CDC data reveal the pandemic’s impact

CDC data reveal the pandemic’s impact

adolescent male seen from the profile with light shed on his faceShare on Pinterest
New information from the CDC illuminate the pandemic’s effect on teenagers’ mental wellbeing. Sofia Guarisco/EyeEm/Getty Pictures
  • Even before the COVID-19 pandemic, teens’ mental nicely-getting experienced been declining.
  • New data from the Facilities for Disease Handle and Avoidance (CDC) describe pressures brought on by COVID-19 that make an adolescent’s daily life even much more challenging, including complete-relatives stress.
  • Disruptions have influenced schools’ capabilities to provide teenagers with inner thoughts of connectedness.

Even before the arrival of COVID-19, in 2019, an average of virtually 36.7{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} of higher university pupils claimed persistent thoughts of sadness or hopelessness, in accordance to the CDC. For women, the amount was larger, 46.6{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809}.

In the circumstance of lesbian, homosexual, or bisexual adolescents, the variety goes up to 66.3{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809}. The in general ordinary signifies a 40{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} maximize in this kind of feelings in excess of the final 10 decades.

New CDC knowledge produced at the conclusion of March 2022 reveals that the psychological wellness of teens had declined even more for the duration of the pandemic. Much more than a 3rd (37{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809}) of large college students mentioned they have skilled poor mental overall health.

The new knowledge arrives from a January to June 2021 survey of high-school-age pupils requested to describe their behaviors and activities through the COVID-19 pandemic.

The share of teens reporting feelings of disappointment and hopelessness rose to 44.2{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809}.

Dr. Lisa Coyne, senior scientific marketing consultant at the Kid and Adolescent OCD Institute at Maclean Healthcare facility in Belmont, MA, speaks about this crucial developmental stage in Maclean Hospital’s podcast.

“They’re at this developmental time period in which they are going to find autonomy and independence, and that’s also a scary issue in some cases. In addition to that, their whole world […], all of our worlds have been thrown into disarray, but specifically for them, they have a story about what the teenager years are meant to be like. That story is acquiring rewritten in authentic-time.”

In the course of the interval included in the CDC study, 19.9{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} claimed getting seriously regarded as trying suicide. Nine percent reported owning attempted it.

CDC Performing Principal Deputy Director Dr. Debra Houry, summarizes:

“These info echo a cry for assist. The COVID-19 pandemic has created traumatic stressors that have the possible to further erode students’ psychological nicely-becoming. Our investigation reveals that surrounding youth with the right support can reverse these trends and support our youth now and in the foreseeable future.”

– Dr. Houry

The study finds a greater degree of anxiousness at home for all relatives users. 20-nine p.c described that a mother or father or other grownup in the residence lost their career.

Fifty-five per cent of survey individuals noted obtaining skilled emotional abuse by a father or mother or other grownup at property.

Bodily abuse from a father or mother or other older people in the dwelling — together with hitting, kicking, beating, or other physical attacks — was noted by 11{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} of teens.

Far more than a 3rd (36{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809}) of teens reported they experienced been confronted with racist habits just before or throughout the COVID-19 pandemic.

Even though the survey does not report the types of experience encountered, 64{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} of Asian teenagers stated they had encountered racism, as did 55{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} of Black teenagers and 54{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} of multiracial teens.

“Student perceptions of racism have been involved with inadequate psychological well being difficulty concentrating, remembering, or building decisions and a deficiency of link with people at college through the COVID-19 pandemic,” notes the CDC report.

“School connectedness is a important to addressing youth adversities at all times, particularly for the duration of periods of intense disruptions,” states Dr. Kathleen A. Ethier, Director of CDC’s Division of Adolescent and School Well being.

The study uncovered that when teens felt linked to other learners and grown ups at their faculty, they have been a lot less probably to report emotion unhappy or hopeless: 35{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} vs. 53{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809}. They have been also considerably less very likely to have considered suicide, 14{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} vs. 26{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809}, or to have attempted it, 6{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} to 12{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809}.

Fewer than half, 47{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809}, of learners claimed sensation shut to other individuals at faculty.

