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Health Desk articles

What do we know so far about the ability of asymptomatic people to transmit the virus?

Asymptomatic people are those that do not show any symptoms but have been infected with COVID-19. As per a recent study published in the medical journal, JAMA, asymptomatic people have similar amounts of virus as symptomatic people and are capable of spreading the virus as much. Because asymptomatic people may not know that they are infected, they may not isolate themselves and that way can spread the virus even more. The U.S. Centers for Disease Control and Prevention (U.S. CDC) has revised its current best estimate and now advises that it estimates 40% of people infected with COVID-19 are asymptomatic. The World Health Organization has yet to provide an official estimate and noted that it will vary across populations. Some studies have noted that asymptomatic carriers might be the biggest spreaders of COVID-19 in certain populations. There is also evidence to suggest that pre-symptomatic people infected with COVID-19 - people who eventually develop symptoms but haven't had any yet - spread the most amount of virus in the time before they have symptoms. This is why it is very important that everyone wear masks (the U.S. CDC recommends wearing a cloth mask over a surgical mask for increased protection, wash their hands vigorously for 20 seconds, and maintain a distance of six feet (2 meters) between themselves and others.

What does colder weather mean for the spread of COVID-19?

We do not know how the COVID-19 virus will impact people during colder winter months, but many experts predict higher rates of transmission and mortality than during the warmer, summer months. This is likely due to the impact cold weather has on human behavior such as forcing people inside where higher temperatures are preferred and ventilation is not sufficient to combat the spread of the virus. With groups of people congregating in confined spaces with limited airflow, the virus is able to circulate easily through aerosolized particles and respiratory droplets. Additionally, since a large percentage of COVID-19 have asymptomatic infections but they are still able to transmit the virus, many infected people are likely not restricting their movements to one quarantined room or area or taking necessary distancing or masking protocols. Traditionally, viruses like influenza and the common cold tend to increase amounts of infections in the winter and decrease in the summer. As with these other respiratory viruses, COVID-19 transmission will be impacted dramatically by control and prevention measures like social distancing, masking, and vaccination. The more people who engage in these activities, the more likely infections can be prevented. Though some viruses do not like humid, hot conditions, COVID-19 has been shown to spread rapidly in some regions during warm spring and summer months in both hemispheres. A study from October 13, 2020, before widespread prevention measures were undertaken showed that infections increased more quickly in places with less UV light and suggested that without any interventions, case rates may be highest in the winter and lower in the summer. However, weather itself does not appear to have an impact on the ability of the virus to spread though colder weather may make it more difficult for the body to fight respiratory infections. At this point, it is unknown whether or not COVID-19 will become a seasonal virus like influenza but we should expect any event that brings together people in closed environment can lead to an increased spread of the virus.

What do we know so far about inhaled steroids as a treatment or cure for COVID-19?

In early September of 2020, the World Health Organization (WHO) issued guidance that a class of steroids called corticosteroids - specifically dexamethasone, hydrocortisone, and methylprednisolone - should be considered treatments for severe cases of COVID-19, but should not be used in milder cases. These steroids are given systemically, meaning through the veins or in an oral pill form. Inhaled steroids have not be recommended or approved for use in COVID-19 cases by the WHO or U.S. FDA. Inhaled corticosteroids (ICSs) are used to treat asthma and other lung diseases, such as chronic obstructive lung disease (COPD). Due to lack of sufficient scientific evidence, whether ICSs protect or contribute to worse outcomes in COVID-19 patients is still debated. According to NIH Clinical Trials website, a randomized clinical study by Oxford University is underway to understand if ICSs can prevent or treat COVID-19. The Lancet Respiratory Medicine Journal published more information in September 2020 on the relation of COVID-19 mortality and inhaled corticosteroids. The publication states that using ICS might reduce immunity to fight viruses and increase pneumonia in patients with COPD. ICS use has also shown protection against COVID-19 by reducing the frequency of exacerbations and replication of SARS-CoV-2. However, there were significant differences in age and underlying illnesses about the groups studied. Common devices used as inhalers include a metered-dose inhaler (MDI), nebulizer and dry-powder or rotary inhaler. There have been rumors circulating about using "nebulizers" to inhale steroids, such as the anti-inflammatory drug budesonide (brand name Pulmicort), to potentially treat COVID-19. "Nebulizers" are a type of inhaler that change liquid medications, like budesonide, into a mist that can be more easily inhaled into the lungs. Nebulizers can be more expensive than the most common type of inhaler used by people with asthma, and patients usually use nebulizers for specific reasons, such as if a child or someone with severe asthma is having difficulties inhaling medicine. Inhaled steroids like budesonide can have side effects, and are also crucial for patients with health conditions who do not have COVID-19, so these should only be used when recommended by your doctor. Budesonide can be inhaled or taken orally, and when inhaled is part of a family of anti-inflammatory medications called inhaled steroids that are primarily used to help manage symptoms for conditions like asthma and chronic obstructive pulmonary disease (COPD). Budesonide is a prescription-only drug that is not approved by the U.S. Food and Drug Administration (FDA) for treatment of COVID-19.

Is there a specific process through which COVID-19 enters the body? Does COVID-19 first enter through the throat before it "destroys" the lungs?

COVID-19 enters the body through the nose, mouth, and eyes. This happens primarily when someone infected with the virus releases small droplets of liquid that contain part of the virus through actions like coughing, sneezing, speaking, or singing. These small bits of virus range in size, from the wet, teardrop-sized types of droplets you might see when you sneeze, to microscopic ones that are so light and dry, they might remain in the air for hours. When a person is in close contact with these droplets, the virus enters the body through these three areas. Then, the virus lands at the back of the throat, also called the top of the upper respiratory tract, in roughly 80% of people who have mild cases of infection. For other more severe cases, the virus can then move down to the lungs, potentially causing pneumonia, which happens in 15-20% of cases, although most recover. When COVID-19 spreads to the lungs, it does not mean that they will be "destroyed." It means that there is an infection involving fluid within tiny branches of air tubes or sacs in the lungs called 'alveoli.' These air sacs may fill up with so much liquid or pus that they become swollen, and their walls can thicken, so it is hard for oxygen to be processed and delivered through the lungs, making it harder to breathe. Every virus has a different way of infecting humans, though many viruses gain entry into the body through the nose, mouth, and eyes and often cause upper respiratory infections like COVID-19.

Is there a cure for COVID-19? What is the cure?

There is no known cure for COVID-19 right now, but there are ways to manage the symptoms of the disease. A cure is a substance or act that ends and relieves the symptoms of a medical condition so patients can have their health restored. One for COVID-19 is currently being researched in many clinical trials around the world, but no treatment or practice has been shown to effectively meet these standards. Healthcare professionals around the world are researching various treatments for COVID-19, including drugs that already exist to treat other conditions to see if they may be effective against COVID-19 as well. No treatments are currently approved by the U.S. Food and Drug Administration (FDA) for COVID-19, but because COVID-19 is a public health crisis, doctors can treat patients using some drugs that are not technically approved for COVID-19. Emergency use authorization enables unapproved medical products or unapproved uses of approved medical products to be used for diagnosis, treatment or prevention in an emergency setting, even if the treatments may still be under further study. Remdesivir, an antiviral drug manufactured by Gilead Sciences that stops the virus from replicating, received emergency use authorization by the U.S. FDA. It reportedly reduced the recovery time for hospitalized patients from 15 days to 11 days, and early results indicate that it may reduce mortality among patients who are very sick from COVID-19. In terms of clinical management of symptoms, the U.S. National Institutes of Health (NIH) COVID-19 treatment guidelines indicate that Remdesivir supplies are limited and should be prioritized for patients who need it most (hospitalized patients who require supplemental oxygen). The guidelines also recommend the use of dexamethasone, a steroid that can reduce inflammation, for patients who require ventilators or supplemental oxygen (and potentially other corticosteroids). Healthcare professionals may use ventilators and supplemental oxygen to ensure that hospitalized patients have a healthy supply of oxygen in the body, and monitor patients accordingly. Prone positioning (flipping COVID-19 patients onto their bellies in order to open up their lungs ) is also widely used to help patients recover from the virus. At present, there is no cure for COVID-19.

