Though the Omicron variant of Covid-19 has been detected in at least 38 countries, nobody has died from it, the World Health Organisation (WHO) said.
However, WHO warned that the highly-infectious Omicron strain will affect the global economic recovery.
“The Omicron variant pushed the total number of Covid-19 infections in Africa above the 3 million level,” WHO said.
“It will take at least a week to identify how the Omicron variant spreads, if it can develop severe symptoms and the treatment efficacy plan in the long term.”
WHO also predicted that more than half of the Covid-19 patients in Europe will be infected with Omicron in the next two to three months.
Expert advisers to the Food and Drug Administration on Tuesday recommended authorization of the first coronavirus pill to prevent high-risk people from developing severe illness in a divided vote that reflects the complicated mix of benefits and risks of a new and easy mode of treatment.
The drug, molnupiravir, was developed by Merck and Ridgeback Biotherapeutics as a five-day regimen to be taken at home within five days of the onset of coronavirus symptoms. The FDA is not bound by the 13 to 10 vote but typically follows its external advisers’ recommendations. The drug could have an immediate impact on the pandemic if authorized – just as the ominous new omicron variant has emerged, jolting the world with the prospect of a longer and more complicated pandemic.
Merck has pledged to manufacture enough medicine to treat 10 million patients by the end of the year, and the United States has preordered enough medicine to treat 3.1 million people. There are other treatments, monoclonal antibodies, that are harder to administer but are more effective, which led experts to debate who should receive the drug. An easy-to-use medicine that could be taken at home would offer an additional tool to reduce the strain on hospitals as a potential winter surge looms.
When given to people at high risk of developing severe illness, molnupiravir cut the risk of death or hospitalization by 30 percent in patients infected with a range of variants including delta, gamma and mu. Molnupiravir has not yet been tested against the omicron variant, but because it works in a different way than vaccines and monoclonal antibodies that train their firepower on the coronavirus spike protein, it is expected to hold up against a wide range of variants.
“As new variants have been becoming available, we have been testing them for the activity of molnupiravir,” said Nicholas Kartsonis, senior vice president of clinical research for infectious diseases and vaccines at Merck. “We expect, based on what we know about the omicron variant, that molnupiravir would be effective against this particular variant.”
But one committee member cautioned that it was an assumption that the drug would be more variant-proof than vaccines or other treatments.
“If we take a look at the omicron variant and see the number of mutations that virus has, I think in many ways we don’t really understand which direction the virus may even be going in terms of changing,” said W. David Hardy, a scientific and medical consultant at Charles Drew University School of Medicine and Science. “To assume this drug . . . is going to work when the monoclonals don’t is a big jump. We have no assurance of that.”
A second oral pill regimen – it was developed by Pfizer – is also being reviewed by the FDA. That drug could offer advantages that will make it the choice of physicians: That medicine was more effective at preventing hospitalization and death and doesn’t carry safety concerns about its use in pregnant patients. The advisory committee debated whether people who are pregnant should be eligible to receive molnupiravir.
Much of the expert committee’s debate Tuesday focused on the many unknowns about those safety issues, which are intertwined with how molnupiravir works. The drug becomes incorporated into the viral genome, causing genetic mistakes that disable the virus.
There are two concerns about potential unintended consequences: first, that molnupiravir could scramble the genome in the patient’s own cells, causing cancer, genetic diseases or birth defects. The company requested authorization for adults, but said that it should not be recommended for people who are pregnant or breastfeeding and said that people of childbearing age should use contraception during the treatment.
But the short duration of treatment and a gold standard laboratory test in rats designed to flag drugs that have the potential for mutagenesis – the process in which genetic change happens – suggested there was not a major risk to adult patients.
The concern that the drug could cause genetic mutations “in a clinical setting appears to be low,” said Robert H. Heflich, director of the Division of Genetic and Molecular Toxicology at the FDA’s National Center for Toxicological Research.
The second concern is that the drug might induce genetic changes to the virus that fuel the rise of new, threatening variants. FDA reviewers showed data demonstrating that in seven people treated with the drug, viral samples taken after treatments contained worrisome mutations seen in known variants, although the patients cleared the virus.
“Even if the probability is very low, 1 in 10,000 or 1 in 100,000, that this drug would induce an escape mutant for which the vaccines we have do not cover, that would be catastrophic for the whole world,” said James E.K. Hildreth, president of Meharry Medical College.
But FDA reviewers said those mutations also emerge naturally.
“It is unclear to us if molnupiravir would have a substantial impact on the evolutionary patterns that are already happening,” said Patrick R. Harrington, senior clinical virology reviewer at FDA.
