Pfizer, BioNTech experimental COVID-19 vaccine shows promise in early trial: Study

Agencies
July 2, 2020

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.

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Agencies
May 19,2020

Researchers have found that patients with peripheral artery disease or stroke were less likely to receive recommended treatments to prevent heart attack than those with coronary artery disease. All three are types of atherosclerotic cardiovascular disease.

Depending on the location of the blockage, atherosclerosis increases the risk for three serious conditions: coronary artery disease, stroke and peripheral artery disease.

"Our study highlights the need for public health campaigns to direct equal attention to all three major forms of atherosclerotic cardiovascular disease," said senior study author Erin Michos from the Johns Hopkins University in the US.

"We need to generate awareness among both clinicians and patients that all of these diseases should be treated with aggressive secondary preventive medications, including aspirin and statins, regardless of whether people have heart disease or not," Michos added.

Since atherosclerosis can affect arteries in more than one part of the body, medical guidelines are to treat coronary artery disease, stroke and peripheral artery disease similarly with lifestyle changes and medication, including statins to lower cholesterol levels and aspirin to prevent blood clots.

Lifestyle changes include eating a healthy diet, being physically active, quitting smoking, controlling high cholesterol, controlling high blood pressure, treating high blood sugar and losing weight.

What was unclear was if people with stroke and peripheral artery disease received the same treatments prescribed for those with coronary artery disease.

This study compared more than 14,000 US adults enrolled in the 2006-2015 Medical Expenditure Panel Survey, a national survey of patient-reported health outcomes and conditions, and health care use and expenses.

Slightly more than half of the patients were men, the average age was 65, and all had either coronary artery disease, stroke or peripheral artery disease.

These individuals were the representative of nearly 16 million US adults living with one of the three forms of atherosclerotic cardiovascular disease.

Compared to participants with coronary artery disease, participants with peripheral artery disease were twice more likely to report no statin use and three times more likely to report no aspirin use.

Additionally, people with peripheral artery disease had the highest, annual, total out-of-pocket expenditures among the three atherosclerotic conditions.

The findings showed that participants with stroke were more than twice as likely to report no statin or aspirin use.

Moreover, those with stroke were more likely to report poor patient-provider communication, poor health care satisfaction and more emergency room visits.

"Our study highlights a missed opportunity for implementing life-saving preventive medications among these high-risk individuals," Michos said.

The study was presented in the virtual conference at the American Heart Association's Quality of Care & Outcomes Research Scientific Sessions 2020.

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International New York Times
July 7,2020

The coronavirus can stay aloft for hours in tiny droplets in stagnant air, infecting people as they inhale, mounting scientific evidence suggests.

This risk is highest in crowded indoor spaces with poor ventilation, and may help explain superspreading events reported in meatpacking plants, churches and restaurants.

It’s unclear how often the virus is spread via these tiny droplets, or aerosols, compared with larger droplets that are expelled when a sick person coughs or sneezes, or transmitted through contact with contaminated surfaces, said Linsey Marr, an aerosol expert at Virginia Tech.

Follow latest updates on the Covid-19 pandemic here

Aerosols are released even when a person without symptoms exhales, talks or sings, according to Marr and more than 200 other experts, who have outlined the evidence in an open letter to the World Health Organization.

What is clear, they said, is that people should consider minimizing time indoors with people outside their families. Schools, nursing homes and businesses should consider adding powerful new air filters and ultraviolet lights that can kill airborne viruses.

What does it mean for a virus to be airborne?

For a virus to be airborne means that it can be carried through the air in a viable form. For most pathogens, this is a yes-no scenario. HIV, too delicate to survive outside the body, is not airborne. Measles is airborne, and dangerously so: It can survive in the air for up to two hours.

For the coronavirus, the definition has been more complicated. Experts agree that the virus does not travel long distances or remain viable outdoors. But evidence suggests it can traverse the length of a room and, in one set of experimental conditions, remain viable for perhaps three hours.

How are aerosols different from droplets?

