Recently, 'Tomato Flu' has been reported in some parts of Kerala among children under the age of five. After the reports of these cases surfaced, the neighboring state, Tamil Nadu, also increased surveillance at its borders. Total 'Tomato flu' cases in India mount to 100.
What causes 'Tomato Flu'?This rare contagious disease, Tomato fever, is caused by Coxsackie A 16 virus. In this infection, red and painful blisters come up on the patient's body, which gradually expand into the size of a tomato, and that's why, it has been named 'tomato flu'.
All you need to know about Tomato fever
is a rare virus that attacks only children especially those who are under the age of five.
it is not yet confirmed whether this (unknown fever) is viral or dengue, chikungunya.
Most of the children have had problems with rashes, skin irritation and dehydration. Blisters have also been seen in some parts of the body.
Tomato flu is named after the red-colored blisters visible on the body.
TreatmentThere is no specific drug to treat 'Tomato Flu', a self-limiting infection. And the treatment given to children is the same as those given in the case of dengue, chikungunya, and hand, foot, and mouth disease.
Moreover, this infectious disease which is triggered by intestinal viruses is rare to occur in adults. It's because the immune system in adults is strong enough to defend them against 'Tomato Flu' virus.
Those infected with the disease are advised to isolate and take plenty of fluid. Also, you can use a hot water sponge to relieve irritation and rashes.
As a precautionary measure, the Union Health Ministry has asked the states to conduct proper screening by the health authorities and to increase surveillance.
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(NEXSTAR) In case we didnt have enough viruses to worry about, reports of a tomato flu outbreak in India started to surface this month. The virus, named for the bursting red blisters it causes, has infected at least 100 children.
The virus was first identified in Kerala in May, where it infected 82 children all under the age of 5 by the end of July, according to The Lancet medical journal. At least 26 more cases were also confirmed in neighboring states of India.
The most common symptoms appear to be fever, joint pain and the rash that gives the virus its new nickname. Tomato flu gained its name on the basis of the eruption of red and painful blisters throughout the body that gradually enlarge to the size of a tomato, The Lancet reported.
News outlets started to report on the disease as a new virus, but new testing out of the United Kingdom seems to indicate the tomato flu isnt new at all nor is it a type of flu.
Viral swabs were taken from two children who had recently returned from India showing the bright red rash, reports the British medical journal BMJ. The test came back positive for Coxsackie A16, a pathogen commonly associated with Hand, Foot, and Mouth Disease (or HFMD).
According to the Centers for Disease Control and Prevention, HFMD is very common among children, even here in the United States, because of how contagious it is. The symptoms including fever, mouth sores and skin rashes last seven to 10 days for most kids.
When there is a rash with HFMD, the rash usually is not itchy and looks like flat or slightly raised red spots, sometimes with blisters that have an area of redness at their base, says the CDC.
This common disease may have been initially mistaken as a new tomato flu virus because the blisters observed in India were larger.
Doctors in Kerala told BMJ that even in the cases they have seen over the past few months, they have yet to admit any children to the hospital. All of the patients have recovered on their own thus far.
Influenza is caused by influenza viruses that belong to the Orthomyxoviridae virus family, while COVID-19 is caused by the SARS-COV-2 virus that belongs to the Coronaviridae virus family
Claim: The virus that causes influenza (flu) and the virus that causes COVID-19 belong to the same virus family.
Why we fact-checked this: The post containing the claim has over 4,629 views on YouTube, as of writing.
Different families: According to the United States Centers for Disease Control and Prevention (US CDC), flu and COVID-19 are caused by viruses from different virus families. Studies published by the National Library of Medicine (NLM) said that flu is caused by an influenza virus under the virus family of Orthomyxoviridae, while COVID-19 is caused by the SARS-COV-2 virus from the virus family of Coronaviridae.
What this means: The difference in where flu and COVID-19 originate means:
Vaccine schedule: According to the US CDC, flu and COVID-19 vaccines could be given at the same time, and possible side effects are generally similar whether vaccines are given alone or with other vaccines.
However, the US CDC says that, although there is no harm in taking both flu and COVID-19 vaccines at the same time, the public should follow the recommended schedule for either vaccine. The US CDC also recommends the public to get the COVID-19 vaccine as soon as possible and get the flu vaccine during the flu season.
