This must have been (maybe still is) a recurring dream among thousands the world over helpless and frustrated by the isolation of COVID-19 lockdowns during dark winter nights and steamy summer afternoons: A little pill that liberates when popped at the outset of the modern-day plague.
Well, it could be happening soon. Pharma major Merck plans to seek authorisation from health officials in the United States (US) and around the world for the first COVID-19 antiviral pill, The New York Times reports. In a clinical trial, Merck’s drug, molnupiravir, has shown it can cut the risk of hospitalisation or death by half when given to high-risk people early into their infections. (https://www.nytimes.com/2021/10/01/us/merck-antiviral-pill-covid.html?)
Merck and its partner Ridgeback Biotherapeutics said early results showed patients who received the drug within five days of COVID-19 symptoms had about half the rate of hospitalization and death as patients who received a dummy pill. The study tracked 775 adults with mild-to-moderate COVID-19 who were considered higher risk for severe disease due to health problems such as obesity, diabetes or heart disease, US National Public Radio said citing an Associated Press report (https://www.npr.org/2021/10/01/1042247080/merck-drug-pill-covid-death-hospitalization-treat?
Among patients taking molnupiravir, 7.3% were either hospitalised or died at the end of 30 days, compared with 14.1% of those getting the dummy pill. There were no deaths in the drug group after that time period compared with eight deaths in the placebo group, according to Merck. The results were released by the company and have not been peer-reviewed.
Merck said an independent board of experts monitoring its study data had recommended that its trial be stopped early because the drug’s benefit to patients had proved so convincing. The company said that the US Food and Drug Administration had agreed with that decision.
Side-effects were reported by both groups in the Merck trial, but they were slightly more common among the group that received a dummy pill. The company did not specify the problems.
Earlier study results showed the drug did not benefit patients who were already hospitalised with severe disease.
The U.S. has approved one antiviral drug, remdesivir, specifically for COVID-19, and allowed emergency use of three antibody therapies that help the immune system fight the virus. Those drugs have been in high demand recently, but they are expensive, are typically given intravenously, and have proved cumbersome and labour-intensive for hospitals and clinics to administer.
Merck’s pill works by interfering with an enzyme the coronavirus uses to copy its genetic code and reproduce itself. It has shown similar activity against other viruses.
Health experts including the top US infectious disease expert Dr Anthony Fauci have long called for a convenient pill that patients could take when COVID-19 symptoms first appear, much the way the decades-old flu medication Tamiflu helps fight influenza. The Merck drug is to be taken as four capsules twice a day for five days.
The US government has placed advance orders for 1.7 million courses of Merck’s drug, at a price of about $700 per patient if it is authorised by the FDA. That is about one-third of the current cost of a monoclonal antibody treatment. Merck has said it can produce 10 million doses by the end of the year and has contracts with governments worldwide. The company has not announced prices.
Several other companies, including Pfizer and Roche, are studying similar drugs that could report results in the coming weeks and months.
Merck had planned to enrol more than 1,500 patients in its late-stage trial before the independent board stopped it early. The results reported Friday included patients enrolled across Latin America, Europe and Africa. Executives estimated about 10% of patients studied were from the US.
And Denmark could provide another answer to those lockdown blues although far more difficult to achieve. Denmark lifted all of its remaining coronavirus restrictions on 10 September, becoming one of few pioneering countries where vaccines now protect a large percentage of the population from severe disease and are entering a momentous transition: From pandemic to endemic COVID-19, when the virus is still there but ceases to be an overriding public health threat, according to a report in the authoritative Science.org (https://www.science.org/content/article/will-pandemic-fade-ordinary-disease-flu-world-watching-denmark-clues?)
As the second coronavirus winter approaches in the Northern Hemisphere, researchers are closely watching what happens next, because it could yield valuable information about what lies ahead for the rest of the world.
Denmark has fully vaccinated more than 88% of people older than 18 and an astonishing 97% of those over 60, the group most vulnerable to serious COVID-19. That allows the country to try to treat SARS-CoV-2 like influenza and other infectious diseases.
