Nearly a year has passed since SARS-CoV-2 began its deadly sweep across the world. This week, as global infections soared to more than 50 million and deaths to 1.25 million, there emerged evidence that science has found a weapon against COVID-19 in a 90% effective vaccine, writes MedicalBrief.
American multinational pharmaceutical corporation Pfizer and German biotechnology company BioNTech announced on Monday 9 November that their vaccine candidate against COVID-19 was “more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis”.
This is a shortened version of the statement. It is followed by media reports on the vaccine announcement, with links to the full reports.
The mRNA-based vaccine candidate, BNT162b2, demonstrated evidence of efficacy against COVID-19, based on the first interim efficacy analysis conducted on 8 November 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study, the companies reported.
“The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at seven days after the second dose. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a two-dose schedule,” the statement says. There have been no serious safety concerns reported.
Great day for science and humanity
“Today is a great day for science and humanity,” said Dr Albert Bourla, Pfizer Chairman and CEO, continuing later: “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.
The evidence that a vaccine may effectively prevent COVID-19 “is a victory for innovation, science and a global collaborative effort,” said Professor Ugur Sahin, BioNTech co-founder and CEO, according to the statement.
“When we embarked on this journey 10 months ago this is what we aspired to achieve. Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality,” Sahin said.
“We will continue to collect further data as the trial continues to enroll for a final analysis planned when a total of 164 confirmed COVID-19 cases have accrued.”
The Phase 3 clinical trial of BNT162b2 began on 27 July and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate as of 8 November 2020. Around 42% of global participants and 30% of US participants have racially and ethnically diverse backgrounds. The trial is continuing to enroll, the statement said.
The study also will evaluate the potential for the vaccine candidate to protect against COVID-19 in people who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19.
“Based on current projections we expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.”
Reasons for encouragement based on Pfizer’s Covid-19 vaccine results
The world has been waiting for good news on COVID-19 vaccines. On Monday it got a bunch of it, writes Helen Branswell for STAT News. A preliminary analysis of race frontrunner Pfizer-BioNTech’s mRNA vaccine suggested it was 90% effective in preventing symptomatic COVID disease.
While these are early findings – the trial is still ongoing – they suggest the vaccine could be very protective. There’s another important caveat. We don’t yet have details about whether the vaccine blocked mainly mild cases, or if there is evidence that it seemed to prevent some severe infections, too.
Still, the early results are encouraging for the Pfizer-BioNTech partnership. But embedded in the announcement is broader good news for COVID-19 vaccine development.
For instance, we are likely to have multiple successful COVID-19 vaccines.
The Pfizer vaccine targets the spike protein, the knobby protrusion on the SARS-CoV-2 virus that allows the virus to attach to and invade human cells, initiating infection. In fact, all of the vaccines being developed by major manufacturers working with Operation Warp Speed, the the US government effort to fast-track vaccines, target the spike protein, STAT News reports:
“There have been at least theoretical concerns that this was the vaccine development equivalent of putting all our eggs in one basket. The interim Pfizer data suggests the basket is the right one.”
“There was always a discussion: is the spike protein the right target? Well, now we know it’s the right target,” Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told STAT on Monday. “So, it’s not only immediate good news, it really is optimistic about what’s going to roll out in the next several months with the other vaccines.”
All the vaccines being developed with the help of the Coalition for Epidemic Preparedness Innovations – which has been funding research and production with the aim of producing vaccine for worldwide distribution – target the spike protein.
“We believe these interim results also increase the probability of success of other COVID-19 candidate vaccines which use a similar approach,” CEPI CEO Richard Hatchett said in a statement.
This is terrific news for mRNA vaccines. The two frontrunners in the race to develop COVID vaccines are Pfizer and Moderna; both use a new vaccine production technology known as mRNA. Other manufacturers are also developing mRNA vaccines.
Research has been underway for years on this innovative approach to make vaccines, but to date no mRNA vaccine has been brought to market.
The platform offers huge promise, both in terms of how quickly a vaccine can be designed and how quickly batches can be made. But there are no givens in vaccine development. Until something is shown to work, you don’t know that it will.