According to the Philippine Department of Health, it is preferable to give flu vaccinations to Filipinos from February to June. Lorenz Pasion/Rappler.com
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Employees in cleanroom suits test the procedures for the manufacturing of the messenger RNA (mRNA) ... [+] for the Covid-19 vaccine at the new manufacturing site of German company BioNTech on March 27, 2021 in Marburg, central Germany. (Photo by Thomas Lohnes / AFP) (Photo by THOMAS LOHNES/AFP via Getty Images)
This is a short series about a recent breakthrough on the road to developing a much sought-after broadly neutralizing vaccine against all influenza A viruses. If successful, it may act as a precursor to a truly universal flu vaccine, one that protects against all types, subtypes, and lineages of the virus. The breakthrough may also provide a blueprint for developing a Covid-19 vaccine that retains its efficacy in the face of new variants.
In the first part of this series, I gave a brief overview of the history and nature of influenza viruses, including why it has been so difficult to develop successful vaccines. Here, and in the previous article, I discuss some of the attempts that have been made to overcome these challenges, including their shortcomings. And in the last few installments I will offer a detailed analysis of the latest and most promising advances in the field.
Understanding mRNA Technology
Traditional influenza vaccines are based on killed influenza viruses. Inactivated viruses cannot cause infection or disease, but when injected they rally our immune system into action all the same. While our immune system clears the viruses, it learns about them. Next time were exposed, it is already primed to defend against infection.
But there are a couple issues with influenza vaccines that rely on inactivated viruses. For one, they take a long time to produce. Candidate vaccine viruses need to be grown, either in fertilized hens eggs or in mammalian cells, before being inactivated and purified for use in vaccines this is a biological production process, and can take up to six months to complete. This means the wild type viruses circulating across the globe can continue to mutate while the vaccines are being made. If the viruses change enough, they may be able to evade the immunological memory the vaccines would provide us. Slow production times also render inactivated vaccines poorly suited to pandemic response, where speed is of the essence.
Enter messenger RNA (mRNA) technology. Unlike traditional flu vaccines, mRNA vaccines do not depend on the cultivation of viruses. Instead, they are based on the synthesis of carefully designed mRNA.
All of the cells in the human body contain proteins. These are the building blocks of life, involved in almost all of our bodys vital processes. Messenger RNA, in turn, is crucial to the synthesis of proteins. Our cells need instructions to build proteins, and mRNA provides these instructions in the form of genetic information. In a sense, mRNA acts as a kind of blueprint.
Vaccines can take advantage of this, using mRNA to instruct our cells how to produce a protein or even just a small section of a protein that is unique to whatever virus the vaccines are meant to protect us from. In the case of Covid-19, for example, vaccines include mRNA that teaches our cells to make the SARS-CoV-2 spike protein, which the virus uses to bind to our cells. Our immune system then recognizes these proteins as foreign entities and quickly gets to work, as it would against inactivated viruses or the wild-type virus itself.
Lightning Fast Manufacturing
Messenger RNA vaccines can be manufactured extremely quickly because they bypass the need for inactivated viruses or virus antigens. Unlike traditional vaccines, mRNA vaccines are synthesized chemically. The process is more akin to how a pharmaceutical drug like aspirin is produced than it is to how current flu shots are produced.
As soon as researchers have a complete sequence of a virus genome, they can isolate the section they want to use for vaccination usually, the gene corresponding to the surface protein the virus uses to bind and enter our cells and artificially synthesize it in the lab. The gene can then be inserted into a small, circular piece of DNA known as a plasmid. Plasmids are easy to replicate, allowing researchers to produce large amounts of the target viral gene at once. Finally, the plasmids are put into a reactor with a molecule that transcribes the viral RNA into mRNA. Any remaining plasmid material is broken down and the mRNA put through a series of purifiers before being packaged into the protective lipid shell. The whole process takes a matter of weeks rather than months. Or maybe even less: in 2013, a team of scientists at Novartis generated an mRNA vaccine candidate in the span of eight days.
Messenger RNA technology skips a large chunk of the usual vaccine manufacturing process by recruiting our very own cells as factories to make the antigen onsite, instead of having to produce it externally and administer it after the fact. All thats needed for the mRNA vaccines is the relevant sliver of genetic material and a protective lipid shell. The rest of the work is done by us, inside our cells.
The protective lipid shell is crucial. Messenger RNA on its own is very fragile and any free floating or misplaced mRNA molecules in our body are quickly chopped up and broken down by enzymes. Added to this is the fact that mRNA cannot enter cells on its own, meaning it would never even be able to deliver the necessary genetic instructions. Lipid nanoparticles (LNPs) form a bubble around the delicate mRNA, helping to shield it and shuttle it into our cells (Figure 1).
