Child winter respiratory illness on rise in summer

Parents are being warned to look out for the signs of a common childhood respiratory illness, RSV, cases of which unusually appear to be rising rapidly in the summer.

RSV is a very common winter virus – but social distancing and lockdowns kept it at bay earlier this year.

And this means young children have not been exposed and developed immunity.

Public Health England said it would just cause mild illness for most but some under-twos were at higher risk.

These can include infants born prematurely or with a heart condition.

And they can be at risk of more serious complications, including breathing difficulties caused by bronchiolitis.

PHE said parents should contact their GP or call NHS 111 if their child:

  • has taken less than half their usual amount during the past two or three feeds
  • has had a dry nappy for 12 hours or more
  • has a persistent temperature of 37.8C or above
  • seems very tired or irritable

They should dial 999 for an ambulance if:

  • the child is having difficult breathing
  • the child’s tongue or lips are blue
  • there are long pauses in the child’s breathing

PHE medical director Dr Yvonne Doyle said: “This winter, we expect levels of common seasonal illnesses such as cold and flu to increase, as people mix more and given that fewer people will have built up natural immunity during the pandemic.BBC.


Coronavirus: Italy brings in Covid certificate amid spike in infections

Italy is introducing a mandatory Covid vaccination certificate from 6 August, the latest country in Europe to announce such a scheme.

The move will allow those aged 12 and over who have received at least one jab to access a range of venues, including indoor restaurants, cinemas and gyms.

However, after disagreements within the governing coalition, the pass will not be needed for transport.

The virus is surging again in Italy, driven by the delta variant.

The number of new cases doubled over the past week, with more than 5,000 infections reported on Thursday.

About half of Italians are now fully vaccinated – but the summer holiday season is dissuading some to turn up for their appointments, says the BBC’s Mark Lowen, in Rome.


Covid vaccine: Eight-week gap seen as sweet spot for Pfizer jab antibodies

A longer gap between first and second doses of the Pfizer-BioNTech Covid vaccine makes the body’s immune system produce more infection-fighting antibodies, UK researchers have found.

Experts say the findings support the UK’s decision on extending dosing intervals from the initial recommendation of three weeks.

An eight-week gap seems to be the sweet spot for tackling the Delta variant.

The UK initially extended the dosing gap to 12 weeks at the end of 2020.

But as the vaccination programme has been rolled out through the age groups – everyone over 18 has now been offered at least their first jab – people have been encouraged to bring their second jab forward and get it after eight weeks.

The government-funded work is published in a pre-print paper not yet peer reviewed.

For the study, the researchers compared the immune responses of 503 NHS staff who received their two shots at different intervals in late 2020 and early 2021, when the Alpha Covid variant, first identified in Kent, was rapidly spreading.

Antibody levels in their blood were measured a month after the second vaccine dose.

The findings suggest:

  • both short and long dosing intervals of the Pfizer vaccine generated strong immune responses overall
  • a three-week schedule generated fewer of the neutralising antibodies that can bind the virus and stop it infecting cells than a 10-week interval
  • while antibody levels dipped after the first dose, levels of T-cells – a different type of immune cell – remained high
  • the longer schedule led to fewer T-cells overall but a higher proportion of a specific type or subset, called helper T-cells, which according to the researchers, supports immune memory

Prof Susanna Dunachie, the joint chief investigator in the Pitch study, at Oxford University, said two doses were better than one but the timing of the second was somewhat flexible depending on the circumstances.

For the UK’s current situation, she said: “Eight weeks is about the sweet spot for me, because people do want to get the two vaccine [doses] and there is a lot of Delta out there right now.

“Unfortunately, I can’t see this virus disappearing, so you want to balance that against getting the best protection that you can.”

Dr Rebecca Payne, one of the study authors, from Newcastle University, said: “Our study provides reassuring evidence that both dosing schedules generate robust immune responses against Sars-CoV-2 after two doses.