STAT continues: “It validates the mRNA platform,” Fauci said. “You have every reason to believe, unless something strange happens, that Moderna will likely have similar results.” That would be extra sweet news for Fauci. The vaccine construct Moderna is developing was created in NIAID’s vaccine research center.
However, it is early days and, as Fauci told STAT, we don’t want to get ahead of ourselves. Plus, it’s important to note that at this point, there’s no way to estimate how long protection from this or any COVID vaccine would last. The duration of protection will only become clear after the vaccines are in use for a while.
Pfizer, BioNTech say COVID vaccine is more than 90% effective — ‘Great day for science and humanity’
Dr Albert Bourla, chairman and CEO of Pfizer, hailed the trial results as a “great day for science and humanity”. Pfizer and BioNTech said the case split between vaccinated individuals and those who received a placebo indicated a vaccine efficacy rate of above 90% at seven days after the second dose, writes Sam Meredith for CNBC.
It means that protection from COVID-19 is achieved 28 days after the initial vaccination, which consists of a two-dose schedule.
Pfizer and BioNTech announced on Monday their coronavirus vaccine was more than 90% effective in preventing COVID-19 among those without evidence of prior infection, hailing the development as “a great day for science and humanity.”
“I think we can see light at the end of the tunnel,” Pfizer Chairman and CEO Dr Albert Bourla told CNBC’s Meg Tirrell on ‘Squawk Box: “I believe this is likely the most significant medical advance in the last 100 years, if you count the impact this will have in public health, global economy.”
Scientists have been hoping for a coronavirus vaccine that is at least 75% effective, reports CNBC, while White House coronavirus advisor Dr Anthony Fauci has said one that is 50% or 60% effective would be acceptable.
The companies said they planned to submit for emergency use authorisation to the US Food and Drug Administration soon after they have two months of data, which is currently on track for the third week of November.
Based on current projections, Pfizer and BioNTech expect to produce up to 50 million vaccine doses in 2020, and up to 1.3 billion doses in 2021. The vaccine requires two doses per person.
Though the companies didn’t take any money from the federal government for research and development for the drug, they reached a nearly $2 billion agreement in July to supply 100 million doses to the US government as part of the Trump administration’s Operation Warp Speed. That money is helping with manufacturing and distribution.
The Associated Press – Pfizer says COVID-19 vaccine is looking 90% effective
Pfizer Inc. said on Monday that its COVID-19 vaccine may be a remarkable 90% effective, based on early and incomplete test results that nevertheless brought a big burst of optimism to a world desperate for the means to finally bring the catastrophic outbreak under control, write Lauran Neergaard and Linda A Johnson for The Associated Press.
“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.”
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.
Dr Anthony Fauci, the US government’s top infectious-disease expert, said the results suggesting 90% effectiveness are “just extraordinary”, adding: “Not very many people expected it would be as high as that.”
“It’s going to have a major impact on everything we do with respect to COVID,” Fauci said as Pfizer appeared to take the lead in the all-out global race by pharmaceutical companies and various countries to develop a well-tested vaccine against the virus.
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.
Global markets, already buoyed by the victory of President-elect Joe Biden, rallied on the news from Pfizer.
According to the article by The Associated Press, Pfizer’s vaccine is among four candidates already in huge studies in the US, with still more being tested in other countries. Another US company, Moderna Inc, also hopes to file an application with the FDA late this month.
Both companies’ shots are made with a brand-new technology. These ‘mRNA vaccines’ are not made with the coronavirus itself, meaning there’s no chance anyone could catch it from the shots. Instead, the vaccine contains a piece of genetic code that trains the immune system to recognise the spiked protein on the surface of the virus.
Pfizer initially opted not to join the Trump administration’s Operation Warp Speed, which helped fund a half-dozen vaccine makers’ research and manufacturing scale-up. Pfizer instead invested $2 billion of its own money in testing and expanding manufacturing capacity. Still, in July Pfizer signed a contract to supply the US with 100 million doses for $1.95 billion, assuming the vaccine is cleared by the FDA.