A big part of the reason mRNA technology wasnt introduced into the mainstream until recently is because finding the right combination of lipid nanoparticles had given researchers difficulties. In 2004, while working on small-interfering RNA (siRNA), which can selectively silence genes in mammalian cells, researchers at Alnylam Pharmaceuticals made a breakthrough: attaching a cholesterol molecule to the siRNA allowed it to pass through cell membranes. A later breakthrough improved on this discovery by adding a transient positive charge to the lipid nanoparticle, creating a bubble around the siRNA that protected it and helped ferry it into cells more effectively. Although designed for siRNA, the same delivery technology opened the door for improved mRNA therapeutics. In fact, Pfizer and Moderna used very similar lipid nanoparticles to ferry the mRNA in their respective Covid-19 vaccines. And according to Alnylam, the lipid nanoparticle formulation is too similar to its own, leading them to file a lawsuit against the two pharmaceutical companies.
FIGURE 1. A schematic diagram of lipid nanoparticles used to protect and shuttle mRNA (red) during ... [+] vaccination.
Messenger RNA vaccines may soon become even quicker and cheaper to produce by implementing self-amplifying mRNA (samRNA) technology. With conventional mRNA vaccines, the amount of mRNA in the vaccine is the amount of mRNA that will end up in the cell, and by extension, the amount of antigen produced. Self-amplifying technology combines the mRNA with enzymes from alphaviruses, which help the mRNA make copies of itself once inside the cell (Figure 2). This means fewer mRNA molecules need to be used per vaccine. The samRNA vaccines may also induce a more robust immune response, as the mRNA stays in the body for a longer period of time.
FIGURE 2. samRNA delivery system (left) compared to conventional mRNA delivery system (right).
Faster production should allow manufacturers to keep up with new viral mutations; as soon as a variant of concern pops up, researchers could begin production of a bespoke vaccine to neutralize it. In the case of influenza, mRNA technology would improve the odds of vaccines being well matched to the circulating wild type viruses something we continue to have trouble with, even as recently as this past flu season.
Drawbacks?
Unlike Covid-19 outbreaks, which are usually driven by one dominant circulating variant, seasonal flu outbreaks are characterized by multiple cocirculating strains. These strains are derived from the four main influenza viruses: influenza A(H3N2), influenza A(H1N1), and two influenza B viruses. To account for differences in the hemagglutinin surface protein between strains, traditional flu shots are quadrivalent, meaning they contain an inactivated version of each of the four viruses. But a synthesized mRNA sequence can only make one particular protein; an effective mRNA influenza vaccine would need four different sequences to make four different HA proteins. A 2020 study led by researchers at the Icahn School of Medicine at Mount Sinai suggests this shouldnt be an issue. The team of scientists manufactured an mRNA vaccine against an influenza subtype that encoded four different proteins at once. They have since repeated the experiment for two additional influenza subtypes, and they plan to test a combined vaccine that encodes for a total of 10 to 12 different antigens across subtypes. This is part of a larger movement towards mRNA flu shots.
A more serious concern is that mRNA technology comes at the cost of thermostability. The delicate nature of mRNA renders it thoroughly unstable at room temperature, leading to degradation and loss of quality. In general, mRNA vaccines need to be stored and transported well below freezing Pfizers Covid-19 vaccine needs to be stored at -94 Fahrenheit, colder than Antarctic winter. This makes global distribution and storage a serious challenge, especially in areas without ready access to electricity.
But, this too, is already becoming a problem of the past. A process known as lyophilization, or freeze-drying, allows researchers to dehydrate the mRNA solution and turn it into a powder. This powder is stable at room temperature and can be mixed with diluents just before administration. In 2017, researchers used this method to produce a rabies mRNA vaccine that retained its efficacy after being stored at 113 degrees Fahrenheit for 12 months. Even when stored at 158 degrees Fahrenheit for three months, the vaccine managed to protect mice from disease. In India, Gennova Biopharmaceuticals has just received emergency use authorization for their lyophilized Covid-19 mRNA vaccine, which can be stored between 35 to 45 degrees Fahrenheit without degradation. Instead of sub zero temperatures, standard refrigeration will do just fine.
What remains unclear is whether mRNA technology by itself could address a major issue plaguing current influenza vaccines: waning immunity. A 2018 meta-analysis of influenza vaccine durability found that protection can vanish as early as 90 days post vaccination. Recombinant and inactivated vaccines both suffer from this issue, even though they trigger immune responses in different ways. If the Covid-19 mRNA vaccines are anything to go by, waning immunity will likely continue to be a factor even if influenza vaccines made the switch to mRNA technology.
The next article in this series will look at the nasal spray flu vaccine live attenuated influenza vaccine [LAIV] which has faced a bumpy road ever since it was first introduced. What did it promise, and why has it fallen short?