“We now need to carry out more follow-up studies to understand the full clinical significance of our findings.”

Real-world data from Public Health England shows the Pfizer vaccine is effective at reducing levels of serious disease, hospital admissions and death, even after one dose


Medics fear surge in winter viruses alongside Covid

A surge in flu and other respiratory viruses could put pressure on people’s health and the NHS this winter, warns a report by leading medics.

They say testing for flu, Covid and a respiratory virus common in children and the elderly – called RSV – may help doctors treat cases more quickly.

The Academy of Medical Sciences report calls for people with any symptoms to isolate and stay at home.

This will help protect against all respiratory viruses this winter.

The report, by 29 leading experts and requested by the government, says there is great uncertainty about what the next few months will hold across the UK, but it urges policymakers to prepare for a challenging winter.

Comeback of winter viruses

During lockdown last winter, the UK population was hardly exposed to the viruses which normally circulate. But they are now set to make a comeback as restrictions lift and society opens up.

Already this summer, there has been a rise in winter viruses in children coming to A&E.

Report author Prof Azra Ghani, from Imperial College London, says their modelling suggests a summer peak of Covid-19 infections “with subsequent local outbreaks over winter”.

But “we can’t completely rule out another winter wave”, she said.

“Whilst we expect the peak in deaths to be considerably lower than last winter, under some scenarios we could see hospital admissions rise to similar levels.”

In a worst-case scenario this could mean around twice the levels of flu and respiratory syncytial virus (RSV) as a normal autumn and winter, the report says.

There are between 10,000 and 30,000 deaths from flu in a normal winter, and about 20,000 children under five are admitted to hospital each year with RSV, which can cause a lung infection called bronchiolitis.

Triple tests

The authors say these viruses often produce similar symptoms, so testing for all three at once would help distinguish between them.

This could be done through Test and Trace or in GP practices, but the turnaround would need to be very fast so that anti-virals could be used to treat flu in the most vulnerable.

Dr Alexander Edwards, from the University of Reading, said the “triple tests” had “great appeal”, but the logistics could be a challenge.

“Whether there will be enough instruments and testing capacity available for this to be available widely in primary care remains to be seen,” he said.

The report also recommends booster Covid vaccines alongside flu vaccines this autumn to reduce the spread of the virus, which is already being planned by the NHS for the over-50s, and improving infection control in hospitals. BBC


What the new CDC guidance for schools means for children

(CNN)Five full days a week, every week: After more than a year of remote learning, hybrid schedules and missed experiences, getting back to school — “normal” school — is all many parents and students want. But with Covid-19 surging again in some US states and concerns over new virus variants growing, what classrooms will look like exactly in the fall is still evolving.The US Centers for Disease Control and Prevention issued new guidance last week on the importance of having all schools opened for in-person, full-time instruction in the fall. To safely keep schools open, the CDC recommended what it calls “a layered mitigation strategy.” This is a systematic strategy involving multiple interventions to reduce risk, such as including the use of indoor masks for unvaccinated students and teachers.

What happens if schools reopen but don’t enforce these procedures? For example, what should parents do if schools don’t require masks? Should vaccinated children over 12 feel comfortable removing their masks in schools? And when might vaccines be available for younger children?


What are hiccups?

Hiccups are repetitive, uncontrollable contractions of the diaphragm muscle. Your diaphragm is the muscle just below your lungs. It marks the boundary between your chest and abdomen.

The diaphragm regulates breathing. When your diaphragm contracts, your lungs take in oxygen. When your diaphragm relaxes, your lungs release carbon dioxide.

The diaphragm contracting out of rhythm causes hiccups. Each spasm of the diaphragm makes the larynx and vocal cords close suddenly. This results in a sudden rush of air into the lungs. Your body reacts with a gasp or chirp, creating the sound characteristic of hiccups.

Onset of hiccups

There’s no way to anticipate hiccups. With each spasm, there’s usually a slight tightening of the chest or throat prior to making the distinctive hiccup sound.

