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Pharmaceutical companies Merck & Co. and Ridgeback Biotherapeutics announced Monday they requested emergency use authorization to the Food and Drug Administration for molnupiravir, an antiviral drug that offers the promise that COVID-19 could soon be treated by a pill.
Molnupiravir, an orally ingested antiviral pill, is used to treat mild to moderate adult cases of COVID-19 that are at risk of worsening to severe COVID-19 or hospitalization, according to the companies. It was created by researchers at Emory University in Atlanta and is given as four pills taken twice a day for five days.
An interim analysis from a clinical trial found the antiviral medicine reduced the risk of hospitalization or death by approximately 50%.
Since early in the pandemic, public health officials have hoped for effective antivirals that could help prevent severe infection in people exposed to the SARS-CoV-2 virus. Several existing drugs were tested against the virus early on but shown to have no benefit for patients.
In June, the Biden administration allocated $3.2 billion toward the development of an antiviral, saying the drugs would be a crucial part of the fight against the virus.
If the medicine receives emergency use authorization, Merck says it will supply about 1.7 million doses of molnupiravir to the U.S. government for distribution.
Also in the news:
►Amazon reversed course Monday and announced in a blog post that it will allow many tech and corporate workers to continue working remotely indefinitely as long as they can commute to the office when necessary. Previously, most employees were expected to work in the office at least three days a week after offices reopened in January.
►Portugal became the world's first country to vaccinate 85% of its population against COVID-19.
►Nearly 90% of students, faculty and staff at Michigan State University have been vaccinated for COVID-19, according to university officials.
►The 125th Boston Marathon, moved from its traditional April date because of coronavirus concerns, was a bit smaller and more subdued than usual Monday but featured a familiar finish – with Kenyans claiming the men's and women's races. The field of about 20,000 runners was 10,000 less than previous years and started in waves. Crowds along the route were asked to shelve the tradition of offering food and drinks to the runners.
►Thailand will no longer require international visitors from at least 10 low-risk nations – including the U.S. – to quarantine beginning next month if they are fully vaccinated for COVID-19, Prime Minister Prayuth Chan-ocha said Monday.
📈Today's numbers: The U.S. has recorded more than 44.4 million confirmed COVID-19 cases and more than 713,900 deaths, according to Johns Hopkins University data. Global totals: More than 238.2 million cases and 4.85 million deaths. More than 187 million Americans – 56.4% of the population – are fully vaccinated, according to the CDC.
📘What we're reading: For a time, the U.S. vaccine rollout was the envy of much of the world. Since then, the United States has become a global vaccine laggard, the percentage of its population inoculated lower than dozens of other nations. Supply isn’t the problem — a complicated and confounding lack of demand is to blame.
Texas Gov. Greg Abbott orders ban on COVID-19 vaccine mandates
Texas Gov. Greg Abbott, an avowed opponent of vaccine and mask mandates, doubled down Monday when he issued an executive order banning vaccine requirements in the state.
The order forbids any entity to compel vaccination of state residents, "including an employee or consumer, who objects to such vaccination for any reason of personal conscience, based on a religious belief, or for medical reasons, including prior recovery from COVID-19.''
Abbott also asked the Texas legislature to add the ban as an agenda item to be considered during its Third Special Session and make it a law.
Making vaccination a condition of employment has proven effective at convincing those who are reluctant to get the shots in many parts of the country, but Abbott maintains they should not be mandatory.
"The COVID-19 vaccine is safe, effective, and our best defense against the virus, but should remain voluntary and never forced," he said.
WHO may recommend extra dose for those older or immunocompromised
The World Health Organization has steadfastly opposed booster shots for the general population, arguing that those doses of COVID-19 vaccines should go to countries with low vaccination rates. But the group appears open to an extra shot for the most vulnerable.
An expert group advising the WHO has recommended that older people and those with compromised immune systems get an extra dose as part of their regular schedule, in line with what many wealthy countries including the U.S., Britain and France have already recommended for their populations.
The WHO’s vaccines director, Dr. Kate O’Brien, said the objective would be to produce an immune response to protect those people from severe disease, hospitalization and death. She said the third dose should be given between one to three months after the second and emphasized that the recommendation does not apply to healthy, younger adults who have a normal immune response to vaccination.
Wisconsin mother sues school district after her son is infected
A Wisconsin woman has filed a federal lawsuit against the Waukesha School District and school board saying her son got sick after being exposed to a classmate who had COVID-19 symptoms because of the district's lack of mitigation protocols. Attorney Frederick Melms filed the lawsuit on behalf of Shannon Jensen and other parents and K-12 Waukesha School District students.
The board removed a mask requirement and many other COVID-19 mitigation measures that were in place for most of the 2020-21 school year, according to the lawsuit. School officials declined to comment.
– Alec Johnson, Milwaukee Journal Sentinel
Ivermectin battle being waged in New York state
New York state is on the front lines of a national legal battle over the use of an anti-parasitic drug, ivermectin, to treat COVID-19 patients. At least 14 lawsuits have sought to force New York hospitals to administer the drug to severely ill COVID-19 patients, court records show. In most cases, family members of patients, many of them kept alive by breathing machines, sued hospitals to try to use ivermectin to save their parent or spouse after other treatments failed. Hospitals and doctors are opposed, citing in part the potentially far-reaching ethical and medical ramifications of judges overruling health officials on the safety and effectiveness of drugs. Read more here.
One Dutchess County woman noted her husband of 63 years was among the rare COVID-19 vaccine breakthrough infections that resulted in a serious illness.
“My husband has done everything he was told to do by the federal and New York state governments and health departments,” she said. "He deserves an opportunity to live.”
Parents eager to vaccinate their kids; pediatricians ask for patience
With an official application submitted last Thursday for the Pfizer-BioNTech COVID-19 vaccine to be used on children ages 5 to 11, more than 28 million kids could become eligible to receive the shot around Halloween, and pediatricians and pharmacists are bracing for a crush. But parents need to be prepared to wait a few days after the FDA gives its expected go-ahead, experts say, while the system gears up to give the new lower-dosage formulation for that age group.
“There is probably going to be a period of time where demand exceeds supply, very similar to what we saw in doses for adults back in December," said Dr. Shereef Elnahal, CEO of University Hospital in Newark, New Jersey.
– Elizabeth Weise, USA TODAY
In California, inconsistent school COVID rules are the norm
While California has a few statewide requirements for all schools, such as requiring all public and private school teachers and students to wear face masks indoors, and a vaccinate-or-test rule for teachers starting in mid-October, many other details are left to local school officials. That includes who, when, where and how to test for COVID-19, and ever-shifting quarantine rules.
Some large urban districts such as Los Angeles, San Francisco and Oakland tell students to mask up for outdoor recess, while many others do not. Some schools have rigorous on-site mandatory COVID-19 testing programs, but many don’t.
Across the state, parents who want to see more testing are looking to the Los Angeles Unified School District – the nation’s second-largest – as a model. The L.A. school district has an ambitious program that mandates weekly on-site testing for all 600,000 students and 75,000 employees.
“It’s crazy that a school district as huge as Los Angeles can pull it off, and we’re just twiddling our thumbs over here,” said Samantha Benton, a mother of two in Sacramento, where only voluntary testing is offered.
Contributing: The Associated Press
This article originally appeared on USA TODAY: FDA asked to emergency authorize antiviral drug molnupiravir for COVID