Connect with us

Health

Pfizer says COVID-19 pill near 90% protective against hospitalization, death

Published

 on

Pfizer Inc on Tuesday said its antiviral COVID-19 pill showed near 90% efficacy in preventing hospitalizations and deaths in high-risk patients, and recent lab data suggests the drug retains its effectiveness against the fast spreading Omicron variant of the coronavirus.

The U.S. drugmaker last month said the oral medicine was around 89% effective in preventing hospitalizations or deaths when compared to placebo, based on interim results in around 1,200 people. Data from its final analysis of the trial disclosed on Tuesday includes an additional 1,000 people.

Nobody in the trial who received the Pfizer treatment died, compared with 12 deaths among placebo recipients.

The Pfizer pills are taken with the older antiviral ritonavir every 12 hours for five days beginning shortly after onset of symptoms. If authorized, the treatment will be sold as Paxlovid.

“It’s a stunning outcome,” Pfizer Chief Scientific Officer Mikael Dolsten said in an interview.

“We’re talking about a staggering number of lives saved and hospitalizations prevented. And of course, if you deploy this quickly after infection, we are likely to reduce transmission dramatically,” Dolsten said.

Pfizer also released early data from a second study suggesting that the treatment reduced hospitalizations by around 70% in a smaller trial of standard-risk adults, including some higher-risk vaccinated people.

Pfizer said those results showed a positive trend, but were not statistically significant. They are following the results and plan to release data from the final 20% of participants in the 1,100-patient trial.The trial did not show that the drug alleviated symptoms of COVID-19 in that population.

Dolsten said he expects authorization for use in high-risk individuals from the U.S. Food and Drug Administration and other regulatory agencies soon. He does not believe an FDA advisory panel meeting will be needed.

“We’re in very advanced regulatory dialogues with both Europe and the UK, and we have dialogues with most of the major regulatory agencies globally,” Dolsten said.

‘VERY EXCITING RESULTS’

Pfizer submitted data to the FDA last month, asking for emergency use authorization (EUA) of the drug.

“These are very exciting results,” said Dr. Paul Sax, a professor at Harvard Medical School.

Sax said the FDA should try to accelerate the authorization process as much as possible, noting there are very limited treatment options for high-risk people outside of the hospital.

There are currently no oral antiviral treatments for COVID-9 authorized in the United States.

Analysts on average forecast 2022 revenue of more than $24 billion from the pill, which would more than make up for any decline in vaccine sales after 2021.

Rival Merck & Co has asked for an EUA for its antiviral pill molnupiravir. But that drug only reduced hospitalizations and deaths in its clinical trial of high-risk patients by around 30%.

Some scientists have also raised safety concerns about the potential for birth defects from the Merck drug, as well as worries that it could cause the virus to mutate.

Pfizer’s treatment works differently. It is part of a class of drugs called protease inhibitors currently used to treat HIV, hepatitis C and other viruses.

Recent laboratory testing showed that activity against the protease of the Omicron variant is as “good as basically any SARS-COV-2 variant of concern,” Dolsten said.

The company has said it can have 180,000 treatment courses ready to ship this year and plans to produce at least 80 million more in 2022.

Dolsten said Pfizer is looking to expand that output further as new variants, like the newly-discovered Omicron, could push the need for antivirals substantially higher. Current vaccines appear to be less effective at preventing infection with Omicron.

Pfizer, which makes one of the leading COVID-19 vaccines with German partner BioNTech, has agreed to allow generic manufacturers to supply versions of the drug to 95 low- and middle-income countries through a licensing agreement with international public health group Medicines Patent Pool (MPP). However, Dolsten said that for next year he expects the drug will be mainly produced by Pfizer.

The MPP told Reuters in a statement, that it will be “well into next year” before pills produced by generic manufacturers under its licenses will be ready for use.

The U.S. government has already secured 10 million courses of the Pfizer treatment for $5.29 billion.

