The first effective coronavirus vaccine can prevent more than 90% of people from getting Covid-19, a preliminary analysis shows. The developers – Pfizer and BioNTech – described it as a “great day for science and humanity”. Their vaccine has been tested on 43,500 people in six countries and no safety concerns have been raised. The companies plan to apply for emergency approval to use the vaccine by the end of the month.
Pfizer and German partner BioNTech SE are the first drugmakers to release 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 U.S. authorization this month for emergency use of the vaccine.
If authorized, the number of doses will initially be limited and many questions remain, including how long the vaccine will provide protection. However, the news provides hope that other COVID-19 vaccines in development may also prove effective.
No vaccine has gone from the drawing board to being proven highly effective in such a short period of time. There are still huge challenges ahead, but the announcement has been warmly welcomed with scientists describing themselves smiling “ear to ear” and some suggesting life could be back to normal by spring.
“I am probably the first guy to say that, but I will say that with some confidence,” said Sir John Bell, regius professor of medicine at Oxford University. A vaccine – alongside better treatments – is seen as the best way of getting out of the restrictions that have been imposed on all our lives.
The data shows that two doses, three weeks apart, are needed. The trials – in US, Germany, Brazil, Argentina, South Africa and Turkey – show 90% protection is achieved seven days after the second dose.
However, the data presented is not the final analysis as it is based on only the first 94 volunteers to develop Covid so the precise effectiveness of the vaccine may change when the full results are analysed.
Dr Albert Bourla, the chairman of Pfizer, said: “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.” Prof Ugur Sahin, one of the founders of BioNTech, described the results as a “milestone”.
A limited number of people may get the vaccine this year. Pfizer and BioNTech say they will have enough safety data by the third week of November to take their vaccine to regulators. Until it has been approved it will not be possible for countries to begin their vaccination campaigns. The two companies say they will be able to supply 50 million doses by the end of this year and around 1.3 billion by the end of 2021. Each person needs two doses.
The UK should get 10 million doses by the end of the year, with a further 30 million doses already ordered.
Who would get it?
Not everyone will get the vaccine straight away and countries are each deciding who should be prioritised. Hospital staff and care home workers will be near the top of every list because of the vulnerable people they work with, as will the elderly who are most at risk of severe disease.
The UK is likely to prioritise older resident in care homes and the people that work there. But it says a final decision has not been made, saying it will depend on how well the vaccine works in different age-groups and how the virus is spreading. People under 50 and with no medical problems are likely to be last in the queue.
Are there any potential problems?
There are still many unanswered questions as this is only interim data. We do not know if the vaccine stops you spreading the virus or just from developing symptoms. Or if it works equally well in high-risk elderly people. The biggest question – how long does immunity last – will take months or potentially years to answer.
There are also massive manufacturing and logistical challenges in immunising huge numbers of people, as the vaccine has to be kept in ultra-cold storage at below minus 80C. The vaccine appears safe from the large trials so far but nothing, including paracetamol, is 100% safe.
How does it work?
There are around a dozen vaccines in the final stages of testing – known as a phase 3 trial – but this is the first to show any results. It uses a completely experimental approach – that involves injecting part of the virus’s genetic code – in order to train the immune system.
Previous trials have shown the vaccine trains the body to make both antibodies – and another part of the immune system called T-cells to fight the coronavirus. “Today is a great day for science and humanity,” Albert Bourla, Pfizer’s chairman and chief executive, said.
“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.”
BioNTech Chief Executive Ugur Sahin told Reuters he was optimistic the immunisation effect of the vaccine would last for a year although that was not certain yet.
“The efficacy data are really impressive. This is better than most of us anticipated,” said William Schaffner, infectious diseases expert at Vanderbilt University School of Medicine, Nashville, Tennessee. “The study isn’t completed yet, but nonetheless the data look very solid.”
The prospect of a vaccine electrified world markets with S&P 500 futures hitting a record high and tourism and travel shares surging. Stocks in European airlines such as ICAG, Lufthansa and AirFrance KLM jumped a third. “Light at the end of the tunnel. Let’s just hope the vaccine deniers won’t get in the way, but 2021 just got a lot brighter,” said Neil Wilson, chief market analyst at Markets.com
Shares of other COVID-19 vaccine developers in the final stage of testing also rose with Johnson & Johnson up 3.3% in pre-market trading and Moderna 4.1% stronger. Britain’s AstraZeneca, however, was down 2.1% after earlier rising 0.5% on the news.
Pfizer expects to seek broad U.S. authorization for emergency use of the vaccine for people aged 16 to 85. To do so, it will need two months of safety data from about half the study’s 44,000 participants, which his expected late this month.
“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 and BioNTech have a $1.95 billion contract with the U.S. government to deliver 100 million vaccine doses beginning this year. They have also reached supply agreements with the European Union, the United Kingdom, 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 to protect 25 million people this year.
To confirm the efficacy rate, Pfizer said it would continue the trial until there are 164 COVID-19 cases among participants. Bourla told CNBC on Monday that based on rising infection rates, the trial could be completed before the end of November. 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.
“These are interesting first signals, but again they are only communicated in press releases,” said Marylyn Addo, head of tropical medicine at the University Medical Center Hamburg-Eppendorf in Germany. “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.”
GLOBAL RACE
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 U.S. 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 10 million infections and over 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 new 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.