Most cases of hiccups start and end abruptly, for no discernable reason. Episodes generally last only a few minutes.

Hiccups that last longer than 48 hours are considered persistent. Hiccups that last longer than two months are considered intractable, or difficult to manage.c

Causes

Numerous causes of hiccups have been identified. However, there’s no definitive list of triggers. Hiccups often come and go for no apparent reason.

Possible common causes of short-term hiccups include:

  • overeating
  • eating spicy food
  • consuming alcohol
  • drinking carbonated beverages, such as sodas
  • consuming very hot or very cold foods
  • a sudden change in air temperature
  • swallowing air while chewing gum
  • excitement or emotional stress
  • aerophagia (swallowing too much air)

Hiccups that last longer than 48 hours are categorized by the type of irritant that caused the episode.

The majority of persistent hiccups are caused by injury or irritation to either the vagus or phrenic nerve. The vagus and phrenic nerves control the movement of your diaphragm. These nerves may be affected by:

  • irritation of your eardrum, which may be caused by a foreign object
  • throat irritation or soreness
  • a goiter (enlargement of the thyroid gland)
  • gastroesophageal reflux (stomach acid backing up into the esophagus, the tube that moves food from the mouth to the stomach)
  • an esophageal tumor or cyst

Other causes of hiccups may involve the central nervous system (CNS). The CNS consists of the brain and spinal cord. If the CNS is damaged, your body may lose the ability to control hiccups.

CNS damage that may lead to persistent hiccups includes:

Hiccups that last for longer periods can also be caused by:

Sometimes, a medical procedure can accidentally cause you to develop long-term hiccups. These procedures are used to treat or diagnose other conditions and include:

  • use of catheters to access the heart muscle
  • placement of an esophageal stent to prop open the esophagus
  • bronchoscopy (when an instrument is used to look inside your lungs)
  • tracheostomy (creation of a surgical opening in the neck to allow breathing around an airway obstruction)

Risk factors for hiccups

Hiccups can occur at any age. They can even occur while a fetus is still in the mother’s womb. However, there are several factors that can increase your likelihood of developing hiccups.

You may be more susceptible if you:

  • are male
  • experience intense mental or emotional responses, ranging from anxiety to excitement
  • have received general anesthesia (you were put to sleep during surgery)
  • had surgery, especially abdominal surgery

Everything You Need to Know About Hiccups

What are hiccups?

Hiccups are repetitive, uncontrollable contractions of the diaphragm muscle. Your diaphragm is the muscle just below your lungs. It marks the boundary between your chest and abdomen.

The diaphragm regulates breathing. When your diaphragm contracts, your lungs take in oxygen. When your diaphragm relaxes, your lungs release carbon dioxide.

The diaphragm contracting out of rhythm causes hiccups. Each spasm of the diaphragm makes the larynx and vocal cords close suddenly. This results in a sudden rush of air into the lungs. Your body reacts with a gasp or chirp, creating the sound characteristic of hiccups.

Singultus is the medical term for hiccups.null

Onset of hiccups

There’s no way to anticipate hiccups. With each spasm, there’s usually a slight tightening of the chest or throat prior to making the distinctive hiccup sound.

Most cases of hiccups start and end abruptly, for no discernable reason. Episodes generally last only a few minutes.

Hiccups that last longer than 48 hours are considered persistent. Hiccups that last longer than two months are considered intractable, or difficult to manage.

Causes of hiccups

Numerous causes of hiccups have been identified. However, there’s no definitive list of triggers. Hiccups often come and go for no apparent reason.

Possible common causes of short-term hiccups include:

  • overeating
  • eating spicy food
  • consuming alcohol
  • drinking carbonated beverages, such as sodas
  • consuming very hot or very cold foods
  • a sudden change in air temperature
  • swallowing air while chewing gum
  • excitement or emotional stress
  • aerophagia (swallowing too much air)

Hiccups that last longer than 48 hours are categorized by the type of irritant that caused the episode.

