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| Pfizer Begins Human Trials of Possible Coronavirus Vaccine | Pfizer Begins Human Trials of Possible Coronavirus Vaccine |
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| Pfizer and the German pharmaceutical company BioNTech announced that their potential coronavirus vaccine began human trials in the United States on Monday. If the tests are successful, the vaccine could be ready for emergency use here as early as September. | Pfizer and the German pharmaceutical company BioNTech announced that their potential coronavirus vaccine began human trials in the United States on Monday. If the tests are successful, the vaccine could be ready for emergency use here as early as September. |
| The two firms are jointly developing a vaccine candidate based on genetic material known as messenger RNA, which carries the instructions for cells to make proteins. By injecting a specially designed messenger RNA into the body, the vaccine could potentially tell cells how to make the spike protein of the coronavirus without actually making a person sick. | The two firms are jointly developing a vaccine candidate based on genetic material known as messenger RNA, which carries the instructions for cells to make proteins. By injecting a specially designed messenger RNA into the body, the vaccine could potentially tell cells how to make the spike protein of the coronavirus without actually making a person sick. |
| Because the virus typically uses this protein as a key to unlock and take over lung cells, the vaccine could train a healthy immune system to produce antibodies to fight off an infection. The technology also has the advantage of being faster to produce, and tends to be more stable than traditional vaccines, which use weakened virus strains. | Because the virus typically uses this protein as a key to unlock and take over lung cells, the vaccine could train a healthy immune system to produce antibodies to fight off an infection. The technology also has the advantage of being faster to produce, and tends to be more stable than traditional vaccines, which use weakened virus strains. |
| Moderna, Inovio, CanSino and several other pharmaceutical companies are trying similar approaches, some of which began the first phase of tests in humans a few weeks ago. But no vaccine made with this technology for other viruses has ever reached the global market. | Moderna, Inovio, CanSino and several other pharmaceutical companies are trying similar approaches, some of which began the first phase of tests in humans a few weeks ago. But no vaccine made with this technology for other viruses has ever reached the global market. |
| Pfizer, which is based in New York, and BioNTech injected the first human volunteers with their vaccine candidate, called BNT162, in Germany last month. The experimental shot was given to just 12 healthy adults, although the trial will eventually expand to 200 participants. | Pfizer, which is based in New York, and BioNTech injected the first human volunteers with their vaccine candidate, called BNT162, in Germany last month. The experimental shot was given to just 12 healthy adults, although the trial will eventually expand to 200 participants. |
| In the United States, the drug companies plan to test the vaccine on 360 healthy volunteers for the first stage of the study, adding up to 8,000 volunteers by the end of the second stage. The study will be conducted at New York University’s Grossman School of Medicine, the University of Maryland School of Medicine, the University of Rochester Medical Center and the Cincinnati Children’s Hospital Medical Center. | In the United States, the drug companies plan to test the vaccine on 360 healthy volunteers for the first stage of the study, adding up to 8,000 volunteers by the end of the second stage. The study will be conducted at New York University’s Grossman School of Medicine, the University of Maryland School of Medicine, the University of Rochester Medical Center and the Cincinnati Children’s Hospital Medical Center. |
| Participants will be divided into groups to compare four variations of the vaccine, each representing a format of messenger RNA with instructions to make a distinct piece of the spike protein machinery. Doctors will closely monitor the participants’ antibody levels, liver enzymes and other indicators of possible side effects. | Participants will be divided into groups to compare four variations of the vaccine, each representing a format of messenger RNA with instructions to make a distinct piece of the spike protein machinery. Doctors will closely monitor the participants’ antibody levels, liver enzymes and other indicators of possible side effects. |
| “Vaccines are given to healthy people to keep them healthy, so they have to be very, very safe,” said Dr. Mark Mulligan, an infectious disease specialist at N.Y.U. | “Vaccines are given to healthy people to keep them healthy, so they have to be very, very safe,” said Dr. Mark Mulligan, an infectious disease specialist at N.Y.U. |
| Testing multiple candidates in parallel is one way the companies hope to compress the amount of time it takes to gather enough proof to apply for emergency-use approval by the Food and Drug Administration. Once that approval is received, Pfizer and BioNTech could distribute the first few million doses here. | Testing multiple candidates in parallel is one way the companies hope to compress the amount of time it takes to gather enough proof to apply for emergency-use approval by the Food and Drug Administration. Once that approval is received, Pfizer and BioNTech could distribute the first few million doses here. |
| As soon as pharmaceutical companies can show evidence that a vaccine is effective and has produced no serious harms, they can apply for this kind of approval, which allows doctors to administer the vaccine to those most in need. But more detailed study results may still be needed to persuade federal regulators to approve a candidate for the broader public. | As soon as pharmaceutical companies can show evidence that a vaccine is effective and has produced no serious harms, they can apply for this kind of approval, which allows doctors to administer the vaccine to those most in need. But more detailed study results may still be needed to persuade federal regulators to approve a candidate for the broader public. |
| Updated 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 super-spreading 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. Aerosols are released even when a person without symptoms exhales, talks or sings, according to Dr. Marr and more than 200 other experts, who have outlined the evidence in an open letter to the World Health Organization. | |
| Common symptoms include fever, a dry cough, fatigue and difficulty breathing or shortness of breath. Some of these symptoms overlap with those of the flu, making detection difficult, but runny noses and stuffy sinuses are less common. The C.D.C. has also added chills, muscle pain, sore throat, headache and a new loss of the sense of taste or smell as symptoms to look out for. Most people fall ill five to seven days after exposure, but symptoms may appear in as few as two days or as many as 14 days. | |
