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
July 15,2020

The first COVID-19 vaccine tested in the US revved up people's immune systems just the way scientists had hoped, researchers reported Tuesday -- as the shots are poised to begin key final testing.

No matter how you slice this, this is good news, Dr. Anthony Fauci, the U.S. government's top infectious disease expert, told The Associated Press.

The experimental vaccine, developed by Fauci's colleagues at the National Institutes of Health and Moderna Inc., will start its most important step around July 27: A 30,000-person study to prove if the shots really are strong enough to protect against the coronavirus.

But Tuesday, researchers reported anxiously awaited findings from the first 45 volunteers who rolled up their sleeves back in March. Sure enough, the vaccine provided a hoped-for immune boost.

Those early volunteers developed what are called neutralizing antibodies in their bloodstream -- molecules key to blocking infection -- at levels comparable to those found in people who survived COVID-19, the research team reported in the New England Journal of Medicine.

This is an essential building block that is needed to move forward with the trials that could actually determine whether the vaccine does protect against infection, said Dr. Lisa Jackson of the Kaiser Permanente Washington Research Institute in Seattle, who led the study.

There's no guarantee but the government hopes to have results around the end of the year -- record-setting speed for developing a vaccine.

The vaccine requires two doses, a month apart.

There were no serious side effects. But more than half the study participants reported flu-like reactions to the shots that aren't uncommon with other vaccines -- fatigue, headache, chills, fever and pain at the injection site. For three participants given the highest dose, those reactions were more severe; that dose isn't being pursued.

Some of those reactions are similar to coronavirus symptoms but they're temporary, lasting about a day and occur right after vaccination, researchers noted.

Small price to pay for protection against COVID, said Dr. William Schaffner of Vanderbilt University Medical Center, a vaccine expert who wasn't involved with the study.

He called the early results a good first step, and is optimistic that final testing could deliver answers about whether it's really safe and effective by the beginning of next year.

It would be wonderful. But that assumes everything's working right on schedule, Schaffner cautioned.

Moderna's share price jumped nearly 15 percent in trading after US markets closed. Shares of the company, based in Cambridge, Massachusetts, have nearly quadrupled this year.

Tuesday's results only included younger adults. The first-step testing later was expanded to include dozens of older adults, the age group most at risk from COVID-19.

Those results aren't public yet but regulators are evaluating them. Fauci said final testing will include older adults, as well as people with chronic health conditions that make them more vulnerable to the virus and Black and Latino populations likewise affected.

Nearly two dozen possible COVID-19 vaccines are in various stages of testing around the world. Candidates from China and Britain's Oxford University also are entering final testing stages.

The 30,000-person study will mark the world's largest study of a potential COVID-19 vaccine so far. And the NIH-developed shot isn't the only one set for such massive U.S. testing, crucial to spot rare side effects. The government plans similar large studies of the Oxford candidate and another by Johnson & Johnson; separately, Pfizer Inc. is planning its own huge study.

Already, people can start signing up to volunteer for the different studies.

People think this is a race for one winner. Me, I'm cheering every one of them on, said Fauci, who directs NIH's National Institute of Allergy and Infectious Diseases.

We need multiple vaccines. We need vaccines for the world, not only for our own country. Around the world, governments are investing in stockpiles of hundreds of millions of doses of the different candidates, in hopes of speedily starting inoculations if any are proven to work.

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News Network
March 6,2020

Mar 6: The spread of the new coronavirus is shining the spotlight on a little-discussed gender split: men wash their hands after using the bathroom less than women, years of research and on-the-ground observations show.

Health officials around the world advise that deliberate, regular handwashing is one of the best weapons against the virus which causes a flu-like respiratory illness that can kill and has spread to around 80 countries.

The Centers for Disease Control and Prevention's online fact sheet "Handwashing: A corporate activity," cites a 2009 study that finds "only 31% of men and 65% of women washed their hands" after using a public restroom.

Social media comments about men's handwashing lapses forced an august British institution to caution visitors about bathroom behaviour this week.

After author Sathnam Sanghera complained on Twitter about "grown," "educated" men in the British Library toilets not washing their hands, the library responded, putting up additional signs reminding patrons to wash their hands in men's and women's bathrooms.

Thanks to "visitor feedback," a spokesman told Reuters, "we have increased further the number of posters in public toilets so that visitors are reminded of the importance of good hygiene at exactly the point where they can wash their hands."

Men and women approach handwashing after using the restroom differently, according to multiple surveys and field studies.

"Women wash their hands significantly more often, use soap more often, and wash their hands somewhat longer than men," according to a 2013 Michigan State University field study conducted by research assistants who observed nearly 4,000 people in restrooms around East Lansing, Michigan.

The study found 14.6% of men did not wash their hands at all after using the bathroom and 35.1% wet their hands but did not use soap, compared to 7.1% and 15.1% of women, respectively.

"If you stand in the men's bathroom at work, and watch men leave, they mostly don't wash their hands if they used the urinal," said one New York City public relations executive, who did not want to be identified for fear of alienating his colleagues.

