Brushing aside a dramatic rebuke from government researchers and independent experts, AstraZeneca on Wednesday night announced that a new analysis found its COVID-19 vaccine to be 76 percent effective at preventing symptomatic COVID-19—down from the 79 percent efficacy estimate it announced in a press release Monday.
The new estimate is still high, according to an independent board of experts tasked with overseeing the vaccine’s trial and data analysis. The trial’s Data and Safety Monitoring Board (DSMB) sent a highly unusual letter to AstraZeneca soon after the Monday press release, noting that trial data it had seen during February and March meetings suggested that the vaccine’s efficacy was actually between 69 percent and 74 percent.
“The DSMB is concerned that AstraZeneca chose to use data that was already outdated and potentially misleading in their press release,” the letter stated. “The point that is clear to the board is that the [vaccine efficacy number]… they chose to release was the most favorable for the study as opposed to the most recent and most complete. Decisions like this are what erode public trust in the scientific process.”
In an equally stunning statement issued in the wee hours of Tuesday, the National Institute of Allergy and Infectious Diseases echoed the point that AstraZeneca’s Monday press release may have “provided an incomplete view of the efficacy data.”
“We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible,” the NIAID statement read.
AstraZeneca is standing by its earlier efficacy estimate, however. In the announcement Wednesday night, the company said that the latest estimate is “consistent with the pre-specified interim analysis announced on Monday 22 March 2021.”
According to the company, the new analysis of the 32,449-person trial included 190 symptomatic cases, up from the 141 symptomatic cases included in the analysis from Monday.
Based on those 190 cases, the vaccine appeared 76 percent effective at preventing symptomatic disease occurring 15 days or more after receiving the second of two doses, which were given four weeks apart. The confidence interval for the estimate—which suggests the plausible range of efficacy based on the data—was between 68 percent and 82 percent, the company noted.
AstraZeneca added that, as before, vaccine efficacy appeared comparable across age groups, with an estimated 85 percent efficacy in people 65 years and older. The vaccine again appeared to prevent severe disease. Eight cases of severe COVID-19 were included in the new analysis, all of which were in people who received a placebo. None of the vaccinated participants required hospitalization and the company still saw no safety concerns from the vaccine.
“The primary analysis is consistent with our previously released interim analysis, and confirms that our COVID-19 vaccine is highly effective in adults, including those aged 65 years and over,” Mene Pangalos, an AstraZeneca executive, said in the Wednesday announcement. “We look forward to filing our regulatory submission for Emergency Use Authorization in the US and preparing for the rollout of millions of doses across America.”
The announcement noted that the latest results “have been presented to the independent Data Safety Monitoring Board.”
The first batch of preliminary laboratory data on the omicron coronavirus variant has come out, and the results are largely what health experts have anticipated: protective antibodies from two doses of the Pfizer-BioNTech vaccine are considerably less effective at thwarting the new variant than older versions of the virus. However, antibody potency appears to rebound to fight omicron after a booster dose.
The results suggest that people who have only two doses of the mRNA vaccine may not be protected from infection but would likely remain protected from severe disease. The findings also suggest that maintaining high levels of protection against omicron will require a booster dose of the current vaccines—or even an omicron-specific shot in the future.
The top-line findings and conclusions come from three separate sets of laboratory experiments—all of which are extremely preliminary, involve small sample numbers, and have not been peer-reviewed or published in scientific journals.
Pfizer and BioNTech data
The freshest data comes from preliminary results reported online Wednesday morning by Pfizer and BioNTech. The companies conducted laboratory experiments that pitted antibodies from the blood serum of vaccinated people against a pseudovirus engineered to mimic the omicron variant. The experiments specifically measured the activity of neutralizing antibodies, which are a subset of antibodies that can bind to SARS-CoV-2 virus particles in such a way that the virus is prevented from entering human cells. Neutralizing antibodies are the most potent at preventing infection, but the immune system also produces a diverse array of other antibodies that can help fight an infection. Additionally, the immune system has protective cell-based responses that are not captured in these types of laboratory experiments.
In experiments using the blood sera of people fully vaccinated with the Pfizer-BioNTech vaccine (two doses), neutralizing antibody levels fell 25-fold against the omicron-mimicking pseudovirus compared with levels seen against a pseudovirus mimicking an older version of the virus. But when the companies looked at blood sera from fully vaccinated people one month after they received a vaccine booster shot (three doses), neutralizing antibody levels rebounded 25-fold against omicron, making them comparable to neutralizing antibody levels seen against older versions of the virus.
