(Get Free Alerts for AZN) COVID-19 vaccine demonstrated 74% efficacy at preventing symptomatic disease.
In people aged 65 and older, the efficacy increased to 83.5%
Overall efficacy of 74% was lower than the interim 79% reported in March, a result AstraZeneca revised days later to 76% after a rare public rebuke from health officials that the figure was based on "outdated information."
The study included data from more than 26,000 volunteers in the United States, Chile, and Peru.
There were no cases of severe or critical symptomatic COVID-19 among the more than 17,600 participants who got the vaccine, compared with 8 cases among the 8,500 volunteers on placebo.
There were also two deaths in the placebo group but none among those who received the vaccine.
"I was pleasantly surprised," Dr. Anna Durbin, a vaccine researcher at Johns Hopkins University and one of the study's investigators, said of the overall result. "It was also highly protective against severe disease and hospitalization," she said.
No blood clotting side effects linked to the vaccine were observed during the study.
AstraZeneca said it plans to file for full approval with the FDA rather than seek emergency use authorization.
Illustration shows how a nanomaterial links with receptors on the immune system's B cells and helps them initiate antibody production. The top two panels show anti-immunoglobulin antibody fragments (brown) binding to immune system B cell receptors (blue). Micelles (spheres) don't interact with B cell receptors without these fragments (bottom left panel). In the presence of the fragments, the micelles link the fragments and B cell receptors (bottom right panel), boosting antibody production. Credit: Nanovaccine Institute
The researchers' original task was to figure out how certain polymer nanomaterials provided for a low-inflammatory immune response and yet were able to boost antibody production as part of a single dose of vaccine.
Once they learned how these nanomaterials just 20 to 30 billionths of a meter in size acted as vaccine-aiding adjuvants, they decided to take the next scientific step.
Could these same tiny adjuvants carry real-world antigens to the immune system's B cells and turn them into antibody-secreting factories? In addition, could this be an alternative way to produce laboratory antibodies for diagnostic and therapeutic applications?
The answers were yes. Cell-culture experiments with the technique produced antibodies against key antigens from the coronavirus that causes COVID-19 and the bacterium that causes pneumonic plague.
The initial observation and subsequent discovery show how researchers affiliated with the Nanovaccine Institute based at Iowa State University look at their research from many perspectives:
"This is a great example of the healthy tug of war between a basic research finding about the mechanism of antibody production and a translational benefit that we may have invented a new antibody-production platform," said Balaji Narasimhan, the director of the Nanovaccine Institute, an Iowa State Anson Marston Distinguished Professor in Engineering and the Vlasta Klima Balloun Faculty Chair. "The Nanovaccine Institute is burning both sides of that candle."
The journal Science Advances recently published the researchers' findings. First author is Sujata Senapati, a former Iowa State doctoral student in chemical and biological engineering. Corresponding authors are Narasimhan and Surya Mallapragada, an Iowa State Anson Marston Distinguished Professor in Engineering, an associate vice president for research and the Carol Vohs Johnson Chair in Chemical and Biological Engineering. (See sidebar for the full research team.)
Grants from the National Institute of Allergy and Infectious Diseases, a part of the National Institutes of Health, supported the researchers' work.
It's like a ladder
It was clear to the researchers that these nanomaterials—"pentablock copolymer micelles," according to the researchers' paper—helped B cells initiate antibody production. (Micelles are structures that self-assemble in water or oils as their molecules align because of their water-loving or water-hating properties.)
"From our studies, we understood very early on that these self-assembling micelles are different from the other types of adjuvants out there," Senapati said. "What we didn't know was the reason behind this unique type of immune response generated by them and that to me was the most intriguing part of this project."
Mallapragada said the researchers were able to tailor the chemistry of the nanomaterials, creating "micelles with added functionality."
One of those functions is the ability of positively charged micelles to associate with multiple antigens and directly interact with receptors on B cells, according to the paper. This cross-linking of the B cell receptors led to better antibody production and an enhanced immune response to a vaccine.
"These micelles act like a scaffold to cross-link two receptors," said Michael Wannemuehler, an associate director of the Nanovaccine Institute and an Iowa State professor of veterinary microbiology and preventive medicine.
He said the cross-link is strong and stable, like a ladder hooked at both ends, and is effective at stimulating antibody production by the B cells.
That cellular activation came without the inflammatory response that accompanies other vaccine adjuvants, potentially producing a "'just right' immune response" that could be "critical in the rational design of vaccines for older adults" who often suffer from chronic inflammation, according to the paper.
