One of the leading coronavirus vaccine candidates has proven to be 90 per cent effective, marking a major breakthrough in the global race to stop the disease.
Pfizer and BioNTech today said that early results from a massive clinical trial suggest nine out of 10 people who get their jab are protected from coronavirus by it.
In an update on progress in the ongoing study, the pharmaceutical companies said that of 94 people infected with the virus so far, at least 86 of them had been in the placebo group.
The placebo group is one in which people are given a fake vaccine so that what happens to them can be compared with those who get the real thing. Pfizer’s trial has split the participants half and half across the placebo and vaccine groups.
The company’s chairman hailed the breakthrough a ‘great day for science’ while an independent expert said the results are ‘excellent’ and ‘really impressive’.
Pfizer and BioNTech are expected to apply for approval to give out the jab in the US as soon as possible, but they must wait for long-term safety data to be completed.
Pictured is the first patient to have received the Pfizer vaccine, at the University of Maryland in May this year. Since then, more than 43,000 people have been enrolled in the ground-breaking trial
Pfizer and German partner BioNTech are the first drugmakers to show successful data from a large-scale clinical trial of a coronavirus vaccine.
The companies said they have so far found no serious safety concerns and expect to seek US emergency use authorization later this month.
If authorized, the number of vaccine doses will initially be limited. Many questions also remain including how long the vaccine will provide protection.
However, the news provides hope that other vaccines in development against the novel coronavirus may also prove effective.
‘Today is a great day for science and humanity,’ said Albert Bourla, Pfizer’s chairman and chief executive.
‘We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen.’
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.
‘I’m near ecstatic,’ Bill Gruber, one of Pfizer’s top vaccine scientists, said in an interview. ‘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 said the interim analysis was conducted after 94 participants in the trial developed Covid-19, and examined 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, but 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 Covid-19 cases among participants. Given the recent spike in US infection rates, that number could be reached by early December, Gruber said.
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.
Pfizer and BioNTech have a $1.95billion (£1.45m) 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 50million doses, or enough vaccine to protect 25million people, this year.
Pfizer said it expects to produce up to 1.3billion doses of the vaccine in 2021.
The global race for a vaccine has seen wealthier countries forge multibillion-dollar supply deals with drugmakers like Pfizer, AstraZeneca Plc and Johnson & Johnson, raising questions over when middle income and poorer nations will get access to inoculations.
The US quest for a vaccine has been the Trump administration’s central response to the pandemic. The United States has the world’s highest known number of COVID-19 cases and deaths with more than 10million infections and more than 237,000 fatalities.
President Donald Trump repeatedly assured the public that his administration would likely identify a successful vaccine in time for the presidential election, held last Tuesday. On Saturday, Democratic rival Joe Biden was declared the winner.
Vaccines are seen as essential tools to help end the health crisis that has shuttered businesses and left millions out of work. Millions of children whose schools were closed in March remain in remote learning programs.
Dozens of drugmakers and research groups around the globe have been racing to develop vaccines against COVID-19, which on Sunday exceeded 50 million infections since the novel coronavirus first emerged late last year in China.
The Pfizer and BioNTech vaccine uses messenger RNA (mRNA) technology, which relies on synthetic genes that can be generated and manufactured in weeks, and produced at scale more rapidly than conventional vaccines.
Moderna Inc, whose vaccine candidate employs similar technology, is expected to report results from its large-scale trial later this month. The mRNA technology is designed to trigger an immune response without using pathogens, such as actual virus particles.
Pfizer alone will not have the capacity to immediately provide enough vaccines for the entire United States. The Trump administration has said it will have enough supply for all of the 330 million U.S. residents who wish to be vaccinated by the middle of 2021.
The US government has said the vaccines will be provided for free to Americans, including the insured, uninsured and those in government health programs such as Medicare.
WHICH VACCINES HAS THE UK SECURED DEALS FOR?
1. GlaxoSmithKline and Sanofi Pasteur: 60million doses
The Government revealed on July 29 it had signed a deal with pharmaceutical giants GlaxoSmithKline (GSK) and Sanofi Pasteur
If the vaccine proves successful, the UK could begin to vaccinate priority groups, such as frontline health and social care workers and those at increased risk from coronavirus, as early as the first half of next year, the Department for Business, Energy & Industrial Strategy (BEIS) said.
