Johnson & Johnson COVID-19 vaccine booster, after single dose primary regimen, provided rapid and robust increase in spike-binding antibodies
New studies build on data demonstrating strong durability through eight months after immunization
https://finance.yahoo.com/news/johnson-johnson-announces-data-support-104500343.html
Merck (MRK) said VAXNEUVANCE met key immunogenicity and safety endpoints in the PNEU-PED study in healthy infants. The Pneumococcal 15-valent Conjugate Vaccine showed a safety profile generally comparable to the licensed 13-valent pneumococcal conjugate vaccine (PCV13). At 30 days following the third dose, VAXNEUVANCE was non-inferior to PCV13 for all 13 shared serotypes.
Merck said VAXNEUVANCE also achieved key safety objectives in the phase 3 PNEU-LINK (V114-031) study in infants.
On July 16, 2021, the FDA approved VAXNEUVANCE for adults 18 years of age. The company said its plans are on track for submission of a supplemental regulatory licensure application to the FDA for use in children before the end of the year.
The National Institutes of Health has initiated a late-stage study to test plasma-derived COVID-19 therapies including Emergent BioSolutions Inc's candidate for those at high risk of disease progression, the drug developer said.
Emergent said on Wednesday the study will evaluate the safety and efficacy of polyclonal antibodies derived from plasma of individuals who have recovered from COVID-19.
The trial will include immunocompromised adults and those above 55 years.
Emergent is one of the two companies providing plasma-derived products for the trial, which will enroll approximately 800 patients across the United States and international clinical trial sites.
Emergent's candidate, COVID-HIG, is in development through funding from the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, and the Biomedical Advanced Research and Development Authority.
https://finance.yahoo.com/news/1-emergents-covid-19-plasma-110516392.html
Histological Analysis Demonstrates Treatment Potential of LPCN 1144 in NASH
- Both LPCN 1144 treatment arms met with statistical significance the pre-specified histology based regulatory endpoint of NASH resolution with no worsening of fibrosis
- Treatment effect observed on fibrosis improvement needs confirmation in a larger study
- Changes in key liver enzymes and body composition support beneficial treatment effects of LPCN 1144
- LPCN 1144 was well tolerated with an overall safety profile comparable to placebo
- Positive topline results support LPCN 1144 development for regulatory approval
-- Conference Call Scheduled for 8:30 a.m. ET today
Management will host a conference call and webcast today at 8:30 a.m. Eastern time to discuss LPCN 1144 Phase 2 LiFT clinical study key secondary endpoint topline results. To participate in the conference call, please dial 1-877-451-6152 from the U.S. or 1-201-389-0879 from outside the U.S. In addition, following the completion of the call, a telephone replay will be accessible until September 1, 2021, by dialing 1-844-512-2921 from the U.S. or 1-412-317-6671 from outside the U.S. and entering conference ID #13722634. Those interested in listening to the conference call live via the internet may do so by using the following link: http://public.viavid.com/index.php?id=146385. An archive of the webcast will also be available on the webcast page of the Company's website for 90 days.
https://finance.yahoo.com/news/lipocines-lpcn-1144-met-non-103000283.html
A shareholder firm called for the Food and Drug Administration to halt Cassava Sciences' (SAVA) studies in Alzheimer's disease, leading SAVA stock to plummet Wednesday.
Cassava is working on an Alzheimer's treatment called simufilam which binds to and stabilizes an altered version of the protein filamin A. But a "whistleblower submission" from Labaton Sucharow calls into question three major areas of concern and six smaller concerns surrounding the company's data. The firm claims Cassava engaged in "data manipulation and misrepresentation."
The company responded to the Labaton Sucharow's claims saying it "stands behind its science, its scientists and its scientific collaborators."
Immunity to COVID-19 from vaccines might be declining over time as the highly contagious delta variant surges across the country, according to new research from the Centers for Disease Control and Prevention.
