Pill treating Covid-19 cuts risk of death in half

Merck and Ridgeback Biotherapeutics will seek emergency authorization 'as soon as possible'
Originally Published: 01 OCT 21 04:30 ET
Updated: 01 OCT 21 16:04 ET

(CNN) — A pill has cut the risk of hospitalization or death from Covid-19 by half in a study, Merck and Ridgeback Biotherapeutics said Friday.

It would become the first oral medicine that fights viral infection for Covid-19 if approved by the US Food and Drug Administration for emergency use authorization.

Also on Friday, California Gov. Gavin Newsom said his state will become the nation’s first to require Covid-19 vaccinations for students.

The mandate will be a condition of in-person attendance for the 6 million students in the state’s public schools. Independent study is an option for those unvaccinated, Newsom’s office said in a release.

Previously required are vaccines against diseases such as diptheria, polio, measles, mumps and chicken pox.

In August, the state required all school staff to either show proof of Covid vaccination or submit to weekly testing.

Merck seeking emergency use authorization ‘as soon as possible’

“At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%,” Merck said in a news release. “7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization (28/385), compared with 14.1% of placebo treated patients (53,377). Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo.”

Merck said it will seek FDA emergency use authorization “as soon as possible.”

Molnupiravir is not a vaccine. It is an oral antiviral, and experts have said developing such a drug could be the next chance to thwart Covid-19. A short-term regimen of daily pills would aim to fight the virus early after diagnosis and prevent symptoms from developing after exposure.

Merck has been producing doses while awaiting the study results and expects to produce 10 million by the end of the year.

One antiviral drug has been approved to treat Covid. Remdesivir is given intravenously to sick patients in the hospital. It is not meant for early, widespread use.

Vaccination still the best tool, White House official says

The announcement by Merck is “very good news,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Friday in a White House Covid-19 briefing.

“The news of the efficacy of this particular antiviral is obviously very good news,” Fauci said. “The company, when they briefed us last night, had mentioned that they will be submitting their data to the FDA imminently.”

The best way to think about the antiviral, when it is authorized or approved, is as an additional tool, White House Covid-19 Response Coordinator Jeff Zients added.

“If approved, I think the right way to think about this is this is a potential additional tool in our toolbox to protect people from the worst outcomes of Covid,” Zients said. “I think it’s really important to remember that vaccination, as we’ve talked about today, remains far and away our best tool against Covid-19. It can prevent you from getting Covid in the first place. And we want to prevent infections, not just wait to treat them once they happen.”

Some states are seeing increased vaccinations

Meanwhile, more states and health care systems are moving toward mandatory inoculations for certain workers. Officials hope the incentive of employment will eliminate hesitancy over Covid-19 vaccines — while one governor is making contingency plans.

Connecticut Gov. Ned Lamont has instructed the National Guard to prepare in case of staffing shortages when a mandate and testing requirement go into effect at the end of Monday. State employees must provide proof of vaccination or submit to weekly tests; those who don’t will be put on unpaid leave.

As of Thursday, more than 63% — 20,000 employees — were fully vaccinated, while 12% of employees have started weekly testing, Lamont said. More than 8,000 non-compliant employees remain, yet some 2,000 have updated their status in the last two days.

“We have provided most state employees with the option to get tested weekly instead of getting vaccinated, providing more flexibility than our neighboring states. We have also provided our employees with a compliance grace period. There is no reason all our employees should not be in compliance,” Lamont said.

Connecticut is one of several states that face pushback over mandating vaccinations for critical workers. Health experts say it is necessary to protect people at a higher risk for Covid-19. But it has been met with resistance from a minority wishing to remain unvaccinated and in their current roles.

In Rhode Island, the Health Department announced in August that “all employees, interns, and volunteers in RIDOH-licensed healthcare facilities” would be required to get their first dose of the vaccine by Friday.

