Exclusive: Eighty-seven per cent of UK pharmacies have had to contend with staff absences since the emergence of the Omicron wave, a new survey indicates.

The Pharmacy Magazine survey, which ran on January 7-8, reveals that just 13 per cent of respondents have had no absenteeism in their pharmacy as a result of Covid since Omicron took hold in Britain in December.  

Seventy-four per cent of respondents reported staff absences due to infection, while 60 per cent reported staff having to self-isolate because they had been a close contact of someone with Covid-19.

The survey, which had 220 responses from pharmacists and support staff members, suggests that the average pharmacy has had one pharmacist and two members of support staff off work because they were required to isolate.

Respondents working in independent pharmacies reported slightly higher infection rates, while those working in multiples had slightly higher rates of self-isolation as a result of being a close contact.

Workload and stress levels rising

Ninety per cent said these absences have had a significant impact on workload for remaining staff, while 89 per cent said this had led to increased stress levels among staff. Three-quarters said the level of service provided to patients had been compromised.

“Patients have to wait longer for prescriptions,” said one respondent, adding that some services such as NMS have been suspended.  

Discontented patients were a frequently cited issue, with one respondent noting that they “aren’t very understanding when it comes to staff sickness”.

One pharmacist summed up their experience: “Staff cuts during the pandemic have left us with no contingencies. This has created major safety and effectiveness risks”

An individual working at a multiple said it was “hard to keep up with targets from management,” adding that “not much support” had been offered by their company.

Meanwhile, 69 per cent of pharmacists said their pharmacy had faced significant difficulties sourcing locum cover to deal with these absences. One contractor accused locum pharmacists of “misusing the situation” by “texting the day before to cancel shifts and then working elsewhere for higher rates”.

Despite these difficulties, 69 per cent of respondents said their pharmacy was managing well overall, compared to 31 per cent who felt the business was struggling to cope or not coping at all.

One respondent said the current situation “has resulted in staff working many additional hours’ unpaid overtime out of professional pride to ensure patients receive their medicines”

Pharmacies ‘already operating on the edge’

Leyla Hannbeck, chief executive of the Association of Independent Multiple Pharmacies, told Pharmacy Network News: “We are being challenged by the impact on our staffing from Omicron infections daily. Our members have both business interruption and collapse down plans but each new day brings a new set of challenges.

“Pharmacies were already operating on the edge of their available capacity with no slack in the system, even as little as one or two absentees can have devastating effect on business as usual and many pharmacies have been forced to close under this regime of test and isolate.”

Pharmacists' Defence Association director Paul Day said: "Insufficient levels of suitably trained and competent staff seem to have been normalised at some pahrmacies and some pharmacists and their teams are already sacrificing their own wellbeing to keep pharmacies safe for patients. Covid-related absences will amplify those already challenging situations."

Mr Day claimed that some employers have forced PDA members to come to work even after testing positive, and that others have been told to use their annual leave to cover the isolation period. 

NPA: Investment needed

Helga Mangion, Policy Manager at the NPA commented: “The sector as a whole is currently under significant pressure with many pharmacies facing challenges in maintaining full services due to the current Omicron wave. 

“The overarching factor in England is the lack of NHS investment in community pharmacy services over the past six years.

“Our members have worked very hard to insulate patients from the effects of staff shortages, but the situation is not sustainable.

Company Chemists’ Association chief Malcolm Harrison said the Omicron wave was having a “significant impact, adding: “We are seeing this across all staff roles and, inevitably, in some cases this has forced closures.

“Unfortunately, this short-term crisis is exacerbating the longer term workforce shortage, making it harder and harder to avoid impacting patients. 

PSNC legal director Gordon Hockey told PNN: “We know that contractors are working tirelessly to keep their doors open through this latest wave, but the NHS needs to take a pragmatic and flexible approach to support pharmacies over the winter.