That does not mean Denmark is out of the woods. There are still susceptible people, including children and adolescents who aren’t yet fully vaccinated, and people in whom the vaccines have not elicited sufficient immunity. Since the measures were dropped, case numbers have been slowly rising ending a long summer lull. The continuing spread should result in more natural immunity in unvaccinated children and adults, and as vaccine coverage keeps inching upward, hopefully, end in herd immunity next spring.
Denmark started to give booster shots to vulnerable groups in September and has said it expects to give the entire population a third dose eventually. Norway, with similarly high vaccine uptake, followed Denmark’s lead last week. But many countries around the world do not have access to enough vaccines to vaccinate even the most vulnerable groups. And even in Europe, awash in vaccines, few countries are as ready as Denmark to attempt this transition.
Meanwhile, scientists are trying to figure out how endemic COVID-19 will behave. Endemic COVID-19 probably won’t be like measles, which is highly infectious but leaves people immune from infection for life. That results in a childhood disease with a wave every few years, once a large enough new cohort has been born.
With SARS-CoV-2, it’s already clear that immunity from infection wanes. As a result, it might follow the trajectory of the four endemic coronaviruses—which all cause the common cold—in which protection from infection erodes over time, but protection from severe disease does not. That leads to a pattern of a first infection in early childhood, followed by recurring mild infections—like a case of the sniffles—later in life.
Influenza is a more sobering analogy. It, too, causes infections throughout life, but reinfections are often more severe than those caused by the four endemic coronaviruses because the virus evolves faster and escapes host immunity. And Trevor Bedford of the Fred Hutchinson Cancer Research Centre notes that so far, SARS-CoV-2 has evolved about five times faster than H3N2, one of the three influenza types circulating in humans. That rate is likely to slow over time to something comparable to the flu, Bedford says. But given SARS-CoV-2’s high transmissibility and the low vaccine uptake in the US, he thinks it might well infect one-third of the US population every year, causing 50,000 to 100,000 deaths, after society fully reopens.
It’s a grim vision of endemic COVID-19. Measures like better ventilation and even continuing to test, trace, and isolate could reduce the toll, but Bedford doubts there will be any appetite for that, given that the US routinely tallies 30,000 deaths each year from flu. “We never really did anything about it. People still show up to work sick and so forth,” he says. “I don’t know if 50,000 people dying a year of COVID would somehow be different.”
HIV program to get a new head
US President Joe Biden plans to nominate virologist John Nkengasong to direct the President’s Emergency Plan for AIDS Relief—which will make him the first PEPFAR leader of African origin in its 18-year history. Born in Cameroon, Nkengasong is currently the inaugural head of the Africa Centres for Disease Control and Prevention. Through the PEPFAR program, the US government has spent more than $85 billion on programs that have helped more than 50 countries with their HIV/AIDS responses, providing antiretroviral treatment to more than 18 million people. The International AIDS Society said it “applauds the appointment of a leader from the world’s most heavily HIV-affected region where many PEPFAR programs are implemented.” (www.science.org/content/article/news-glance-new-bat-viruses-underground-robot-contest-and-stopping-meningitis)
Push to defeat meningitis starts
The World Health Organization and partners this week announced a plan to eliminate the deadly epidemics of bacterial meningitis that regularly sweep across a swathe of Africa, killing 250,000 annually and leaving half a million more with deafness, cognitive impairment, and other lasting disabilities. The plan targets the four major bacterial causes of meningitis, an inflammation of the membranes that surround the brain and spinal cord. Stopping epidemics will require increasing access to existing vaccines, some of which are pricey; introducing new, affordable vaccines; and improving surveillance and diagnosis. In addition, the plan calls for reducing cases of bacterial meningitis worldwide by 50% and deaths by 70% by 2030. A central focus is improving care for affected people. The road map does not have a price tag yet. (www.science.org/content/article/news-glance-new-bat-viruses-underground-robot-contest-and-stopping-meningitis)
2.2 years of expected life has been lost to COVID-19 for men in 2020, according to a University of Oxford study. Men and women lost ground in most of the 29 countries studied, which included most of Europe. The declines in life expectancy were the largest since World War II and erased years of gains.