The majority of persistent hiccups are caused by injury or irritation to either the vagus or phrenic nerve. The vagus and phrenic nerves control the movement of your diaphragm. These nerves may be affected by:

Other causes of hiccups may involve the central nervous system (CNS). The CNS consists of the brain and spinal cord. If the CNS is damaged, your body may lose the ability to control hiccups.

CNS damage that may lead to persistent hiccups includes:

Hiccups that last for longer periods can also be caused by:

Sometimes, a medical procedure can accidentally cause you to develop long-term hiccups. These procedures are used to treat or diagnose other conditions and include:

  • use of catheters to access the heart muscle
  • placement of an esophageal stent to prop open the esophagus
  • bronchoscopy (when an instrument is used to look inside your lungs)
  • tracheostomy (creation of a surgical opening in the neck to allow breathing around an airway obstruction)

Risk factors for hiccups

Hiccups can occur at any age. They can even occur while a fetus is still in the mother’s womb. However, there are several factors that can increase your likelihood of developing hiccups.

You may be more susceptible if you:

  • are male
  • experience intense mental or emotional responses, ranging from anxiety to excitement
  • have received general anesthesia (you were put to sleep during surgery)
  • had surgery, especially abdominal surgery

Treating hiccups

Most hiccups aren’t an emergency, or anything to worry about. However, a prolonged episode can be uncomfortable and disruptive to daily life.

Contact a doctor if you have hiccups that last longer than two days. They can determine the severity of your hiccups in relation to your overall health and other conditions.

There are numerous options for treating hiccups. Typically, a short-term case of hiccups will take care of itself. However, the discomfort may make waiting out hiccups unbearable if they last longer than a few minutes.

Although none of these have been proven to stop hiccups, the following potential treatments for hiccups can be tried at home:

  • Breathe into a paper bag.
  • Eat a teaspoon of granulated sugar.
  • Hold your breath.
  • Drink a glass of cold water.
  • Pull on your tongue.
  • Lift your uvula with a spoon. Your uvula is the fleshy piece of tissue that’s suspended above the back of your throat.
  • Attempt to purposefully gasp or belch.
  • Bring your knees to your chest and maintain this position.
  • Try the Valsalva maneuver by shutting your mouth and nose and exhaling forcibly.
  • Relax and breathe in a slow, controlled manner.

The following tests may be useful in determining the cause of persistent or intractable hiccups:

  • blood tests to identify signs of infection, diabetes, or kidney disease
  • liver function tests
  • imaging of the diaphragm with a chest X-ray, CT scan, or MRI
  • an echocardiogram to assess heart function
  • an endoscopy, which utilizes a thin, lighted tube with a camera on the end to investigate your esophagus, windpipe, stomach, and intestine
  • a bronchoscopy, which utilizes a thin, lighted tube with a camera on the end to examine your lungs and airways

Treating any underlying causes of your hiccups will usually make them go away. If persistent hiccups have no obvious cause, there are several anti-hiccup medications that may be prescribed. The more commonly used drugs include:

There are also more invasive options, which can be used to end extreme cases of hiccups. They include:

  • nasogastric intubation (insertion of a tube through your nose into your stomach)
  • an anesthetic injection to block your phrenic nerve
  • surgical implantation of a diaphragmatic pacemaker, a battery-powered device that stimulates your diaphragm and regulates breathing

Possible complications of untreated hiccups

A long-term episode of hiccups can be uncomfortable and even harmful to your health. If left untreated, prolonged hiccups can disturb your sleeping and eating patterns, leading to:

How to prevent hiccups

There’s no proven method for preventing hiccups. However, if you experience hiccups frequently, you can try to reduce your exposure to known triggers.