Typically, universities supply mental well being, actual physical wellness, and social expert services, as effectively as chances for beneficial reinforcement by academic accomplishment. In the course of the pandemic, nevertheless, educational facilities have also faced disruptions, which include closures, staff members shortages and resignations, and protection considerations.

States Dr. Ethier, “Students want our assist now far more than at any time, no matter whether by generating sure that their colleges are inclusive and secure or by delivering prospects to interact in their communities and be mentored by supportive grownups.”

The CDC’s Dr. Jonathan Mermin notes the benefit of concerted endeavours among all grownups:

“In the deal with of adversity, assist from educational facilities, family members, and communities safeguards adolescents from probably devastating effects.”

Dr. Archana Basu, investigation scientist at the Harvard T.H. Chan School of Public Well being, speaking on Harvard University’s Heart on the Producing Baby podcast, also notes:

“[O]pen conversation genuinely can help to fully grasp what kids are observing and dealing with, and can enable them not be by itself in their concerns. I would say that would be the variety a person objective, to aid youngsters realize what they are emotion, validate individuals thoughts, and for them to feel that they are not alone in this expertise.”

Novavax COVID-19 vaccine (Nuvaxovid): Data on side effects

New vaccines for COVID-19 are emerging. One such vaccine is Novavax. Early studies indicate that it may have similar efficacy to the Pfizer and Moderna vaccines but fewer side effects. Further trials and analyses of the initial results are underway to understand its effects better.

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What side effects can the Novavax vaccine cause? Image credit: Mariano Vimos/Vizzor Image/Getty Images.

Medical News Today has contacted over 20 experts for comment on the potential side effects of the Novavax COVID-19 vaccine, Nuvaxovid. As of the time of publication, they have declined to comment until additional peer-reviewed data become available.

On January 31, 2022, Novavax submitted a request to the Food and Drug Administration (FDA) for emergency use authorization for its COVID-19 vaccine candidate.

Over 30 countries, including the United Kingdom, Australia, and Germany, have already approved this vaccine for emergency use.

Unlike mRNA vaccines, such as Pfizer and Moderna, the Novavax vaccine uses a longer-standing protein-based technology. The flu vaccine and the hepatitis B vaccine, which doctors have administered throughout the U.S. since 1986, use this technology.

The proteins inside the Novavax vaccine mimic COVID-19’s spike protein. They were created in moth cells and then assembled into nanoparticles – small particles made of a few hundred atoms. While they share COVID-19’s molecular structure, they do not replicate or cause COVID-19.

The vaccination involves injecting the nanoparticles into arm muscles alongside a compound extracted from the soapbark tree, which acts as an adjuvant to attract immune cells to the injection site.

A full course of the vaccine requires two doses taken 3 weeks apart.

The results from two large phase 3 trials on Novavax have been published.

One trial in the United States and Mexico included 29,949 participants ages 18 and over who had not previously contracted SARS-CoV-2. On a ratio of 2:1, they received two doses of either the Novavax vaccine or a placebo.

Overall, the researchers found that the Novavax vaccine was 92.6{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} effective against the Alpha and Beta variants of the virus. They also tracked side effects for 7 days after each dose.

While side effects occurred after the first dose, they were more common after the second dose. Common side effects included:

  • tenderness at the injection site for 73{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} of participants
  • pain upon and after vaccination for 60{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} of participants
  • fatigue for 50{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} of the participants
  • muscle pain for 48{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} of participants
  • headache for 44{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} of participants
  • malaise for 39{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} of participants

Less common side effects after the second dose included:

  • fever for 6{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} of participants, including severe cases for 0.37{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809}
  • nausea and vomiting for 11{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} of participants, including severe cases for 0.23{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809}
  • joint pain for 22{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} of participants, including severe cases for 2.44{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809}

A smaller trial including 15,187 participants in the UK found similar results.

Data so far suggest, that on the whole, the Novavax vaccine may have fewer side effects than both the Pfizer and Moderna vaccines.

After a second dose of the Pfizer vaccine:

  • 66{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} reported pain
  • 60{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} fatigue
  • 52{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} headache
  • 38{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} muscle pain
  • 22{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} joint pain
  • 16{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} fever
  • 2{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} vomiting.