A study released Tuesday showed vaccine effectiveness decreased among health care workers who were fully vaccinated since the time that the delta variant became widespread, which could be due to waning effectiveness of the vaccine over time, the higher transmissibility of the delta variant or other factors, experts said.
The CDC said the trend should also be “interpreted with caution” because a decline in vaccine effectiveness could be due to “poor precision in estimates due to limited number of weeks of observation and few infections among participants.”
A second study found about a quarter of COVID-19 cases between May and July in Los Angeles were breakthrough cases, but that hospitalizations were significantly lower for those who had been vaccinated. Unvaccinated people were more than 29 times more likely to be hospitalized than vaccinated people, and about five times more likely to be infected.
The studies show the importance of being fully vaccinated, because the benefit of being vaccinated when it comes to hospitalization did not decline even with the recent wave, Dr. Eric Topol, a professor of molecular medicine and vice president for research at the Scripps Research Institute, told USA TODAY.
"If you take these two studies together, and everything else that’s been reported… you see consistent attrition of protection with people who are fully vaccinated," he said. "But the benefit of vaccination is still there despite the breakthrough infections because hospitalizations are really markedly protected."
The research comes as the FDA has given its full approval of the Pfizer-BioNTech COVID-19 vaccine, and soon after the agency and the CDC recommended a third vaccine dose to those who have compromised immune systems. A booster shot is expected to be available to fully vaccinated Americans who got their second dose at least eight months prior beginning Sept. 20, according to the White House.
That’s too long to wait, Topol said. Based on the research, Topol said immunity may begin to go down at around the five- or six-month mark, leaving vaccinated people more vulnerable to infection.
If you wait until eight months, you’re two or three months vulnerable while delta is circulating. Whatever you’re doing in life, unless you live in a cave, you're getting incremental exposures," Topol said.
The study among health care personnel and other frontline workers was conducted in eight locations across six states beginning in December 2020 and ending Aug. 14. The research shows vaccine effectiveness was 91% before the dominance of the delta variant, and it has since dropped to 66%.
Topol said he doesn’t believe the decline in effectiveness can be solely attributed to waning immunity over time, but has a lot to do with the delta variant’s contagious nature. Other factors, such as laxed mitigation measures – relaxation of masking and distancing – could contribute, but are harder to quantify.
“Although these interim findings suggest a moderate reduction in the effectiveness of COVID-19 vaccines in preventing infection, the sustained two thirds reduction in infection risk underscores the continued importance and benefits of COVID-19 vaccination,” the CDC said.
Topol said the research underscores the need for vaccines for all, but also the need to protect vaccinated people. The delta wave will pass eventually, but even those who are fully vaccinated need to “keep your guard up,” he said.
“We’re not getting the word out enough that people who have been vaccinated are not protected as much as they think. They need to mask up, they need to do everything they can. Make believe that there wasn't a vaccine," he said.
Two separate research teams have reported on laboratory tests of monoclonal antibodies that appear to protect against a broad range of COVID-19 virus variants.
One study, published in The New England Journal of Medicine, identified "high-level, broad-spectrum" antibodies in blood samples from survivors of the original SARS outbreak in 2003 who recently received the Pfizer/BioNTech vaccine against SARS-CoV-2, the virus that causes COVID-19.
In test tube experiments, some of the SARS survivors' antibodies induced by the vaccine could neutralize not only all of the current SARS-CoV-2 variants of concern, but also five viruses that have been identified in bats and pangolins and that have the potential to cause human infection.
In a separate study, published in Immunity, another research team describes an antibody that was highly protective at low doses against a wide range of COVID-19-causing variants in mice.
"The antibody attaches to a part of the virus that differs little across the variants, meaning that it is unlikely for resistance to arise at this spot," the authors said.
The findings from these studies could be a step toward developing new antibodies that would be effective against multiple different coronaviruses, the two teams say.
SOURCES: https://bit.ly/3kgzEZU https://bit.ly/3kgzEZU, New England Journal of Medicine, online August 18, 2021, and https://bit.ly/3kk3HzS Immunity, online August 19, 2021.