The New York Times – Pfizer’s early data shows vaccine is more than 90% effective
Pfizer announced positive early results from its coronavirus vaccine trial, cementing the lead in a frenzied global race that has unfolded at record-breaking speed, write Katie Thomas, David Gelles and Carl Zimmer for The New York Times.
The drug maker Pfizer announced on Monday that an early analysis of its coronavirus vaccine trial suggested the vaccine was robustly effective in preventing COVID-19, a promising development as the world has waited anxiously for any positive news about a pandemic that has killed more than 1.2 million people.
The New York Times article continues: Pfizer said analysis found that the vaccine was more than 90% effective in preventing the disease among trial volunteers who had no evidence of prior coronavirus infection.
“If the results hold up, that level of protection would put it on par with highly effective childhood vaccines for diseases such as measles. No serious safety concerns have been observed, the company said.”
According to The New York Times, independent scientists have cautioned against hyping early results before long-term safety and efficacy data has been collected. “And no one knows how long the vaccine’s protection might last.”
Still, the development vaults Pfizer “to the front of a frenzied global race that began in January and has unfolded at record-breaking speed”.
Eleven vaccines are in late-stage trials, including four in the United States. Pfizer’s progress could bode well for Moderna’s vaccine, which uses similar technology. A Moderna spokesman said that it expected interim findings from its study this month.
Operation Warp Speed, the federal effort to rush a vaccine to market, has promised Pfizer $1.95 billion to deliver 100 million doses to the federal government, which will be given to Americans free of charge.
Scientists have been stunned by the data so far, The New York Times continues. “This is really a spectacular number,” said Akiko Iwasaki, an immunologist at Yale University. “I wasn’t expecting it to be this high. I was preparing myself for something like 55%.”
The backdrop
Work on the vaccine began in Mainz, Germany, in late January, when Ugur Sahin, the chief executive and co-founder of BioNTech, read about the virus in the Lancet and was filled with dread. “I almost instantly knew that this would affect us,” Sahin said. That same day, the first European cases were detected, in France.
Sahin assembled a 40-person team to work on the vaccine. Many employees canceled vacations and Sahin authorized overtime pay. They called it Project Lightspeed.
“BioNTech used a technology that had never been approved for use in people. It takes genetic material called messenger RNA and injects it into muscle cells, which treat it like instructions for building a protein – a protein found on the surface of the coronavirus. The proteins then stimulate the immune system and are believed to result in long-lasting protection against the virus.
BioNTech quickly identified 20 vaccine candidates, and began testing them on rodents, according to The New York Times. But the company lacked the experience and resources to rapidly conduct a major clinical trial. So it partnered up with Pfizer.
After early human trials, they determined that two vaccine candidates produced a robust immune response, including antibodies against the virus and powerful immune cells known as T cells. They chose the one with fewer side effects to start a trial with more than 30,000 volunteers in the United States, Argentina, Brazil and Germany. In September the company expanded the trial to 44,000 participants.
The Guardian – Pfizer-BioNTech vaccine is cause for cautious celebration
It is not yet the end of the pandemic, but the announcement by Pfizer-BioNTech that their vaccine has been 90% successful in the vital large-scale trials has got even the soberest of scientists excited, writes Sarah Boseley for The Guardian.
These are interim results and the trial will continue into December to collect more data. The two companies – a tiny German biotech with the big idea and the giant pharma company Pfizer with the means to develop it – have not yet published their detailed data, so it is all on trust.
And yet, nobody is suggesting the results have been over-egged. It looks as though the vaccine not only works, but works better than anyone hoped.
Most of us will not be vaccinated by Christmas, but it is possible the first shots will be given before the end of the year, The Guardian article continues. WHO has said health and care workers should be first in line, but some countries including the UK may want to vaccinate their elderly populations first, as long as it appears the vaccine works well in that age group and has no significant side-effects.
Europe, the US and the UK have all pre-bought supplies of the Pfizer-BioNTech vaccine – there will be 200 million doses going to the EU, 100 million to the US and 40 million to the UK. But although manufacturing is already well under way, there will not be enough to supply everyone who wants it straight away.