In scientific terms, is it absolutely safe to say that "bald men are more likely to have COVID-19?"

No, it is not safe to say in scientific terms that bald men are more likely to have COVID-19. In May 2020, a research study was widely reported in news headlines, which suggested male pattern baldness (androgenetic alopecia) could mean higher risks for severe COVID-19 symptoms. However, this is not exactly what the researchers found. The authors of this publication also acknowledged there were research limitations meaning their results cannot be generalized to a larger population and further studies are needed. Published in the Journal of the American Academy of Dermatology (JAAD), the researchers wrote that out of 122 men and 53 women admitted with COVID-19 to hospitals in Madrid, Spain, they found 79% of the male patients had some hair loss or baldness (alopecia) while estimating the prevalence of baldness in the general population is only 31%-53%. However, the researchers acknowledged limitations of their findings, including how only 175 people were studied (in research terminology, this is considered a** **small sample size that limits how findings can be generalized to a larger population). They also acknowledged that patients in the study were all admitted to a hospital with COVID-19, meaning there was no comparison group (control group) of participants without COVID-19 to compare the findings against the general population. Additionally, the research did not include information about patient outcomes (such as how the patients fared after they were admitted to the hospital), so it was not possible for researchers to compare outcomes for patients with and without baldness. In general, many researchers and doctors have cautioned that older people and men are more likely to have severe cases of COVID-19 requiring hospitalization, and older men are also more likely to be bald. For these reasons, "bald men are more likely to have COVID-19" is an incorrect interpretation of the published research.

Can gasoline and/or diesel be used to disinfect masks, surfaces, or even skin? What are potential dangers, if any, in doing so?

No. Gasoline and/or diesel should not be used as a disinfectant, does not work as a disinfectant, has not been shown to kill the virus that causes COVID-19, and may be very harmful to human health. According to the U.S. National Institute for Occupational Safety and Health, gasoline exposure through the skin or eyes, drinking, or breathing can cause many health problems including the following: ·      Irritation or burns of the eyes, skin, or mucous membranes (i.e. the tissues in the nose, eyes, mouth, throat) ·      Headache, weakness, blurred vision, dizziness, slurred speech, confusion, convulsions ·      Chemical pneumonitis (when liquid gasoline is inhaled into the lungs and causes damage) ·      Possible liver or kidney damage ·      Long-term exposure may cause cancer ·      Gasoline is flammable and improper storage / use can lead to fires and burn injuries Gasoline exposure should be avoided and, if accidental exposure does happen, washing the exposed area is important. When exposed to gas fumes, it is important to leave the area where the fumes are to an area with fresh air or ventilation. Seek medical help for breathing problems as well as slurred speech, dizziness, confusion, or other symptoms of neurological (brain and nervous system) problems. 

What must regulating bodies, such as the Food and Drug Administration (FDA), look out for when approving a vaccine for Emergency Use Authorization (EUA) vs. approving a vaccine for general use?

Regulatory agencies in multiple countries began granting approvals for emergency use of COVID-19 vaccine candidates in late 2020. The standards can vary from place to place but are typically rigorous, with a focus on evidence for safety and efficacy from large-scale clinical trials. Notable exceptions include China and Russia, which provided early approvals of vaccine candidates before large-scale clinical trials were completed and began widespread vaccinations of people outside of trials months earlier than most other countries. The process for emergency use authorizations can vary widely. For example, some regulatory agencies need to consider not only their country’s policies, but also regional agreements between countries like in the European Union. A few regulatory agencies, such as the U.S. FDA, also do their own careful analysis of the raw data, as opposed to relying on the findings provided from the vaccine manufacturers like the U.K. regulatory agency.  Several health experts have now raised the importance of approving the COVID-19 vaccines for general use, not just emergency use. A major concern is that COVID-19 vaccines may still be needed after the emergency nature of the current pandemic has finally subsided, in order to continue to protect people against COVID-19 in the future. As regulatory licensing for general use can take time and require even higher standards of evidence (ex. often the completion of phase 3 clinical trials), experts are urging regulatory agencies to continue these processes in order to be prepared for health needs after the pandemic. Otherwise, there is a risk of a gap in being able to vaccinate people against COVID-19 once the immediate emergency is over, if only emergency use authorizations have been granted.

In what way could the public better understand efficacy rates of COVID-19 vaccines published by various companies, and do the efficacy rates affect a population’s herd immunity if that is the ideal goal of vaccination programs?

Vaccine efficacy and vaccine effectiveness may sound similar, but are actually different terms to scientists and health professionals. According to the U.S. Centers for Disease Control and Prevention (U.S. CDC), vaccine efficacy is a term used to describe how well the vaccine protects clinical trial participants from getting sick or getting very sick. Vaccine efficacy refers to results reported from clinical trials and reflects circumstances specific to the research settings, rather than describing how well a vaccine works on the general public in real-world conditions.  So far many of the vaccine efficacy rates that have been released (ex. Moderna and Pfizer/BioNTech’s vaccine efficacy rates of ~95%) refer to how COVID-19 vaccine candidates can prevent symptomatic disease in people, not how the vaccine candidates reduce transmission. Researchers are still studying how effective the COVID-19 vaccines are in reducing transmission. “Herd immunity” refers to a given percentage of people that need to become immunized to a virus, through vaccines or through becoming infected naturally, against a virus in order to provide safety for an entire population - i.e. the herd. It’s the idea that if most people have developed immunity, then the rate of transmission will be low or non-existent. Researchers are still learning about what herd immunity for COVID-19 looks like. It is hypothesized that we may need at least 60-70% of the population vaccinated or recovered from infection in order to achieve herd immunity, but this has not yet been confirmed in real-world settings. Furthermore, the COVID-19 vaccine efficacy rates published by pharmaceutical companies do not yet tell us the exact vaccine effectiveness rates that can be expected in actual populations, and focus on how the vaccines prevent disease symptoms rather than how the vaccines reduce transmission. Researchers are still understanding how vaccine efficacy reported from clinical trials will impact herd immunity. It is currently thought that the percentage of people who agree to get vaccinated will be a more important factor for achieving herd immunity. It is important to remember that the goal of vaccination is not only to achieve herd immunity and reduce community transmission, in order to reduce the pressures on the healthcare system and protect at-risk individuals who may not be able to receive the vaccine for health reasons - vaccinations are also intended to protect individuals from getting sick or dying. Vaccinations play an important role for individual health as well as for public health on a societal level. Everyone who is able to get a vaccine is highly encouraged to do so, to help protect themselves as well as others.

What do we know so far about how the U.K. is approving and rolling out vaccines?