Aerosols are droplets, droplets are aerosols — they do not differ except in size. Scientists sometimes refer to droplets fewer than 5 microns in diameter as aerosols. (By comparison, a red blood cell is about 5 microns in diameter; a human hair is about 50 microns wide.)

From the start of the pandemic, the WHO and other public health organizations have focused on the virus’s ability to spread through large droplets that are expelled when a symptomatic person coughs or sneezes.

These droplets are heavy, relatively speaking, and fall quickly to the floor or onto a surface that others might touch. This is why public health agencies have recommended maintaining a distance of at least 6 feet from others, and frequent hand washing.

But some experts have said for months that infected people also are releasing aerosols when they cough and sneeze. More important, they expel aerosols even when they breathe, talk or sing, especially with some exertion.

Scientists know now that people can spread the virus even in the absence of symptoms — without coughing or sneezing — and aerosols might explain that phenomenon.

Because aerosols are smaller, they contain much less virus than droplets do. But because they are lighter, they can linger in the air for hours, especially in the absence of fresh air. In a crowded indoor space, a single infected person can release enough aerosolized virus over time to infect many people, perhaps seeding a superspreader event.

For droplets to be responsible for that kind of spread, a single person would have to be within a few feet of all the other people, or to have contaminated an object that everyone else touched. All that seems unlikely to many experts: “I have to do too many mental gymnastics to explain those other routes of transmission compared to aerosol transmission, which is much simpler,” Marr said.

Can I stop worrying about physical distancing and washing my hands?

Physical distancing is still very important. The closer you are to an infected person, the more aerosols and droplets you may be exposed to. Washing your hands often is still a good idea.

What’s new is that those two things may not be enough. “We should be placing as much emphasis on masks and ventilation as we do with hand washing,” Marr said. “As far as we can tell, this is equally important, if not more important.”

Should I begin wearing a hospital-grade mask indoors? And how long is too long to stay indoors?

Health care workers may all need to wear N95 masks, which filter out most aerosols. At the moment, they are advised to do so only when engaged in certain medical procedures that are thought to produce aerosols.

For the rest of us, cloth face masks will still greatly reduce risk, as long as most people wear them. At home, when you’re with your own family or with roommates you know to be careful, masks are still not necessary. But it is a good idea to wear them in other indoor spaces, experts said.

As for how long is safe, that is frustratingly tough to answer. A lot depends on whether the room is too crowded to allow for a safe distance from others and whether there is fresh air circulating through the room.

What does airborne transmission mean for reopening schools and colleges?

This is a matter of intense debate. Many schools are poorly ventilated and are too poorly funded to invest in new filtration systems. “There is a huge vulnerability to infection transmission via aerosols in schools,” said Don Milton, an aerosol expert at the University of Maryland.

Most children younger than 12 seem to have only mild symptoms, if any, so elementary schools may get by. “So far, we don’t have evidence that elementary schools will be a problem, but the upper grades, I think, would be more likely to be a problem,” Milton said.

College dorms and classrooms are also cause for concern.

Milton said the government should think of long-term solutions for these problems. Having public schools closed “clogs up the whole economy, and it’s a major vulnerability,” he said.

“Until we understand how this is part of our national defense, and fund it appropriately, we’re going to remain extremely vulnerable to these kinds of biological threats.”

What are some things I can do to minimize the risks?

Do as much as you can outdoors. Despite the many photos of people at beaches, even a somewhat crowded beach, especially on a breezy day, is likely to be safer than a pub or an indoor restaurant with recycled air.

But even outdoors, wear a mask if you are likely to be close to others for an extended period.

When indoors, one simple thing people can do is to “open their windows and doors whenever possible,” Marr said. You can also upgrade the filters in your home air-conditioning systems, or adjust the settings to use more outdoor air rather than recirculated air.

Public buildings and businesses may want to invest in air purifiers and ultraviolet lights that can kill the virus. Despite their reputation, elevators may not be a big risk, Milton said, compared with public bathrooms or offices with stagnant air where you may spend a long time.

If none of those things are possible, try to minimize the time you spend in an indoor space, especially without a mask. The longer you spend inside, the greater the dose of virus you might inhale.

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News Network
July 9,2020

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.

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