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Generic drugmakers to sell Pfizer’s Paxlovid for $25 or less in low-income countries

Several generic drugmakers that will produce versions of Pfizer’s COVID-19 antiviral treatment Paxlovid have agreed to sell the medicine in low-income…

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Generic drugmakers to sell Pfizer’s Paxlovid for $25 or less in low-income countries

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NEW YORK, May 12 (Reuters) – Several generic drugmakers that will produce versions of Pfizer’s (PFE.N) COVID-19 antiviral treatment Paxlovid have agreed to sell the medicine in low- and middle-income countries for $25 a course or less, the Clinton Health Access Initiative (CHAI) said on Thursday.

CHAI said it could not disclose the names of the manufacturers who have agreed to the price ceiling, because they are still in the early stage of product development and have not received regulatory approval.

In March, 35 generic drugmakers around the world signed on to make cheap versions of Pfizer’s pills for 95 poorer countries through a licensing arrangement with the U.N.-backed Medicines Patent Pool (MPP). read more

Pfizer sells Paxlovid to the U.S. government for about $530 for a five-day course.

CHAI said the generic drugmakers would dedicate capacity for 4.5 million treatment courses a month for these countries. It said the $25 price ceiling would apply only if there is demand from the poorer countries for at least 1 million treatment courses a year.

In order to guarantee the price, orders need to be for at least 50,000 courses, it said.

The Clinton Health Access Initiative said it also plans to work with donors and governments to raise funds for an advance purchase agreement for the product to meet country needs.

Paxlovid has become an important tool in the fight against COVID-19. In a clinical trial, it reduced hospitalizations in high-risk patients by around 90% when taken for five days shortly after symptoms begin.

Pfizer’s coronavirus disease (COVID-19) pill Paxlovid is packaged in Ascoli, Italy, in this undated image obtained by Reuters on November 16, 2021. Pfizer/Handout via REUTERS

The results were significantly better than for Merck & Co’s (MRK.N) rival antiviral pill molnupiravir in its clinical trial.

Still, as Paxlovid has become more widely used, some patients have reported a recurrence of COVID-19 symptoms after completing the treatment and experiencing improvement. read more

A generic course of molnupiravir is expected to cost about $20 in poorer nations, compared with the roughly $700 per course Merck is charging the United States.

Reporting by Michael Erman Editing by Bill Berkrot

Our Standards: The Thomson Reuters Trust Principles.

 

Reuters source:

https://www.reuters.com/business/healthcare-pharmaceuticals/generic-drugmakers-sell-pfizers-paxlovid-25-or-less-low-income-countries-2022-05-12

 

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Government

FDA to soon authorize Pfizer’s COVID booster shot for younger kids – NYT

U.S. health regulators are expected to authorize a booster shot of Pfizer/BioNTech’s COVID-19 vaccine for children aged 5 to 11 as soon as May 17, the…

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FDA to soon authorize Pfizer’s COVID booster shot for younger kids – NYT

(Reuters) – U.S. health regulators are expected to authorize a booster shot of Pfizer (PFE.N)/BioNTech’s COVID-19 vaccine for children aged 5 to 11 as soon as Tuesday, the New York Times reported on Monday, citing people familiar with the matter.

The companies submitted an application to the U.S. Food and Drug Administration for the authorization last month.

They have cited data from a mid- to late-stage study showing a third dose of their shot increased protection against the original coronavirus version and the Omicron variant among children in the age group. read more

It is unclear how much demand there is for the third dose in the age group. Just 28.8% of children aged 5 to 11 are fully vaccinated, according to data from the U.S. Centers for Disease Control and Prevention.

Empty vials of the Pfizer-BioNTech coronavirus disease (COVID-19) vaccine are seen at The Michener Institute, in Toronto, Canada January 4, 2021 in this file photo. REUTERS/Carlos Osorio/File Photo

A meeting of outside vaccine experts on an advisory committee to the Centers for Disease Control and Prevention has been scheduled for Thursday, the report said.

The FDA declined to comment, while Pfizer and BioNTech did not respond to requests for comment.

Reporting by Mrinalika Roy in Bengaluru; Editing by Anil D’Silva

Our Standards: The Thomson Reuters Trust Principles.

 

Reuters source:

https://www.reuters.com/business/healthcare-pharmaceuticals/fda-authorize-pfizers-covid-booster-shot-younger-kids-soon-nyt-2022-05-16

 

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Government

FDA declines to authorize common antidepressant as COVID treatment

The U.S. Food and Drug Administration decided not to authorize the antidepressant fluvoxamine to treat COVID-19, saying the data has not shown the drug…

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FDA declines to authorize common antidepressant as COVID treatment

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(Reuters) – The U.S. Food and Drug Administration has decided not to authorize the antidepressant fluvoxamine to treat COVID-19, saying that the data has not shown the drug to be an effective therapeutic for fighting the virus.

“Based on the review of available scientific evidence, the FDA has determined that the data are insufficient to conclude that fluvoxamine may be effective in the treatment of nonhospitalized patients with COVID-19 to prevent progression to severe disease and/or hospitalization,” the agency said in a document published on Monday.