“PSNC will continue to monitor the situation but, in the meantime, contractors may still seek to use the emergency pandemic provisions to temporarily close or reduce their opening hours."

https://www.pharmacymagazine.co.uk/news/omicron-wave-9-in-10-pharmacies-struggling-with-staff-absences

Scientists at Scripps Research, University of Chicago and Icahn School of Medicine at Mount Sinai have identified a new Achilles' heel of influenza virus, making progress in the quest for a universal flu vaccine. Antibodies against a long-ignored section of the virus, which the team dubbed the anchor, have the potential to recognize a broad variety of flu strains, even as the virus mutates from year to year, they reported Dec. 23, 2021 in the journal Nature.

• Vitamin D, also known as the “sunshine” vitamin, is a fat-soluble vitamin that exists in two main forms: D-2 and D-3.
• As an essential micronutrient and one that is primarily derived from sunlight, vitamin D is important for the development of bones and teeth and the regular functioning of the immune system.
• Beyond these functions, previous studies suggest an association between low vitamin D levels and a higher likelihood of developing cardiovascular disease.
• In a new study, researchers have established that it is worthwhile to check vitamin D levels when assessing a person’s cardiovascular risk.

Worldwide, cardiovascular diseases (CVDs)Trusted Source are one of the leading causes of death. Every year, an estimated 17.9 million people around the world die as a result of complications from heart diseases. For context, this means that CVDs are responsible for 32% of all deaths globally.

Prior studiesTrusted Source show that various factors — such as several health conditions, age, family history, diet, and lifestyle — combine to influence the risk of developing CVD.

Using a novel analytical approach, researchers in Australia have discovered an additional factor that may increase a person’s likelihood of CVD.

Lead author Prof. Elina Hyppönen, director of the Australian Centre for Precision Health at the University of South Australia Cancer Research Institute, outlined the results of the study for Medical News Today,

“We found evidence that vitamin D deficiency can increase blood pressure and the risk of CVD.”

“However,” she added, “increasing vitamin D concentrations will only be helpful for those participants who ‘need it,’ and further benefits from elevating concentrations beyond the nutritional requirement are going to be modest, if they exist.”

The results from the study appear in the European Heart Journal.

The coronavirus that causes COVID-19 can spread to the heart and brain within days of infection and can survive for months in organs, according to a new study by the National Institutes of Health.

The virus can spread to almost every organ system in the body, which could contribute to the ongoing symptoms seen in "long COVID" patients, the study authors wrote. The study is considered one of the most comprehensive reviews of how the virus replicates in human cells and persists in the human body. It is under review for publication in the journal Nature.

"This is remarkably important work," Ziyad Al-Aly, MD, director of the Clinical Epidemiology Center at the Veterans Affairs St. Louis Health Care System in Missouri, told Bloomberg News. Al-Aly wasn't involved with this study but has researched the long-term effects of COVID-19.

"For a long time now, we have been scratching our heads and asking why long COVID seems to affect so many organ systems," he said. "This paper sheds some light and may help explain why long COVID can occur even in people who had mild or asymptomatic acute disease."

The NIH researchers sampled and analyzed tissues from autopsies on 44 patients who died after contracting the coronavirus during the first year of the pandemic. They found persistent virus particles in multiple parts of the body, including the heart and brain, for as long as 230 days after symptoms began. This could represent infection with defective virus particles, they said, which has also been seen in persistent infections among measles patients.

"We don't yet know what burden of chronic illness will result in years to come," Raina MacIntyre, PhD, a professor of global biosecurity at the University of New South Wales, told Bloomberg News.

"Will we see young-onset cardiac failure in survivors or early-onset dementia?" she said. "These are unanswered questions which call for a precautionary public health approach to mitigation of the spread of this virus."

Unlike other COVID-19 autopsy research, the NIH team had a more comprehensive post-mortem tissue collection process, which typically occurred within a day of the patient's death, Bloomberg News reported. The researchers also used a variety of ways to preserve tissue to figure out viral levels. They were able to grow the virus collected from several tissues, including the heart, lungs, small intestine, and adrenal glands.

"Our results collectively show that while the highest burden of SARS-CoV-2 is in the airways and lung, the virus can disseminate early during infection and infect cells throughout the entire body, including widely throughout the brain," the study authors wrote.

Cite this: Coronavirus Can Spread to Heart, Brain Days After Infection - Medscape - Dec 28, 2021.