A view of the city skyline seen from the Police Headquarters at ITO during the first day of national lockdown imposed by PM Narendra Modi to curb the spread of coronavirus on March 25, 2020 in New Delhi, India. (Photo by Sonu Mehta/Hindustan Times vi
NEW DELHI, India - Researchers in India say they are monitoring an outbreak of the tomato flu, or tomato fever, in the country calling it a new virus as the world continues to grapple with the COVID-19 pandemic.
Their findings were recently published in the medical journal "The Lancet," saying cases have been detected in the state of Kerala in children younger than 5 years old.
They said so far, the rare viral infection is considered non-life threatening but they want to prevent further outbreaks.
According to the journal, the tomato flu virus has symptoms similar to COVID-19 such as fever, fatigue, and body aches. Symptoms can also include large, red blisters that can become the size of a tomatohence the name.
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Researchers believe the virus is "self-limiting" with no specific drug existing to treat it.
Meanwhile, they believe the virus is spread through close contact and urge people to practice proper hygiene and sanitization. They suggest people who have the virus to isolate five to seven days after the onset of symptoms.
Health experts advise getting tested by a health care provider but here are some key differences between COVID-19, the flu and the common cold as told by a nurse educator.
But whether or not the virus is "new" is up for debate among scientists.
The Lancet reported that the tomato flu was first identified in the Kollam district of Kerala in May 2022. As of July, more than 80 children, younger than 5, were diagnosed with the illness.
However, doctors in Europe said the tomato flu is not new and is a variant of the hand, foot, and mouth disease (HFMD), publishing their findings in The BMJ.
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Currently, neither the Centers for Disease Control and Prevention nor the World Health Organization specifically points out tomato flu.
Researchers in India said more follow-ups and studies are needed to understand and treat the tomato flu.
This story was reported from Los Angeles.
Colds and the flu are generally associated with colder weather, but there have been increased reports of people suffering from summer colds this year.
A number of factors could be responsible including pandemic-era lockdowns, mask wearing and social distancing giving us less exposure to common colds in recent years.
Heatwaves and humidity fluctuations in many countries may also have played a role in the transmission of common cold viruses this year.
The advice for getting over a summer cold is the same as it would be if you caught one in the winter drink plenty of fluids, get lots of rest and eat nutritious foods.
Most of us associate colds and the flu with colder weather. But that doesnt mean you cant still catch a cold during the summer. Some viruses are even more common in summer than in the winter.
Both viruses cause typical cold symptoms, including a runny nose, low energy, muscle aches, cough, headaches and sore throat. Parainfluenza can sometimes causebronchitis and pneumoniain people who have a poorly functioning immune system. While these symptoms are similar to allergies, the telltale difference is thatallergies tend not to causefevers or body aches, and rarely cause coughs. Colds last from a few days to two weeks, but, depending on what triggered the allergy, allergy symptoms can last all summer for some people.
It seems counter-intuitive that certain viral infections are more common in warmer months when we spend more time outdoors. But in the warmer months, we also socialise and travel more meaning were mixing with a greater number of people, sometimes from different parts of the world. Many of us also gravitate towards air-conditioned indoor environments when the weather is hot.
But the structure of a virus may also explain why some spread more easily in the warmer months.
For a virus to spread and infect healthy cells, it needs to survive both outside and inside the body and it also needs to use the machinery of human cells (such as their DNA) to create copies of itself.
Viruses are surrounded by a protein coat, called a capsid, which not only gives the virus its shape but also protects the genetic material inside. The capsid also helps the virus attach to human cells to cause infections.
Some viruses (called enveloped viruses) are also surrounded by a lipid (fatty acid) envelope. This viral envelope helps the virus to avoid being destroyed by the immune system. It also plays a role in interacting with human cells to cause infection.
Many winter viruses (including influenza and RSV) are enveloped viruses. Enveloped viruses tend to bemore vulnerable to heat and drynessthan viruses that lack envelopes. This is one of the reasons why its thought that these winter cold viruses survive best in colder winter environments.
While some summer colds (such as enteroviruses) lack an envelope, others (parainfluenza virus 3) have an envelope. In fact, parainfluenza virus 3 is more common whentemperatures are high and humidity is low(though it can survive in a range of different humidities). This suggests that other parts of a viruss structure, aside from the envelope, may play some role in what conditions it can best survive and spread in but more research will be needed to better understand this.
The interplay between temperature and the immune response to a virus may also play a role. One study found that mice exposed totemperatures of 36Chave a diminished immune response against the flu virus. However, more research is needed to confirm this finding in humans.
Immune response
Many people have reported suffering from summer colds this year, leaving many to wonder why this is the case and if the pandemic has played a role.
