Merck & Co said on Friday updated data from its study of its experimental COVID-19 pill showed the drug was significantly less effective in cutting hospitalizations and deaths than previously reported.
The drugmaker said its pill showed a 30% reduction in hospitalizations and deaths, based on data from 1,433 patients. In October, its data nL1N2QX0QJ showed a roughly 50% efficacy, based on data from 775 patients. The drug, molnupiravir, was developed with partner Ridgeback Biotherapeutics.
The lower efficacy of Merck’s drug could have big implications in terms of whether countries continue to buy the pill. Interim data from 1,200 participants in Pfizer Inc’s trial for its experimental pill, Paxlovid, showed an 89% reduction in hopsitalizations and deaths.
Merck’s shares fell 3.5% to $79.39 in morning trading.
Merck released the data before the U.S Food and Drug Administration published a set of documents on Friday intended to brief a panel of outside experts who will meet on Tuesday to discuss whether to recommend authorizing the pill.
The agency’s staff did not make their own recommendation as to whether the pill should be authorized.
FDA staff asked the panel to discuss whether the benefits of the drug outweigh the risks and whether the population for whom the drug should be authorized should be limited.
They also asked the committee to weigh in on concerns over whether the drug could encourage the virus to mutate, and how those concerns could be mitigated.
Pills like molnupiravir and Paxlovid could be promising new weapons in the fight against the pandemic, as they can be taken as early at-home treatments to help prevent COVID-19 hospitalizations and deaths. They could also become important tools in countries and areas with limited access to vaccines or low inoculation rates.
The Merck and Pfizer pills are cheaper to produce and easier to administer than existing treatment options such as antibody therapies from Regeneron and Eli Lilly, which are mostly administered as intravenous infusions.
The two experimental drugs have different mechanisms of action. Merck’s is designed to introduce errors into the genetic code of the virus. Pfizer’s drug, part of a class known as protease inhibitors, is designed to block an enzyme the coronavirus needs in order to multiply.
Merck filed for a U.S. authorization of molnupiravir on Oct. 11, following the interim data, and submitted the updated data to the FDA this week.
The molnupiravir arm of the study had a hospitalization and death rate of 6.8%, according to the updated data. The placebo group had a hospitalization and death rate of 9.7%.
One patient in the molnupiravir arm died, versus nine in the placebo group.
The United Kingdom conditionally approved molnupiravir, branded as Lagevrio, earlier this month.
Merck expects to produce 10 million courses of the treatment by the end of this year, with at least 20 million set to be manufactured in 2022. It has a contract with the U.S. government to supply as many as 5 million courses at a price of $700 per course. Several other countries have already secured millions of courses of the pill.
Merck has said data shows molnupiravir is not capable of inducing genetic changes in human cells, but men enrolled in its trials had to abstain from heterosexual intercourse or agree to use contraception. Women of child-bearing age also had to use birth control.
Still, the FDA said in its briefing document that there are safety concerns about potential birth defects from the drug and asked the panel to discuss whether the drug should be available to pregnant women.
(Reporting by Manas Mishra in Bengaluru and Michael Erman in New JerseyEditing by Shounak Dasgupta, Frances Kerry and Emelia Sithole-Matarise)
COVID-19 in Nova Scotia, Jan. 21: weekly recap, 94 hospitalized, 601 new cases – Halifax Examiner
There are now now 94 people in hospital who were admitted because of COVID symptoms, 13 of whom are in ICU. Those 57 range in age from 0 to 100 years old, and the average age is 68.