The Food and Drug Administration has approved tralokinumab for the treatment of moderate to severe atopic dermatitis (AD) in adults whose disease is not well controlled with topical prescription therapies or when those therapies are not advisable.

Administered subcutaneously, tralokinumab is a fully human IgG4 monoclonal antibody that specifically binds to interleukin-13, a key driver of underlying inflammation in AD. The drug, which has been developed by LEO Pharma, comes as a single-dose (150 mg) prefilled syringe with needle guard.

In two pivotal phase 3 trials, ECZTRA 1 and ECZTRA 2, tralokinumab monotherapy was superior to placebo at week 16 for all primary and secondary endpoints. For example, at week 16, for the ECZTRA 1 and 2 monotherapy trials, respectively, 16% and 21% of patients treated with tralokinumab 300 mg every other week achieved clear or almost clear skin (IGA 0/1) versus 7% and 9% with placebo.

In addition, 25% and 33% of patients treated with tralokinumab 300 mg every other week achieved an improvement of 75% or more in the Eczema Area and Severity Index score (EASI-75) versus 13% and 10% with placebo. At 52 weeks, 51% and 60% of patients who responded at week 16 maintained IGA 0/1 response with tralokinumab 300 mg every other week in ECZTRA 1 and 2, respectively.

Trial offers first look at how tralokinumab-treated patients weather COVID-19

Finally, 60% and 57% of patients who responded at week 16 maintained EASI-75 response with tralokinumab 300 mg every other week.

In the drug's third pivotal trial, ECZTRA 3, researchers evaluated the efficacy and safety of tralokinumab 300 mg in combination with topical corticosteroids (TCS) as needed in adults with moderate to severe atopic dermatitis who are candidates for systemic therapy. At week 16, 38% of patients treated with tralokinumab 300 mg every other week plus TCS achieved clear or almost clear skin (IGA 0/1) versus 27% with placebo plus TCS. In addition, 56% of patients treated with tralokinumab 300 mg every other week plus TCS achieved an improvement of 75% or more in the EASI-75 versus 37% with placebo plus TCS. At 32 weeks, 89% and 92% of patients who responded at week 16 maintained response (IGA 0/1 and EASI-75, respectively) with tralokinumab 300 mg every other week.

Cite this: FDA Gives Nod to Tralokinumab for Adults With Moderate to Severe AD - Medscape - Dec 28, 2021.

Topline results from a phase 3 trial of P2B001, a fixed-dose combination of extended release (ER) formulations of pramipexole and rasagiline, showed it was superior to its individual components as a first-line treatment for early Parkinson's disease.

Study participants also reported less daytime sleepiness with P2B001, according to a statement from the drug's manufacturer.

The trial data "support our view that P2B001 can provide clinical benefits comparable to higher doses of commercially available dopamine agonists, while mitigating the side effects typically associated with this class of medicine such as somnolence, orthostatic hypotension, and hallucinations," Sheila Oren, MD, chief executive officer of Pharma Two B, said in a statement.

"This is important for PD patients of all ages and is critical for the elderly, who typically do not tolerate side effects of dopamine agonists," Oren added.

Promising Results

The 12-week, international, randomized, double-blind trial was designed to study the efficacy, safety, and tolerability of P2B001 compared to its individual components and to a calibration arm of pramipexole ER in 544 patients with early PD.

Participants received P2B001, a once-daily ER combination product composed of pramipexole 0.6 mg and rasagiline 0.75 mg; pramipexole ER capsule 0.6 mg once daily; rasagiline ER capsule 0.75 mg once daily; or the currently marketed product pramipexole ER capsules titrated to an optimal dose for each individual patient (1.5 to 4.5 mg).

The adjusted mean change from baseline in total Unified Parkinson's Disease Rating Scale (UPDRS) score was -2.66 points for P2B001 vs pramipexole (P = .0018) and -3.30 points for P2B001 vs rasagiline (P = .0001). There was no significant difference in UPRDRS scores between P2B001 and pramipexole ER.

The adjusted mean change from baseline in the Epworth Sleepiness Scale score for P2B001 vs pramipexole ER was -2.66 points (P < .0001).

