Long COVID Stemmed from Mild Cases of COVID-19 in Most People ... GovExec.com
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Since early in the pandemic, researchers have been working to develop a vaccine for SARS-CoV-2 that could be administered in the form of a nasal spray, as such a spray would be simpler to administer than an injection and would hypothetically enhance immune protections where the coronavirus enters the body. Unfortunately, one such experimental vaccine, developed by scientists at the University of Oxford and AstraZeneca, performed dismally in a small Phase 1 clinical trial, according to results published Tuesday (October 10) in eBioMedicine, and the researchers behind the project say they plan to abandon it, at least in its current form.
The nasal approach is intended to enhance mucosal immunity, or the immune systems ability to fend off pathogens at the point of contact on mucosal membranes rather than with antibodies or immune cells circulating in the bloodstream. The aim is to prevent more cases of COVID-19 than could be done with injected vaccines, which excel at preventing serious disease and death but not at heading off mild infections. However, the new studys results show that fewer than half of the study participants produced detectable levels of mucosal antibodies a month following administration, and in those who did, the level of SARS-CoV-2 antibodies was lower than that conferred by either injected vaccines or prior SARS-CoV-2 infection. University of Oxford researchers say that the results dont warrant further testing, according to The Guardian, which notes that one problem with the approach may be that much of the vaccine is accidentally swallowed and digested in the stomach before it can do much good.
The nasal spray did not perform as well in this study as we had hoped, Sandy Douglas, the chief investigator on the trial at Oxfords Jenner Institute, says in a university press release. Delivery of vaccines to the nose and lungs remains a promising approach, but this study suggests there are likely to be challenges in making nasal sprays a reliable option.
In the trial, 30 unvaccinated volunteers received a low, medium, or high dose of the nasal vaccine14 were given a second, identical dose 28 days later, and 12 others were given an injected vaccine dose 3 to 7 weeks later. The rest of the participants only received their initial nasal dose. Additionally, 12 other volunteers who had already received vaccine injections were given the nasal spray as a booster. While no safety issues were detected, seven of the participants developed symptomatic SARS-CoV-2 infection within the four-month follow-up period following vaccination.
Other nasal vaccines have shown more promise: The Chinese government recently approved CanSino Biologics nasal vaccine, which is delivered as a mist generated by a nebulizer. And last month, Indias government approved Bharat Biotechs vaccine, which is dropped into the nose, according to Reuters.
University of Cambridge vaccinologist Gordon Dougan, who didnt work on the University of Oxford and AstraZeneca nasal vaccine, tells The Guardian that the concept of nasal vaccines for COVID-19 is still promising, adding that data from the trial as well as that from the Chinese and Indian vaccines can help experts figure out the best way to proceed.
We need better science to understand how to induce immunity through nasal and oral delivery, he says. Its still not well understood. Nasal vaccines offer an opportunity to induce local immunity, potentially limiting transmission, which will be vital to prevent the emergence of vaccine escape variants.
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Earlier this month, the Food and Drug Administration issued its first emergency use authorization (EUA) for a vaccine against COVID-19 in people aged 16 years and older.
Under this EUA, Pfizer-BioNTechs new COVID-19 vaccine can now be distributed in the United States.
The FDA issued this authorization after reviewing the available efficacy and safety data on the new vaccine. Based on evidence from ongoing clinical trials, the FDA found that the known and potential benefits of the vaccine outweigh the known and potential risks.
The available data suggests that after two doses, the vaccine is 95 percent effective at preventing COVID-19. So far, research has also found that the vaccine has a good safety profile.
Based on the large number of folks that have been closely monitored during the study, the patient safety profile is excellent in terms of side effects, Dr. Matthew Heinz, a hospitalist based in Tucson, Arizona, told Healthline.
Of course, we have to continue to monitor going forward. We need to continue to collect data to make sure it stays that way, he said.
The Pfizer-BioNTech COVID-19 vaccine is administered in two doses, 3 weeks apart.
To date, safety data on the vaccine has been collected from 37,586 participants enrolled in an ongoing phase 3 clinical trial.
Among those participants, 18,801 have received the vaccine and 18,785 have received a placebo. They have been followed for a median of 2 months following vaccination.