Additionally, there are:
• 73 people admitted to hospital for other reasons but who tested positive for COVID during the admissions screening or who were admitted for COVID but no longer require specialized care
• 113 people in hospital who contracted COVID in the hospital outbreaks
The 94 people now hospitalized because of COVID have the following vaccination status:
The vaccination status of those 94 is:
• 11 (11.7%) have had 3 doses
• 60 (63.8%) have had 2 doses but not 3
• 4 (4.3%) have had 1 dose
• 19 (20.2%) are unvaccinated
Note that only 9.3% of the population is unvaccinated
My very rough calculation of the rate by vaccination status of those hospitalized (based on numbers of the population in each category two weeks ago) is as follows:
• (11) a rate of 6.1 per 100K with 3 doses
• (60) a rate of 9.8 per 100K with 2 doses (but not 3)
• (4) a rate of 5.7 per 100K with 1 dose only
• (19) a rate of 18.0 per 100k unvaccinated
Additionally, the province announced 601 new cases of COVID-19 today. The new cases are people who received a positive PCR test result from a Nova Scotia Health lab; it does not include people who tested positive using a take-home rapid (antigen) test.
By Nova Scotia Health zone, the new cases break down as:
• 269 Central
• 120 Eastern
• 49 Northern
• 163 Western
Public Health estimates that there are 5,241 active cases in the province; the actual number is undoubtedly much higher.
The graph above shows the weekly (Sat-Fri) number of new cases for the duration of the pandemic.
The graph above shows the number of weekly cases (green, left axis) and weekly deaths (red, right axis). If deaths lag three weeks behind cases, we may (nothing is certain) see 10-20 more deaths in the next couple of weeks.
The graph above shows the number of weekly cases (green, left axis) and the number hospitalized on Fridays (orange, right axis) for the duration of the pandemic.
“Active COVID-19 cases at the provincial jail in Burnside are down to 11,” reports Zane Woodford:
The Central Nova Scotia Correctional Facility has had an outbreak since late-December, and Justice Department spokesperson Heather Fairbairn told the Halifax Examiner there have now been a total of 140 cases at the jail.
“As of Jan. 21, there are 11 active cases among those currently in custody at the Central Nova Scotia Correctional Facility,” Fairbairn wrote in an email.
As has been the case throughout, according to Fairbairn, none of the prisoners is in hospital and there are no cases in the jail’s women’s unit.
Fairbairn said since January 1, five people have been approved for temporary absences or early release. The population at the jail, as of January 20, was 223. That means about 63% of prisoners at the facility have had COVID-19.
There are two new cases at ongoing hospital outbreaks, one each at:
• Cape Breton Regional Hospital for a total of fewer than 10 in that ward
• Victoria General for a total of fewer than 10
Vaccination data were not reported today “due to a technical issue.”
The graph above shows the vaccination progress as captured on Fridays through the pandemic, except Thursday for this week. The yellow line is people with at least one dose of vaccine The blue line is people with only one dose. The green line is people with two doses but not three. The grey line is people with three doses. The red line is 80% of the population.
Appointments for boosters are now open to people 30 and over for whom 168 days have passed since their second shot.
Vaccination appointments for people 5 years of age and older can be booked here.
People in rural areas who need transportation to a vaccination appointment should contact Rural Rides, which will get you there and back home for just $5. You need to book the ride 24 hours ahead of time.
There are many drop-in Pfizer vaccine clinics scheduled, starting next week, several for kids five years old and older.
Nova Scotia Health labs completed 3,975 PCR tests yesterday, with a positivity rate of 15.1%.
If you test positive with a rapid (antigen) test, you are assumed to definitely have COVID, and you and your household are to self-isolate as required.
But take-home rapid testing kits are no longer widely available.
Pop-up testing has been scheduled for the following sites:
Halifax Central Library, 11am-6pm
Alderney Gate, 10am-2pm
Glace Bay Legion, 11am-3pm
Halifax Central Library, 11am-6pm
Knights of Columbus (KOC) Hall (New Waterford), 11am-3pm
Halifax Central Library, noon-7pm
Hubbards Lions Club, 11am-3pm
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Mexican president has cardiac catheterization, health said to be good
Mexican President Andres Manuel Lopez Obrador underwent a cardiac catheterization in hospital on Friday and was found to be in good health, the interior ministry said in a statement.