“Although two doses of the vaccine may still offer protection against severe disease caused by the omicron strain, it’s clear from these preliminary data that protection is improved with a third dose of our vaccine,” Pfizer CEO Albert Bourla said in a statement. “Ensuring as many people as possible are fully vaccinated with the first two-dose series and a booster remains the best course of action to prevent the spread of COVID-19.”
The companies also reported that they are still working on an omicron-specific vaccine dose in case it is needed. The timeline for the first batches to be available is still within 100 days from now, the companies said.
Editor’s Note: This is the first in an occasional series of profiles of people helping to lead the commercial space industry, which NASA Deputy Administrator Pam Melroy has called “the envy of the world.” Everyone knows who Elon Musk and Jeff Bezos are. But there are many other people working to usher in a future in which spaceflight is sustainable and economic activity in space is profitable. These are some of their stories.
Dylan Taylor seemed almost in shock when we spoke by telephone in late October.
“This,” he said, his voice breaking, “has been a dream of mine for almost my entire life.”
Taylor had called to say the crew lineup for the third human flight of Blue Origin’s New Shepard flight had been finalized, and he was among four paying passengers. The flight, launching on Saturday from West Texas, will include higher-profile crew members. Notably, Good Morning America co-anchor Michael Strahan and Laura Shepard Churchley, the eldest daughter of Alan Shepard, are both flying as guests alongside Taylor, Evan Dick, Lane Bess, and Cameron Bess.
But for commercial space, Taylor is one of the most consequential space entrepreneurs yet to go to space, perhaps second only to Blue Origin founder Jeff Bezos and Virgin Galactic’s Sir Richard Branson, who both flew earlier this summer.
Flying on New Shepard this week is an important step in Taylor’s personal journey, and he hopes to share the experience with others. In 2017, he founded Space For Humanity, which is buying seats on New Shepard and Virgin Galactic’s VSS Unity spacecraft to create opportunities for “citizen astronauts.” The goal is to sponsor people from all over the world to go to space, experience the overview effect, and return to Earth to share it with their communities.
But his impact goes far beyond simply spreading awareness of spaceflight. In recent years, Taylor has had an increasingly important, if quiet, influence on the development of commercial space. He is chairman and founder of Voyager Space Holdings, which has built a portfolio of new space companies. One small Voyager company, Nanoracks, recently won a $160 million contract from NASA to begin developing a commercial space station in low Earth orbit.
For Taylor, this marked a hugely validating moment. He counts himself as one of “Gerry’s kids,” a cohort of idealistic space cadets who believe humans should settle space and that the best place to do so is in massive O’Neill cylinders—first theorized by physicist Gerry O’Neill—orbiting Earth and the Moon. Privately developed space stations represent a concrete first step toward this goal.
“I’m a true believer,” Taylor, 51, said. “If the end state is O’Neillian, the way my brain works is—what are the obstacles and what are the constraints, and how do we overcome them?”
There are already plenty of companies building rockets, he believes. So the biggest constraint now is the development of economic activity in space, giving humans a purpose to go there.
His answer ultimately has come in the form of Voyager, which he describes as a “sustainable and benevolent” operating company. It seeks to acquire promising small space companies focusing on in-space activities, such as habitats, mitigating orbital debris, and satellite servicing. Taylor looks at the new space industry and sees a lot of companies struggling, even though they have good ideas. Maybe they have capital constraints or can’t scale easily.
Through Voyager, Taylor wants space entrepreneurs to do what they do best: innovate. So Voyager acquires their companies, provides the funding they need to scale, and helps with the business side of things. In this way, Taylor might best be seen as someone who helps promising new space companies survive the “valley of death” most startups go through.
Getting into business
Taylor grew up in Idaho and is the son of a metallurgical engineering professor at the University of Idaho. He was an avid baseball player and enjoyed the social side of school more than academics. Still, he got good enough grades to go to almost any school in the country, eventually choosing the University of Arizona because he liked the sunshine. Taylor followed in his father’s footsteps and studied engineering, but he knew he wanted to eventually become a lawyer or businessman.