Treatment-related adverse events were mostly mild or moderate and were similar among groups.

"The initiation of treatment of patients with Parkinson's disease represents an area of unmet need due to the side effects associated with current treatments," Warren Olanow, MD, professor emeritus of neurology and neuroscience at the Icahn School of Medicine at Mount Sinai in New York City, said in a statement from the manufacturer.

"Based on the data from this well-designed, rigorous, active-controlled study, P2B001 has the potential to become a leading treatment option for PD, particularly as first line therapy for early-stage patients of all ages," Olanow added.

The company plans to file a new drug application in 2022.

Cite this: Positive Phase 3 Topline Results for Early Parkinson's Drug - Medscape - Dec 27, 2021.

The oral Janus kinase 1 inhibitor abrocitinib has been approved in Europe for the treatment of moderate to severe atopic dermatitis (AD) in adults, who are candidates for systemic therapy, the manufacturer announced.

Approval by the European Commission was based on the results of studies that include four phase 3 clinical trials (JADE MONO-1, JADE-MONO-2, JADE COMPARE, JADE REGIMEN) and an ongoing open-label extension study (JADE EXTEND) in over 2,800 patients, according to the Pfizer press release announcing the approval. The approved doses are 100 and 200 mg a day; a 50-mg dose was approved for patients with moderate and severe renal impairment and "certain patients receiving treatment with inhibitors of cytochrome P450 (CYP) 2C19," the release said.

The approval follows a positive opinion by the Committee for Medicinal Products for Human Use of the European Medicines Agency supporting marketing authorization for treating AD, issued in October. It will be marketed as Cibinqo.

Abrocitinib is under review at the Food and Drug Administration. It was approved earlier in 2021 for treating AD in the United Kingdom, Japan, and Korea.
Abrocitinib Approved for Atopic Dermatitis in Europe - Medscape - Dec 13, 2021.

Most of the U.S. will see significant growth in COVID-19 cases during the next four weeks, according to the latest forecasting models by the PolicyLab at Children's Hospital of Philadelphia.

Large metropolitan areas, especially those in the Northeast, are already seeing a major increase in cases following Thanksgiving, and that trend is expected to continue.

"Why? Simply stated, the large amount of Thanksgiving travel and gatherings undermined the nation's pandemic footing and has elevated disease burden in areas of the country that were fortunate to have lower case rates before the holidays," the forecasters wrote.

Case numbers in New York City are expected to double throughout December, the forecasters said. Similar growth could happen across Boston, Philadelphia, and Baltimore.

Overall, COVID-19 cases, hospitalizations, and deaths are rising across the U.S. but remain below levels seen during the summer and last winter's surges, according to The New York Times. The increase is still being driven by the Delta variant, though it remains unclear how the Omicron variant, which has been detected in 27 states, could affect the trends in coming weeks.

During the past week, the U.S. has reported an average of more than 120,000 new cases each day, the newspaper reported, which is an increase of 38% from two weeks ago.

The daily average of COVID-19 hospitalizations is around 64,000, which marks an increase of 22% from two weeks ago. More than 1,300 deaths are being reported each day, which is up 26%.

Numerous states are reporting double the cases from two weeks ago, stretching across the country from states in the Northeast such as Connecticut and Rhode Island to southern states such as North Carolina and Texas and western states such as California.

The Great Lakes region and the Northeast are seeing some of the most severe increases, the newspaper reported. New Hampshire leads the U.S. in recent cases per capita, and Maine has reported more cases in the past week than in any other seven-day period during the pandemic.

Michigan has the country's highest hospitalization rate, and federal medical teams have been sent to the state to help with the surge in patients, according to The Detroit News. Michigan's top public health officials described the surge as a "critical" and "deeply concerning" situation on Friday, and they requested 200 more ventilators from the Strategic National Stockpile.

Indiana, Maine, and New York have also requested aid from the National Guard, according to USA Today. Health officials in those states urged residents to get vaccines or booster shots and wear masks in indoor public settings.

The Omicron variant can evade some vaccine protection, but booster shots can increase efficacy and offer more coverage, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said Sunday.