Other questions that arose, without resulting in satisfying answers, included why the drug didn’t appear to work in people with type 2 diabetes. It also was less effective against the delta variant.
Additionally, when preliminary data on the drug was released in early October, molnupiravir appeared to cut risk of death and hospitalization in half, a finding so persuasive that the trial was halted at its midpoint. After continued follow-up of patients, the drug appeared less impressive, with risk of death and hospitalization reduced by 30 percent.
There are already three treatments, called monoclonal antibodies, authorized in the United States to help keep high-risk people from ending up in the hospital. Monoclonals are highly effective, but they are more cumbersome to administer and their uptake has often been uneven. Unlike pills that can be picked up at a pharmacy and taken at home, monoclonals are given through lengthy infusions or injections that are less convenient than a doctor prescribing a pill – and new variants can pose a threat to their use.
“As we enter the winter months, another surge is imminent, potentially in the setting of emerging new variants of concern,” Kartsonis said. “We remain in dire need of novel, effective, well tolerated and conveniently administered therapies to treat covid-19 in the outpatient.”
People infected by omicron in South Africa are showing very different symptoms to those suffering from the delta strain, said the doctor who alerted government scientists to the possibility of a new variant.
Patients who contracted it complain of fatigue, head and body aches and occasional sore throats and coughs, said Angelique Coetzee, who is also chairwoman of the South African Medical Association. Delta infections, by comparison, caused elevated pulse rates, resulted in low oxygen levels and a loss of smell and taste, she said.
After weeks of almost no Covid patients at her practice in Pretoria, the capital and epicenter of South Africa’s current surge, Coetzee said she suddenly started seeing patients complain of the symptoms on Nov. 18. She immediately informed the government’s Ministerial Advisory Council on Covid-19, and laboratories the next week identified a new variant, she said.
“I said these different symptoms can’t be delta, they are very similar to beta or it must be a new strain,” she said in an interview on Monday. “I don’t think it will blow over but I think it will be a mild disease hopefully. For now we are confident we can handle it.”
The World Health Organization is analyzing the new mutation, and has said it’s too early to say how transmissible and severe it is. It’s called on countries to start testing widely for omicron, saying the divergent design could fuel future surges of Covid-19.
South Africa announced the identification of a new variant on Nov. 25, saying a few cases had first been identified in neighboring Botswana and then others had followed in Tshwane, the municipal area in which Pretoria is located. The announcement caused a global panic, roiling markets and resulting in travel bans on southern African nations.
Scientists advising South Africa’s government told a media briefing on Monday that while omicron appeared to be more transmissible, cases appeared to very mild.
Coetzee’s patients have been relatively young. A vaccinated 66-year-old patient did return a positive test on Monday but was only mildly ill, she said.
BioNTech, Moderna and Johnson & Johnson are working to adapt their Covid-19 vaccines to address the omicron variant, with the German partner of Pfizer saying it could have a new version ready within 100 days if necessary.
BioNTech said Monday that it has started development in order to move as quickly as possible. The first steps of developing a new vaccine overlap with the research necessary in order to evaluate whether the shot will be needed – a process that both it and Moderna began last Thursday as news of the new variant began to spread around the world.
Drugmakers have been preparing for months for the possibility of needing to tweak their vaccines to deal with a new variant. BioNTech, Pfizer and Moderna will be able to move at unprecedented speed: Both vaccines use messenger RNA technology, which shortens the timeline for a new shot to only a few months.
J&J’s vaccine relies on a different technology called a viral vector. The company said it’s testing immune blood components from participants in trials of its booster to look for responses to omicron and is pursuing a vaccine that specifically targets the variant that it will take into human studies if needed.
Omicron has raised concerns around the world, with countries implementing travel bans to buy time as researchers race to study whether it will evade vaccines and spread more rapidly. Understanding the new strain will probably take several weeks, according to scientists.
BioNTech’s American depositary receipts climbed 5.6% in trading before U.S. exchanges opened, extending a 14% jump on Friday. Moderna shares surged more than 10%. J&J was little changed before U.S. markets opened.
BioNTech and Moderna have both said it should become clear within weeks whether they’d need to adjust their shots. Pfizer and its partner put plans in place months ago to be able to ship a new version of their shot within 100 days if necessary, according to a spokeswoman.
It’s standard procedure to begin developing an updated vaccine in parallel with running tests of how the new strain reacts with the existing shot “in order not to waste any time,” BioNTech said. “Lab tests will deliver more information on whether or not adaption of the vaccine will be necessary.”