**Approval status:** On December 2, 2020, the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) granted an emergency-use authorization to a 2-dose mRNA vaccine developed by Pfizer and BioNTech, roughly seven months after the clinical trials started. Other vaccine candidates are currently under review by the regulator. **Approval processes:** In the United Kingdom, vaccines are approved by the regulator (the MHRA) based on criteria including safety, quality, and efficacy. The MHRA has been using a "rolling review" process since June 2020 to assess COVID-19 vaccines in an accelerated timeframe, with teams of scientists often requesting and reviewing data on various topics in parallel. The European Union (EU) requires vaccines to be authorized by the European Medicines Agency (EMA), but allows individual countries to use an emergency procedure to distribute a vaccine for temporary use in their domestic market. The MHRA chief executive stated that they used this existing EU provision to fast-track approval in the U.K. before the rest of the EU, since the U.K. is still subject to EU rules until their transition period for leaving is completed on December 31, 2020. **Distribution status:** The U.K. announced that 357 million doses of seven different vaccines have been purchased, which includes 40 million doses of the Pfizer and BioNTech vaccine. An initial delivery of 800,000 doses of the Pfizer and BioNTech vaccine (which can provide two doses to 400,000 people) was received from a manufacturing site in Belgium, and was divided between the four countries of the U.K. on the basis of population (with most going to England and Wales, 65,500 doses going to Scotland, and 25,000 doses going to Northern Ireland). The first vaccinations outside of trials in the U.K. began on December 8, 2020, prioritizing residents and caretakers in care homes for older adults (also known as aged-care). A 90-year-old woman was the first person outside of trials to receive a vaccine dose in her country. **Distribution priorities:** The U.K. Joint Committee on Vaccination and Immunisation (JCVI) identified that the first phase of vaccinations should focus on directly preventing mortality and supporting the National Health Service (NHS) as well as the social care system. This first phase includes nine priority groups, which taken together are estimated to represent 99% of preventable mortality: 1. Residents in a care home for older adults and their carers 2. All those 80 years of age and over and frontline health and social care workers 3. All those 75 years of age and over 4. All those 70 years of age and over and clinically extremely vulnerable individuals 5. All those 65 years of age and over 6. All individuals aged 16 years to 64 years with underlying health conditions which put them at higher risk of serious disease and mortality 7. All those 60 years of age and over 8. All those 55 years of age and over 9. All those 50 years of age and over The next phase of vaccinations will focus on further reducing hospitalization and targeting those at high risk of exposure and/or those delivering key public services. This next phase is likely to include people at increased risk of exposure to COVID-19 due to their occupation, such as first responders, the military, those involved in the justice system, teachers, transport workers, and public servants essential to the pandemic response. **Distribution processes:** The Pfizer and BioNTech vaccine requires storage in ultra-cold temperatures of -70 degrees Celsius. A shipping box has been developed that is packed with dry ice to maintain the necessary temperature for 5,000 doses, which can be transported by airplane. Once the doses arrive in the target country, the country can store the dry ice packs in a freezer farm for up to 6 months. If unopened, the dry ice packs can keep the doses cold for up to 10 days during transport. After the vaccine is thawed, it can be stored for up to 5 days at between 2 and 8 degrees Celsius. The U.K. Security Service (MI5) and National Cyber Security Centre (NCSC) are working to provide security for the vaccine supply chain and distribution, which could be disrupted by hacking and other attacks. The U.K. Ministry of Defence has announced that it is providing 60 military planners to work with the government's vaccine task force and 56 personnel to help construct vaccination centers. The U.K. Armed Forces Minister announced that more than 2,000 military personnel have been deployed so far to help with testing and other COVID-19 response, and that 13,500 military personnel remain on "high readiness" to provide support. In England, 50 NHS hospitals are serving as initial hubs for administering the vaccine.

What do rising COVID-19 cases during the fall of 2020 in U.S. Midwestern states mean for other states, like Florida?

Without a distinct, explicit, and obvious uptick in travel pattern volumes, and access to data about those travel pattern volumes, it is not possible to predict how the number of cases in one state or geographical region, such as the U.S. Midwest, will impact COVID-19 infection rates in another state or region, such as Florida. Known mass migration from one region to another could help epidemiologists predict how COVID-19 may spread, but U.S. travel tends to be spontaneous and multidirectional, with individuals traveling across and between different regions, rather than traveling as a large group from one specific region to another. Though widespread travel and transmission patterns are difficult to predict, we can reasonably conclude that a high volume of COVID-19 cases throughout the United States means that the likelihood of transmission of COVID-19 in the country is high, compared to other parts of the world. To prevent the spread of COVID-19, public health experts continue to recommend that people wash their hands, wear masks (the U.S. Centers for Disease Control and Prevention recommends wearing a cloth mask over a surgical mask for increased protection), avoid crowds (especially indoors), practice social distancing, and stay home when possible. Out of the top five states that have seen COVID-19 cases rise the fastest during the first couple weeks of October 2020, four states (Idaho, Nebraska, South Dakota, North Dakota) are in the Midwest. Some health care workers and public health researchers have referred to the rising cases in the Midwest during the fall of 2020 as a "third wave," after the summer wave and the initial wave of COVID-19 cases. Dr. Anthony Fauci and other infectious disease experts have warned that states across the U.S. could see another wave of COVID-19 cases, particularly with current case numbers remaining high in several places, colder weather setting in and coinciding with what is typically the annual influenza (flu) season, and people starting to become fatigued with maintaining pandemic prevention measures. Simultaneously in Florida, 5,558 new COVID-19 cases were reported on October 22, 2020, which is one of the highest single-day increases that the state has seen since mid-August 2020 (the only days with higher numbers in the fall of 2020 are thought to be due to irregularities in reporting). The reported increase brings Florida's statewide total to 768,091 COVID-19 cases and over 16,470 deaths related to COVID-19 as of October 22, 2020. Following the Florida Governor's decision on September 25, 2020 to move to Phase 3 of their reopening plans, including fully open bars and restaurants, public health experts have been warning that Florida could see a rise in COVID-19 cases and that this could also coincide with the anticipated flu season.

What would successful contact tracing look like following the President of the United States’ COVID-19 infection?

Given that the the period between exposure to COVID-19 and symptom onset can be between 2-14 days, U.S. President Donald Trump could have been infected as early as two weeks ago. He could have been contagious as early as approximately 12 days before his positive test result. Since other prominent individuals in Donald Trump’s circles have also tested positive in days following Trump’s positive result — such as Melania Trump, presidential adviser Hope Hicks, and Trump campaign manager Bill Stepien — all infected members of the White House may have overlapping chains of transmission and as a result, contact tracing efforts will be complex. As a result, the optimal, comprehensive contact tracing approach in this situation would look as follows:  1. Donald Trump and all individuals who tested positive in his close circles would provide detailed information on where they were and who they had close contact with in the 14 days prior each of their positive test results. Close contact includes anyone who has been within 6 feet (2 m) of any of them for at least 15 minutes, or indoors with any of them without a mask on within two days of any of the three diagnoses 2. A team of contact tracers would then quickly alert the identified individuals, to let them know that they may have been exposed to COVID-19 3. The individuals from the close contact group would then be assessed for symptoms and tested for COVID-19 4. The people from the close contact group who test negative for COVID-19 would then be instructed to self-quarantine for 14 days after they were exposed, keep social distance from others, self-monitor for COVID-19 symptoms, and send doctors and the state health department daily health updates 5. The people from the close contact group who don’t have symptoms, but have also not been tested, would be instructed to follow guidelines as if they tested negative 6. The people from the close contact group who test positive would be instructed to self-isolated and recover at home for minimum 10 days and then self-quarantine for 14 days after being exposed, seek medical care if they experience emergency warning signs, and monitor symptoms and avoid spreading the virus 7. The people from the list who have symptoms of COVID-19 but can’t be tested would be asked to follow the guidelines as if they tested positive 8. Each close contact would get tested again one week after initial testing 9. Contact tracing steps 1-8 would repeat for the close contacts of each individual who tests positive Though the incubation period of the virus that causes COVID-19 is 2-14 days, the incubation period of infection is most often 3-5 days, so it's most likely that Trump was infected between Saturday, 9/26/2020, and Monday, 9/28/2020. That makes him mostly likely infectious as of Tuesday, 9/29/2020. This entry was updated with new information on October 4, 2020.