Making lab antibodies
Now that the researchers understood the "behind-the-scenes" mechanism of the micelles' antibody boost, Senapati said they wanted to see what else they could find.
"The next obvious step then was to test our hypothesis with antigens from some real-world pathogens and see if these micelles could be potentially used to produce antibodies against them," she said.
They used the micelle scaffolds to present antigens for SARS-CoV-2, the virus that causes COVID-19, and Yersinia pestis, the bacterium that causes pneumonic plague, to B cells in culture.
Those cells began generating "laboratory-scale quantities of therapeutic antibodies" against the two antigens, "further expanding the value of these nanomaterials to rapidly develop countermeasures against infectious diseases," according to the paper.
Those antibodies could potentially be used for diagnostic test kits or for treatments such as the monoclonal antibodies that have been developed to treat COVID-19, Wannemuehler said.
"There are different ways to produce antibodies," Narasimhan said. "The method we found is an alternative that could be quite powerful if it's generalized to other diseases. It could be a plug-and-play platform."
Because it's an effective vaccine adjuvant and antibody producer, the paper says the nanomaterial platform developed by the study team is "a highly versatile tool in the development of multiple countermeasures against emerging and reemerging infectious diseases."
More information: Sujata Senapati et al, Self-assembling synthetic nanoadjuvant scaffolds cross-link B cell receptors and represent new platform technology for therapeutic antibody production, Science Advances (2021). DOI: 10.1126/sciadv.abj1691
A large team of researchers affiliated with a host of institutions in the U.K. and Brazil has partially solved the mystery of why some people are less naturally resistant to COVID-19 than others. In their paper published in the journalScience, the group describes their study of the interferon system and the role it plays in combating the SARS-CoV-2 virus.
As the global pandemic has unfolded, it has become clear that some people have much more serious symptoms when contracting COVID-19 than others. Indeed, some people have been found to exhibit no symptoms at all, while others become so sick that they die. In this new effort, the researchers conducted extensive interferon-stimulatedgene expressionscreening to isolate possible enzymes involved in alerting the immune system to an infection. Interferons are signaling proteins that alert the body when invasive entities such as bacteria and viruses are detected.
The work by the researchers led them to OAS1, an enzyme that reacts to interferon signaling by calling for an immune response when the SARS-CoV-2 virus is detected. Prior research has shown that OAS1 attaches to membranes using a prenyl group as part of the signaling process. Prior research has also shown that this signaling can inhibit replication of the SARS-CoV-2 virus. Noting its value in protecting people against COVID-19, the researchers looked at the transcriptomes of 500 COVID-19 patients who had experienced a wide range of symptoms and found that those who did not have prenylated OAS1 experienced much more severe symptoms. Why some people are born without the enzyme is still a mystery, but the work by the team could help lead to new types of vaccines against COVID-19 and other types of infections.
Intrigued by their findings, the researchers turned their attention to another mammal possibly involved in the pandemic—the horseshoe bat. They found it did not possess the form of prenylated OAS1 that protects humans from the virus, helping to explain why the virus is so deadly to that species. The finding could also help explain why the bats are such prolific hosts to a variety of viruses.
The Department of Homeland Security (DHS) is reportedly concerned about a potential increase in migrants trying to enter the U.S. if COVID-19 restrictions are partially lifted on Thursday.
NBC News reported on Thursday that Secretary Alejandro Mayorkas, during a phone call with senior DHS officials this week, asked if the department was ready for a potential surge of migrants attempting to cross the border in October, according to two DHS officials familiar with the conversation.
Personnel at the department is reportedly concerned about a possible influx of migrants if Title 42 — the policy the Biden administration has used amid the pandemic to return border crossers without giving them an opportunity to apply for asylum — is lifted, according to the DHS officials.
Federal District Judge Emmet Sullivan earlier this month ordered that the Biden administration stop using Title 42 to drive out families with children who cross the U.S.-Mexico border.
The ruling was handed down after families filed a class-action lawsuit arguing that the policy, which was crafted under the Trump administration, wrongly barred them from seeking humanitarian protections.
Sullivan’s ruling, which only applies to families, is set to take effect on Thursday, though the Biden administration has appealed the decision. More than 16,000 “individuals in a family unit” were expelled in August.
The Biden administration previously weighed nixing the measure by the end of July, according to NBC News, but ultimately decided against such a move. Officials were reportedly concerned that lifting it would cause a “catastrophic” migrant surge.
Two DHS officials told NBC News that the department is concerned that migrants may view the lifting of Title 42 as a green light to cross the border, and that they will be permitted to remain in the U.S. despite rulings on their asylum cases.