Meanwhile, after a second dose of the Moderna vaccine:

  • 88{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} experienced pain
  • 16{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} fever, including 1.4{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} severe cases
  • 59{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} headache
  • 66{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} fatigue
  • 43{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} joint pain
  • 19{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} vomiting.

Like the Novavax vaccine, side effects were more common after the second vaccine dose.

The World Health Organization (WHO) recommends Novavax for:

  • those living with conditions that increase the risk of severe COVID-19, such as cardiovascular disease, respiratory disease, and diabetes
  • people who have contracted COVID-19 in the past
  • people who are breastfeeding and those who are not

The WHO the following not to get the vaccine:

  • people with a history of anaphylaxis to any component inside the vaccine
  • people with symptomatic PCR-confirmed COVID-19 until they have recovered and finished self-isolation
  • people with a body temperature of over 38.5°C until they no longer have a fever
  • people under 18 years old, as research studying its safety and efficacy is still underway.

The WHO also highlights that data on having the vaccine during pregnancy is not yet available. However, as other protein-based vaccines have comparable efficacy in pregnant and non-pregnant people, they say that the Novavax vaccine may be the same.

Therefore, they recommend that pregnant people receive information about the risks of COVID-19 during pregnancy, the potential benefits of vaccination, and safety data limitations so that they can make their own decision. However, they recommend pregnant people get vaccinated in situations where the benefits outweigh the risks.

Any side effects from the vaccine were largely mild to moderate and transient. The phase 3 trial in the U.S. and Mexico, and the U.K did not raise any safety concerns.

According to Prof. Paul Heath, professor of paediatric infectious diseases and director of the Vaccine Institute, St George’s, University of London and St George’s Hospital, London, and chief investigator of the Novavax United Kingdom trial:

“The results are very reassuring and importantly show that this vaccine appears to be safe and effective in populations from a range of communities and demographic groups, and those with a range of underlying comorbidities, now (across both trials) with a total number of participants of more than 45,000.”

“Both the U.K. and the US. and Mexico trials used the same case definitions, and these consistent results, therefore, provide much confidence in the use of this vaccine for the global population. We now await the peer-reviewed publication. We also look forward to the results of the trial’s adolescent arm (12–17 years), which recently completed enrolment,” Prof Heath adds.

According to Dr. Peter English, a retired consultant in communicable disease control, former editor of Vaccines in Practice, and immediate past chair of the BMA Public Health Medicine Committee:

“[t]he vaccine is a much more traditional sort of vaccine than the mRNA and vector vaccines currently in use. The actual spike protein is injected, in the form of nanoparticles, instead of inserting the genetic material enabling our cells to create the spike protein.”

He adds that:

“It remains to be seen whether this will have consequences in terms of real-world effectiveness or safety; but the more different types of vaccine we have, the greater our ability will be to optimize effectiveness and safety in different groups.”

For live updates on the latest developments regarding the novel coronavirus and COVID-19, click here.

Harnessing data analytics and AI-powered decision-making for supply chain resiliency

Customarily, the most difficult section of mapping a supply chain is pinpointing all the unique silos and sidings wherever pertinent details may well be saved.

“With automotive, you could spend your whole lifetime trying to design the entire offer chain and all the worldwide implications,” says Jafaar Beydoun, revenue director at program firm o9 Answers. “For some thing like EV batteries, you could get all the way to lithium mining.” It is achievable to design all individuals associations in time, he says, but it is better for providers to concentration very first on their most vital companions and suppliers.

“One of our consumers was working with our software for supply-and-demand from customers predictions, but they realized that without the need of getting the suppliers instantly associated, their details was often out-of-date,” Beydoun suggests. “To get authentic-time data in just one location, they figured out the most critical and greatest-expend suppliers and initial integrated the ones they labored very best with 1st, then adopted suppliers farther down the record later on on.”

Mapping this way is iterative and right after perfecting the onboarding and info exchange processes with the first established of 15 suppliers, it is a lot easier to prolong it to the subsequent group of 10 or 15, all the way down to the smallest suppliers. As an illustration, Beydoun cites a small supplier in Bangladesh that did not have a reputable world wide web relationship, but which could add a one weekly facts sheet to tell forecasting versions.