What do we know about the ingredients used in the Pfizer-BioNTech and Moderna COVID-19 vaccines?

Like other vaccines, COVID-19 vaccines contain an active ingredient that aims to teach the body how to recognize the virus, so that the defend itself when exposed. There are multiple ingredients in vaccines in addition to the active ingredient. The Pfizer-BioNTech and Moderna COVID-19 vaccines both use mRNA as the active ingredient and also contain ingredients like potassium chloride, monobasic potassium, phosphate, sodium chloride, dibasic sodium phosphate, and sucrose. Potassium, chloride, and phosphate are minerals that are commonly found in foods and medications. Sodium chloride is another name for salt, and sucrose is a type of sugar. All of these ingredients are commonly used in vaccines to deliver the medication as a liquid solution, and to maintain stability and pH levels. Unlike other vaccines, mRNA vaccines use very small fats (lipid nanoparticles) to deliver the mRNA into your body. Once in the body, these fats protect the mRNA, so that the mRNA can make it to cells, where it helps the body develop immunity. Once the mRNA is delivered to the cells, the lipids dissolve and are removed from the body. One part of the lipid nanoparticle is something called polyethylene glycol (PEG), an ingredient used in many toothpastes, shampoos, and other products as a thickener, moisture carrier, and solvent. PEG is also used in medications, including as laxatives, and in biopharmaceutical products. PEG has occasionally resulted in severe allergic reactions in some people. PEG has not been used in an approved vaccine before. Some scientists have suggested that PEG could be the reason for the allergy-like reactions that a small number of people have had following COVID-19 vaccination. However, this speculation has not been confirmed, and there remains considerable debate about whether or not PEG may have caused these reactions. The US National Institute of Allergy and Infectious Diseases is currently working with the US Food and Drug Administration to study how people respond to the mRNA vaccines when they have a history of allergic reactions or have high levels of antibodies against PEG. Severe reactions to vaccines can happen, but reactions to the mRNA COVID-19 vaccines have been rare (as of February 2021). In general, vaccination is both recommended and safe for most people.

What do we know about claims that masks do not work?

Despite ongoing claims that masks do not work, research shows that masks do work to help prevent transmission of respiratory diseases like COVID-19 and influenza (flu). A recent lab study conducted by the U.S. Centers for Disease Control and Prevention found that by wearing two masks, people's protection against virus in the air (also called aerosolized particles) was dramatically increased. The study demonstrated that wearing any kind of mask provides significantly more protection against infectious aerosols than not wearing a mask. Additionally, when dummies who wore two masks - like cloth face masks over surgical masks - were exposed to infectious aerosols, their level of protection was roughly 92%. (The group now recommends fitting a cloth mask over a medical procedure mask, and knotting the ear loops of a medical procedure mask and then tucking in and flattening the extra material close to the face. However, the U.S. CDC does not recommend wearing two disposable masks at one time or another mask on top of a KN95 or N95 mask.) Research before the COVID-19 pandemic had already shown the effectiveness of masks in healthcare settings, in homes of infected people, as well as in public settings during previous outbreaks of diseases like severe acute respiratory syndrome (SARS). Research during the COVID-19 pandemic has provided more evidence that masks are effective for reducing community transmission and saving lives. Many governments that responded effectively to the COVID-19 pandemic and lost fewer lives as a result, such as Taiwan, have used policies that include wearing masks in public settings. Beyond health research on the benefits of wearing masks for reducing transmission and saving lives, economic research has also shown links between wearing masks and improved long-term business/economic outcomes. For example, research by Goldman Sachs suggests that adopting a national mask mandate requiring the public to wear masks in the U.S. could potentially reduce the need for renewed lockdowns that "would otherwise subtract nearly 5% from GDP (Gross Domestic Product)." As there are many different types of masks in the market, it is important to remember that masks can differ in effectiveness. For example, now that healthcare workers have a better supply of personal protective equipment (PPE) such as medical-grade N95 respirators and surgical masks, some public health professionals are now calling for the general public to also wear more effective medical-grade masks. Previous recommendations focused on fabric face coverings for the general public, in order to ensure supply of medical-grade masks for healthcare workers. Now that the supply chain has improved in response to the COVID-19 pandemic, community transmission may be reduced further by encouraging the public to switch to more effective medical-grade masks when possible. Some European countries have moved to require medical-grade masks in public settings. Similarly, some public health professionals suggest that the public can increase the effectiveness of fabric face coverings by wearing multiple layers to filter out more respiratory particles. Dr. Anthony Fauci, a leading doctor and scientist for the U.S. COVID-19 response, has encouraged doubling up masks to increase the protection offered by porous fabric face coverings. In summary, masks do work and this is supported by research, although different types of masks vary in their effectiveness and masks alone are insufficient to respond to the COVID-19 pandemic (other public health measures, like maintaining physical distance and hygiene, are also needed). Experts suggest now focusing on how to make wearing masks in public even more effective.

What is the existing research on copper's effectiveness in dealing with COVID-19, particularly when used in face masks?

There has been research suggesting that SARS-CoV-2, the virus that causes the disease COVID-19, does not survive long on copper surfaces. However, this does not mean that copper products are always effective in protecting against COVID-19. In fact, many copper-based products currently on the market do not contain a sufficient concentration of copper for significant antimicrobial effects. One study that is commonly used as evidence on the effectiveness of copper is an April 2020 publication in the New England Journal of Medicine, which found that “no viable SARS-CoV-2 was measured after 4 hours” on copper surfaces. It is important to remember that this study in a controlled laboratory setting does not mean all commercial products with copper are able to protect against COVID-19 in real life. Products containing copper can vary widely and many products have not been designed, manufactured, and tested properly to ensure effectiveness. Furthermore, copper does not act instantaneously against microbes such as viruses, with research findings showing that copper can take 45 minutes just to reduce the amount of virus on a surface by half.  Dr. Lindsay Marr, an aerosol scientist from Virginia Polytechnic Institute and State University (Virginia Tech), suggested in a New York Times article that copper-based face coverings could potentially “come in handy for people who mishandle their mask,” assuming that “a hefty dose of copper could diminish the chances of viable virus making it into the eyes, nose or mouth via a wayward hand that’s touched the front of a mask.” Unfortunately, if a copper face covering does not contain sufficient copper, the product “won’t confer any more benefit than just regular masks” according to Dr. Karrera Djoko, a biochemist and microbiologist from Durham University. Additionally, Dr. Djoko also warns that there could be issues with durability of copper products, particularly for face masks that may be repeatedly disinfected, because many common household cleaners have compounds that can strip copper ions from a surface.  There can be some promising uses of copper to protect against COVID-19, such as using copper surfaces in healthcare settings to help reduce risk of hospital-acquired infections. That said, health experts warn against relying on commercially sold products with copper, such as copper face coverings, which are not carefully regulated and have not been rigorously tested for effectiveness.

What do we know so far about the new virus mutation in South England?