Vaccinated people should still be protected, depending on how long ago they got their shots, and for now the best advice is to take one of the current Covid vaccines, Moderna Chief Medical Officer Paul Burton said on Sunday on the BBC’s “Andrew Marr Show.”
Pfizer’s and BioNTech’s vaccine is on track to be the best-selling pharma product ever on a yearly basis. Another vaccine maker, AstraZeneca, said Friday it’s also investigating the variant.
Some polymerase chain reaction (PCR) test kits may unable to detect the Omicron Covid-19 variant as the virus may have a growth advantage, Ramathibodi Hospital Centre for Medical Genomics said on its Facebook page on Saturday.
The World Health Organisation (WHO) recently announced that the latest Omicron variant is among variants of concern similar to the Delta strain.
Meanwhile, an African scientist has uploaded 115 samples of Omicron genetic code on GISAID coronavirus database in a bid to enable other scientists worldwide to conduct researches.
The centre explained that it has conducted a test using 115 Omicron samples and PCR test kits approved by WHO via the Nextclade programme.
“We found that some PCR test kits may give weakly positive or false negative as the virus may have a growth advantage,” the centre said.
The centre also advised Covid-19 test centres to use PCR test kits which able to detect the Omicron variant.
More U.S. adults who do not already have children are saying they are unlikely to ever have them, a new Pew Research Center survey finds – findings that could draw renewed attention to the risks of declining birthrates for industrialized nations.
Experts are concerned that the U.S. birthrate, which has declined for the sixth straight year, may not fuel enough population growth on its own to keep the future economy afloat and fund social programs.
Women between the ages of 18 to 49 and men between 18 and 59 who said they are not parents were asked the question, “Thinking about the future, how likely is it that you will have children someday?”
In October, 26 percent of them said it is “very likely,” a six-point drop from 2018, when 32 percent answered “very likely.” Meanwhile, the share of Americans who answered “not too likely” in 2021 grew to 21 percent, compared to 16 percent in 2018.
When asked for a reason, 56 percent of childless adults who said it is not at all or not too likely they will ever have children said it’s because they just don’t want them. That’s a change from in 2018, when 63 percent of childless adults in these categories said it was because they had no desire for children.
This time around, 43 percent cited other reasons including medical issues, economic or financial reasons, and lack of partner.
Coupled with the recent release of federal demographic data, this poll points to a long-term evolution in parenthood trends in the United States. The spiraling costs of child care, health care and education – along with global instability, including the coronavirus pandemic and climate change – could all be contributing to a broader change in attitudes to marriage and priorities in life.
In April, the Census Bureau reported that in the last decade the U.S. population grew at the second-slowest rate for any 10-year period since the nation’s founding.
Pew surveyed 3,866 parents and non-parents online in late October as part of a broader study of nearly 10,000 U.S. adults known as the American Trends Panel survey. Those who said they have no children were asked to rate their desire to have them in the future, while adults who said they already have children were asked to rate their likelihood of having more. The same questions were asked in a similar poll Pew conducted in late July to early August 2018, enabling a comparison of trends over time.
There was no difference based on gender in the responses among parents and non-parents; according to Pew, “men and women are equally likely to say they will probably not have kids (or more kids) in the future.” There was a difference based on age, however, with adults in their 40′s far more likely than younger adults to say they are unlikely to have any or any more children in the future.
The Biden administration has attempted to tackle some of the roadblocks to higher fertility through its roughly $2 trillion Build Back Better bill, which recently passed the House and is now moving to the Senate. The bill includes funding for universal pre-K as well as the first national paid family and medical leave program.
Chula’s Pharmaceutical Science Has Developed a User-friendly and Rapid Test Kit to Keep People Away from COVID-19.
Chula Pharmaceutical Science helps increase public confidence to keep COVID-19 at bay with their new test kit to verify the safety and efficacy of hand sanitizers and alcohol-based gel and spray products.
Since the onset of the Covid-19 pandemic, many are now accustomed with the New Normal lifestyle in which require social distancing, frequent hand washing, and sanitizing with hand sanitizer and alcohol sprays to clean their hands and belongings. But how can we be sure that the products we use are safe for our health and effective in cleaning and disinfecting?
Asst. Prof. Dr. Supakarn Chamni, Department of Pharmacognosy and Pharmaceutical Botany, Faculty of Pharmaceutical Science, Chulalongkorn University, explained the problems of hand-sanitizing gel and spray products as appeared in the media and reported from the Smart Buy Testing Center, The Foundation for Consumers.
