic outlook is from the outside factors. Right now that means the development of a vaccine, which is why we are following news on this front closely.
“The base case we have already is that we are likely to get a vaccine by year-end and that it will be rolled out.
“So we do see news like this as positive.
“The worrying sign would be if we get negative news say on testing, that would hurt how we view the economic outlook.”