A recent surge of coronavirus cases in London and surrounding areas of Southeast England is thought to be linked to a new, fast-spreading variant of the COVID-19 virus. The new variant was detected in samples taken in late September in the Southeast English county of Kent, and now accounts for approximately 60% of COVID-19 cases in London. Aptly named “Variant Under Investigation,” or VUI-202012/01 for short, there are insufficient data and too many unknowns at this time to draw any conclusions about the new variant, according to the UK government’s New and Emerging Respiratory Threat Advisory Group (NERVTAG) and Science Magazine. Until scientists and public health officials run rigorous laboratory experiments and checks, they cannot provide definitive answers about the new variant. They stress the importance of care providers, public health practitioners, researchers, and policymakers keeping a vigilant eye on the new strain to learn more about its behavior and potential impacts on disease burden and spread.  Importantly, media channels report that there is no indication that the Pfizer-BioNTech and Moderna coronavirus vaccines will be less effective in protecting people from contracting this mutation of the virus. Additionally, there is no definitive evidence to suggest that the new variant is more deadly or linked to more severe illness. All viruses mutate and in the case of COVID-19, researchers have observed thousands of tiny modifications of since March 2020. However, the new variant of COVID-19 raises alarm for three primary reasons:  1 ) Early evidence indicates with “moderate confidence” that the new variant is significantly more transmissible than previous versions. One study from Imperial College London suggests that it is up to 70% more transmissible. Another way scientists measure virus transmission at a population level is by looking at the virus’ R0, or “R naught”, which describes the number of people one person can infect. A higher R naught is an indicator of pandemic growth, though actual growth depends on public health actions taken by the public. In recent weeks, the R naught in the region with the mutation is thought to have increased by 0.4 with the emergence of the new variant. From early laboratory experiments, scientists studying the new coronavirus variant have identified up to 23 changes to its genetic makeup, according to multiple sources. It is unprecedented to see the coronavirus seemingly acquire more than a dozen mutations at once, according to Science Magazine. One of these mutations demonstrated improved ability to infect human cells. This change is linked to the rapidly growing number of infections in Southeast England that, unabated, may only continue to rise. 2 ) Many of the mutations altered an important part of the virus called the spike protein, a crown-like structure encasing the viral genetic material and giving the virus its name. One such change alters a key piece of the spike protein, known as the “receptor-binding domain,” that binds to and unlocks the entryway into human cells. The new variant’s uncanny skill at entering and infecting cells likely gives it a leg up over other strains. This novel behavior may in part explain why the new variant has been detected in the majority of new cases in London, ousting other strains that may be less skilled in this mechanism.  3 ) The fact that the new variant has begun to rapidly replace other versions of COVID-19 as seen across testing centers in parts of England puts scientists on high alert. Virus mutations have the potential to introduce new and possibly aggressive behaviors, as well as increased transmission. For this reason, it is critical that scientists keep a close watch. These early research findings together suggest that the new variant is highly contagious, more so than previous strains. Its rapid dominance remains particularly concerning especially as it may take months to accurately capture how the new variant will take hold. However, it’s also important to not panic before we have more data and a more complete picture of this variant and its implications.

With healthcare workers getting many of the first vaccine distributions, how can vaccinations be coordinated for off-site emergency medical services (EMS) personnel?

The prioritization of initial COVID-19 vaccinations varies widely from location to location, with decisions being made at the federal, state, county and facility level. Emergency medical services (EMS) personnel are often included among the groups receiving the highest priority for the first shipments of the COVID-19 vaccine. Since the initial supply is not sufficient to vaccinate everyone within the highest priority groups, however, difficult decisions are being made about who is to receive the COVID-19 vaccines first. Some places are choosing to include EMS personnel outside of hospitals, such as in the fire department, in the first wave of COVID-19 vaccinations. Other places are distributing their first shipments of the COVID-19 vaccine straight to hospitals first. Decision-makers for each location can set priorities by taking into account public health guidance as well as data about their specific context regarding what resources are available and what are the most urgent needs.  Several public health frameworks exist and have informed decision-makers, including the U.S. Centers for Disease Control and Prevention (CDC), as they set their vaccination priorities for COVID-19.  In John Hopkins University’s framework for COVID-19 vaccine priority groups, Tier 1 includes front-line EMS personnel and Tier 2 includes other essential workers such as personnel in fire and police departments. In the National Academies of Medicine preliminary framework for equitable allocation of the COVID-19 vaccine, Phase 1a’s earliest “jumpstart phase” includes first responders like EMS, police and fire personnel. Depending on which public health frameworks are used, there can be differences in the recommendations for when to include EMS personnel outside of a hospital, such as in a fire department.  Additionally, the U.S. CDC previously made suggestions for sub-categorization of Tier 1 vaccine distribution when there is an “extremely short supply” during a pandemic of other diseases, such as influenza. The proposed ranking of groups within Tier 1 in this situation is: 1. Front-line inpatient and hospital-based health care personnel caring for sickest persons; health care personnel with highest risk of exposure 2. Deployed and mission critical personnel who play essential role in national security 3. Front-line EMS 4. Front-line outpatient health care personnel, pharmacists and pharmacy technicians, and public health personnel who provide immunizations and outpatient care 5. Front-line law enforcement and fire services personnel 6. Pregnant women and infants aged 6 -11 months old 7. Remaining groups within Tier 1, including but not limited to: inpatient and outpatient healthcare personnel not vaccinated previously; public health personnel; other EMS, law enforcement, and fire services personnel; manufacturers of pandemic vaccine and antiviral drugs While this guidance can be a point of reference for some locations seeking to decide how to allocate vaccinations to EMS personnel outside of hospital settings (who in this case might be categorized in group 3 or 7, depending on their involvement in front-line care), there are some notable differences that should be taken into account for COVID-19, compared to influenza. For example, COVID-19 has been especially deadly for older adults in long-term care settings, which is why long-term care residents and personnel are among the top tier priorities for COVID-19 vaccinations according to U.S. federal recommendations.  While the specific prioritization of EMS personnel outside of hospital settings may vary depending on the location, it is important for decision-makers to have a plan for how to vaccinate non-hospital-based EMS personnel and communicate this plan with transparency.

What do we know about the Pfizer vaccine so far?