Immunity to common cold viruses is short-lived. So each season, when we are exposed to new variants, our immune system has to adapt. But during the pandemic, various lockdown measures, such as distancing and wearing masks, limited the exposure that many people had to these viruses.
When we gathered again after lockdown,cold viruses began to circulate, but our immunity had not been boosted by exposure to that virus the previous year. While the predictability of seasonal viruses has changed since the emergence of COVID, the increases in summer colds seen this year are probably due to us travelling more, more social mixing, less mask wearing and distancing, and less exposure to respiratory viruses the previous year.
This year many parts of the world have also seen extremely hot temperatures and a spate of heatwaves. These temperatures and humidity fluctuations may have played a role in the transmission of common cold viruses this year. These factors will also become even more relevant in the future and may even change what time of year we see certain viruses. Climate change may furtherworsen the spreadofviruses in the future.
Since theres no vaccine for summer colds, the best thing you can do to avoid getting one is to stay away from people who are sick (if possible), wash your hands and avoid touching your face. If youre unlucky enough to have gotten one, the advice for getting over a cold is the same as it would be if you caught one in the winter: drink plenty of fluids, get lots of rest and eat nutritious foods. To protect others, coughing or sneezing into your elbow or tissues is also recommended.
It may also be worthwhile thinking about how you can protect yourself from getting sick as the temperatures cool in the coming months. The flu vaccine is recommended each winter for certain people, so its wise to check if you are due for a flu vaccine this year. This year the flu has been particularly bad for Australia, and predictions suggest it willbe the samefor many parts of the world this winter.
Thearticle originally appeared in the World Economic Forum.
The FDA recommends to take at least two COVID-19 antigen tests 48 hours apart before ruling out a possible infection. Justin Paget/Getty Images hide caption
The FDA recommends to take at least two COVID-19 antigen tests 48 hours apart before ruling out a possible infection.
We regularly answer frequently asked questions about life during the coronavirus crisis. If you have a question you'd like us to consider for a future post, email us at goatsandsoda@npr.org with the subject line: "Weekly Coronavirus Questions." See an archive of our FAQs here.
Ah, the start of a new school year. Maybe you're one of millions of Americans who have started mingling with peers in the dorms and suddenly find yourself sniffling and wondering if you have COVID-19.
Or you're just getting back from your summer vacation and the back of your throat has a worrisome itch.
You consider taking an at-home rapid test, but you have lots of questions. With new FDA recommendations on testing, how many times should you test for a definitive result? And, how infectious are you if the positive line is faint? And what if the test turns positive but only after an hour?
We posed your questions to the experts: Dr. Abraar Karan, infectious disease researcher at Stanford; Meriem Bekliz, virologist at the University of Geneva; and Dr. Preeti Malani, professor of medicine at the University of Michigan. Here's the scoop:
So I caught COVID-19 and after 10 days I'm still testing positive. But the line on my rapid test is really faint now compared to a week ago. What's the deal? Exactly how contagious am I?
"The faintness or darkness of the line probably has some correlation to degree of infectiousness especially early on [during the infection]," says Karan.
So if the line is faint, that could mean your risk of accidentally passing the virus on to others is low.
"Some people may not be infectious because the tests could be picking up viral debris from a waning infection," says Bekliz.
But don't rip off your mask just yet: There could be other reasons for a faint line.
There is "some room for error" with those rapid tests, Karan says. You're sticking a cotton swab up your nose and hoping to snare some virus. A faint line could mean you've collected less virus this time around. Maybe you swabbed for less time or in only one nostril when your test instructions say to swab both.
"In general, a darker line is a result of more virus [on the swab]," says Malani. "But antigen tests are not especially sensitive, so even with a negative test, you can be contagious."
So the bottom line, say our experts: If you're testing positive even with a faint line you should behave as if you are contagious.
If there's any hint of a positive line, Bekliz recommends you continue to wear a mask, work from home if possible and generally limit contact with other people.
Last week I tested positive for COVID-19 and went through the recommended 5 days of isolation and additional 5 days of masking. How many times do I need to test negative before it's OK to assume I'm virus-free?
Figuring out when it's OK to ease up on your safety measures after catching COVID-19 can be tricky.
If you suspect that you may have COVID but haven't tested positive yet, the FDA now recommends serial testing, which means you should repeat your home test after 48 hours to make sure you aren't accidentally getting a false negative test.
And what should you do if you already tested positive and want to know when you're finally negative?
"The recommendations for serial testing are for people that have been exposed and are trying to diagnose themselves," says Karan. "They're saying to repeat the test after a day or two, but not if your first test is already positive and you're testing to become negative."
