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| Pfizer Begins Human Trials of Possible Coronavirus Vaccine | Pfizer Begins Human Trials of Possible Coronavirus Vaccine |
| (30 days later) | |
| 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. |
| 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. |
| Updated June 2, 2020 | |
| Mass protests against police brutality that have brought thousands of people onto the streets in cities across America are raising the specter of new coronavirus outbreaks, prompting political leaders, physicians and public health experts to warn that the crowds could cause a surge in cases. While many political leaders affirmed the right of protesters to express themselves, they urged the demonstrators to wear face masks and maintain social distancing, both to protect themselves and to prevent further community spread of the virus. Some infectious disease experts were reassured by the fact that the protests were held outdoors, saying the open air settings could mitigate the risk of transmission. | |
| Exercise researchers and physicians have some blunt advice for those of us aiming to return to regular exercise now: Start slowly and then rev up your workouts, also slowly. American adults tended to be about 12 percent less active after the stay-at-home mandates began in March than they were in January. But there are steps you can take to ease your way back into regular exercise safely. First, “start at no more than 50 percent of the exercise you were doing before Covid,” says Dr. Monica Rho, the chief of musculoskeletal medicine at the Shirley Ryan AbilityLab in Chicago. Thread in some preparatory squats, too, she advises. “When you haven’t been exercising, you lose muscle mass.” Expect some muscle twinges after these preliminary, post-lockdown sessions, especially a day or two later. But sudden or increasing pain during exercise is a clarion call to stop and return home. | |
| States are reopening bit by bit. This means that more public spaces are available for use and more and more businesses are being allowed to open again. The federal government is largely leaving the decision up to states, and some state leaders are leaving the decision up to local authorities. Even if you aren’t being told to stay at home, it’s still a good idea to limit trips outside and your interaction with other people. | |
| 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. | |
| 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. | |
| 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.) | |
| More than 40 million people — the equivalent of 1 in 4 U.S. workers — have filed for unemployment benefits since the pandemic took hold. One in five who were working in February reported losing a job or being furloughed in March or the beginning of April, data from a Federal Reserve survey released on May 14 showed, and that pain was highly concentrated among low earners. Fully 39 percent of former workers living in a household earning $40,000 or less lost work, compared with 13 percent in those making more than $100,000, a Fed official said. | |
| Taking one’s temperature to look for signs of fever is not as easy as it sounds, as “normal” temperature numbers can vary, but generally, keep an eye out for a temperature of 100.5 degrees Fahrenheit or higher. If you don’t have a thermometer (they can be pricey these days), there are other ways to figure out if you have a fever, or are at risk of Covid-19 complications. | |
| The C.D.C. has recommended that all Americans wear cloth masks if they go out in public. This is a shift in federal guidance reflecting new concerns that the coronavirus is being spread by infected people who have no symptoms. Until now, the C.D.C., like the W.H.O., has advised that ordinary people don’t need to wear masks unless they are sick and coughing. Part of the reason was to preserve medical-grade masks for health care workers who desperately need them at a time when they are in continuously short supply. Masks don’t replace hand washing and social distancing. | |
| 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. | |
| If you’re sick and you think you’ve been exposed to the new coronavirus, the C.D.C. recommends that you call your healthcare provider and explain your symptoms and fears. They will decide if you need to be tested. Keep in mind that there’s a chance — because of a lack of testing kits or because you’re asymptomatic, for instance — you won’t be able to get tested. | |
| 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.” |