“This OEM achieved pretty much total supply-chain visibility in two yrs with this phased method, about fifty percent the time it would have taken if they’d tried out to employ all distributors at when,” he claims.
Equally o9 Options and Palantir use Amazon Internet Products and services (AWS) as their cloud-computing platform, which permits them to spin up computing electrical power as wanted. But AWS’s experience will come into engage in in other approaches, far too.

 “Many corporations are reconfiguring their IT requires all over the platforms that Amazon Web Solutions provides,” claims Manish Govil, the company’s provide chain world wide segment chief. “We have the capability to collect and organize information from disparate methods, these kinds of as stage-of-sale, ERP and Web of Items (IoT) equipment.” AWS’ information ingestion, transmission and storage pipeline offers the capacity to stitch alongside one another knowledge from all those disparate units for close-to-conclusion visibility. 

The enterprise also has a good deal of know-how running its individual offer chain, with numerous associates who have remarkably specialized abilities in distinctive locations of the supply chain. “We comprehend demand from customers-shaping, sensing and scheduling, transportation management, true-time transportation visibility and warehouse management,” Govil states. “There are a lot of corporations that can provide a person or two of these locations of experience, but we have a incredibly substantial ecosystem that provides them all alongside one another.”

Together with Apple, Proctor & Gamble, McDonald’s, and Unilever, Amazon is just one of five businesses deemed a “supply-chain master” by consulting business Gartner, best known for its yearly checklist of the leading 25 supply-chain management providers. “That expertise informs how AWS helps other corporations create very similar types of programs,” Govil suggests. “There are now business enterprise networks that have developed the connective tissue for offer-chain visibility by way of AWS.”

Although the info is owned by the particular person organizations, this connectivity lets pretty unique information to be shared from a lot of disparate players considerably faster than any conventional info-gathering method – and velocity is of the essence.

Experts tout boosters; CDC releases omicron data: COVID updates

Setback for CDK, Reynolds in effort to block Arizona dealership data law

A federal appeals courtroom turned down an work to block enforcement of an Arizona law built to give auto merchants far more manage of data inside dealership management units, upholding a very similar selection final calendar year by a reduced court.

In a final decision Monday, a a few-choose panel of the U.S. Courtroom of Appeals for the Ninth Circuit agreed with a federal district judge’s July 2020 view that DMS giants CDK Global Inc. and Reynolds and Reynolds Co. “were being not likely to succeed on the deserves of their statements” in a lawful challenge to the condition facts regulation.

The law, handed in 2019, took influence in July 2020 soon after U.S. District Judge G. Murray Snow denied CDK’s and Reynolds’ ask for for an injunction. CDK and Reynolds afterwards appealed that injunction selection.

It was not immediately obvious Tuesday how CDK and Reynolds will react. A CDK spokesman on Tuesday explained the corporation does not remark on active lawful matters, although a spokesman for Reynolds and Reynolds did not promptly reply to a concept in search of comment.

Bobbi Sparrow, president of the Arizona Vehicle Sellers Association, which intervened in the circumstance, mentioned the affiliation is “thrilled” with the appeals court’s view and that the statute could provide as a lawful framework for other states thinking about equivalent legislation.

“I think it is now the road map for the other states,” she said, incorporating that it is a positive consequence for both of those auto sellers and individuals.

Arizona Gov. Doug Ducey signed the regulation in April 2019. It will allow dealerships to share information stored inside their DMS with third-social gathering vendors deemed licensed integrators, and prevents providers which include CDK and Reynolds from charging fees or putting other constraints on that info access. Other states have adopted equivalent legislation, which include Montana, Oregon and Hawaii.

CDK and Reynolds very first submitted suit in July 2019 towards Arizona Lawyer Basic Mark Brnovich and John Halikowski, director of the state transportation office, while Halikowski eventually was eliminated as a defendant.

In a statement, Katie Conner, a spokeswoman for the Arizona lawyer general’s workplace, stated: “Right now is a terrific working day for shoppers and for the protection of their private information and facts.”

Several unique statements have been dismissed in May 2020 and CDK and Reynolds afterwards filed a revised grievance.