The Pfizer vaccine is being developed and produced by Pfizer, Inc. and the biotech company BioNTech SE. It is a genetic mRNA vaccine (mRNA-1273) currently in Phase 3 clinical trials across the globe. Here is a breakdown of everything you need to know so far about this vaccine’s development. **Collaborators: **Biopharmaceutical company Pfizer Inc, based in New York City, and BioNTech, biotechnology company based in Mainz, Germany, are collaborating on vaccine development and testing for the mRNA-based vaccine candidate BNT162b2. **Latest information on how well the vaccine works:** On November 30, 2020 with primary efficacy analysis data from its Phase 3 trial, Pfizer announced its experimental COVID-19 vaccine to be 95% effective 28 days after the first of two doses.  Out of approximately 44,000 total study participants, 170 contracted COVID-19. 162 who got infected were from the placebo group—meaning they didn’t receive the vaccine—and only 8 who got infected were in the group that was vaccinated with the Pfizer vaccine.  Ten of the COVID-19 cases were severe. Nine of those people were from the placebo group. One severe case was in the vaccinated group. This suggests the vaccine has high protection for severe COVID-19 cases, at 95% efficacy, meaning that if 100 study participants were the vaccine doses, 95 patients would not contract the disease and 5 would.  There have been no reported COVID-19-related deaths in the study. These new results of 95% efficacy are higher than the vaccine’s first interim analysis conducted during the study (announced on November 9th, 2020), which reported 90% efficacy based on an analysis of 94 COVID-19 cases among trial participants. Based on a study published in February 2021 in the New England Journal of Medicine, the Pfizer-BioNTech vaccine was found to appear to be highly effective against the more transmissible variant of the virus first detected in the U.K. (B.1.1.7) (virtually no drop from 95% efficacy). However, the vaccine showed a decreased ability to neutralize the strain first detected in South Africa (B.1.351). Specifically, they found that there was about a two-thirds drop in neutralization power (antibody power) against this variant compared to other forms of the SARS-CoV-2 coronavirus. It’s important to note that the vaccine was still able to neutralize the virus, and likely still may protect individuals from getting severe forms of the virus. In addition, these are initial lab experiments that are difficult to extrapolate results from. Pfizer has said that evidence is needed to understand how the vaccine works against the variant in real life. The company stated, "Nevertheless, Pfizer and BioNTech are taking the necessary steps, making the right investments, and engaging in the appropriate conversations with regulators to be in a position to develop and seek authorization for an updated mRNA vaccine or booster once a strain that significantly reduces the protection from the vaccine is identified.” **Approvals:** As of December 2, 2020, the U.K. authorized the distribution of Pfizer and BioNTech’s COVID-19 mRNA vaccine BNT162b2 for emergency supply, making the vaccine the first in the world to achieve authorization for COVID-19. Two days following the U.K.’s authorization, Bahrain approved the emergency use of the Pfizer and BioNTech vaccine, making it the second country in the world to do so. Five days following on December 9, Canada’s regulatory agency Health Canada approved the vaccine. On Friday, December 11, 2020, the U.S. Food and Drug Administration (FDA) authorized the Pfizer and BioNTech vaccine. Soon after, Pfizer and BioNTech bega rolling review processes with other global regulatory bodies, including in the U.S., Europe, Australia and Japan, and has been submitting applications to other regulatory agencies around the world, primarily in the Global North, with a range of approvals. **Distribution timeline:** Following the U.K.’s emergency approval on December 2, 2020, the companies began delivering the first doses to the U.K. nearly immediately, starting on December 8, 2020. Canada is set to receive 249,000 doses before the end of December to distribute across 14 different vaccination sites throughout Canadian cities. Following the U.S. approval of the vaccine on December 11, 2020, the U.S. will initially distribute approximately 2.9 million doses to all 50 states. The distribution timeline for other countries undergoing the approval process will depend on the distribution decisions made by regulators there. Some countries are already coordinating pre-approval distribution and in many of these regions and countries, logistics surrounding the supply chain of the vaccine are being decided upon and run through so that when there is an approval, distribution can begin immediately. **Distribution plan:** In projections, Pfizer hopes to produce and supply up to 25 million vaccine doses in 2020 and 100 million doses before the start of March, with an estimated total distribution of up to 1.3 billion doses in 2021. Four of Pfizer’s facilities are part of the manufacturing and supply chain; St. Louis, MO; Andover, MA; and Kalamazoo, MI in the U.S.; and Puurs in Belgium. BioNTech’s German sites will also be leveraged for global supply. Each of these sites are important links in a global supply chain being assembled to tackle the massive logistical challenge of distributing COVID-19 vaccines around the world.  Jurisdictions primarily have the responsibility of determining who receives the vaccine in what order. For instance, within the U.S. each state will receive a certain number of doses of the vaccine based on residential populations. States have been asked to create their own plans for who will get the first doses.  In the U.K., British front-line health-care workers, as well as care-home staff and residents, are receiving the first doses. Bahrain has said that they plan to inoculate everyone 18 years and older at 27 different medical facilities, hoping to be able to vaccinate 10,000 people a day; so far, they have the second-highest vaccination rate in the world behind Israel. In general, the most likely distribution plan is for the vaccine to first go to emergency department clinicians, outpatient clinicians, testers at symptomatic sites, other high-risk health care workers, immunocompromised individuals, EMTs, and potentially essential federal employees, followed by the rest of the general population.  Vaccination distribution in some countries is moving more slowly than anticipated. In the U.S, for example, just 2.6 million individuals were vaccinated by December 31, 2020 compared to the 20 million goal by the end of 2020. In response, scientists and public health practitioners are considering vaccination tactics that differ from those that the FDA and other country’s health regulatory bodies approved. The tactics being considered are primarily halving doses of vaccines and delaying second doses to get first doses to more individuals, but also include reducing the number of doses and mixing and matching doses.  Health officials in the UK have already decided to delay second doses of two vaccines, one made by AstraZeneca and one made by Pfizer and BioNTech, and to mix and match the two vaccines for the two doses under limited circumstances. This decision has received mixed responses from scientists and public health practitioners, many of whom are concerned about the lack of data, particularly with regards to a mix-and-match approach.  The U.S. FDA critiqued the idea of halving the doses of the Moderna vaccine, saying that the idea was “premature and not rooted solidly in the available science.” Studies are underway to determine whether doses of the Moderna COVID-19 vaccine can be halved to 50 micrograms in order to double the supply of the vaccination doses in the U.S., according to the National Institutes of Health and Moderna. **Vaccine storage conditions:** Storage requirements are important to consider for new vaccines. In order for vaccines to be safe and effective, they must be held at the correct temperature during distribution and storage in health centers, pharmacies, and clinics. Maintaining the correct storage temperature can be difficult, especially if the vaccine’s temperature requirement is very cold.  The Pfizer and BioNTech vaccine can be stored for five days at refrigerated 2-8°C (36-46°F) conditions (refrigerators that are commonly available at hospitals); up to 15 days in Pfizer thermal shippers in which doses will arrive that can be used as temporary storage units by refilling with dry ice; and up to 6 months in ultra-low-temperature freezers, which are commercially available and can extend the vaccine’s shelf life.  With regards to transit, Pfizer is using dry ice to maintain the recommended temperature conditions of -70°C±10°C (-94°F) for up to 10 days while in transit. However, Pfizer and BioNTech have determined that the vaccine can be moved only four times. **Type of vaccine:** The mRNA-1273 vaccine is what scientists are calling a genetic mRNA vaccine. This type of vaccine works by using genetic information from the coronavirus, which is injected into the body. The genetic information enters into human cells, instructs the body to make special spike proteins like the coronavirus, and causes the immune system to respond. **Dosage:** In the current Phase 3 clinical trial, participants receive two injections of 30 micrograms each into their upper arm muscle. The injections are given 21 days apart. Once an individual gets the first dose, they must get the second dose three weeks later in order to complete the vaccination. If approved, researchers expect that the same dosage and schedule will be prescribed to the public. A recent Israeli study that released results in February 2021 by the Lancet found that a single dose of the Pfizer vaccine was 85% effective against COVID-19 infection between two and four weeks after the first dose, and that the overall reduction in infections was 75%, including asymptomatic cases. Public health practitioners are enthusiastic about this finding of high efficacy after just one dose; However, the authors cautioned that the low numbers of COVID-19 cases in the study, and the fact that the study was conducted at one hospital, make it difficult to reach exact estimates and that these findings should be interpreted with caution. The study also does not determine the length of protection. Pfizer did not comment on the data, stating that “the vaccine’s real-world effectiveness in several locations worldwide, including Israel.”   