Experts have said that we need more than one vaccine to end the global pandemic. There are several more on the horizon, notably the Oxford University-AstraZeneca vaccine that uses a different technology. The great news for all the vaccine makers out there is that it is possible.
There is one downside to overcome, according to The Guardian. The Pfizer-BioNTech vaccine needs ultra-cold chain. That means freezers that can store it at -80C (-112F). Low-income countries do not have them, although UN organisations are already working on supply in case it is necessary.
The Guardian – UK rollout of Covid vaccine could start before Christmas
Britain could start distributing a coronavirus vaccine by Christmas, the deputy chief medical officer has said as he and Boris Johnson hailed “a significant scientific breakthrough” – but cautioned the public of hurdles to come, writes Jessica Elgot for The Guardian.
Professor Jonathan Van-Tam said news that large-scale trials showing the Pfizer-BioNTech candidate to be 90% effective was “very exciting” but warned that no vaccine would come soon enough to stop significant restrictions on public life during the second wave.
“I’m hopeful … but not yet certain that we could begin to see some vaccine by Christmas.” He said the progress was also significant for other vaccines in development. “Almost all of the vaccines coming also target the S protein,” he said.
“This is like getting to the end of a playoff final, it’s gone to penalties. The first player goes up, scores the goal. You haven’t won the cup yet, but what it does is it tells you that the goalkeeper can be beaten. And that’s where we are today that first sign.”
Boris Johnson said the vaccine was “very, very early days” but the UK would be ready to distribute it. “I have [talked] about the distant bugle of the scientific cavalry coming over the brow of the hill. I can tell you that tonight that the bugle is louder, but it’s still some way off. We absolutely cannot rely on this news as a solution.”
He said should the Pfizer vaccine pass all the vigorous safety checks, the UK had ordered 40 million doses for about a third of the population, since each person needs two doses, and “that puts us towards the front of the international pack on a per capita basis”.
It remains unclear if the vaccine prevents people catching the virus and passing it on, or rather prevents someone developing symptoms. Van-Tam said older people would be first in line for the vaccination, with prioritisation decided by an independent committee.
According to The Guardian, Johnson warned that advice from Sage on Friday found the R number (showing reproduction) was still above one in England, though without taking into account the current national restrictions, and that deaths had doubled in 24 days.
“We are heading towards the levels of the previous peak,” he said. “Neither mass testing nor progress on vaccine, though they’re both vital arrows in our epidemiological quiver…they are no substitute for the national restrictions.”
[link url="https://www.businesswire.com/news/home/20201109005539/en/"]Statement: Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study[/link]
[link url="https://www.statnews.com/2020/11/09/four-reasons-for-encouragement-based-on-pfizers-covid-19-vaccine-results/?utm_source=STAT+Newsletters&utm_campaign=00a79720d8-Daily_Recap&utm_medium=email&utm_term=0_8cab1d7961-00a79720d8-152512097"]STAT News: Four reasons for encouragement based on Pfizer’s Covid-19 vaccine results[/link]
[link url="https://www.cnbc.com/2020/11/09/covid-vaccine-pfizer-drug-is-more-than-90percent-effective-in-preventing-infection.html"]CNBC: Pfizer, BioNTech say Covid vaccine is more than 90% effective – ‘great day for science and humanity’[/link]
[link url="https://apnews.com/article/pfizer-vaccine-effective-early-data-4f4ae2e3bad122d17742be22a2240ae8"]The Associated Press: Pfizer says COVID-19 vaccine is looking 90% effective[/link]
[link url="https://www.nytimes.com/2020/11/09/health/covid-vaccine-pfizer.html"]The New York Times: Pfizer’s Early Data Shows Vaccine Is More Than 90% Effective[/link]
[link url="https://www.theguardian.com/world/2020/nov/09/pfizer-biontech-vaccine-announcement-analysis"]The Guardian: Pfizer/BioNTech vaccine announcement is cause for cautious celebration[/link]
[link url="https://www.theguardian.com/world/2020/nov/09/uk-rollout-of-covid-vaccine-could-start-before-christmas"]The Guardian: UK rollout of Covid vaccine could start before Christmas[/link]