The DMS organizations declare the facts regulation is unconstitutional and obscure, and leaves consumers’ private data possibly susceptible to cyber threats and misuse. In their revised grievance, CDK and Reynolds wrote that the legislation interferes with their DMS contracts with dealerships and needs giving “totally free and unfettered obtain” to third functions, together with likely destructive actors.

“These provisions retroactively rewrite Plaintiffs’ negotiated contracts and undercut Plaintiffs’ considerable initiatives to secure the confidentiality, integrity and availability of their DMSs by restricting obtain to approved consumers and barring or detecting unauthorized intrusions,” according to their amended complaint.

The Ninth Circuit panel, having said that, wrote that Arizona’s legislation includes provisions to ensure that data is secured, adding that “CDK might disagree with the State’s policy option, but that does not imply that the legislation violates the Structure.”

Brad Miller, director of authorized and regulatory affairs and senior counsel of electronic affairs for the Nationwide Automobile Sellers Affiliation, which supported Arizona’s dealership affiliation in the litigation, explained in a assertion that the Ninth Circuit choice “is a apparent victory for the AADA and Arizona sellers.”

What we know about molnupiravir: Data and safety concerns

In the search for effective COVID-19 treatments, many drugs have failed to live up to their early promise. In a recent trial, seen as an important advance, the oral antiviral drug molnupiravir halved the risk of hospital admissions and deaths from COVID-19. Medical News Today explored the evidence to see whether this optimism is justified.

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The experimental drug molnupiravir has brought fresh hope in the fight against COVID-19. But what do we know about it so far? Image credit: Jordan Lye/Getty Images

A global trial, led by the pharmaceutical company Merck — known as MSD outside the United States and Canada — and Ridgeback Therapeutics, has found that the companies’ experimental antiviral drug molnupiravir reduces the risk of hospital admission or death from COVID-19 by approximately 50{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809}.

Although this was a small-scale trial, these positive results have led to countries rushing to sign up for supplies of the drug.

In the randomized, phase 3 trial, scientists gave molnupiravir or a placebo to 775 people. All the participants had tested positive for SARS-CoV-2 infections and experienced mild to moderate COVID-19 symptoms that had begun no more than 5 days earlier.

Stay informed with live updates on the current COVID-19 outbreak and visit our coronavirus hub for more advice on prevention and treatment.

Every participant had at least one risk factor for severe COVID-19 but had not been admitted to a hospital. Risk factors included obesity, an age of over 60 years, diabetes, and heart disease.

The scientists allocated each of the 775 participants randomly to one of two groups. One group received molnupiravir and the other a placebo. The participants took the capsules twice a day for 5 days.

Of the 385 patients taking molnupiravir, 28 were admitted to a hospital, compared with 53 of those in the placebo group. Eight of the placebo group participants died, while all those receiving the antiviral were alive at the end of the 29-day study period.

Recruitment into the study has now been halted because of these overwhelmingly positive results. The manufacturer, Merck, is applying for emergency use authorization from the Food and Drug Administration (FDA).

The Singapore health ministry has signed a purchase agreement for molnupiravir, and the European Medicines Agency is considering a rolling review of the drug.

“With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic.”

– Robert M. Davis, chief executive officer and president of Merck

Merck plans to produce 10 million courses of the treatment in 2021 and more in 2022.

The study results have been greeted with optimism. Prof. Tim Spector, a professor of genetic epidemiology at King’s College London, told MNT: “This is an exciting result from a randomized study of 775 patients, showing major effects in reducing severity and death from a simple pill given at the onset of infection.”

Molnupiravir belongs to a class of antivirals called mutagenic ribonucleosides. These change the viral genetic material and introduce errors to prevent replication and transcription of the viral genome.

Inside the host cell, molnupiravir is converted to molnupiravir triphosphate. When the virus tries to replicate, molnupiravir triphosphate is incorporated into the viral RNA instead of the nucleoside cytidine, causing a mutation.

The mutation stops the virus from replicating. This keeps numbers of the virus in the body low and should reduce the severity of the disease.