“Sixty-seven percent of the products surveyed have alcohol concentration lower than 70% by volume, which is not adequate for killing germs. Moreover, these products were found to be contaminated with harmful chemicals that could irritate the respiratory tract, and if it gets into the eyes, can cause blindness.”
Based on such concerns, Asst. Prof. Dr. Supakarn has developed the Q-E-S-T 3-in-1 Alcohol Test Kit to enable the public to check the standards and safety of alcohol and sanitizing products by themselves.
Is Your Alcohol Sanitiser Safe and Effective? “This test can analyze both the type and concentration of alcohol to confirm the effectiveness of its cleaning and disinfection property to reduce the risk of spreading the COVID-19 virus.”
Get to Know the different types of alcohol Alcohol has antimicrobial properties against viruses, bacteria, and fungi, by killing or stopping the growth of the microbes and can therefore be used to clean and disinfect the skin and various surfaces.
There are different types of alcohol depending on their chemical structures: Ethanol and isopropanol are the alcohol types used for human consumption. Ethanol is the alcohol found in liquor. It can be used both externally and orally. It costs the highest compared to other types of alcohol. Isopropanol is for external use only, such as for cleaning wounds. Methanol is an alcohol used in the fuel industry. It is a solvent in the paint industry and a precursor in the plastics industry.
All three types of alcohol have similar characteristics. They are all clear, colorless liquid that evaporate easily and is flammable. The only difference is the smell.
“Isopropanol used to clean wounds has a pungent smell, while ethanol and methanol have a mild scent. Therefore, it is difficult to distinguish them olfactorily,” Asst. Prof. Dr. Supakarn warned about the potential danger should unscrupulous manufacturers mix methanol in with hand sanitizing alcohol.
Methanol poisoning and symptoms Methanol is highly toxic to humans, and should not be inhaled, let it come in contact with the skin, or, under no circumstances, ingested. Those working with methanol need to wear masks and gloves for protection.
Exposure to more than 40 mg/kg of methanol or inhalation of more than 200 ppm per day can lead to nausea, vomiting, respiratory problems, bronchitis, and even blindness, and death.
Asst. Prof. Dr. Supakarn cited incidents in foreign countries as a warning of the dangers of methanol. “In 2020, there was a reported 1,000 deaths from methanol-contaminated alcohol in countries such as Iran, Russia, and Mexico, and data from the US Centers for Disease Control and Prevention (US CDC) showed 15 people in Arizona and New Mexico accidentally ingested alcohol-based hand sanitizer – four were dead, and three went blind.”
Basic alcohol test you can do yourself “Alcohol-based hand sanitizers have become essential items to prevent the spread of COVID-19. Therefore, consumers must be able to check the efficacy and safety of the products themselves,” Asst. Prof. Dr. Supakarn said.
“The Q-E-S-T 3-in-1 Alcohol Test Kit can test both pure alcohol and alcohol-based gel and liquid products, or even products with added colors and scents. The chemicals used for testing are safe, and have been certified by the National Institute of Metrology (Thailand).”
Is Your Alcohol Sanitiser Safe and Effective?
The test kit can detect all three types of alcohol: ethanol, isopropanol, or methanol, and can specify the ethanol concentration in the range of 30-90 percent (±10 percent) by volume (v/v) within three to five minutes.
“The test is simple to use. Measure one ml. of the alcohol sample into the provided container. Then add five drops of the first solution which is an alkaline solution, and add one drop of the second solution that is green. Close the cap, shake well, and observe the color change at the three-minute mark to interpret the result according to the color chart,” Asst. Prof. Dr. Supakarn explained.
Ethanol is displayed in orange, but if the result is yellow, it means that it is methanol. Isopropanol is displayed in gradients.
Is Your Alcohol Sanitiser Safe and Effective?
For ethanol concentration analysis, read the result at the 3-minutes mark. If 80% v/v ethanol is present, an orange precipitate will form. With 70% v/v ethanol, the solution will become orange, and if there is less than 70% ethanol v/v, the solution will be brown, or greenish-brown.
Is Your Alcohol Sanitiser Safe and Effective?
“Quality alcohol can kill germs. The test result should be orange,” Asst. Prof. Dr. Supakarn reminded us.
How to store alcohol over a long period Alcohol is a volatile substance at room temperature, so, care should be taken when storing and choosing the right container.
“Putting alcohol in a wide-mouth pump bottle will allow the alcohol to evaporate more easily than a spray bottle. Alcohol should be stored in a container with a tight lid. Do not leave the lid open or leave it in the sun for a long time. Once opened, or repacked into other containers, the expiration date changes.”
