FDA requested emergency clearance of antiviral drug molnupiravir for COVID



Pharmaceutical companies Merck & Co. and Ridgeback Biotherapeutics announced Monday that they have applied for emergency use authorization from the Food and Drug Administration for molnupiravir, an antiviral drug that promises COVID-19 could soon be treated with a pill.

Molnupiravir, an antiviral pill taken by mouth, is used to treat mild to moderate adult cases of COVID-19 who are at risk of worsening into severe COVID-19 or hospitalization, according to the companies. It was created by researchers at Emory University in Atlanta and is given as four tablets taken twice a day for five days.

An interim analysis of a clinical trial found that the antiviral drug reduced the risk of hospitalization or death by about 50%.

Since the start of the pandemic, public health officials have been hoping for effective antivirals that could help prevent serious infections in people exposed to the SARS-CoV-2 virus. Several existing drugs were tested against the virus early on, but were shown to have no benefit for patients.

In June, the Biden administration allocated $ 3.2 billion to develop an antiviral, saying the drugs would be a crucial part of the fight against the virus.

If the drug receives emergency use authorization, Merck says it will supply approximately 1.7 million doses of molnupiravir to the US government for distribution.

Also in the news:

â–ºAmazon turned the tide on Monday and announced in a blog post that it will allow many technicians and company employees to continue working remotely indefinitely as long as they can get to the office if needed. Previously, most employees had to work in the office at least three days a week after the offices reopened in January.

â–ºPortugal has become the first country in the world to vaccinate 85% of its population against COVID-19.

â–º Almost 90% of Michigan State University students, faculty and staff have been vaccinated against COVID-19, according to university officials.

â–ºThe 125th Boston Marathon, moved from its traditional April date due to coronavirus concerns, was a bit smaller and more subdued than usual on Monday, but featured a familiar finish – with Kenyans claiming the men’s and women’s races . The field of around 20,000 riders was 10,000 fewer than in previous years and started in waves. Crowds along the route were asked to put aside the tradition of providing food and drink to runners.

â–ºThailand will no longer force international visitors from at least 10 low-risk countries – including the United States – to self-quarantine from next month if they are fully vaccinated against COVID-19, said Prime Minister Prayuth Chan-ocha on Monday.

Numbers of the day: The United States has recorded more than 44.3 million confirmed cases of COVID-19 and more than 713,700 deaths, according to data from Johns Hopkins University. Global totals: Over 238.1 million cases and 4.85 million deaths. More than 187 million Americans – 56.4% of the population – are fully immunized, according to the CDC.

What we read: For a while, the vaccine’s rollout in the United States was the envy of much of the world. Since then, the United States has become a global vaccine laggard, with a lower percentage of its population vaccinated than dozens of other countries. Supply is not the problem – a complicated and confusing lack of demand is to blame.

Keep refreshing this page for the latest news. Want more? Sign up for USA TODAY’s Coronavirus Watch newsletter to receive updates direct to your inbox and join our Facebook group.

WHO may recommend additional dose for the elderly or immunocompromised

The World Health Organization has strongly opposed booster injections for the general population, arguing that these doses of COVID-19 vaccines should go to countries with low vaccination rates. But the group seems open to an additional blow for the most vulnerable.

A group of experts advising the WHO recommended that the elderly and those with weakened immune systems receive an extra dose as part of their regular schedule, in line with what many wealthy countries, including the United States, Great Britain and France, have already recommended for their populations.

WHO director of vaccines Dr Kate O’Brien said the goal would be to produce an immune response to protect these people from serious illness, hospitalization and death. She said the third dose should be given between one and three months after the second and stressed that the recommendation does not apply to healthy young adults who have a normal immune response to the vaccination.

Wisconsin mother sues school district after son becomes infected

A Wisconsin woman filed a federal complaint against the Waukesha School District and School Board, claiming her son fell ill after being exposed to a classmate who was showing symptoms of COVID-19 due to lack of protocols district mitigation. Lawyer Frederick Melms filed a complaint on behalf of Shannon Jensen and other parents and students in the K-12 Waukesha School District.

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 Sentry

The battle for ivermectin takes place in New York state

New York State is at the forefront of a national legal battle over the use of an antiparasitic drug, ivermectin, to treat patients with COVID-19. At least 14 lawsuits have sought to force New York hospitals to administer the drug to critically ill COVID-19 patients, court records show. In most cases, family members of patients, many of whom are kept alive with breathing apparatus, have sued hospitals in an attempt to use ivermectin to save their parent or spouse after the failure of ‘other treatments. Hospitals and doctors oppose it, citing in part the potentially far-reaching ethical and medical ramifications of judges overturning health authorities on the safety and effectiveness of drugs. Read more here.

A woman from Dutchess County noted that her 63-year-old husband was among the few breakthrough infections from the COVID-19 vaccine that resulted in serious illness.

“My husband has done everything requested of him by the federal and state New York governments and health departments,” she said. “He deserves an opportunity to live.”

Parents wishing to have their children vaccinated; pediatricians require patience

With an official request submitted last Thursday for the Pfizer-BioNTech COVID-19 vaccine to be used on children aged 5 to 11, more than 28 million children could become eligible to receive the vaccine around Halloween, and those pediatricians and pharmacists are preparing for a crush. But parents should be prepared to wait a few days after the FDA gives its expected green light, experts say, as the system prepares to deliver the new, lower-dose formulation to this age group.

“There will likely be a period when demand exceeds supply, very similar to what we saw with adult doses in December,” said Dr. Shereef Elnahal, CEO of University Hospital in Newark, New Jersey. .

– Elizabeth Weise, USA TODAY

In California, inconsistent schools COVID rules are the norm

While California has a few statewide requirements for all schools, such as requiring all teachers and students in public and private schools to wear face masks indoors, and a vaccination or testing rule. for teachers from mid-October, many other details are left to local school officials. This includes who, when, where, and how to test for COVID-19, and evolving quarantine rules.

Some large urban neighborhoods such as Los Angeles, San Francisco, and Oakland require students to mask themselves for outdoor recess, while many others do not. Some schools have rigorous mandatory on-site COVID-19 testing programs, but many do not.

Statewide, parents who want to see more testing are looking to the Los Angeles Unified School District – the second largest in the country – as a role model. The LA 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 be successful, and we’re just twiddling our thumbs here,” said Samantha Benton, mother of two in Sacramento, where only voluntary testing is offered.

Contribution: The Associated Press



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