Care New England, one of the largest hospital systems in the state, reported Thursday more than 95% of its health care employees have been vaccinated. Staff vaccination “continues to climb by the day and the hour,” said CEO James E. Fanale.

The deadline has passed in other states. California’s 2 million health care workers needed to be vaccinated by Thursday or risk losing their jobs, with exemptions available for religious beliefs or qualifying medical reasons.

In New York, none of the health care facilities shut down as a result of vaccine mandates for workers, Gov. Kathy Hochul said Thursday. Earlier this week, it was reported 92% of nursing home staff, 89% of adult care facilities staff, and 92% of hospital staff have received at least one dose statewide.

“You will see that number go higher quickly, because what we’re finding is, you know, as more people are furloughed or suspended, that that number is going to go up,” Hochul said.

A group of public school teachers asked the Supreme Court on Thursday to block the New York City vaccine mandate set to go into effect Friday afternoon.

New York City’s teachers are now 93% vaccinated, with the deadline approaching at the end of the day, Mayor Bill de Blasio said Friday morning.

New York City Schools Chancellor Meisha Porter does not expect to have a shortage of teachers on Monday after a vaccine mandate for educators goes into effect, she said.

“We have more subs that are vaccinated than unvaccinated. Teachers and our superintendents have been working with our principals to develop plans to ensure our students get the education and continue to get the education they deserve in person,” Porter told CNN.

Vaccines for younger kids be available soon, but poll finds hesitancy remains

The resumption of in-person learning in schools has already been complicated by Covid-19 outbreaks and the quarantining of exposed students and staff.

Yet despite evidence vaccinations are lowering infections and severity among eligible age groups, hesitancy remains among some parents about inoculating children 5 to 11, a survey says.

One-third of parents of 5- to 11-year-olds say that they will vaccinate their child as soon as possible, according to the Kaiser Family Foundation Vaccine Monitor on Thursday. A similar percentage, 32%, say that they will wait and see how the vaccine is working, and 24% say that they definitely won’t get their kids vaccinated.

The bulk of interviews, conducted September 13 to 22 from a sample of more than 1,500 adults, were before Pfizer announced that clinical trials showed their Covid-19 vaccine was safe and generated an immune response in this age group.

The Pfizer/BioNTech vaccine is approved for people age 16 and older and has an emergency use authorization for people ages 12 to 15.

Friday, the FDA announced two meetings of its vaccine advisers, including one October 26 to discuss Pfizer’s Covid-19 vaccine for children 5 to 11. Pfizer has submitted data about the age group to the agency but has not yet formally requested emergency use authorization.

The group of advisers will also meet October 14 and 15 to discuss boosters for the two-dose Moderna Covid-19 vaccine and Johnson & Johnson’s single-shot vaccine. The agency added the group will also discuss data on “mix and match” boosters.

Among those already eligible for vaccines, the latest data from the US Centers for Disease Control and Prevention shows nearly 200 million US adults have gotten at least one dose of the vaccine. Nearly 67% of US adults are fully vaccinated.

Death rates in non-metropolitan areas are higher, study finds

Researchers are looking at the pandemic’s effects on different parts of the nation.

Deaths from Covid-19 in non-metropolitan areas are occurring at more than twice the rate in metropolitan areas, according to an analysis of Johns Hopkins University data from the University of Iowa’s Center for Health Policy Analysis.

In the two weeks ending September 15, non-metropolitan areas had an average of 0.85 Covid-19 deaths for every 100,000 residents. Metropolitan areas had an average of 0.41.

Deaths in non-metropolitan areas have outpaced those in metropolitan areas consistently since the beginning of the study in April 2020. The numbers from September 15 are the fourth time the non-metro death rate has been at least double the metro. The non-metro rate had not doubled the metro since December 1.

Correction: An earlier version of this story incorrectly identified a drug maker involved in the production of molnupiravir. It is Ridgeback Biotherapeutics.

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