The duration of use depends on the environment. Asst. Prof. Dr. Supakarn suggested that “if you put (the alcohol) in a bag and stay in an air-conditioned office, it will last about six months. If it is placed outside the building, it will last three months. Do not put alcohol in the car, because alcohol can evaporate, and permeate the cabin, and could spark if exposed to a lighter or a charging port. This can be dangerous.”
Use alcohol safely, and stay away from diseases Asst. Prof. Dr. Supakarn reiterated the guidelines for safe use of alcohol that “every time after touching public objects, you should sanitize your hands with hand sanitizers with 70% v/v ethanol by rubbing the sanitizer evenly over all areas of the fingers, palms, and wrists for at least 30 seconds.”
“If you touch the alcohol, and it’s no longer cold to the touch, or if the alcohol has abnormal characteristics such as stratification, coagulation, sedimentation, or discoloration, don’t use it.”
Finally, Asst. Prof. Dr. Supakarn advised consumers to purchase alcohol sanitizing gel and spray from reputable sources, with a label indicating the registered number, and expiration date. And if you are not sure of the product’s efficacy, you can also check it with the Q-E-S-T 3-in-1 Alcohol Test Kit.
“If the tested product has ethanol alcohol content of less than 70%, or methanol is found, you can send the tested sample for confirmation to the Bureau of Cosmetics and Hazardous Substances, Department of Medical Sciences, Ministry of Public Health,” Asst. Prof. Dr. Supakarn said.
Q-E-S-T 3-in-1 Alcohol Test Kit is available at Osotsala, Faculty of Pharmacy, Chulalongkorn University, Tel. 0-2218-8428-9. (A test kit is priced at 200 baht containing 10 tests).
A year after coronavirus vaccines dangled visions of an end to the pandemic, science has delivered inspiring results again: two antiviral pills that dramatically reduce the risk of hospitalization and death.
The notion that a fearsome infection could soon be treatable with a handful of pills is an exhilarating idea nearly two years into a pandemic that has killed more than 5 million people, at least 770,000 in the United States. But experts – who are thrilled about the prospect of two powerful new medicines – worry that enthusiasm for the idea of treatments may distract from their limitations and the necessity of preventing illness in the first place.
If regulators deem the five-day treatment courses from Pfizer and Merck and its partner Ridgeback Biotherapeutics safe and effective in coming weeks, as most people expect, the drugs could make getting sick far less scary. The United States has already prepurchased millions of treatments. The good news arrives like an echo of last year, when two remarkably effective vaccines were authorized in the middle of the holiday season as a winter surge in new cases loomed.
But these treatments alone aren’t likely to close the book on the coronavirus. Instead, they will be a valuable addition to an armamentarium that the world is going to have to keep building and maintaining long term: vaccines, booster shots, more antiviral pills, virus-fighting antibodies engineered to stick around in people’s bodies and fast-turnaround testing linked to treatment options.
“It’s a huge part of the toolbox; if we can move everything upstream, instead of trying to treat hospitalized patients with late-stage severe disease,” said David Boulware, an infectious-disease physician at the University of Minnesota Medical School. “I’m an optimist. Six months from now, I think things are going to be great.”
Drugs that can be taken at home to keep mildly sick people from ending up in the hospital will be a turning point. But a major lesson of the pandemic has been that around each corner are more corners.
Remember, the vaccines were better than anyone expected. But more people in the United States, where vaccines are plentiful, have died of covid-19 in 2021, after shots became available, than in the year before.
Antivirals, too, will be powerful but won’t be a get-out-of-jail-free card by themselves.
Initially, they will be available to people at increased risk of severe illness due to age or other factors. People will need to recognize their symptoms early, get tested and start treatments right away.
The drugs are good, but not perfect: Merck and Ridgeback’s molnupiravir slashed hospitalization and death by half in a clinical trial, but that means some people still ended up in the hospital. Pfizer’s Paxlovid reduced hospitalizations and death by an impressive 89%, but must be taken within days of symptoms.
And scientists have learned not to underestimate the virus. As soon as treatments become widespread, scientists will be watching for signs of resistance.
“There’s always a sense of optimism with a new strategy that comes along, and I’m optimistic, too, that this is one additional thing that is going to help in our fight against this disease,” said Erica Johnson, chair of the Infectious Disease Board of the American Board of Internal Medicine and a physician at the Johns Hopkins Bayview Medical Center. “But I’m also cautious that it is just a single strategy, and it really only works if all the other strategies are healthy and working, too.”