(Reporting by Michael Erman in New Jersey and Deena Beasley in Los Angeles, Additional reporting by Mrinalika Roy in Bengaluru and Francesco Guarascio in Brussels; Editing by Nick Zieminski and Bill Berkrot)

Health

Third COVID-19 outbreak declared this month at Cambridge Memorial Hospital – TheRecord.com

Published

 on


Cambridge Memorial Hospital (CMH) has declared its third COVID-19 outbreak of the month.

The outbreak was announced on Jan. 18 in medicine B (wing B, level 4) with two patients and one staff member testing positive.

A hospital outbreak is declared when two or more patients and/or staff test positive for a respiratory illness that was acquired in hospital within a time frame that is consistent with the epidemiology of the disease, and when there is a link between the cases.

According to CMH, safety precautions added include: enhanced surveillance by increased swabbing and testing non-infected patients and staff; enhanced cleaning, especially to high touch areas; and visits to inpatients have been paused for the entire hospital as of Jan. 8.

Virtual visits and phone connections for patients and families can be arranged.

The outbreak in medicine B could be declared over on Jan. 28 after 10 consecutive days with no new infections.

The hospital is still in outbreak in two other units, rebab and inpatient surgery.

The rehabilitation unit outbreak was declared Jan. 4.

As of Jan. 19, 12 patients and three staff have been infected, with the last positive test detected on Jan. 16, targeting the earliest possible end date at Jan. 26 if there are no new cases.

The inpatient surgery outbreak was declared Jan. 7 and at this time, seven patients and six staff have been infected. The last positive test was detected on Jan. 15, which targets the outbreak’s end date at Jan. 25 should there be no new cases.

Adblock test (Why?)



Source link

Continue Reading

Health

Those who had COVID-19 and are vaccinated have best protection, study finds – National | Globalnews.ca – Globalnews.ca

Published

 on


A new study in two states that compares coronavirus protection from prior infection and vaccination concludes getting the shots is still the safest way to prevent COVID-19.

The study examined infections in New York and California last summer and fall and found people who were both vaccinated and had survived a prior bout of COVID-19 had the most protection.

But unvaccinated people with a past infection were a close second. By fall, when the more contagious delta variant had taken over but boosters weren’t yet widespread, that group had a lower case rate than vaccinated people who had no past infection.

Read more:

Vaccination may lower risk of ‘long COVID’ studies say — but experts aren’t so sure

The Centers for Disease Control and Prevention, which released the study Wednesday, noted several caveats to the research. And some outside experts were cautious of the findings and wary of how they might be interpreted.

“The bottom line message is that from symptomatic COVID infection you do generate some immunity,” said immunologist E. John Wherry of the University of Pennsylvania. “But it’s still much safer to get your immunity from vaccination than from infection.”

Vaccination has long been urged even after a prior case of COVID-19 because both kinds of protection eventually wane — and there are too many unknowns to rely only on a past infection, especially a long-ago one, added immunologist Ali Ellebedy at Washington University in St. Louis.

“There are so many variables you cannot control that you just cannot use it as a way to say, `Oh, I’m infected then I am protected,”’ Ellebedy said.


Click to play video: 'Quebec’s COVID-19 death toll highest in the country'



1:56
Quebec’s COVID-19 death toll highest in the country


Quebec’s COVID-19 death toll highest in the country

The research does fall in line with a small cluster of studies that found unvaccinated people with a previous infection had lower risks of COVID-19 diagnosis or illness than vaccinated people who were never before infected.

The new study’s findings do make sense, said Christine Petersen, a University of Iowa epidemiologist. She said a vaccine developed against an earlier form of the coronavirus is likely to become less and less effective against newer, mutated versions.

However, experts said, there are a number of possible other factors at play, including whether the vaccine’s effectiveness simply faded over time in many people and to what extent mask wearing and other behaviors played a part in what happened.

