AstraZeneca and Oxford University on Wednesday acknowledged a manufacturing error that is raising questions about preliminary results of their experimental COVID-19 vaccine.
A statement describing the error came days after the company and the university described the shots as “highly effective” and made no mention of why some study participants didn’t receive as much vaccine in the first of two shots as expected.
In a surprise, the group of volunteers that got a lower dose seemed to be much better protected than the volunteers who got two full doses. In the low-dose group, AstraZeneca said, the vaccine appeared to be 90% effective. In the group that got two full doses, the vaccine appeared to be 62% effective. Combined, the drugmakers said the vaccine appeared to be 70% effective. But the way in which the results were arrived at and reported by the companies has led to pointed questions from experts.
The partial results announced Monday are from large ongoing studies in the U.K. and Brazil designed to determine the optimal dose of vaccine, as well as examine safety and effectiveness. Multiple combinations and doses were tried in the volunteers. They were compared to others who were given a meningitis vaccine or a saline shot.
Did researchers mean to give a half dose?
Before they begin their research, scientists spell out all the steps they are taking, and how they will analyze the results. Any deviation from that protocol can put the results in question.
In a statement Wednesday, Oxford University said some of the vials used in the trial didn’t have the right concentration of vaccine so some volunteers got a half dose. The university said that it discussed the problem with regulators, and agreed to complete the late stage trial with two groups. The manufacturing problem has been corrected, according to the statement.
What about the results themselves?
Experts say the relatively small number of people in the low dose group makes it difficult to know if the effectiveness seen in the group is real or a statistical quirk. Some 2,741 people received a half dose of the vaccine followed by a full dose, AstraZeneca said. A total of 8,895 people received two full doses.
Another factor: none of the people in the low-dose group were over 55 years old. Younger people tend to mount a stronger immune response than older people, so it could be that the youth of the participants in the low-dose group is why it looked more effective, not the size of the dose.
Another point of confusion comes from a decision to pool results from two groups of participants who received different dosing levels to reach an average 70% effectiveness, said David Salisbury, and associate fellow of the global health program at the Chatham House think tank.
“You’ve taken two studies for which different doses were used and come up with a composite that doesn’t represent either of the doses,″ he said of the figure. “I think many people are having trouble with that.″
Why would a smaller first dose be more effective?
Oxford researchers say they aren’t certain and they are working to uncover the reason.
Sarah Gilbert, one of the Oxford scientists leading the research, said the answer is probably related to providing exactly the right amount of vaccine to trigger the best immune response.
“It’s the Goldilocks amount that you want, I think, not too little and not too much. Too much could give you a poor quality response as well,” she said. “So you want just the right amount and it’s a bit hit and miss when you’re trying to go quickly to get that perfect first time.”
What are the next steps?
Details of the trial results will be published in medical journals and provided to U.K. regulators so they can decide whether to authorize distribution of the vaccine. Those reports will include a detailed breakdown that includes demographic and other information about who got sick in each group, and give a more complete picture of how effective the vaccine is.
Moncef Slaoui, who leads the U.S. coronavirus vaccine program Operation Warp Speed, said Tuesday in a call with reporters that U.S. officials are trying to determine what immune response the vaccine produced, and may decide to modify the AstraZeneca study in the U.S. to include a half dose.
“But we want it to be based on data and science,” he said.
The European Union (EU) will give the green light to a new vaccine contract, said European Commission President Ursula von der Leyen on Tuesday.
Through the purchase of up to 160 million doses of vaccines produced by American pharmaceutical company Moderna, the EU will be able to enrich its COVID-19 vaccine portfolio, reports Xinhua.
"Only a safe and effective vaccine will provide a lasting and sustainable solution to this pandemic," noted von der Leyen.
It needs to be approved by the European Medicines Agency for safety and efficiency before any vaccine is allowed to hit the European market.
Apart from Moderna, the EU's current vaccine portfolio includes purchase agreements with AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV, BioNtech-Pfizer and CureVac.
The death toll from Covid-19 reached 1,409,301 globally on Wednesday while the confirmed cases of coronavirus stood at 59,762,055, according to data compiled by Johns Hopkins University (JHU).
According to the data, COVID-19 is affecting 191 countries and territories around the world.
The wife of Colombian President Ivan Duque, Maria Juliana Ruiz, has tested positive for COVID-19, the president's office confirmed Tuesday.
"Today, Nov. 24, the results of the tests carried out the day before were delivered, and those of the nation's First Lady were positive. At this moment she is asymptomatic and following quarantine protocols established by the Ministry of Health," according to the statement.
"Since the beginning of the pandemic and periodically, both the President of the Republic, Ivan Duque Marquez, and the First Lady of the nation, Maria Juliana Ruiz, have been tested for COVID-19, given the high level of exposure and interaction that they maintain," said the statement.