"If you want to be optimally protected, absolutely get a booster," he said on ABC's "This Week."

In addition, New York Gov. Kathy Hochul has announced a statewide mask mandate, which will take effect on Monday. Masks will be required in all indoor public spaces and businesses, unless the location implements a vaccine requirement instead, the news outlet reported.
Cite this: Major COVID-19 Case Growth Expected in Coming Weeks - Medscape - Dec 13, 2021.

Deploying more emergency medical response teams, reimbursing healthcare providers to counsel Medicaid patients about vaccinations, and an education campaign to stress the importance of immunization are three immediate actions the White House COVID-19 Response Team is taking as winter and the possible spread of the Omicron variant approach.

"We are actively taking steps to stay ahead of Omicron," Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, MPH, said at a Friday press briefing by the White House COVID-19 Response Team and public health officials.

"We are equipped and prepared to fight the Omicron variant head on," she said.

CDC staff already are working with state and local health officials to investigate and conduct contact tracing among the initial cases of the Omicron variant identified in California, Minnesota, New York, and elsewhere across the country.

In the meantime, "We are urging providers to get all eligible Americans boosted right away," Walensky said.

The CDC also is supporting efforts to enhance and optimize genomic sequencing to track the continued emergence of Omicron. Furthermore, she said, "We are continuously monitoring vaccine effectiveness in our real world surveillance studies."

It should be "a matter of days to weeks until we'll know more about transmission and severity of the disease," Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said during the briefing, reiterating the timeline for the essential science and clinical work to be completed.

Creating More Emergency Response Teams

As the scientists work behind the scenes on all things Omicron, the task force announced three specific actions the government will start today in the fight against the SARS-CoV-2 virus.

The three-prong plan centers on expanding teams of emergency volunteers to help treat COVID-19 patients around the country, reimbursing doctors for COVID-19 vaccine counseling, and launching a public education campaign to encourage more eligible Americans to get a booster shot.

Ordering Reinforcements

On December 2, President Joe Biden announced $20 million to strengthen the national Medical Reserve Corps and provide an additional 60 emergency medical response teams to support hospitals and healthcare facilities overwhelmed with COVID-19 patients now and in the coming months.

"The Medical Reserve Corps has dedicated more than [a] million hours to their local COVID-19 response, often working tirelessly at under-resourced health centers and often without much recognition," US Surgeon General Vivek Murthy, MD, MBA, said during the briefing.

The World Health Organization (WHO) on Friday classified a new COVID-19 variant from South Africa as a variant of concern, which means it could be more contagious, cause more severe disease, and reduce the efficacy of vaccines and treatments.

WHO convened an independent group of experts on Friday to assess the new variant based on the rapid increase in COVID-19 infections in South Africa this week. Known scientifically as B.1.1.529, the variant was named Omicron.

"Omicron has some concerning properties. This variant has a large number of mutations, and some of these mutations have some worrying characteristics," Maria Van Kerkhove, PhD, WHO's technical lead on the coronavirus pandemic, said in a video statement.

"Preliminary evidence suggests an increased risk of reinfection with this variant, as compared to other [variants of concern]," WHO said in a statement. "The number of cases of this variant appears to be increasing in almost all provinces in South Africa."

In response, the White House announced new travel restrictions for flights from South Africa, Botswana, Eswatini, Lesotho, Malawi, Mozambique, Namibia, and Zimbabwe. Foreign nationals from those countries will be prohibited from entering the United States.

"These new restrictions will take effect on November 29," President Joe Biden said in a statement. "As we move forward, we will continue to be guided by what the science and my medical team advises."

US Monitoring for Variant

The United States hasn't detected any cases of the new variant yet, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, told CNN. 

Cite this: New COVID Variant of Concern Drives US Travel Bans - Medscape - Nov 26, 2021.

Atrial fibrillation is the most common sustained cardiac rhythm disturbance seen in clinical practice. A number of trials have shown that the condition, which is most prevalent among the elderly, increases the chance of cerebrovascular accidents and of blood clots forming in the heart, increasing total mortality. These aspects are well-established, as is the use of anticoagulants to prevent thromboembolism in individuals with relevant risk scores. Yet although previous research has looked at the association between atrial fibrillation and cognitive decline, no studies to date have explored the effects of oral anticoagulants on the cognitive and functional aspects of patients.