The concern within the department comes after the administration last week dealt with an unexpected influx of more than 25,000 Haitian migrants in Texas.
The camp where the migrants were staying has since been cleared, but photos circulated amid the chaos that depicted border officers on horseback trying to disperse the migrants.
Mayorkas said an investigation into the situation is underway.
One-third of parents want to vaccinate their 5- to 11-year-olds “right away” when the coronavirus vaccine is approved for their age group, according to a new report from the Kaiser Family Foundation.
The report found that 34 percent of parents polled will get their 5- to 11-year old children vaccinated immediately, with most of the interviews conducted before Pfizer released their clinical trial results for the age group in September.
Thirty-two percent of respondents say they would want to “wait and see” before getting young children vaccinated, 7 percent would do so if it was required and 24 percent would “definitely not” get their kids vaccinated.
The percentage of those who would get their children vaccinated right away has gone up from a July survey by Kaiser, when 26 percent of parents said they would get their 5- to 11-year olds vaccinated right away when the vaccine was approved.
The Pfizer vaccine is only authorized for those 12 and older. Forty-eight percent of those surveyed said they have had their 12- to 17-year old children vaccinated.
The poll found 44 percent of respondents with kids ages five to 11 would get their children vaccinated while 42 percent would not.
The Kaiser Family Foundation survey was conducted between Sept. 13 and Sept. 22. The group surveyed 1,519 people and reports a margin of error of plus or minus 3 percentage points.
Two service members filed a potential class action lawsuit against Defense SecretaryLloyd Austinto attempt to block him from requiring all troops receive a COVID-19 vaccine.
Army Staff Sgt. Dan Robert and Marine Corps Staff Sgt. Hollie Mulvihill, who filed the complaint Aug. 17 in the U.S. District Court of Colorado, also want the Pentagon to create a vaccine exemption for those previously infected with the coronavirus as they already have “natural immunity.”
The two, who are both based in North Carolina, argue that the Defense Department’s vaccine mandate “is in open violation” of the rights of service members and is unconstitutional.
Austin is named as a defendant in the lawsuit as are Health and Human Services Secretary Xavier Becerra and Janet Woodcock, acting commissioner of the Food and Drug Administration (FDA).
The Pentagon chief in late August ordered service members to “immediately begin” receiving the COVID-19 vaccine, with the military services setting the deadlines for the requirement.
The Pentagon has also made clear it would only require a COVID-19 vaccine that had full FDA approval, which the Pfizer shot received on Aug. 23.
But Robert and Mulvihill, who filed their complaint days prior to the FDA decision, base their argument on the Pfizer vaccine’s previous emergency-use authorization standing.
They also say they should be exempt from the mandate because they already caught and recovered from COVID-19.
More than 372,000 coronavirus cases — 244,300 of which were service members — have been reported among U.S. military personnel, with 5,274 hospitalizations and 515 deaths, according to Defense data.
As of Wednesday, 58 troops, sailors and airmen have died from the illness.
A group of New York City public school teachers who refuse COVID-19 inoculation have asked the Supreme Court to block a vaccine mandate set to take effect Friday.
The teachers, who expressed various reasons for refusing to vaccinate, are united in their view that New York City’s public health measure runs afoul of the law.
“Thousands of school teachers will lose their livelihoods if they are without pay and cannot work anywhere else, their ability to serve the children of New York City, and, of course, their ranking as teachers,” their lawyer Vinoo Varghese told The Hill.
The teachers’ request was submitted to Justice Sonia Sotomayor, who handles emergency matters arising from New York, after their legal bid was rebuffed by lower federal courts over the past week.
The dispute arose after New York City officials in August announced that public school employees would be required to get vaccinated against the coronavirus in the interest of protecting the health of those who populate America’s largest school system.
The policy initially provided teachers the ability to opt-out of the vaccine requirement by agreeing instead to undergo weekly COVID-19 screenings. That option was later withdrawn for teachers, however, even as firefighters and police officers continue to be able to opt-out of receiving jabs.
Part of the teachers’ legal complaint is that school employees are being treated differently than other city workers.
“There is no rational and non-discriminatory basis for treating applicants differently than other municipal workers,” the teachers wrote in their Supreme Court filing.
The New York-based challenge follows a recent legal fight over another mandatory school vaccine policy.
In that case, a group of Indiana University students sought to block the school’s requirement that students be vaccinated against COVID-19 before attending classes this fall. Justice Amy Coney Barrett, who handles emergency matters from Indiana, denied their request without comment.