Human clinical studies of the vaccine will begin in September followed by a phase 3 study in December.
The vaccine is based on the existing technology used to produce Sanofi’s seasonal flu vaccine. Genetic material from the surface protein of the SARS-CoV-2 virus is inserted into insect cells – the basis of Sanofi’s influenza product – and then injected to provoke an immune response in a human patient.
2. AstraZeneca (manufacturing University of Oxford’s): 100million
AstraZeneca, which is working in partnership with Oxford University, is already manufacturing the experimental vaccine after a deal was struck on May 17.
Professor Sarah Gilbert, who is leading the Oxford team, is confident the jab could be ready for the most vulnerable people by the end of the year.
Her comments came after the results from the first phase, published in The Lancet on July 20, showed promise.
The team have genetically engineered a virus to look like the coronavirus – to have the same spike proteins on the outside – but be unable to cause any infection inside a person. This virus, weakened by genetic engineering, is a type of virus called an adenovirus, the same as those which cause common colds, that has been taken from chimpanzees.
3. BioNTech/Pfizer: 30million
US drug giant Pfizer – most famous for making Viagra – and German firm BioNTech were revealed to have secured a deal with the UK Government on July 20.
It reported positive results from the ongoing phase 2/3 clinical trial of one called BNT162b1 on July 1. The company is still running phase 2 trials at the moment.
Pfizer’s vaccine is one called an mRNA vaccine, which do not directly inject bits of the virus into the body but send genetic material.
mRNA vaccines programme the body to produce parts of the virus itself by injecting the body with a molecule that tells disease-fighting cells what to build. The immune system then learns how to fight it.
4. Valneva: 60million
The Government has given Valneva — whose vaccine is understood to be in the preclinical stages of development — an undisclosed amount of money to expand its factory in Livingston, Scotland.
While the Government revealed a 60million dose deal on July 20, the company said it had reached agreement in principle with the UK government to provide up to 100million doses.
Valneva’s jab is an inactivated whole virus vaccine, meaning it injects a damaged version of the coronavirus itself into the body.
The virus has been destroyed in a way that makes it unable to cause infection, but the body still recognises it as a dangerous intruder and therefore mounts an immune response which it can remember in case of a real Covid-19 infection.
5. Janssen (Johnson & Johnson): 30million
The Government has agreed to buy 30million doses of a vaccine made by Janssen if it works.
Officials have agreed to help the company in its development of the jab by part-funding a global clinical trial. The first in-human trials of Janssen’s jab began in mid-July and are being done on adults over the age of 18 in the US and Belgium.
The jab is named Ad26.COV2-S, recombinant, and is a type of jab called a viral vector recombinant vaccine.
Proteins that appear on the outside of the coronavirus are reproduced in a lab and then injected into the body to stimulate an immune reaction.
The ‘Ad’ part of the vaccine’s name means it works using an adenovirus – a virus best known for causing the common cold – as a vehicle to transport the coronavirus genetics into the body.
6. Novavax: 60million
Britain has ordered 60million doses of a vaccine being developed by the US-based company Novavax. It will help to fund late-stage clinical trials in the UK and also boost plans to manufacture the vaccine in Britain.
Novavax’s jab, named NVX-CoV2373, showed positive results in early clinical trials.
It produced an immune response in 100 per cent of people who received it, the company said, and was safe and ‘generally well-tolerated’.
Novavax’s candidate is also a recombinant vaccine and transports the spike proteins found on the outside of the coronavirus into the body in order to provoke the immune system.
7. Imperial College London: Unknown quantity
Imperial College London scientists are working on Britain’s second home-grown hope for a jab. The candidate is slightly behind Oxford’s vaccine in terms of its progress through clinical trials, but is still a major player.
The UK Government is understood to have agreed to buy the vaccine if it works but details of a deal have not yet been publicised.
Imperial’s jab is currently in second-phase human trials after early tests showed it appeared to be safe.
Imperial College London will try to deliver genetic material (RNA) from the coronavirus which programs cells inside the patient’s body to recreate the spike proteins. It will transport the RNA inside liquid droplets injected into the bloodstream.