The following may help reduce your susceptibility to hiccups:

  • Don’t overeat.
  • Avoid carbonated beverages.
  • Protect yourself from sudden temperature changes.
  • Don’t drink alcohol.
  • Remain calm, and try to avoid intense emotional or physical reactions.

What is Piles?

Piles refer to a physiological condition whereby there is an inflammation of the vascular structures guarding the anal canal. Owing to the inflammation of the hemorrhoids or blood vessels guarding the anal passage; the pathogenic condition of piles develops.

Causes of Piles

  • A number of factors are responsible for the development of piles.
  • Irregularity in bowel movement with susceptibility towards constipation and diarrhea is one of the causes.
  • Constipation aids the condition of piles by giving way to prolonged straining.
  • Absence of fiber, imbalanced diet with insistence on junk food contributes towards piles.
  • Hereditary factors may also be responsible for the pathogenic condition of piles.
  • Pregnancy may well give rise to the condition of piles with the developing fetus exerting pressure on the vascular structures.
  • Obese people and those prone to long hours of sitting are also more likely to develop piles.
  • An obstruction or abnormal growth on the way to the anal canal can also lead to piles.
  • Other factors contributing to the pathological condition of piles include age and vascular structure guarding the anal passage lacking in valves.

Types of Piles

  • Piles can be broadly classified into two broad kinds on the basis of their locations.
  • The ones located internally.
  • The ones located externally.

Symptoms of Piles

  • Piles which tend to affect elderly people, often turns out to be a major source of irritation.
  • The one located externally are more painful than the internal ones.
  • The external ones exist as painful inflammation or swelling.
  • Internally located piles can be a source of extreme irritation when they tend to hang out through the anal passage.
  • The ones located internally are susceptible to take on a necrotic form, whereby they develop into clots of blood. Necrotic ones are however quite painful.
  • One of the most common clinical features of piles includes passage of blood along with stool.
  • Along with bleeding itching and irritation may also persist.

Diagnoses of Piles

  • The piles which exist in prolapsed form can be usually diagnosed by means of an external examination of areas surrounding the anal cavity.
  • Proctoscpy usually serves to highlight the presence of internal piles.
  • By means of proctoscopy the presence of tumors or polyps and that of an inflamed prostate are also detected as the detection is valuable in determining the line of treatment.
  • Proctoscopy or anoscopy is usually performed with patients being subject to sedation.

Treatment for Piles

  • The course of treatment which follows the findings of rectal examination includes the administration of anti inflammatory drugs of non steroidal nature.
  • Traditional line of treatment is geared to the increased consumption of dietary fibers.
  • If constipation happens to be the underlying cause, insistence is given on the inclusion of green and yellow vegetables apart from being well hydrated by increasing the fluid intake.
  • Certain topical formula and suppositories are also available as treatment options; but long drawn usage of the same should be discouraged on account of their tendency to cause localized irritations.
  • Generally surgical removal of the inflamed vessels is resorted to as the last possible alternative.
  • Means based on cauterization and cryosurgery has also been found to be quite effective.
  • Ligation with the help of rubber band is also resorted to so that the blood supply to the inflamed tissues can be cut off.
  • Decartelization using an ultra sound Doppler has also been used so as to rectify the prolapsed structure of piles.
  • Resectioning of the inflamed tissue which involves partial surgical interference is also made use of so that one can avoid the intensely painstaking procedure of total removal.

Self care and Natural Remedies for Piles

  • Person suffering from piles should take all necessary steps so as to have his system well toned up.
  • Apart from overcoming the draw backs of a sedentary life style by means of exercising and resorting to a few yogic postures, he should ensure for himself a regulated life style consisting of balanced diet, normal sleep and regularized bowel habits.
  • Sufficient helpings of fruits, yellow and green vegetables will help to overcome the conditions of constipation- a condition which aids the existence of piles.
  • Besides these a number of natural options, which particularly serve to overcome the painful conditions of piles are also available.
  • One such herbal option includes the use of dry figs and that of chebulic myroblan. There are others making use of a wide variety of natural stuffs including mango seeds, grated radish and turnip.
  • As part of the naturopathic option, diet centering merely on fruits is also recommendable. The fruit centric diet serves significantly in overcoming the malady of constipation besides giving rest to the digestive system.
  • Regular consumption of unsweetened curd , avoiding spicy food items and those of synthetically flavored drinks also rank amongst some of the healthy options so that the menace of piles can be avoided.