Studies out of the U.K., which has been the quickest to inoculate its population, have also found that a single dose of the Pfizer vaccine could avert most COVID-19-related hospitalizations, though investigators stated it was too early to give precise estimates of the effect. **How the vaccine is being studied:** Vaccines are tested and studied in multiple phases (phased testing) to determine if they are safe and work to prevent illness. Before a vaccine is tested on humans, which is known as the preclinical phase, it is tested on laboratory cells or animals. Once it is approved for human research, there are three phases that take place before the vaccine can be considered for approval for public use. During the first stage (Phase I), the new vaccine is provided to small groups of people—the first time the vaccine is tested in humans to test safety (primarily) and efficacy of the vaccine.  The second stage (Phase II) involves testing the vaccine on people who have similar characteristics (such as age and physical health) to the target population, or the group for which the vaccine is intended. The goal of this stage is to identify the most effective doses and schedule for Phase III trials. The final stage (Phase III) provides the vaccine to thousands of people from the target population to see how safe and effective it is.  Once the vaccine has undergone Phase 3 testing, the manufacturer can apply for a license from regulatory authorities (like the FDA in the US) to make the vaccine available for public use. Once approved, the drugmaker will work with national governments and international health organizations to monitor vaccine recipients for potential side effects from the vaccine that were not seen in clinical trials (this is called surveillance). This phase also helps researchers understand how well a vaccine works over a longer time frame and how safe it is for the population. **How Pfizer looked for COVID-19 cases in their trials:** Researchers have standard definitions for routinely detecting COVID-19 cases for both symptomatic and asymptomatic individuals. For symptomatic individuals, there are three definitions considered for defining a COVID-19 case for the study. The first two are for regular cases, and the third is for severe cases.  The first definition is the presence of at least one COVID-19 symptom and a positive COVID-19 test (such as a PCR test) during, or within 4 days before or after, the symptomatic period, either at the central laboratory or at a local testing facility. The second definition is the same, but expands the definition to include four additional COVID-19 symptoms defined by the CDC (fatigue; headache, nasal congestion or runny nose, nausea). The third definition, which defines severe COVID-19 cases for the study, is a confirmed COVID-19 test per the above guidelines in addition to one of the following symptoms: clinical signs at rest indicative of severe systemic illness, respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to an ICU, or death. The Pfizer research protocol states that for individuals who do not clinically present COVID-19 (that is, asymptomatic individuals), a serological test is used for defining a case, which measures the amount of antibodies or proteins present in the individual’s blood, and a positive case is defined as the presence of antibodies in an individual who had a prior negative test. By using these four definitions, researchers are able to detect COVID-19 cases in both symptomatic and asymptomatic individuals. However, the pharmaceutical company has stated that there are more data on the vaccine’s safety and efficacy for symptomatic cases, and that more data is needed to better understand the vaccine’s safety and efficacy for asymptomatic cases. **Preclinical testing:** Before testing could begin on humans, the trial vaccine was tested on primates at both 30 micrograms and 100 micrograms. On September 9, 2020, results were published demonstrating that the Pfizer vaccine had strong antiviral protection against the virus SARS-CoV-2. As a result, the Pfizer and BioNTech were permitted to advance the vaccine into human clinical trials by the FDA in the form of through the Investigational New Drug application (IND). **Phase 1 trial:** 45 healthy adults 18–55 and 65–85 years old were randomly assigned to either the placebo group or the vaccine group to receive 2 doses at 21-day intervals of placebo or either of 2 mRNA-based vaccines (BNT162b2 or BNT162b1, which was one of several RNA-based SARS-CoV-2 vaccines studied in parallel for selection to advance to a next trial). Participants received either 10, 20, or 30 microgram dose levels of BNT162b1, or BNT162b2 on a 2-dose schedule, 21 days apart. Both participants and observers working on the study were “blinded,” or not aware of which participants were receiving the active vaccines (and which ones) versus the treatment, in order to help prevent bias.  Both with 10 micrograms and 30 micrograms of vaccine BNT162b1, and t 7 days after a second dose of 30 micrograms of the BNT162b2 vaccine, “SARS-CoV-2–neutralizing antibodies” were elicited—special proteins that disable viruses in the body—in younger adults (18-55 years of age) and older adults (65-85 years of age). Younger participants had 3.8 times more antibodies than people who had recovered from the virus. In older adults (65-85 years of age) the vaccine candidate triggered antibodies at 1.6 times the volume of those who had recovered from the virus in the same age group. Vaccine BNT162b2, now known as the “Pfizer vaccine,” was associated with fewer reactions (such as fever and chills), and was therefore selected for Phase 2/3 trials.  In terms of safety and tolerability of vaccine BNT162b2, reactions were still reported. Study participants reported pain at the injection site, headache, fatigue, muscle pain, chills, joint pain, and fever. Most of these reactions and symptoms peaked by the day after vaccination and resolved by day 7.  **Phase 2/3 trial: **In an effort to speed up the trial, Phases 2 and 2 of the Pfizer vaccine were combined. This phase continued off of Phase 1 and also contained a placebo group as a control with patients randomly assigned into either the placebo group or vaccine group for vaccine BNT162b2. As with Phase 1, the observers and participants were also “blinded.” The first 360 participants enrolled made up the “Phase 2” portion, with 180 randomly assigned to receive the active vaccine and 180 to receive the placebo, stratified equally between 18 to 55 years and >55 to 85 years. Phase 3 enrolled 43,538 trial participants overall, half of whom were randomly assigned to receive the vaccine and half of whom were randomly assigned to receive the placebo. Out of 170 cases of COVID-19 among the study participants,162 cases of COVID-19 were observed in the placebo group versus 8 cases in the vaccine group, indicating 95% efficacy of the vaccine. No serious safety concerns were observed. Data collection is ongoing. **Reported side effects and safety concerns:** The study’s Data Monitoring Committee did not report any serious safety concerns related to the vaccine based on the trial data. Adverse events at or greater than 2% in frequency that were reported were fatigue at 3.8% and headache at 2.0%. Potential allergic reactions occurred in 0.63% of those who received the vaccine, compared with 0.51% of those who received the placebo.  On December 9, one day after the Pfizer and BioNTech vaccine began being distributed to individuals outside of the clinical trial in the UK, UK regulators advised that individuals with a history of anaphylaxis to a vaccine, medication, or food should not receive the vaccine. This warning was issued in response to two reports of anaphylaxis (severe allergic reaction) -- both among individuals with histories of severe allergies -- and one report of a possible allergic reaction since distribution in the UK began. Pfizer and BioNTech have stated that they are working with investigators to better understand the cases and causes of the reactions.  Within the clinical trial, individuals with a history of severe allergic reactions were excluded from the trials, and doctors were asked to look for such reactions in trial participants who weren’t previously known to have severe allergies. UK regulators also required health care workers to report any negative reactions to help regulators collect more information about safety and effectiveness.  In addition, four people who received the vaccine during trials later developed Bell’s palsy at 3, 9, 37, and 48 days after vaccination, respectively. Because these trials were so large, however, this is not more than we would expect to develop Bell’s palsy in a group of this size by chance. Bell’s palsy is a weakness or paralysis of one side of the face which is usually temporary. Any cases of Bell’s palsy and any other potential side effects or adverse reactions will continue to be monitored and evaluated for as the vaccine continues to be rolled out to the public. **Impact on different populations:** Pfizer and BioNTech both say they aimed to make their trials as diverse as possible to understand the vaccine’s effect on different populations. The trial participants are approximately 30% U.S. participants and 42% non-U.S. participants from across 150 trial sites globally. The participants are reported to have racially and ethnically diverse backgrounds. In the trials, 41% of global and 45% of U.S. participants are 56-85 years of age. Efficacy was reported to be consistent across age, gender, race and ethnicity demographics.  Notably, the observed efficacy in individuals over 65 years of age was observed to be greater than 94%. In September 2020, Pfizer and BioNTech expanded Phase 3 enrollment to approximately 44,000 participants. This expansion allowed for the enrollment of new, more diverse, populations, including adolescents as young as 16 years of age, and individuals with chronic, stable human immunodeficiency viruses (HIV), Hepatitis C, or Hepatitis B infection. In October 2020, Pfizer and BioNTech received permission from the FDA to enroll adolescents as young as 12. Their explanation for these expansions is to enable better understanding of the potential safety and efficacy of the vaccine in individuals from more ages and backgrounds. **Other relevant notes:** N/A