Another thing to consider: The “staunchly unvaccinated” aren’t likely to get tested and the study only included lab-confirmed cases, Wherry said.

“It may be that we’re not picking up as many reinfections in the unvaccinated group,” he said.

Read more:

4,132 people in Ontario hospitals with COVID, 589 in intensive care

CDC officials noted other limitations. The study was done before the omicron variant took over and before many Americans received booster doses, which have been shown to dramatically amplify protection by raising levels of virus-fighting antibodies. The analysis also did not include information on the severity of past infections, or address the risk of severe illness or death from COVID-19.

The study authors concluded vaccination “remains the safest strategy” to prevent infections and “all eligible persons should be up to date with COVID-19 vaccination.”

The researchers looked at infections in California and New York, which together account for about 18 per cent of the U.S. population. They also looked at COVID-19 hospitalizations in California.

Overall, about 70 per cent of the adults in each state were vaccinated; another five per cent were vaccinated and had a previous infection. A little under 20 per cent weren’t vaccinated; and roughly five per cent were unvaccinated but had a past infection.


Click to play video: 'Toronto to collect COVID-19 data through wastewater'



1:49
Toronto to collect COVID-19 data through wastewater


Toronto to collect COVID-19 data through wastewater

The researchers looked at COVID-19 cases from the end of last May until mid-November, and calculated how often new infections happened in each group. As time went on, vaccine-only protection looked less and less impressive.

By early October, compared with unvaccinated people who didn’t have a prior infection, case rates were:

— Six-fold lower in California and 4.5-fold lower in New York in those who were vaccinated but not previously infected.

— 29-fold lower in California and 15-fold lower in New York in those who had been infected but never vaccinated.

— 32.5-fold lower in California and 20-fold lower in New York in those who had been infected and vaccinated.

But the difference in the rates between those last two groups was not statistically significant, the researchers found.

Hospitalization data, only from California, followed a similar pattern.

© 2022 The Canadian Press

Adblock test (Why?)



Source link

Continue Reading

Health

Over 1.2 million people died from drug-resistant infections in 2019 – study

Published

 on

More than 1.2 million people died in 2019 from infections caused by bacteria resistant to multiple antibiotics, higher than HIV/AIDS or malaria, according to a new report published on Thursday.

Global health officials have repeatedly warned about the rise of drug-resistant bacteria and other microbes due to the misuse and overuse of antibiotics, which encourages microorganisms to evolve into “superbugs”.

The new Global Research on Antimicrobial Resistance report, published in The Lancet, revealed that antimicrobial resistance (AMR) was directly responsible for an estimated 1.27 million deaths and associated with about 4.95 million deaths. The study analysed data from 204 countries and territories.

“These new data reveal the true scale of antimicrobial resistance worldwide… Previous estimates had predicted 10 million annual deaths from AMR by 2050, but we now know for certain that we are already far closer to that figure than we thought,” said Chris Murray, co-author of the study and a professor at the University of Washington.

Last year, the World Health Organization warned that none of the 43 antibiotics in development or recently approved medicines were enough to combat antimicrobial resistance.

Cornelius Clancy, professor of Medicine at the University of Pittsburgh, said one of the ways to tackle AMR is to look at a new treatment model.

“The traditional antibiotic model that we’ve had for past number of decades since penicillin. I think it is tapped out.”

Most of 2019’s deaths were caused by drug resistance in lower respiratory infections such as pneumonia, followed by bloodstream infections and intra-abdominal infections.

AMR’s impact is now most severe in Sub-Saharan Africa and South Asia, while around one in five deaths is in children aged under five years.

There was limited availability of data for some regions, particularly many low and middle-income countries, which may restrict the accuracy of the study’s estimates.

Clancy said the focus has been on COVID-19 for the past two years, but AMR is a “long-term kind of challenge”.

 

(Reporting by Mrinalika Roy in Bengaluru; Editing by Krishna Chandra Eluri and Devika Syamnath)

Continue Reading

Trending