But a Brazilian trial that brings to light the significant effects of anticoagulants on brain health was recently presented at the American Heart Association Scientific Sessions 2021.

The Cognitive Impairment Related to Atrial Fibrillation (GIRAF) study evaluated the effects of the anticoagulants warfarin and dabigatran on cognitive and functional impairment, bleeding occurrence, and cerebrovascular complications. It was led by cardiologist Bruno Caramelli, MD, PhD, associate professor and director of the interdisciplinary medicine in cardiology unit at the Heart Institute (InCor) of the University of São Paulo School of Medicine Clinics Hospital.

"There was no difference between the patients in the dabigatran group and the patients in the warfarin group," he told Medscape Medical News.

The adequate use of anticoagulants can prevent cognitive decline in elderly patients with atrial fibrillation, Caramelli and his colleagues determined after 2 years of follow-up. This conclusion is based on data obtained from scales that measure memory, executive function, language, and attention. All participants completed a series of 90-minute cognitive and functional evaluations at baseline and during follow-up visits. Patients also underwent a brain MRI at baseline and after 2 years to identify possible stroke.

"There was no control group, as it would have been unethical to provide inadequate or incomplete treatment. That's why I can't say for certain that, if well treated, patients won't develop cognitive decline. On the other hand, using historic control data from previous studies allows us to make this inference, which, while speculative, has a good chance of being correct," Caramelli said.

The randomized, multicenter, prospective GIRAF trial evaluated 200 patients (62% male) older than 70 years with confirmed atrial fibrillation. Participants were randomly assigned to a 2-year course of dabigatran 110 mg or 150 mg twice daily, or to warfarin once daily at a dose sufficient to clot the blood. Most were treated at public hospitals in Brazil's Unified Healthcare System.

When designing the study, the investigators were concerned whether they would find tools sensitive enough to assess higher cognitive function.

Cite this: Anticoagulants Can Ease Cognitive Decline in AF Patients - Medscape - Nov 25, 2021.

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, signed off on a recommendation Friday evening to let all US adults get a COVID-19 booster shot.

The endorsement, following a unanimous vote by a panel of CDC advisors earlier in the day backing a third dose of a Moderna or Pfizer mRNA COVID vaccine, now means everyone over the age of 18 is eligible for a booster.

“After critical scientific evaluation, today’s unanimous decision carefully considered the current state of the pandemic, the latest vaccine effectiveness data over time, and review of safety data from people who have already received a COVID-19 primary vaccine series and booster.

"Booster shots have demonstrated the ability to safely increase people’s protection against infection and severe outcomes and are an important public health tool to strengthen our defenses against the virus as we enter the winter holidays. Based on the compelling evidence, all adults over 18 should now have equitable access to a COVID-19 booster dose,” Walensky said in a prepared statement.

Earlier Friday the US Food and Drug Administration (FDA) authorized boosters for both the Pfizer and Moderna vaccines for all adults, setting the stage for the CDC's decision.

The Advisory Committee on Immunization Practices, or ACIP, recommended that the additional dose be given at least 6 months after the second dose.

They also strengthened a recommendation that everyone over the age of 50 should get a third dose of, whether or not they have an underlying health condition that may increase their risk from a COVID-19 infection.

The committee voted 11 to 0 to in favor of both policies.

Reassuring Safety Information

The panel based its decision on the results of a new study of boosters in Pfizer vaccine recipients, as well as reassuring safety information that’s being collected through the CDC and the FDA's monitoring systems.

Pfizer presented the early results from a study of 10,000 people who had all received two doses of its vaccine. Half of the study participants received a third shot, or booster. The other half got a placebo.

The study is ongoing, but so far, six of the people in the booster group have gotten a COVID-19 infection with symptoms compared to 123 people who got COVID-19 in the placebo group, making boosters 95% effective at keeping people from getting sick.