In recent weeks, Duque's wife visited the islands of San Andres and Providencia, and the northwest department of Choco, attending to the victims of rainy season floods.
So far, Colombia has registered 1,262,494 cases of COVID-19 and 35,677 deaths from the disease.
China says it has detected the coronavirus on packages of imported frozen food, but how valid are its claims and how serious is the threat to public health?
Frozen shrimp imported from an Ecuadorian company was banned for one week on Tuesday in a continuing series of such temporary bans.
While experts say the virus can survive for a time on cardboard and plastic containers, it remains unclear how serious a risk that poses. Like so many issues surrounding the pandemic, the matter has swiftly become politicized.
China has rejected complaints from the U.S. and others, saying it is putting people’s lives first. Experts say they generally don’t consider the presence of the virus on packaging to be a significant health risk.
A look at the issue and some of the conclusions so far:
Packaging first became a major issue with outbreaks in China linked to wholesale food markets, including one in June on the outskirts of Beijing. That prompted the removal of smoked salmon from supermarket shelves and has snowballed into multiple cases nationwide involving chicken, beef and seafood from nearly two dozen countries. At some supermarkets, imported meat now comes with a sticker declaring it to be virus-free.
Infections among freight handlers have also placed suspicion on packaging. Person-to-person transmission hasn’t been ruled out, however, and China has yet to release evidence that packaging was indeed the route of infection.
Trading partners, including the U.S., New Zealand, Canada and the EU, say they’re unclear on China’s methodology and have seen no solid evidence that their products carried the virus. The U.S. has questioned whether China’s crackdown is scientifically based and suggested the bans may amount to an unfair trade barrier.
Chinese foreign ministry spokesperson Zhao Lijian called the U.S. accusations “totally groundless and unreasonable.” China’s measures are “necessary following the spirit of putting people’s lives first and protecting people’s health,” he said last week.
In a statement to The Associated Press, the World Health Organization said cases of live viruses being found on packaging appear to be “rare and isolated.” While the virus can “survive a long time under cold storage conditions,” there is no evidence of people contracting COVID-19 from consuming food, it said.
The virus SARS-CoV-2 that causes COVID-19 is overwhelmingly transmitted through respiratory droplets and smaller sized particles passed through the air, underscoring the importance of mask-wearing.
Yet the virus can also be present on surfaces, and public health officials have urged people to wash their hands carefully and avoid physical contact with others. In general, the colder and dryer that conditions are, the longer the virus can survive on surfaces.
Wiping down countertops, handrails and other surfaces is a common way to ensure safety. Some people have also gone to the extreme of disinfecting packages brought into their homes, both by themselves or by delivery services.
WHAT EXPERTS SAY
Virus traces found on packaging can be infectious or non-infectious. The extremely sensitive tests being used can detect both active viruses and their remnants, without being able to distinguish between them, said Timothy Newsome, a virologist at the University of Sydney.
“It is possible and may represent some risk, but it’s certainly at the lower end of risk for transmission,” he said. “We know low temperatures do stabilize the virus. Nonetheless, I think things which have been transported and surface transmission — there’s a low risk of it.”
A positive test “doesn’t indicate infectious virus, just that some signal from the virus is present on that surface,” said Andrew Pekosz of Johns Hopkins University’s Bloomberg School of Public Health.
“I’ve seen no convincing data that SARS-CoV-2 on food packaging poses a significant risk for infection,” he said.
Deep in the Mars-like landscape of Utah’s red-rock desert lies a mystery: A gleaming metal monolith in one of the most remote parts of the state.
The smooth, tall structure was found during a helicopter survey of bighorn sheep in southeastern Utah, officials said Monday.
A crew from the Utah Department of Public Safety and Division of Wildlife Resources spotted the gleaming object from the air Nov. 18 and landed to check it out during a break from their work.
They found the three-sided stainless-steel object is about as tall as two men put together. But they discovered no clues about who might have driven it into the ground among the undulating red rocks or why.
“This thing is not from another world,” said Lt. Nick Street of the Utah Highway Patrol, part of the Department of Public Safety.
Still, it’s clear that it took some planning and work to construct the 10- to 12-foot (3- to 4-meter) monolith and embed it in the rock.
The exact location is so remote that officials are not revealing it publicly, worried that people might get lost or stranded trying to find it and need to be rescued.
The monolith evokes the one that appears in the Stanley Kubrick movie “2001: A Space Odyssey.” Because it’s on federal public land, it’s illegal to place art objects without authorization.
Bureau of Land Management officials are investigating how long it’s been there, who might have created it and whether to remove it.