Other drugs that interfere with viral RNA have shown potential as COVID-19 treatments. Remdesivir, an intravenously administered drug that interferes with an enzyme essential for replicating viral RNA, showed early promise.

Although the FDA has granted approval to remdesivir, the World Health Organization (WHO) no longer recommends it as a COVID-19 treatment, due to insufficient evidence to support its use.

The advantage of molnupiravir is that, unlike all the other potential treatments so far, it is an oral tablet that a person can take outside a clinical setting. At a projected cost of around $700 per person for a 5-day course, it is also more affordable than other drugs. However, this cost is still likely to limit its use.

“Antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed. We are very encouraged by the results from the interim analysis and hope molnupiravir, if authorized for use, can make a profound impact in controlling the pandemic.”

– Wendy Holman, chief executive officer of Ridgeback Biotherapeutics

Prof. Sir Peter Horby, a professor of emerging infectious diseases and global health at the University of Oxford, is largely optimistic: “A safe, affordable, and effective antiviral would be a huge advance in the fight against COVID.”

However, he retained a note of caution: “It is important to remember that the absolute risks were 14{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} reduced to 7{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809}, so quite a lot of people need to be treated to prevent one hospitalization or death. This means the drug needs to be very safe and affordable.”

This caution was echoed by Prof. William Schaffner, a professor of infectious diseases at the Vanderbilt University School of Medicine, who said: “In the studies in very high risk patients, it reduced the level of serious disease by only half. It’s not a magic pill.”

He added: “In research settings, you can ensure that people take the pill as directed. In practice, there is usually a lower success rate than in clinical trials.”

Dr. Peter English, a retired consultant in communicable disease and a past chair of the British Medical Association Public Health Medicine Committee, has also expressed doubts: “The problem for antivirals like Merck’s molnupiravir is that they would have to be used before people are (usually) deemed ill enough to need anything other than symptomatic self-care treatment.”

“Unless an antiviral medication could be made so cheap and so safe that it can be used ‘on spec’ by people who might have COVID-19, [it is] unlikely to be widely useful,” he adds.

Despite widespread optimism following the study results, some experts have raised concerns about the safety of a drug that works by causing mutations.

As molnupiravir causes viral RNA to mutate, there are concerns that it might cause mutations in host cells, as well. One study in animal cell cultures found mutations in cells treated with molnupiravir.

This has led to worries that the drug might cause cancers or birth abnormalities. The authors of the animal cell study recommend that this mutagenic potential be assessed in vivo, focusing on rapidly dividing cells. Additionally, they recommend monitoring to assess potential genotoxic side effects.

“It’s worth noting that people involved in the trial were instructed to abstain from heterosexual sex or use contraception. While this is routine practice with some other medicines, such as cancer chemotherapy, it suggests that the drug has the potential to cause birth defects should someone become pregnant.”

Dr. Simon Clarke, associate professor of cellular microbiology at the University of Reading

Prof. Schaffner was less concerned about the possible genetic implications: “The FDA would certainly not have permitted clinical trials in humans if they thought there were any reasonable danger. […] Animal studies showed no adverse effects.”

In this trial, molnupiravir was effective against all variants, including the Delta variant, which was shown in a recent study to have a 235{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} increased risk of intensive care unit admission, compared with the original variant.

These positive results applied to people who had received molnupiravir soon after the onset of mild to moderate symptoms. A previous trial showed no benefit in giving the drug to patients already in hospital with COVID-19.

As an early treatment, molnupiravir could, Prof. Schaffner agrees, “offer another opportunity to prevent serious disease.”

“Although [this trial] had relatively small numbers analysed (fewer than 400 per group), it had much better results than the study done in hospitalized patients. It approximately halved the rate of hospitalization and notably reduced the number of deaths. Preventing the virus from replicating at an early stage seems very beneficial.”

Prof. Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine

So, is molnupiravir the drug we have been waiting for to bring COVID-19 under control? Perhaps, but the evidence is not yet conclusive.

Prof. Spector is among those keen to see more trial results. “We are told there were few side effects, but it would be good to know more details and see a full peer-reviewed publication,” he said. “But if this pans out, it will be a major game-changer for [COVID-19] treatment and possibly other viruses.”

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