Scientists find new human coronavirus that originated in dogs

Coronavaris found in dogs.

Scientists have reportedly discovered a new kind of coronavirus that is believed to have originated in dogs – in what may be the eighth unique form of the bug known to cause disease in humans.

Researchers in a study published in the Clinical Infectious Diseases journal said their findings from patients hospitalized with pneumonia in 2017-2018 underscored the public health threat of animal coronaviruses, Reuters reported.

They said they had tested nasal swab samples taken from 301 pneumonia patients at a hospital in the east Malaysian state of Sarawak.

Eight of the samples — mostly from kids under the age of 5 — tested positive for a canine coronavirus, according the report.

Additional genomic sequencing found that the new strain — CCoV-HuPn-2018 — shared characteristics of other viruses known to have infected cats and pigs but was mostly similar to one that is known to have infected dogs.

It also carried a genetic mutation not found in any known canine coronaviruses but was present in human strains such as SARS-COV and SARS-COV-2, the deadly bug behind the COVID-19 pandemic.

The source of the SARS-COV-2 coronavirus itself remains unclear, Reuters reported.

The scientists said the findings indicated that the virus likely recently jumped from animals to humans, but stressed that additional studies are necessary to determine whether it can be transmitted between humans.

The authors also said it was unclear whether the virus could make people sick, adding that it was possible it was merely “carried” in the patient’s airways without causing illness.

Seven coronaviruses are known to cause illness in humans: four that cause the common cold, and three that cause the diseases commonly known as SARS, MERS and COVID-19.


Who is at risk for developing blood clots?

Blood clots can affect people of all ages, according to the Centers for Disease Control and Prevention (CDC), and several factors can increase risks including hospital stay or surgery, obesity, hormonal birth control and injury.

The CDC estimates venous thromboembolism (VTE), or clotting in the veins, affects some 900,000 Americans annually, and 100,000 succumb to blood clots each year. VTE includes other forms like deep vein thrombosis (clotting usually in the legs or arms) and pulmonary embolism, a potentially fatal blockage in the lungs.

Another severe, rare type of clotting prompted federal health officials to recommend a pause in Johnson & Johnson COVID-19 vaccinations. On Tuesday, officials with the Food and Drug Administration said six instances of cerebral venous sinus thrombosis (CVST) in combination with low platelets was reported among over 6.8 million vaccine recipients. 

According to Johns Hopkins Medicine, CVST is a “rare form of stroke” said to affect five in 1 million people each year. It “occurs when a blood clot forms in the brain’s venous sinuses. This prevents blood from draining out of the brain. As a result, blood cells may break and leak blood into the brain tissues, forming a hemorrhage.”

All six cases involved women between the ages of 18 and 48, and symptoms occurred between six and 13 days post-vaccination. FDA officials said one case was fatal, and another patient is in critical condition. The pause will now give experts time to review available data and inform health care providers how to properly treat CVST with low platelets, which requires an alternative therapy compared to other clotting issues. 

So far, however, FDA and CDC officials said it was too early to single out particular subgroups considered at-risk for developing this type of clot after vaccination. 

Dr. Peter Marks, director at FDA Center for Biologics Evaluation and Research, said a probable cause behind the clotting that occurred among vaccine recipients might include a similar mechanism seen with AstraZeneca’s product, another adenoviral vector vaccine being rolled out in Europe, in which a rare immune response occured post-vaccination, leading to activation of platelets and “extremely rare” blood clots.