Most people in the study had gotten their original doses about 10 months earlier. They’ve been followed for about 10 weeks since their booster.

Importantly, there were no study participants hospitalized for COVID-19 infections in either the placebo or booster group, indicating that the first two doses were still very effective at preventing severe outcomes from infection.

Cite this: CDC Director Endorses Pfizer, Moderna Boosters for All US Adults - Medscape - Nov 19, 2021.

The antiviral Lagevrio (molnupiravir) is safe and effective at reducing the risk of hospitalisation and death in people with mild to moderate COVID-19 who are at increased risk of developing severe disease, the Medicines and Healthcare products Regulatory Agency (MHRA) announced today.

This follows a rigorous review of its safety, quality and effectiveness by the UK regulator and the government’s independent expert scientific advisory body, the Commission on Human Medicines, making it the first oral antiviral for the treatment of COVID-19 to be approved.

Developed by Ridgeback Biotherapeutics and Merck Sharp & Dohme (MSD), Lagevrio works by interfering with the virus’ replication. This prevents it from multiplying, keeping virus levels low in the body and therefore reducing the severity of the disease.

Based on the clinical trial data, Lagevrio is most effective when taken during the early stages of infection and so the MHRA recommends its use as soon as possible following a positive COVID-19 test and within five days of symptoms onset

Molnupiravir has been authorised for use in people who have mild to moderate COVID-19 and at least one risk factor for developing severe illness. Such risk factors include obesity, older age (>60 years), diabetes mellitus, or heart disease.

Health and Social Care Secretary Sajid Javid said:

“Today is a historic day for our country, as the UK is now the first country in the world to approve an antiviral that can be taken at home for COVID-19. This will be a gamechanger for the most vulnerable and the immunosuppressed, who will soon be able to receive the ground-breaking treatment.

“The UK is leading the way to research, develop and roll out the most exciting, cutting-edge treatments, and my thanks goes to the expert teams at the MHRA and MSD for this triumph, as well as the Antivirals Taskforce who have procured the treatment.

“We are working at pace across the government and with the NHS to set out plans to deploy molnupiravir to patients through a national study as soon as possible

“This antiviral will be an excellent addition to our armoury against COVID-19, and it remains vital everyone comes forward for their life-saving COVID-19 vaccine - particularly those eligible for a booster - to ensure as many people as possible are protected over the coming months.”

Dr June Raine, MHRA Chief Executive, said:

“Following a rigorous review of the data by our expert scientists and clinicians, we are satisfied that Lagevrio (molnupiravir) is safe and effective for those at risk of developing severe COVID-19 disease and have granted its approval.

“Lagevrio is another therapeutic to add to our armoury against COVID-19. It is also the world’s first approved antiviral for this disease that can be taken by mouth rather than administered intravenously. This is important, because it means it can be administered outside of a hospital setting, before COVID-19 has progressed to a severe stage.

“With no compromises on quality, safety and effectiveness, the public can trust that the MHRA has conducted a robust and thorough assessment of the data.”

Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines, said:

“The Commission on Human Medicines and its COVID-19 Therapeutics Expert Working Group has independently reviewed the data and endorses the MHRA’s regulatory approval of Lagevrio.

“In clinical trials, Lagevrio was found to be effective in reducing the risk of hospitalisation or death for at-risk non-hospitalised adults with mild to moderate COVID-19 by 50%.

“Based on this and other data that has been carefully reviewed by the Commission and its expert group, it is clear Lagevrio is another safe and effective treatment to help us in our fight against COVID-19.”

Lagevrio is not intended to be used as a substitute for vaccination against COVID-19.

The government and the NHS will confirm how this COVID-19 treatment will be deployed to patients in due course.

https://www.gov.uk/government/news/first-oral-antiviral-for-covid-19-lagevrio-molnupiravir-approved-by-mhra

Pfizer and BioNTech have also announced that they will be providing the US government with an additional 50 million of the 10 μg doses, with an expected delivery by April 30, 2022.

The success of the COVID-19 messenger RNA (mRNA) vaccines from Pfizer/BioNTech and Moderna has given many HIV advocates hope that a preventive mRNA vaccine is on the horizon.