| Scientists around the country have tried to identify everyday materials that do a good job of filtering microscopic particles. In recent tests, HEPA furnace filters scored high, as did vacuum cleaner bags, fabric similar to flannel pajamas and those of 600-count pillowcases. Other materials tested included layered coffee filters and scarves and bandannas. These scored lower, but still captured a small percentage of particles. | |
| A commentary published this month on the website of the British Journal of Sports Medicine points out that covering your face during exercise “comes with issues of potential breathing restriction and discomfort” and requires “balancing benefits versus possible adverse events.” Masks do alter exercise, says Cedric X. Bryant, the president and chief science officer of the American Council on Exercise, a nonprofit organization that funds exercise research and certifies fitness professionals. “In my personal experience,” he says, “heart rates are higher at the same relative intensity when you wear a mask.” Some people also could experience lightheadedness during familiar workouts while masked, says Len Kravitz, a professor of exercise science at the University of New Mexico. | |
| The steroid, dexamethasone, is the first treatment shown to reduce mortality in severely ill patients, according to scientists in Britain. The drug appears to reduce inflammation caused by the immune system, protecting the tissues. In the study, dexamethasone reduced deaths of patients on ventilators by one-third, and deaths of patients on oxygen by one-fifth. | |
| The coronavirus emergency relief package gives many American workers paid leave if they need to take time off because of the virus. It gives qualified workers two weeks of paid sick leave if they are ill, quarantined or seeking diagnosis or preventive care for coronavirus, or if they are caring for sick family members. It gives 12 weeks of paid leave to people caring for children whose schools are closed or whose child care provider is unavailable because of the coronavirus. It is the first time the United States has had widespread federally mandated paid leave, and includes people who don’t typically get such benefits, like part-time and gig economy workers. But the measure excludes at least half of private-sector workers, including those at the country’s largest employers, and gives small employers significant leeway to deny leave. | |
| So far, the evidence seems to show it does. A widely cited paper published in April suggests that people are most infectious about two days before the onset of coronavirus symptoms and estimated that 44 percent of new infections were a result of transmission from people who were not yet showing symptoms. Recently, a top expert at the World Health Organization stated that transmission of the coronavirus by people who did not have symptoms was “very rare,” but she later walked back that statement. | |
| Touching contaminated objects and then infecting ourselves with the germs is not typically how the virus spreads. But it can happen. A number of studies of flu, rhinovirus, coronavirus and other microbes have shown that respiratory illnesses, including the new coronavirus, can spread by touching contaminated surfaces, particularly in places like day care centers, offices and hospitals. But a long chain of events has to happen for the disease to spread that way. The best way to protect yourself from coronavirus — whether it’s surface transmission or close human contact — is still social distancing, washing your hands, not touching your face and wearing masks. | |
| A study by European scientists is the first to document a strong statistical link between genetic variations and Covid-19, the illness caused by the coronavirus. Having Type A blood was linked to a 50 percent increase in the likelihood that a patient would need to get oxygen or to go on a ventilator, according to the new study. | |
| If air travel is unavoidable, there are some steps you can take to protect yourself. Most important: Wash your hands often, and stop touching your face. If possible, choose a window seat. A study from Emory University found that during flu season, the safest place to sit on a plane is by a window, as people sitting in window seats had less contact with potentially sick people. Disinfect hard surfaces. When you get to your seat and your hands are clean, use disinfecting wipes to clean the hard surfaces at your seat like the head and arm rest, the seatbelt buckle, the remote, screen, seat back pocket and the tray table. If the seat is hard and nonporous or leather or pleather, you can wipe that down, too. (Using wipes on upholstered seats could lead to a wet seat and spreading of germs rather than killing them.) | |
| If you’ve been exposed to the coronavirus or think you have, and have a fever or symptoms like a cough or difficulty breathing, call a doctor. They should give you advice on whether you should be tested, how to get tested, and how to seek medical treatment without potentially infecting or exposing others. | |
| Given the need to quash the coronavirus, vaccine makers around the world are racing to speed up their timelines for development, a process that typically takes years. But companies are making extraordinary efforts to stagger trials and, in some cases, skip essential steps, such as animal testing. | Given the need to quash the coronavirus, vaccine makers around the world are racing to speed up their timelines for development, a process that typically takes years. But companies are making extraordinary efforts to stagger trials and, in some cases, skip essential steps, such as animal testing. |
| Some experts have warned that expecting an approved vaccine within 18 months — as Dr. Anthony Fauci, the nation’s leading expert on infectious diseases, has suggested — is overly optimistic. | Some experts have warned that expecting an approved vaccine within 18 months — as Dr. Anthony Fauci, the nation’s leading expert on infectious diseases, has suggested — is overly optimistic. |
| A group of scientists developing a vaccine at Oxford University in England say that even 18 months is too long to wait for a vaccine. With emergency approval, they say they are aiming to have the first few million doses of their vaccine available in September. | A group of scientists developing a vaccine at Oxford University in England say that even 18 months is too long to wait for a vaccine. With emergency approval, they say they are aiming to have the first few million doses of their vaccine available in September. |
| Pfizer and BioNTech say they hope to have several million doses by then, too, if everything goes well with these human trials. | Pfizer and BioNTech say they hope to have several million doses by then, too, if everything goes well with these human trials. |
| “We need to think differently, we need to think faster,” said Dr. Mikael Dolsten, Pfizer’s chief scientific officer. “If we get hit with a second wave of coronavirus infections in October at the same time as the flu, things will be much worse than what we’ve already experienced.” | “We need to think differently, we need to think faster,” said Dr. Mikael Dolsten, Pfizer’s chief scientific officer. “If we get hit with a second wave of coronavirus infections in October at the same time as the flu, things will be much worse than what we’ve already experienced.” |