After graduating from college in 1993, Taylor took a job with a Switzerland-based electronics company, Saia-Burgess, in Chicago. He got in at the right time as just one of a handful of employees in North America. Seven years later, Taylor was a general manager at a company with a few thousand people in the United States. By the turn of the century, he was not yet 30 years old, and he was already a sharp young engineer who had earned an MBA and understood the fundamentals of global business.
At the time, Saia-Burgess moved its North American operations to Troy, Michigan, to be closer to its automotive customers. Taylor disliked the new location and moved back to Chicago to be with his friends and a girlfriend who became his wife. He took a job with LaSalle Partners, which offered investment banking and real estate services. Taylor received several promotions and eventually hired on with Colliers International, a private equity firm in Toronto, in 2009.
Again, he caught a company on the upswing. Over the next six years, Colliers’ annual revenue increased from $400 million to about $3 billion. Taylor also rose to become CEO of the Americas. In 2015, the company went public, and Taylor owned “a significant part” of it. “That was a pretty life-changing event for me,” he said.
But then, in 2019, Colliers fired Taylor for “insider trading.” He was working as CEO of its real estate services division. This could have been another life-changing event, albeit not in a good way. A subsequent investigation, however, found there had been no improper dealings. “Long story short, I had decided to leave,” Taylor said. “And then as I was leaving, there was a disagreement that was completely resolved.” Taylor and Colliers issued a joint statement, amicably settling the matter.
Taylor had wanted to leave Colliers after about a quarter-century in the business world because he was increasingly interested and passionate about spaceflight. He had first started to engage in space as far back as 2007, when he met Space Adventurers co-founder Eric Anderson at the World Economic Forum in Davos, Switzerland.
By then, Taylor was already financially set for life. “I’m sitting at the World Economic Forum, and supposedly you’re king of the world,” he said. “You have more money than you need. Yet, you’re not feeling fulfilled. I started to think about my purpose.” Taylor soon realized that his purpose was to help humanity extend its reach into space to become a spacefaring species. Taylor ended up investing in Anderson’s ventures, and the aerospace engineer began introducing Taylor to his network.
An anime convention held in New York City last month may inadvertently offer the US its first case study on the spread of the omicron coronavirus variant, according to the Centers for Disease Control and Prevention.
Fifty-three thousand anime fans from all 50 states, the District of Columbia, Puerto Rico, and 27 other countries traveled to New York City for the Anime NYC convention, which ran from November 19 and 21 in the city’s Javits Center. Organizers reported afterward that they were overwhelmed by the large attendance and struggled with packed rooms and crowding—conditions ideal for coronavirus transmission.
Last week, officials in Minnesota reported that a resident tested positive for the omicron variant after attending the convention. At the time, it was only the second omicron case detected in the US. But since then, officials have identified cases in at least 18 other US states, as well as over 50 countries worldwide.
The discovery of omicron at a large, tightly packed event with far-flung travelers is concerning. The variant is thought to be ultratransmissible. Preliminary reports from South Africa suggest omicron may spread more than twice as quickly as the already hypertransmissible delta variant. In such a crowded convention, omicron could swiftly spread among attendees and be carried back to home states and countries for further spread.
Omicron is, in all likelihood, rapidly escalating in the US. Despite this, health officials have been relatively slow in detecting the variant. Genomic surveillance of variants is patchy and limited across states, though it has improved since the pandemic began. Another factor working against the country is the still extremely high levels of delta transmission. Any relatively small rise in omicron cases could easily be washed out by the massive delta wave.
But the anime convention provides a specific source of transmission that health investigators can use to get a clearer look at how omicron is spreading. The CDC has teamed up with the Minnesota and New York City health departments to retrace omicron’s steps through the massive event.
In a press briefing Tuesday, CDC director Rochelle Walensky said that the CDC has reached out to all states, territories, and countries with residents who attended the convention and hopes to reach all of the reported 53,000 attendees. So far, health officials have contacted more than 35,000 of them.
“Data from this investigation will likely provide some of the earliest looks in this country on the transmissibility of the variant,” Walensky said during the briefing.
Contact tracers will likely have their work cut out for them. On December 4, Connecticut announced that it had detected its first omicron case in a man in his 60s. The man had a family member who had tested positive for COVID-19 days earlier after returning from the anime convention in New York.
In a New York Times article published December 5, the Minnesota man first found to have an omicron infection after the convention said that roughly half of the 30 vaccinated people he recalls socializing with have tested positive. He told the paper that he had spent his time in New York attending discussion panels at the convention, chatting with strangers, and singing karaoke.