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Virus-fighting strategies, not silver bullets
Carl Dieffenbach, director of the Division of AIDS at the National Institutes of Health, has spent decades battling a different virus, overseeing a $1 billion global research portfolio focused on HIV. Although the long quest for a vaccine has been unsuccessful so far, the disease has been transformed by treatments and prevention strategies. Now, he is trying to apply some of that thinking to covid-19.
No one is willing to outline a minimum threshold of treatments needed against a virus that has been so continually surprising, but when pressed, Dieffenbach says that coronavirus treatments that will soon be reviewed by regulators are “a good start” – not the end.
It’s important to build an arsenal of drugs that use different techniques to stop the virus. One class of drugs can block the coronavirus from entering cells, as monoclonal antibodies already in use are designed to do. Another class could interfere with proteases, enzymes that the virus uses to process its proteins – like Pfizer’s drug. Yet a third could interfere with a different enzyme the virus uses to make copies of itself, like Merck and Ridgeback’s molnupiravir.
Dieffenbach thinks all three angles of attack will be needed, as well as backups for each strategy and cocktails that combine them, to avoid allowing the virus to sneak past the protection given by any individual treatment.
“Six [treatments] at a minimum. Nine would be better. Twelve would be even better,” Dieffenbach said. “We need the companies to make the drugs at scale, as available as aspirin and Tylenol – metric kilotons.”
Both Pfizer and Merck have begun scaling up their pills before they have received a regulatory green light. Pfizer plans to make 50 million treatment courses in 2022. Merck projects having 10 million treatment courses ready by the end of this year, and more in 2022. The United States has prepurchased about 3.1 million treatment courses from Merck and 10 million from Pfizer.
The question now on many scientists’ mind is how the virus will respond as those drugs go into widespread use. Akiko Iwasaki, an immunologist at Yale University School of Medicine, sees combinations of drugs as the future – particularly for people with compromised immune systems who can have covid-19 infections that simmer for weeks or months, allowing the virus to mutate.
“If we have a combination, an antiviral cocktail, it might protect against the emergence of these mutations,” Iwasaki said.
Iwasaki and colleagues recently reported a preprint case study of a woman in her 70s whose cancer had weakened her immune system. The patient was sick for six months with a persistent covid-19 infection, and during her treatment received a course of remdesivir, an intravenous antiviral medication. At first, her fever resolved and levels of the virus dropped – until a mutation that gave the virus resistance to remdesivir allowed it to surge back.
In this case, the resistant virus that was able to thrive in the presence of remdesivir wasn’t going to take over the world – it was less adept at multiplying than the original strain. But the case illustrates the risk of new variants arising after treatment.
To protect immunocompromised people, other companies – including AstraZeneca and Adagio Therapeutics – are trying another angle of attack: laboratory-brewed monoclonal antibodies that have been engineered to stick around in the blood for a long time, on the idea that they could provide a shot of long-term protection, similar to a vaccine. Regeneron recently released data showing that its monoclonal antibody cocktail, currently authorized as a treatment for people infected or recently exposed, remains about 80% effective against symptomatic infections eight months later, bolstering the case for its drug as a preventive for people who don’t respond well to vaccines.
“For us, vaccination has been the jailbreaker, it has allowed us to live life normally,” said Hugh Montgomery, a professor of intensive care medicine at University College London leading a trial of the AstraZeneca drug, which has been submitted to U.S. regulators for emergency authorization. “My sister, who has breast cancer and has just got 18 weeks of chemotherapy and can’t mount an antibody response to the vaccine – as we’ve lifted our lockdown, she’s become a prisoner in her house.”
Instead of one drug or one solution, there will probably be treatment niches – and the market opportunity isn’t a one-time flare; it’s what pharmaceutical executives call “durable.”
On a recent earnings call, Pfizer chief executive Albert Bourla said that he saw a years-long market for antiviral pills. As long as the world needs vaccines, it will also need treatments.
“As long as you have covid around, you will have a need to vaccinate and protect and then you will have a need to treat and save lives,” Bourla said.
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A revolution outside the medicine cabinet
For covid-19 treatments to change the world, the world may also have to change.
Alongside medical tools, Dieffenbach is calling for a societal shift – a new normal in which people with respiratory symptoms test as soon as symptoms appear and start drugs within three to five days.
“What I’m advocating for is a fundamental change in approach,” Dieffenbach said. “In the future, we don’t require people to go to the doctor if they’re feeling sick to get tested. There’s a rapid test you do at home. People are motivated to get a prescription, or already have a prescription so they can start taking it right away. That’s where we’re going to have to get to.”
Even as experts anticipate the arrival of lifesaving drugs, they worry. Will people use the existence of medicines as an excuse to avoid vaccination or boosters? Will people who could clearly benefit – those who have avoided the vaccines – seek out testing at the first sign of a sore throat and get access to drugs quickly enough?