Once you have tested positive and your body starts clearing the virus, a negative rapid test should be a pretty good indication you're no longer infectious, so long as you follow the test protocols correctly and wait an appropriate amount of time before testing.
"If it's been like five days [since the onset of symptoms], and the test is negative, then I would feel good about that," says Karan. "If the test is negative one or two days after symptoms start, then I would maybe think you didn't get a good sample and should test again."
While that's reassuring, there wasn't agreement among our experts about exactly what to do. While Karan says one negative test after an appropriate amount of time is good enough, Malani says you should take two just to be sure.
"Usually you want a couple negative tests," says Malani. "If you have two negative antigen tests, that's really helpful."
So that first negative test is likely a good sign, but taking an additional test 24 hours later is a great way to confirm the result and rule out errors in testing.
I was feeling a bit off and took a COVID-19 test. After 15 minutes it looked like the test was negative. But when I came back to check the test an hour later a positive line had appeared! Then I retested three times and they all came back negative. Does this mean I could have COVID-19?
This is a pretty unusual circumstance, our experts say, but one that could potentially indicate bad news.
"The tests aren't really meant to be read an hour later," says Malani. "But it would be a little bit concerning for someone who has symptoms and has their test turn positive later."
Each test kit has its own recommended timeframe for reading the test. BinaxNOW and iHealth kits say you should read the test after 15 minutes, but not after 30 minutes. INDICAID test kits say you should read the test after 20 minutes, but not after 25 minutes. Reading the test after the recommended time frame could lead to a false positive.
However, Karan agrees that "it would be less likely to be a false positive if someone's having symptoms and we're at a time when there's a high amount of virus being spread."
Following the FDA recommendation to test at least twice and waiting 48 hours between tests can help determine your true COVID-19 status as well.
"My advice would be to probably stay put and not expose anyone, and then perhaps repeat the test," Malani says. "Now, if you're feeling great the next day and your test is negative, maybe it was nothing."
Or simply "assume you're positive if you have symptoms," Karan says. "Try to get a PCR test and retest again [at home] in the next few days. If the PCR test is negative, you're probably OK."
No matter the circumstances, if you're worried that you could have COVID-19, our experts think your best bet is to repeat your at-home test over a couple of days. So if you want to ace COVID Testing 101 this school year, just remember that two negative tests are better than one.
The federal government is set to suspend its offer of free at-home COVID-19 tests by Friday, Sept. 2, without congressional authorization for an extension.
The U.S. Postal Services page for ordering the tests states that orders will pause by next Friday or sooner if supplies run out.
Ordering through this program will be suspended on Friday, September 2 because Congress hasnt provided additional funding to replenish the nations stockpile of tests, a message on the federal governments COVID-19 website reads.
The Biden administration originally announced that it would offer 1 billion free at-home COVID-19 tests in January. The federal government used COVID-19 funding from the American Rescue Plan, President Bidens $1.9 trillion economic stimulus and COVID-19 recovery package that he signed into law last year.
Biden has since offered additional rounds of tests for Americans to order, most recently in May. Households could order an additional eight tests in the most recent round.
The seven-day rolling average of COVID-19 cases has declined slightly in recent weeks following an increase fueled by the highly contagious BA.5 omicron subvariant. But a senior administration official told USA Today that the government needs to hold on to tests for a possible rise in the fall.
The official said that the administration will use its existing limited resources to obtain as many tests as it can, but distribution could resume on a large scale if Congress provides the funding for it.
U.S. Army Spc. Eyza Carrasco, left, with 2nd Cavalry Regiment, administers a COVID-19 vaccination at the 7th Army Training Command's (7ATC) Rose Barracks, Vilseck, Germany, May 3, 2021. The U.S. Army Health Clinics at Grafenwoehr and Vilseck conducted a "One Community" COVID-19 vaccine drive May 3-7 to provide thousands of appointments to the 7ATC community of Soldiers, spouses, Department of the Army civilians, veterans and local nationals employed by the U.S. Army. (Photo Credit: U.S. Army photo by Markus Rauchenberger) VIEW ORIGINAL
WASHINGTON A new COVID-19 vaccine will be available to Soldiers as an alternative to the Pfizer-BioNTech, Moderna and Johnson & Johnsons Janssen vaccines, the Army recently announced.
With the availability of the NOVAVAX vaccine, we are pleased to have another tool to help combat the spread of COVID-19, said Lt. Gen. R. Scott Dingle, Army Surgeon General and commanding general of U.S. Army Medical Command.
The U.S. Food and Drug Administration issued an emergency use authorization July 13, 2022 for the Novavax COVID-19 Vaccine, for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.
