Antibiotic may may kill dangerous skin cancer cells, says study

The American pharmaceutical giant Pfizer Inc. and the European biotechnology company BioNTech SE have conducted an experimental trial of a COVID-19 vaccine candidate and found it to be safe, well-tolerated, and capable of generating antibodies in the patients.

The study, which is yet to be peer-reviewed, describes the preliminary clinical data for the candidate vaccine -- nucleoside-modified messenger RNA (modRNA), BNT162b1.

It said the amount of antibodies produced in participants after they received two shots of the vaccine candidate was greater than that reported in patients receiving convalescent plasma from recovered COVID-19 patients.

"I was glad to see Pfizer put up their phase 1 trial data today. Virus neutralizing antibody titers achieved after two doses are greater than convalescent antibody titers," tweeted Peter Hotez, a vaccine scientist from Baylor College of Medicine in the US, who was unrelated to the study.

Researchers, including those from New York University in the US, who were involved in the study, said the candidate vaccine enables human cells to produce an optimised version of the receptor binding domain (RBD) antigen -- a part of the spike (S) protein of SARS-CoV-2 which it uses to gain entry into human cells.

"Robust immunogenicity was observed after vaccination with BNT162b1," the scientists noted in the study.

They said the program is evaluating at least four experimental vaccines, each of which represents a unique combination of mRNA format and target component of the novel coronavirus, SARS-CoV-2.

Based on the study's findings, they said BNT162b1 could be administered in a quantity that was well tolerated, potentially generating a dose dependent production of immune system molecules in the patients.

The research noted that patients treated with the vaccine candidate produced nearly 1.8 to 2.8 fold greater levels of RBD-binding antibodies that could neutralise SARS-CoV-2.

"We are encouraged by the clinical data of BNT162b1, one of four mRNA constructs we are evaluating clinically, and for which we have positive, preliminary, topline findings," said Kathrin U. Jansen, study co-author and Senior Vice President and Head of Vaccine Research & Development, Pfizer.

"We look forward to publishing our clinical data in a peer-reviewed journal as quickly as possible," Jansen said.

According to Ugur Sahin, CEO and Co-founder of BioNTech, and another co-author of the study, the preliminary data are encouraging as they provide an initial signal that BNT162b1 is able to produce neutralising antibody responses in humans.

He said the immune response observed in the patients treated with the experimental vaccine are at, or above, the levels observed from convalescent sera, adding that it does so at "relatively low dose levels."

"We look forward to providing further data updates on BNT162b1," Sahin said.

According to a statement from Pfizer, the initial part of the study included 45 healthy adults 18 to 55 years of age.

It said the priliminary data for BNT162b1 was evaluated in 24 subjects who received two injections of 10 microgrammes ( g) and 30 g -- 12 subjects who received a single injection of 100 g, and 9 subjects who received two doses of a dummy vaccine.

The study noted that participants received two doses, 21 days apart, of placebo, 10 g or 30 g of BNT162b1, or received a single dose of 100 g of the vaccine candidate.

According to the scientists, the highest neutralising concentrations of antibodies were observed seven days after the second dose of 10 g, or 30 g on day 28 after vaccination.

They said the neutralising concentrations were 1.8- and 2.8-times that observed in a panel of 38 blood samples from people who had contracted the virus.

In all 24 subjects who received two vaccinations at 10 g and 30 g dose levels, elevation of RBD-binding antibody concentrations was observed after the second injection, the study noted.

It said these concentrations are 8- and 46.3-times the concentration seen in a panel of 38 blood samples from those infected with the novel coronavirus.

At the 10 g or 30 g dose levels, the scientists said adverse reactions, including low grade fever, were more common after the second dose than the first dose.

According to Pfizer, local reactions and systemic events after injection with 10 g and 30 g of BNT162b1 were "dose-dependent, generally mild to moderate, and transient."

It said the most commonly reported local reaction was injection site pain, which was mild to moderate, except in one of 12 subjects who received a 100 g dose, which was severe.

The study noted that there was no serious adverse events reported by the patients.

Citing the limitations of the research, the scientists said the immunity generated in the participants in the form of the T cells and B cells of their immune system, and the level of immunity needed to protect one from COVID-19 are unknown.

With these preliminary data, along with additional data being generated, Pfizer noted in the statement that the two companies will determine a dose level, and select among multiple vaccine candidates to seek to progress to a large, global safety and efficacy trial, which may involve up to 30,000 healthy participants if regulatory approval to proceed is received.

Washington DC, Jun 29: Young children with narrow retinal artery diameters were more likely to develop higher blood pressure, and children with higher blood pressure levels were more likely to develop retinal microvascular impairment during early childhood, according to a new study.

The first study to show this connection in children was published today in Hypertension, an American Heart Association journal.

High blood pressure, the main risk factor for the development of cardiovascular disease (CVD), can manifest as early as childhood, and the prevalence of high blood pressure among children continues to rise. In previous studies, analysis of blood vessels in the retina has shown promise as a predictor of CVD risk among adults. In the study titled, "Retinal Vessel Diameters and Blood Pressure Progression in Children," researchers sought to predict the development of high blood pressure in children over four years based on retinal blood vessel measurements.

"Hypertension continues as the main risk factor for the development of cardiovascular diseases and mortality," says Henner Hanssen, M.D., the study's lead author and a professor in the department of sport, exercise and health at the University of Basel in Switzerland. 