Since the virus's spread, he's seen an uptick in men's handwashing at work, he noted. "I, for the record, do wash my hands all the time," he added.

Female medical staff in critical care units "washed their hands significantly more often than did their male counterparts after patient contact," a 2001 study published in the American Journal of Infection Control found.

Middle-aged women with some college education had the highest level of knowledge about hand hygiene, a survey published in 2019 by BMC Public Health, an open access public health journal, found.

Early information about coronavirus infection in China shows that men may be more susceptible to the disease. Just over 58% of the more than 1,000 COVID-19 patients reported in China through Jan. 29, 2020, were male, research published in the New England Journal of Medicine shows.

Researchers have not linked the difference to hand hygiene.

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Agencies
February 24,2020

Singapore, Feb 24: Last week Singapore's Ministry of Trade and Industry revised their 2020 GDP growth projections downwards to -0.5 to 1.5 per cent, confirming fears of economic fallout from the coronavirus COVID-19. Just three days earlier, while visiting Changi Airport, the Prime Minister told the media that the country is bracing for a significant hit on the economy and the possibility of a recession.

In the budget announcement on February 18, various measures to help affected companies were announced.

This included a jobs support scheme to help companies retain workers that will see the government offset 8 per cent of wages up to SGD3,600(USD2,600) per worker, per month, for a three-month period. Companies will also get a 25 per cent rebate on their taxes for the year capped at SGD15,000 (USD10,800) per company.

There will be additional support for sectors directly affected by the virus outbreak such as tourism, aviation and retail. Qualifying companies will be given property tax rebates and can apply for temporary bridging loans to ease cash flow. Rebates will be offered on aircraft landing and parking charges as well as rental rebates for shops and cargo agents at Changi Airport.

Overall, the economic package will cost Singapore some USD 4.6 billion, well in excess of the USD 500 million some analysts had predicted. The resulting spending plan including the virus economic package will see a budget deficit of SGD 10.9 billion or 2.1 per cent of GDP, the highest since the Asian financial crisis of 1997.

It is hoped that with financial support, companies in Singapore will not only be able to ride through the current rough patch but be able to position themselves better to take off once the economic crisis brought upon by the contagion is over.

Which then are the Singapore companies that can potentially ride out the current storm and emerge stronger?

Aviation and hospitality firms are among those most impacted by the virus outbreak and Singapore Airlines (SIA) comes to mind. SIA is a well-run company but has seen its share price fall about 5.2 percent since the beginning of the year. In the short term, revenue and profits will no doubt be affected but it will recover in the long run.

Hospitality sector companies like Ascott Residence whose main sponsor is Capitaland, Southeast Asia's largest landlord, and CDL Hospitality, have seen 1.5 and 5.5 percent (respectively) shaved off their share prices since the start of the year.

In reporting financial results for the quarter which ended in December on February 14, Alibaba CEO Daniel Zhang said that due to the virus, they are seeing large changes in buying patterns. With widespread home confinement, there is a growing demand for delivery services including online food and grocery delivery, as well as office apps and streaming entertainment.

Similarly, in Singapore, with more people staying and working from home, the three main food delivery services, Grab Food, Foodpanda and Deliveroo, are doing roaring business. All three are privately held.

In late January, as the scale of the outbreak became more apparent, investors began pouring money into health-product firms in Asia that they think will benefit from the virus outbreak.

Bloomberg reported that when Chinese pharmaceutical companies like Da An Gene Co, Xilong Scientific and Shanghai Kehua Bio-Engineering said they have developed kits for detecting the virus, their stocks soared to hit the 10 per cent daily limit. Firms manufacturing protection gear and air-cleaning equipment climbed more than 10 per cent in Japan, while Malaysian rubber gloves producers climbed at least 5 per cent.

Naturally, many would view that pharmaceutical companies that have the technology and expertise to develop drugs to treat patients with the virus or are able to develop a vaccine, would stand to benefit from the coronavirus outbreak.

Firms like and Johnson & Johnson, Pfizer, MSD, GlaxoSmithKline (GSK) and Sanofi are the pharmaceutical behemoths that dominate the global vaccine market.

However, industry experts speaking to the BBC warned that a pot of gold is not necessarily waiting for any company that successfully develops a vaccine. Although the global vaccine market is expected to grow to USD60 billion this year, it is costly and time-consuming to develop and pass it through for use by the general public.

It is also unclear if Indian pharmaceutical firms will be able to benefit from the demand for medicines that can treat or prevent the virus.

India is the world's largest manufacturer of generic drugs and it supplies 20 percent of the world's drugs by volume. However, it sources 70 percent of its raw material from China. If supplies are disrupted beyond a month to a month and a half, they may see a slow-down in production. According to a CNN report, the companies that are most impacted by material shortages are GSK India, Pfizer (PFE) and Cipla. Other companies like Aurobindo Pharma, Cadila Healthcare and Sun Pharma are said to be carefully monitoring the situation.

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