The Novavax vaccine is something called a recombinant protein vaccine. These types of vaccines have been used since the 1980s. Other recombinant protein vaccines include the vaccines for shingles, hepatitis B, and human papillomavirus, Dingle said.
Novavax provides an option for Soldiers who are not fully vaccinated and uses a different technology from the mRNA and viral vector vaccine options. Dr. Steven Cersovsky, Deputy Director of the Army Public Health Center, said Novavax performs like a traditional vaccine.
In a more traditional vaccine, like Novavax, the injection gives your body a part of the virus: in this case, its giving you one protein, the spike protein, Cersovsky said. And it allows your body to generate an immune response to that protein.
Novavax, a two-dose vaccine that does not have a recommended booster, has been widely used in Europe since early 2022 and has been shown to be as effective as other vaccines at preventing severe disease, hospitalization and deaths from the coronavirus infection, Cersovsky said.
Soldiers who voluntarily choose to get Novavax will be considered in compliance with the DOD COVID-19 vaccine mandate.
This vaccine, as one component of all recommended vaccines, supports the Armys goals of sustaining a proficient and ready medical force and healthy Soldiers for Life, Army civilians, and families, Dingle said.
Soldiers have the option and can consult [with] their healthcare providers on the medical aspects, and they have the option to consult [with] their chaplains on the religious aspect, said Lt. Col. William Martin, chaplain and religious accommodations and moral ethics officer at the Armys Office of the Chief of Chaplains. This is a religious matter affecting a medical reality; its really a team advisement here in order to give that Soldier the best information so that, in accordance with their sincerely held religious beliefs, they can make the best decision.
Commanders and medical professionals are being provided with information regarding Novavax; if Soldiers are interested in more information to see if Novavax is right for them, they can contact their commanders, chaplains or medical professionals.
Our number-one priority is protecting the health and welfare of our greatest assets our Soldiers, our family members and Army civilians, Dingle said. We will continue to ensure that our personnel have the most accurate information on protective measures they can take to reduce the spread of COVID-19.
DOWNLOAD [PDF]: COVID-19 Vaccination Options
Programming note: We wont be publishing Prescription Pulse from Monday, Aug. 29, to Monday, Sept. 5. Well be back in your inboxes on Wednesday, Sept. 7.
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FDA Commissioner Robert Califf wants the health care system to generate more clinical evidence.
A new report from House Democrats on the Select Subcommittee on the Coronavirus Crisis reveals just how much the Trump Administration pressured the FDA over Covid product authorizations.
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Next week, CDC advisers will meet to decide whether to recommend Covid-19 boosters designed to help prevent infections from currently circulating strains. | Spencer Platt/Getty Images
CDC PANEL TO MEET ON OMICRON BOOSTERS The CDCs independent vaccine advisers will meet Thursday and Friday next week to discuss recommending updated Covid-19 boosters to cover the BA.4 and BA.5 Omicron strains that have dominated U.S. infections this summer. The meeting comes after Pfizer and, as of Wednesday, Moderna have applied to the FDA for emergency use authorization for their Omicron-specific products.
That puts the timeline for an FDA decision sometime next week. But the agency wont convene its own independent advisory committee on vaccines, arguing that the panels June 28 discussion covered enough ground for regulators to make their own call.
FDA has no new questions that warrant committee input, Commissioner Robert Califf tweeted Thursday in an extensive thread about the agencys posture as it reviews both companies applications. When available, new boosters are expected to help provide greater protection against the currently circulating strains, he added.
Outside angst: Some medical experts have urged regulators to hold off on green-lighting the shots until the manufacturers have human clinical data on their efficacy. Pfizers and Modernas applications are underpinned partly by early data on their boosters effects in mice since the FDAs request that they focus on the BA.4 and BA.5 strains instead of the first Omicron variant didnt come until the end of June.
Paul Offit, a Childrens Hospital of Philadelphia infectious disease expert on the FDA expert panel, told Lauren he was unpleasantly surprised that the committee wont meet to publicly assess the data for what he considers a new product.
If you hold this vaccine up as being some sort of magic bullet, then people are going to be disappointed when they get mild illness, Offit said.
The administrations take: Ashish Jha, the White House Covid-19 response coordinator, has bullishly promoted the prospect of the reformulated boosters, saying that all the data suggests [they] should be highly effective against the new variants.
The big-picture bottom line is, these are substantial upgrades in our vaccines in terms of their ability to prevent infection, to prevent transmission, certainly to prevent serious illness and death, Jha said of the bivalent boosters during a U.S. Chamber of Commerce event on Aug. 16.