University of Minnesota professor Dr. David Boulware submitted the emergency use authorization request to the FDA that would have allowed doctors to prescribe fluvoxamine maleate to treat COVID-19 in non-hospitalized patients.

The generic drug belongs to an old, widely-used class of antidepressants called selective serotonin reuptake inhibitors, or SSRIs.

Boulware said that his request is less urgent with the availability of drugs like Pfizer Inc’s (PFE.N) Paxlovid, but he still believes the data supports the drug’s use in some COVID patients.

“There are effective therapeutics that are available. But not everyone has access to them. Not everyone can tolerate them. Some people have contraindications,” Boulware said in an interview. “And if you go elsewhere in the world, low- and middle-income countries, they have access to no therapeutics.”

Boulware’s submission relied on data from three trials, especially a study of 1,497 non-hospitalized COVID patients in Brazil.

While the Brazilian study met its primary endpoint, showing a roughly 30% drop in hospitalizations in the group that received fluvoxamine, the FDA said there were uncertainties about the assessment, which measured reduction in emergency department visits lasting more than 6 hours.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

Boulware said FDA had used a different measure to count hospitalizations in other drug trials, including only acute care that lasted at least 24 hours.

“The standard that they were holding for fluvoxamine was a different standard than the other big pharma trials, with Paxlovid and (Merck’s) molnupiravir and the monoclonals,” he said of other authorized COVID therapeutics.

“I was really quite disappointed that they did that,” he said.

Reporting by Leroy Leo in Bengaluru and Michael Erman in New Jersey; Editing by Bill Berkrot

Our Standards: The Thomson Reuters Trust Principles.

 

Reuters source:

https://www.reuters.com/business/healthcare-pharmaceuticals/fda-declines-authorize-common-antidepressant-covid-treatment-2022-05-16

 

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Spread & Containment

Coronavirus may be linked to cases of severe hepatitis in children

A chain of events possibly triggered by unrecognized infection with the SARS-CoV-2 coronavirus could be causing the mysterious cases of severe hepatitis…

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Coronavirus may be linked to cases of severe hepatitis in children

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(Reuters) – The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review.

SARS-CoV-2 could be at root of mysterious hepatitis in kids

A chain of events possibly triggered by unrecognized infection with the SARS-CoV-2 coronavirus could be causing the mysterious cases of severe hepatitis reported in hundreds of young children around the world, researchers suggest.

Children with COVID-19 are at significantly increased risk for liver dysfunction afterward, according to a report posted on Saturday on medRxiv ahead of peer review. But most of the children with acute hepatitis – which is generally rare in that age group – do not report a previous SARS-CoV-2 infection. Instead, the majority have been found to be infected with an adenovirus called 41F, which is not known to attack the liver. It is possible that the affected children, many of whom are too young to be vaccinated, may have had mild or asymptomatic COVID infections that went unnoticed, a separate team of researchers suggest in The Lancet Gastroenterology & Hepatology. If that were true, they theorize, then lingering particles of the coronavirus in the gastrointestinal tract in these children could be priming the immune system to over-react to adenovirus-41F with high amounts of inflammatory proteins that ultimately damage the liver.

A firefighter from the Marins-Pompiers of Marseille (Marseille Naval Fire Battalion) administers a nasal swab to a child at a testing site for coronavirus disease (COVID-19) in Marseille, France, September 17, 2020. REUTERS/Eric Gaillard

“We suggest that children with acute hepatitis be investigated for SARS-CoV-2 persistence in stool” and for other signals that the liver damage is happening because the spike protein of the coronavirus is a “superantigen” that over-sensitizes the immune system, they said.

Face-down position unhelpful for awake patients

For hospitalized COVID-19 patients who are breathing on their own but with supplemental oxygen, lying face down might not help prevent them from eventually needing mechanical ventilation, according to a new study.

In the study, 400 patients were randomly assigned to usual care or to standard care plus intermittently lying on their stomach, a position known to improve the course of illness in sedated patients on mechanical ventilators. Over the next 30 days, 34.1% in the prone-positioning group and 40.5% in the usual-care group needed to be intubated and put on a ventilator, a difference that was not statistically significant. There might have been a reduction in the risk for intubation with prone positioning among some of the patients, researchers said on Monday in JAMA, but they could not confirm it statistically from their data. The average duration of prone positioning per day was roughly five hours, less than the target of eight to 10 hours per day.

“Long hours of awake prone positioning are challenging and highly influenced by patient comfort and preference,” the researchers said. “The most common reason for interruption of prone positioning was patient request, which might have been related to overall subjective improvement or related to discomfort from prone positioning.”

Click for a Reuters graphic on vaccines in development.

Reporting by Nancy Lapid and Megan Brooks; Editing by Bill Berkrot

Our Standards: The Thomson Reuters Trust Principles.

 

Reuters source:

https://www.reuters.com/business/healthcare-pharmaceuticals/coronavirus-may-be-linked-cases-severe-hepatitis-children-2022-05-16

 

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