Doctors are hopeful that people will realize that avoiding sickness altogether is the best option. Boulware said one colleague puts it this way: syphilis is treatable with penicillin. But it is far better to not get it in the first place.
“It’s almost like applying the correct tool for the task at hand. Treatments are going to play a back up role to vaccines,” said Rajesh Gandhi, an infectious diseases physician at Massachusetts General Hospital.
The existence of treatments could also trigger the start of a philosophical discussion on how to deal with sickness itself. Pre-covid, people hopped on flights and went to school and work with runny noses and coughs. If people go back to old habits, it may be hard to identify and treat people early enough in their illness.
“I don’t think we’re going back to just ignoring people who are sick,” said Larry Corey, a virologist and past president of the Fred Hutchinson Cancer Research Center in Seattle. “Coming to school or coming to work and just assuming that no matter what, it’s not going to hurt you.”
Six-months follow-up of prevention trial showed 83% reduced risk of symptomatic Covid-19, with no severe disease or deaths with AZD7442 Separate treatment trial showed 88 per cent reduced risk of severe Covid-19 or death when treated within three days of symptom onset
New data from the AZD7442 Covid-19 PROVENT prevention and TACKLE outpatient treatment Phase III trials both showed robust efficacy from a one-time intramuscular (IM) dose of the long-acting antibody (LAAB) combination.
In an analysis of the ongoing PROVENT trial evaluating a median six months of participant follow-up, one 300mg IM dose of AZD7442 reduced the risk of developing symptomatic Covid-19 compared to placebo by 83 per cent.
About 2 per cent of the global population is considered at increased risk of an inadequate response to a Covid-19 vaccine. This includes people with blood cancers or other cancers being treated with chemotherapy, patients on dialysis, those taking medications after an organ transplant or who are taking immunosuppressive drugs for conditions including multiple sclerosis and rheumatoid arthritis.
The AZD7442 PROVENT trial is the first Phase III trial prospectively designed to evaluate a monoclonal antibody for pre-exposure prophylaxis of symptomatic Covid-19, with targeted inclusion of high-risk and immunocompromised participants. More than 75 per cent of PROVENT participants at baseline had co-morbidities that put them at high risk for severe Covid-19 if they were to become infected, including people who are immunocompromised and may have a reduced immune response to vaccination.
There were no cases of severe Covid-19 or Covid-19-related deaths in those treated with AZD7442 at either the primary or six-month analyses. In the placebo arm, there were two additional cases of severe Covid-19 at the six-month assessment, for a total of five cases of severe Covid-19 and two Covid-related deaths.
An exploratory analysis of the TACKLE outpatient treatment trial, in patients with mild-to-moderate Covid-19, showed that one 600mg IM dose of AZD7442 reduced the risk of developing severe Covid-19 or death (from any cause) by 88 per cent compared to placebo in patients who had been symptomatic for three days or less at the time of treatment.
A total of 90 per cent of participants enrolled in TACKLE were from populations at high risk of progression to severe Covid-19 if they became infected, including those with co-morbidities.
In both PROVENT and TACKLE, AZD7442 was generally well tolerated. No new safety issues were identified in the six-month analysis of PROVENT.
Hugh Montgomery, Professor of Intensive Care Medicine at University College London, UK and AZD7442 principal investigator, said: “These compelling results give me confidence that this long-acting antibody combination can provide my vulnerable patients with the long-lasting protection they urgently need to finally return to their everyday lives. Importantly, six months of protection was maintained despite the surge of the Delta variant among these high-risk participants who may not respond adequately to vaccination.”
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “AZD7442 is the only long-acting antibody with Phase III data to demonstrate benefit in both pre-exposure prophylaxis and treatment of Covid-19 with one dose. These new data add to the growing body of evidence supporting AZD7442’s potential to make a significant difference in the prevention and treatment of Covid-19. We are progressing regulatory filings around the world and look forward to providing an important new option against SARS-CoV-2 as quickly as possible.”
Full results from PROVENT and TACKLE will be submitted for publication in a peer-reviewed medical journal and presented at a forthcoming medical meeting.
On October 5, the Company announced that it had submitted a request to the US Food and Drug Administration for Emergency Use Authorisation for AZD7442 for prophylaxis of Covid-19.
AstraZeneca has agreed to supply the US Government with 700,000 doses of AZD7442 if granted an Emergency Use Authorization by the FDA, and has agreements to supply to other countries.