Offit questioned the administrations stance urging a broad fall vaccination campaign to decrease the amount of circulating virus as opposed to tailoring recommendations to those most at risk for severe disease given the mRNA vaccines track record of neutralizing antibodies tapering off after three to six months. I think it is like a leaky sieve, Offit said.
HHS HOLDING COMMERCIALIZATION TRANSITION PLANNING MEETING The federal health department is convening pharmacies, providers, government agencies, consumer groups and industry on Aug. 30 for a virtual meeting to plan the potential transition of Covid-19 vaccines and therapies to the commercial marketplace. Leadership from the CDC, CMS, FDA, NIH, the Health Resources and Services Administration and the Administration for Strategic Preparedness and Response will attend the meeting.
Two breakout sessions will be held: One will focus on commercialization plans for Covid-19 vaccines, while the second will center on therapeutics. Discussion topics include reimbursement and coverage, regulatory issues, and how to make products available to under- and uninsured people, according to an event invite obtained by POLITICO.
Given this process will take months and close coordination with stakeholders across the health care continuum, HHS is engaging closely with these stakeholders to plan and ensure that the transition happens smoothly when the time does come, an HHS spokesperson said.
FDA Commissioner Robert Califf would like to see an increase in useful, reliable clinical evidence. | Andrew Harnik/AP Photo
CALIFF: WE NEED TO GENERATE MORE EVIDENCE Academics, health systems and professional societies should prioritize generating more clinical evidence to help the FDA more rapidly understand the risk-benefit profile of medical products, according to FDA Commissioner Robert Califf.
When the FDAs decisions generate controversy, it is often when the system fails to produce reliable evidence that clarifies an interventions risks and benefits during a relevant time frame, Califf wrote in JAMA earlier this week. The gap between FDA clearance or approval of a medical product (particularly when the accelerated approval pathway is used) and use of the product to treat patients should be filled by an invigorated clinical research system that generates evidence that patients, clinicians and health systems need to make well-informed decisions.
CONGRESSIONAL REPORT SHOWS TRUMP WHITE HOUSE PRESSURED FDA ON COVID THERAPEUTICS Democrats on the House Select Subcommittee on the Coronavirus Crisis published a report on Wednesday, detailing how senior Trump officials pressured the FDA around coronavirus authorizations, Katherine reports.
The findings of the report werent much of a surprise, but it offers new color through emails, texts and official testimony from former FDA Commissioner Stephen Hahn about how persistent some of those efforts inside the White House were throughout the summer and fall of 2020.
On hydroxychloroquine: After the FDA revoked authorization for hydroxychloroquine after data emerged showing its inefficacy and potential harm to Covid patients, Trumps trade adviser Peter Navarro and coronavirus response volunteer Steven Hatfill pushed the FDA to reauthorize the drug. Hatfill characterized the disagreement between White House officials and the FDA as a forthcoming knife fight.
On Fauci: According to the report, Hatfill pushed for Anthony Faucis removal throughout the fall after the director of the National Institute of Allergy and Infectious Diseases dismissed the White Houses push for hydroxychloroquine. In September 2020, Hatfill told Navarro, You really need to consider what is likely to happen over the next 2 months if this little idiot and his Covid treatment panel is not fired.
On vaccines: Hahn testified to the subcommittee that the White House wasnt happy with the FDAs requirement that late-stage Covid-19 vaccine trials included a 60-day safety follow-up which would delay their authorization until after the 2020 election.
And on Navarros emails: This report offers more evidence that Navarro used his personal email for presidential matters. The Department of Justice has sued Navarro to get him to turn over other such emails, first revealed by a separate report from the subcommittee, sent from his personal email account.
WASHINGTON AWAITS BIDEN OIRA NOMINEE With the midterm elections approaching, close watchers of the regulatory apparatus are waiting for Biden to nominate someone to lead the small but powerful Office of Information and Regulatory Affairs, POLITICOs Adam Cancryn reports.
The office, charged with reviewing regulations, could play an outsized role in the final two years of Bidens term as the government implements major elements of Democrats just-passed climate, health and tax law.
OIRA is always at the center of administrative activity the joke is its the most powerful agency nobodys ever heard of, said Sharon Block, who served as its acting chief through Bidens first year. Now, it becomes even more important.
The FDA on Tuesday published final guidance for tobacco manufacturers designing and conducting tobacco product perception and intention studies.
The FDA on Thursday published its annual report on the state of pharmaceutical quality.
The HHS Office of Inspector General posted a memo summarizing its findings that, in the first quarter of 2022, eight drug codes met CMS price-substitution criteria and had an average sales price that exceeded the average manufacturer price by 5 percent or more.
CMS on Thursday finalized its plan to indefinitely delay its radiation oncology payment model.