A safety committee for Europe’s regulator confirmed last week that the benefits of AstraZeneca’s COVID-19 vaccine continue to outweigh risks of side effects, after a review of rare and unusual blood clotting reports among vaccinated adults. Officials noted the clotting predominantly affects those younger than 60 and women, but could not recommend any specific measures to reduce risk.

“Based on the current available evidence, specific risk factors such as age, gender, or previous medical history of clotting disorders have not been able to be confirmed as the rare events are seen in all ages and in men and women,” said Emer Cooke, executive director of the European Medicines Agency (EMA).

 As of April 4, the EU drug safety database received 169 total cases of CVST and 53 cases of splanchnic vein thrombosis (SVT) amid a backdrop of 34 million vaccinated individuals.

Nevertheless, if an individual was vaccinated with the J&J shot over a month ago, the related risk of blood clotting is very low, FDA officials said. If vaccination occurred in the last couple of weeks, patients could monitor for severe headaches, abdominal pain, leg pain or shortness of breath. If these symptoms occur, individuals should contact their health care provider and seek medical treatment, the FDA said. Of note, these symptoms are different from the flu-like symptoms that can crop up in some people shortly after COVID-19 vaccination, and tend to resolve over several days.

“Right now, these adverse events appear to be extremely rare,” the FDA said on Twitter. “Treatment of this specific type of blood clot is different from the treatment that might typically be administered.”

At this time, there is no clear association between the clotting events and oral contraceptives, or the birth control pill, in the six reported cases, the FDA said. While the cases occurred in women under 50, not all the cases involved predisposing conditions. Dr. Janet Woodcock, acting FDA commissioner, noted it was difficult to form generalizations based on six reported cases, and officials would not speculate over the number of possible additional cases.


FDA authorizes Roche drug for severely ill COVID-19 patients

The Food and Drug Administration granted emergency approval to Roche’s Actemra (tocilizumab) to boost outcomes among hospitalized COVID-19 patients receiving oxygen and steroid medications.

Data from clinical trials among over 5,600 hospitalized patients indicated infusions, in addition to routine care, cut patients’ length of hospital stay and reduced the risk of death and ventilation after 28 days of follow-up.

“Today’s action demonstrates the FDA’s commitment to making new therapies available through every stage of the global COVID-19 pandemic,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research in a statement posted late Thursday. “Although vaccines have been successful in decreasing the number of patients with COVID-19 who require hospitalization, providing additional therapies for those who do become hospitalized is an important step in combating this pandemic.”

The antibody drug doesn’t target the virus but works to alleviate inflammation by blocking the interleukin-6 receptor involved in the immune response. It was authorized to treat certain hospitalized COVID-19 patients aged 2 and up. Actemra is already approved for other inflammatory diseases, like rheumatoid arthritis. 

The FDA has cleared several antibody drugs for COVID-19 but there has been low demand because of the hurdles of delivering them via IV at hospitals or clinics. Health officials have emphasized the need to develop more pill-based drugs for COVID-19.

The agency cited data from four clinical trials; the open-label RECOVERY trial involving some 4,116 patients with severe COVID-19 pneumonia suggested a reduction in risk of death after 28 days with odds of 30.7% in the treatment group compared to 34.9% for patients receiving usual care. The drug also cut the length of hospital stay by at least nine days (19 vs. over 28). Another trial, the double-blinded EMPACTA study, among 389 hospitalized patients with COVID-19 pneumonia revealed 12% of the treatment group needed mechanical ventilation or died after 28 days, compared with 19.3% of patients taking placebo.

“Even with the availability of vaccines and declines in deaths from COVID-19 in various parts of the world, we continue to see new hospitalisations from severe forms of the disease,” Levi Garraway, M.D., Ph.D., Roche’s chief medical officer and head of global product development, said in a statement. “We are pleased that Actemra/RoActemra is now authorised as an option that may help improve outcomes for adults and children hospitalised with COVID-19 in the United States.”