Thailand is facing severe population challenges. According to the Office of the National Economic and Social Development Council (NESDC), the share of the elderly population will reach approximately 30% of the total population in 2037. This is partly due to the declining fertility rate, which has been below the replacement level for three decades and will continue to decrease. In 2020, the number of new births fell to 587,368 people—the first time Thailand has recorded annual births of fewer than 600,000. Moreover, the issue of population quality is no less, if not more, important than that of demographic structure. These critical issues will have significant implications for Thailands economy and society in the long run.
On October 19, 2021, Kenan Foundation Asia facilitated the Remodeling Demographic Structure Towards Sustainable and Inclusive Society policy forum under the “Smart Family Planning for Women” project, in collaboration with Ministry of Public Health partners with Kenan Foundation Asia and Organon (Thailand) Ltd.
During the forum, experts from the government, academic, and civil society sectors identified key gaps in smart family policy to pave the way for measures to shape the demographic structure, improve the population quality, and build smart families. This then led to the Policy Declaration Ceremony under the same project on November 18th, where relevant agencies shared their visions and jointly built a collaborative network to drive Thailand’s population policy.
Dr. Satit Pitutecha, Deputy Minister of Public Health delivered an opening speech for the ceremony, in which he expressed his vision and a strong intention to drive population policy towards a sustainable and inclusive society in Thailand. He also expressed the determination to enhance the country’s efforts to develop smart families and shape the demographic structure. “The key to moving Thailand forward is to develop the capacity of our people, which will have broad-based impacts on our economic and social development in the near future. Every one of us here might have different roles and responsibilities, but we all aim for the same goal—namely, to build smart families towards a sustainable society. I could not agree more that cross-sector collaobration is vital to ensuring the efficiency and sustainability of our mission.”
Ministry of Public Health partners with Kenan Foundation Asia and Organon Thailand to remodel demographic structure towards sustainable and inclusive society
Based on the previous policy forum, demographic restructuring and population quality enhancing towards a sustainable economy and society require the following actions:
Transformation of the education to foster lifelong learning and promote resilience in handling global changes and disruptions
Appointment of a host agency to execute the policy and build a sense of unity among multi-sector stakeholders
Increasing of awareness, accessibility, and affordability to education, social, and health services
Adoption of the life course approach as a basis for policymaking, with consideration of the multi-stage life and expansion of the life course concept beyond that of traditional families
These key topics served as a framework for the declaration ceremony, in which representatives from government, third-sector organizations and agencies shared their visions. Participating organizations/agencies included the Ministry of Social Development and Human Security, the Ministry of Labour, the Ministry of Public Health, the Ministry of Culture, Ministry of Finance, Ministry of Interior, Ministry of Higher Education, Science, Research and Innovation, the Foundation of Thai Gerontology Research and Development Institute, the National Human Rights Commission of Thailand, and UN Women.
Dr. Suwannachai Wattanayingcharoenchai, Director-General of the Department of Health, remarked that, “The challenges and urgency in dealing with demographic and population changes, including the growing number of elderly people, declining birth rates, increasing mortality rates, and concerns over the quality of life and economic stability amid the COVID-19 crisis, make it necessary for us to speed up our work on smart family planning and reproductive health to increase fertility rates in Thailand. Nonetheless, we need to consider both the demographic structure and the quality aspect of the population to ensure sustainable development.”
Mr. Koen C. Kruijtbosch, Managing Director at Organon (Thailand) Ltd., indicated that “the ceremony was an excellent opportunity for views, expertise, and experiences to be exchanged between key stakeholders in the government, civil society, international development, and private sectors, which would lead to cross-sector collaboration and integration to accelerate the execution of population policy through smart family planning for Thai women and Thailand’s sustainability. This event marks a powerful beginning that will help guide collaborative and sustainable practices for driving the policy continually in the future.”
Mr. Piyabutr Cholvijarn, President and Vice Chairman of Kenan Foundation Asia, emphasized that “the unbalanced demographic structure, with the declining birth rates and increasing elderly proportion, will certainly affect the overall economic and social development. While prevention of such effects can be done through smart family planning that fosters quality births and quality lives for people of all ages, comprehensive collaboration of all key stakeholders to address the issues is vital to sustainable economic and social development.”
The good intentions and generous support clearly visible at the ceremony will lead to a capable and collaborative network for driving initiatives to build smart families and remodel the demographic structure towards a resilient economy and society.
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Is Your Alcohol Sanitiser Safe and Effective?
Is Your Alcohol Sanitiser Safe and Effective?
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Ministry of Public Health partners with Kenan Foundation Asia and Organon Thailand to remodel demographic structure towards sustainable and inclusive society
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