"Primary prevention strategies are needed to focus on screening retinal microvascular health and blood pressure in young children in order to identify those at increased risk of developing hypertension. The earlier we can provide treatment and implement lifestyle changes to reduce hypertension, the greater the benefit for these children."

Researchers screened 262 children ages six to eight from 26 schools in Basel, Switzerland, in 2014, for baseline blood pressure and retinal arterial measurements. Both measures were taken again in 2018. Blood pressure measurements at both baseline and follow-up were performed in a sitting position after a minimum of five minutes of rest and were categorized based on the American Academy of Pediatrics' blood pressure guidelines. These guidelines utilize the same measurements as the American Heart Association/American College of Cardiology 2017 Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults.

Results from the analysis indicate: children with narrower retinal vessel diameters at baseline developed higher systolic blood pressure at follow-up; retinal vessel diameters could explain 29 -31 per cent of the changes in systolic blood pressure progression between 2014 and 2018; children with higher blood pressure levels at baseline developed significantly narrower arteriolar diameters at follow-up, depending on weight and cardiorespiratory fitness; and initial blood pressure measures explained 66-69 per cent of the change in retinal arteriolar diameter from baseline to follow-up.

"Early childhood assessments of retinal microvascular health and blood pressure monitoring can improve cardiovascular risk classification. Timely primary prevention strategies for children at risk of developing hypertension could potentially counteract its growing burden among both children and adults," said Hanssen.

Researchers noted limitations of their study include that they could not confirm blood pressure measurements over a single 24-hour period, so they would not account for "white coat" hypertension, a condition where patients have high blood pressure readings when measured in a medical setting.

Developmental stage including puberty status of each child was not accounted for in the study, as well as genetic factors or birth weight - variables that could impact blood pressure development and microvascular health.

In addition, reference values for appropriate retinal vessel diameters in children do not currently exist, so future studies are needed to determine age-related normal values during childhood.

Washington, Jul 9: Ayurvedic practitioners and researchers in India and the US are planning to initiate joint clinical trials for Ayurveda formulations against the novel coronavirus, the Indian envoy here has said.

In a virtual interaction with a group of eminent Indian-American scientists, academicians, and doctors on Wednesday, Indian Ambassador to the US Taranjit Singh Sandhu said the vast network of institutional engagements have brought scientific communities between the two countries together in the fight against Covid-19.

 “Our Institutions have also been collaborating to promote Ayurveda through joint research, teaching and training programs. Ayurvedic practitioners and researchers in both the countries are planning to initiate joint clinical trials of Ayurvedic formulations against Covid-19,” Sandhu said.

“Our scientists have been exchanging knowledge and research resources on this front,” he said.

The Indo-US Science Technology Forum (IUSSTF) has always been instrumental in promoting excellence in science, technology, and innovation through collaborative activities.

To address Covid-19-related challenges, the IUSSTF had given a call to support joint research and start-up engagements. A large number of proposals are being reviewed on fast track mode by the experts on both the sides, he said.

“Indian pharmaceutical companies are global leaders in producing affordable low-cost medicines and vaccines and will play an important role in the fight against this pandemic,” Sandhu said.

According to the ambassador, there are at least three ongoing collaborations between Indian vaccine companies with US-based institutions.

These collaborations would be beneficial not just to India and the US, but also for the billions who would need to be vaccinated against Covid-19 across the world, he noted.

Asserting that innovation will be the key driver in pandemic response and recovery, he said tech-companies and start-ups have already begun to take the lead in this direction.

"Telemedicine and telehealth will evolve as will other digital platforms across sectors," he said.

Noting that there has been a longstanding collaboration between India and the US in the health sector, he said scientists have been working together in several programs to understand important diseases at the basic and clinical level.

Many such programs have been focused on translational research to develop new therapeutics and diagnostics.

There are over 200 ongoing NIH funded projects in India involving 20 institutions from NIH network and several eminent institutions in India engaged in a wide spectrum of research areas to create health care solutions, the senior diplomat said.

The collaboration under Vaccine Action Program (VAP) resulted in the development of ROTAVAC vaccine against rotavirus which causes severe diarrhea in children.

The vaccine was developed by an Indian company (Bharat Biotech) at an affordable cost. It has been commercialised and introduced in the Expanded Program on Immunisation.

Development of many other vaccines such as TB, Influenza, Chikungunya are also in progress under the VAP, he said.

 “As I speak, the VAP meeting is in progress where experts from both countries are deeply engaged in technical discussions to expedite development of Covid-19 vaccine,” Sandhu said in his remarks.

During the interaction, the eminent experts appreciated India's handling of the Covid-19 pandemic and offered their valuable suggestions and best practices in this regard.

They shared their ideas on deepening the knowledge partnership between India and the US.

The experts who took part in the interaction, were drawn from wide-ranging fields including artificial intelligence, quantum information science, biomedical engineering, robotics, mechanical engineering, earth and ocean science, virology, physics, astrophysics, and health sciences.

Prominent among those who attended the virtual interaction were Subhash Kak Regents Professor at Oklahoma State University, Dr Vijay Kuchroo, Samuel L Wasserstrom Professor of Neurology at Harvard Medical School, Dr Ashish M Kamat, Professor of Urology at MD Anderson Cancer Center, Ashutosh Chilkoti, Alan L Kaganov Professor of Biomedical Engineering and Chair of the Department of Biomedical Engineering at Duke University; and Prof Manu Prakash, a professor in Department of Bioengineering at Sandford University, among others.