What is the context behind the misinformation about fetal cells used in the AstraZeneca COVID-19 vaccine?

The Oxford-AstraZeneca COVID-19 vaccine (AZD1222) does not contain human cells or tissues. The AZD122 (ChAdOx1 nCov-19) is a weakened version of an adenovirus—a harmless virus that usually causes the common cold in chimpanzees— and is used as a way to transport the vaccine's ingredients into the human body. This type of vaccine is called a "vector vaccine," because the adenovirus serves as the vector (or vehicle) for getting the drug into human cells. The adenovirus can stimulate a response from a person's immune system when their body detects it in cells. Essentially, the vaccine helps train human bodies to detect and eliminate a real COVID-19 infection through showing it mock spike proteins, before COVID-19 can cause any severe symptoms or a severe infection. During preclinical research, MRC-5 cells were used to determine how effective the vaccine may be in human clinical trials, but the MRC-5 cells are not used in the manufacturing process for this vaccine. There are different processes used to make vaccines. Often, when vaccines are being made, viruses are propagated (grown in the lab) in special laboratory cells, and the viruses are then collected to make the vaccine. To make this COVID-19 vaccine, the virus is propagated using another type of cells, the HEK 293 cell line. However, there is no evidence that these cells are present in the vaccine itself. The cells are removed through a filtering and purification process that breaks down the cellular pieces and remaining DNA before a vaccine is deployed to humans. The HEK 293 cells and MRC-5 cells (mentioned above), as well as many other research cell lines, were collected from fetal tissue in the 1960s and 1970s. Since then, labs have reproduced those cell lines for some medical purposes, including research and vaccine development. These cells are not part of the vaccine. It is also important to distinguish between fetal cells and cultured (lab grown) cells. Fetal cells are not used in vaccine production.

What do we know about mouth and nose rinses, washes, sprays, or creams to prevent COVID-19?

There is no scientific evidence to support using home or traditional therapies to prevent COVID-19 at this time. The World Health Organization (WHO) and other international health leaders say that caution is needed when considering “traditional remedies” as preventative measures or treatments for COVID-19, because they have not been widely studied and may cause harm in some cases. There are many traditional remedies and home remedies that have been promoted to prevent COVID-19 infection. People have suggested using mouth or nasal washes, sprays, and creams (or fats) could prevent the virus from entering the body or kill the virus in the nasal cavity (nose) and throat before it has a chance to spread. **Nasal (nose) washes:** There is no scientific evidence that suggests rinsing the inside of your nose will prevent COVID-19 infection. Additionally, for patients with COVID-19, researchers have raised a concern about using contaminated nasal rinse bottles (as well as surfaces and rinse fluids), suggesting they could be a source of exposure. **Nasal (nose) sprays:** Ongoing studies seek to learn more about how saline, iodine, special soaps, and other ingredients used as nasal washes and sprays may help improve virus symptoms and decrease the spread of COVID-19.  One Israeli study published in November 2020, and recently re-released with updates as a pre-print in January 2021, shows promising results for a nasal spray known as Taffix. Taffix is a nasal inhaler approved for sale and used for the prevention of respiratory viral infections in Israel and some other countries. The 2020/2021 study analyzed 243 members of a Jewish ultra-orthodox synagogue community during a high holiday, in which individuals were gathered and praying throughout the day. At the two-week follow-up mark of the event, the study investigators found that the individuals who used Taffix had a reduction in odds of COVID-19 infection by 78%, compared to those who did not use Taffix. Eighteen members out of the total 243 were infected with COVID-19, 16 in the no-Taffix group and 2 in the Taffix group, both of whom did not adhere to the recommended use. Studies are ongoing to test over the counter and other types of nasal sprays for protection against COVID-19, with some showing early promise in lab and animal studies. **Mouthwash, rinses, and gargle solutions:** Like nasal washes and sprays, there is no scientific evidence that suggests using mouthwashes, rinses, and gargles will prevent COVID-19 infection. Ongoing studies seek to learn about how special antiseptic mouthwashes may help prevent COVID-19 (see the Experimental Therapies section below). So far, many studies have explored these treatments in laboratory cells, and data on humans is limited. **Alcohol, chlorine, or disinfectant spray:** Alcohol, chlorine (e.g. bleach solutions), or disinfectant sprays should never be sprayed or applied to your nose, mouth, or eyes, and doing so may cause serious harm. Drinking alcohol will not prevent or treat COVID-19. **Fats or oils:** This includes coconut oil, ghee, sesame oil, shea butter, petroleum jelly, and others. There is no scientific evidence that nasal treatments or mouth rinses with different fats will prevent, treat, or cure COVID-19. While many types of fats or oils (like coconut oil, sesame oil, and others) have been shown to kill or stop bad bacteria in cell-based laboratory studies, most of these studies have focused on how these ingredients may be used to prevent bacterial growth on food to improve food safety. Studies have not looked at the effect of fats on prevention of viral or bacterial infections in humans when applied in the nose or used as a mouth rinse. There is no scientific evidence that supports the theory that using these oils would improve health or prevent illness. In addition, though rare, it is possible that inhaling fats from the inside of the nose can cause lung problems. **Steam inhalation:** Though inhaling steam may help to thin mucous or relieve congestion (stuffy nose), there is no scientific evidence to suggest that inhaling steam will prevent or treat COVID-19. Contact with steaming hot water can cause burns, and inhaling steam can burn the inside of your nose. **Experimental therapies:** There are ongoing studies using nasal sprays (and rinses) and special mouthwashes to prevent COVID-19, such as the Taffix study discussed above. Much of the current scientific evidence is based on animal or laboratory cell studies. For humans, efficacy and safety studies are ongoing, and most treatments are not recommended for the public at this time. Currently, studies seek to understand if nasal rinses (using saltwater, special soaps, and other ingredients) may help to improve symptoms and decrease the viral load in patients with COVID-19 (with the thought that decreasing the viral load could decrease how much an infected person may spread the virus). Researchers are also studying whether gargling or rinsing with special solutions (e.g. povidone-iodine) may help prevent healthcare workers from contracting COVID-19. A pre-print study or a nasal spray medication (INNA-051) has shown good results in preventing COVID-19 in ferrets, but human studies have not yet begun. Human study results for Taffix nasal spray and its pre-existing approval for prevention of respiratory viral infections makes it feasible for human use in protection against COVID-19; however, it is not a replacement for mask use and physical distancing. To prevent COVID-19 infection, health authorities continue to recommend avoiding crowds, practicing social distancing measures (at least 6 feet/2 meters apart), frequent and careful handwashing, wearing face masks (wearing a cloth mask over a surgical mask is recommended by the U.S. Centers for Disease Control and Prevention), staying home when possible (especially if you are sick), clean high-touch surfaces often, and avoid touching your nose, eyes, and mouth.
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