The most commonly reported side effect from the vaccine is injection site reaction. Such reactions can cause some pain and other symptoms around the area where the vaccine is injected.
You sometimes get some redness, some warmth, a little bit of mild swelling or firmness around the site of the injection. Thats very typical, Heinz told Healthline.
It can be a little tender, it can hurt to move the arm a little bit, he continued.
Injection site reactions were reported by 84 percent of participants who received the vaccine.
In rare cases, people have developed delayed skin reactions after getting vaccinated.
In early March, a group of doctors wrote a letter to The New England Journal of Medicine describing delayed skin reactions in 12 patients who received the Moderna vaccine. This type of delay reaction might also develop in people who get the Pfizer-BioNTech vaccine.
According to the authors of the NEJM letter, the patients developed rashes, large raised red patches, or other skin symptoms around the injection site four to 11 days after getting their first dose of the vaccine.
The researchers found evidence that these symptoms were caused by a delayed allergic reaction.
The reactions were limited to the area around the injection site and not serious. Symptoms cleared within 2 to 11 days.
All 12 patients were encouraged to get a second dose of the vaccine by their doctors.
Other commonly reported side effects of the Pfizer-BioNTech COVID-19 vaccine include fatigue, headache, and muscle pain.
Fatigue has been reported by roughly 63 percent of research subjects who received the vaccine, while headache and muscle pain have affected about 55 and 38 percent of participants, respectively. In most cases, those symptoms have been mild and resolved within a day or so.
Smaller numbers of participants reported chills, joint pain, or fever following vaccination.
Participants were more likely to report such symptoms following the second dose of the vaccine.
[The reaction to the second dose] tends to be a little more of an intense response, which does make sense, considering your immune system has been exposed already, Heinz said.
It gets hit with another dose of [the vaccine], and it has a sort of quicker and more robust response. That makes a lot of sense immunologically, he added.
Among participants who received the vaccine and those who got the placebo alike, the reported rate of serious adverse events is less than 0.5 percent, with no significant differences between the two groups.
Four cases of Bells palsy have been reported in participants who received the vaccine, while none has been reported in those who got the placebo.
However, those four cases are consistent with the rate of Bells palsy in the general population. In other words, theres no clear evidence that the Bells palsy was caused by the vaccine.
Severe allergic reactions to vaccines are very rare, but they can happen. The FDA recommends that people who have experienced a severe allergic reaction to a previous dose of the Pfizer-BioNTech COVID-19 vaccine, or to any of its ingredients, should not receive it.
Heinz suggested that people might want to schedule their vaccinations at a time when its easier to manage potential side effects such as fatigue or headache.
Dont do it at 9 a.m. on your way to work. Do it at the end of the day, if you work normal daytime hours, or a day when youre already going to be off that kind of thing, he said.
If you develop pain around the injection site, it may be treated with over-the-counter medication. Such medications may also help relieve fever, headache, muscle pain, or joint pain.
A couple of Advil and a dose of Tylenol to help with discomfort and swelling thats all it should really require, Heinz said.
If you develop side effects that are bothersome or do not resolve, contact your healthcare provider. If you think you might be having a severe allergic reaction, call 911 or go to the emergency room.
Its important to recognize that some side effects from the Pfizer-BioNTech COVID-19 vaccine are common and normal. If you experience mild to moderate side effects after the first dose, that doesnt mean you should skip the second dose.
Your immunity is incomplete [after one dose], and it might not be effective. So you have more than likely wasted the first dose, if you dont get the second one in time, Dr. Waleed Javaid, an associate professor of infectious disease at Icahn School of Medicine at Mount Sinai in New York City, he said.
If you have questions or concerns about the vaccine, Javaid recommends speaking with your healthcare provider.
He noted that its important to consider the potential benefits of the vaccine, as well as the potential risks.
Why are we getting the COVID vaccine to begin with? Because we are in a big pandemic. We know the real consequence of not having immunity to COVID, which can lead to somebodys death, Javaid told Healthline.
Injection site reactions, some aches and pains, some other potential side effects versus death. Thats the balance people have to think about, he said.
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