“In this procedure, the heart and the arteries of the president were found to be healthy and functioning appropriately,” the statement said.
Lopez Obrador, 68, who had a serious heart attack in 2013 and recently recovered from his second coronavirus infection, underwent the procedure as part of a check-up every six months that include lab tests, electrocardiograms, stress tests and CT scans, the government said.
The medical team said the latest results indicated the need for a cardiac catheterization, without providing further details on why they performed what they described as a 30-minute procedure.
The government said “no other type of intervention” was needed and that Lopez Obrador was in “perfect health.”
The procedure inserts a thin tube into a large blood vessel leading to the heart and can detect how well the heart is working.
Lopez Obrador said he had mild symptoms from both bouts of COVID-19. In the most recent case earlier this month, he went into isolation for a week before returning to public activities, including lengthy daily news conferences.
On his first day back, he praised honey, pain reliever paracetamol and VapoRub, a topical ointment popular in Mexico, for helping ease his symptoms.
(Reporting by Daina Beth Solomon, Dave Graham and Miguel Angel Gutierrez; Editing by William Mallard)
Small children getting less sick from Omicron; Genetic mutation protects against severe COVID
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.
Small children are getting less sick from Omicron
In very young children, the Omicron variant of the coronavirus causes less severe disease than the Delta variant, according to a new study.
Researchers reviewed data on nearly 80,000 U.S. children under age 5 with a first infection, including 7,201 infected in late December or early January when Omicron was causing more than 90% of cases. After accounting for other risk factors, including medical conditions and socioeconomic circumstances, researchers found children infected during the Omicron surge had a 29% lower risk of emergency department visits, a 67% lower risk of hospitalization, a 68% lower risk of needing intensive care, and a 71% lower risk of needing machines to breathe, compared to children infected with Delta. However, “because of Omicron’s increased transmissibility, the overall number of emergency department visits, hospitalizations, ICU admissions, and mechanical ventilator use in children may still be greater” with Omicron than with Delta, according to a report posted on medRxiv ahead of peer review.
The investigators have also observed that infection rates were disproportionately higher in Black and Hispanic children for both Omicron and Delta for this age group, and the gap widened for infections with Omicron, said study leader Rong Xu of Case Western Reserve University School of Medicine. Not yet published data shows that “children under 5 had the highest infection rate with Omicron” compared to older children and adults in all age groups, she said.
Genetic mutation protects against severe COVID-19
New findings add to evidence that people with a certain version of a gene are less likely to develop severe COVID-19.
Earlier research had identified a specific group of genes, called the OAS1/2/3 gene cluster, as being involved in the risk for severe COVID-19. One version of a gene in that cluster – passed down from Neanderthals – appeared to protect against severe disease, reducing the risk by about 23%. The earlier research was done mainly in people of European ancestry. According to a report published in Nature Genetics, researchers now see the same association of this genetic variant with less severe COVID-19 in people of African ancestry.
“The fact that individuals of African descent had the same protection allowed us to identify the unique variant in the DNA that actually protects from COVID-19 infection,” coauthor Dr. Jennifer Huffman of said in a statement. OAS genes are involved in a cascade of effects that help cells fight viruses, the researchers said. Understanding of these genes and their effect on COVID-19 risks could aid development of future drugs, they added.
Fewer Delta breakthroughs with Moderna vs Pfizer/BioNTech
When the Delta variant of the coronavirus was prevalent in the United States, recipients of two doses of Moderna’s mRNA vaccine were less likely to experience a breakthrough infection – and if they did, were slightly less likely to be hospitalized – than recipients of two doses of the mRNA vaccine from Pfizer and BioNTech, a large study found.
Researchers analyzed health records of more than 637,000 vaccine recipients who were not previously infected with the virus and had not gotten a booster shot. As reported on Thursday in JAMA, breakthrough infections steadily increased every month from July to November 2021, with higher rates in the Pfizer/BioNTech group. In November, there were 2.8 cases among every thousand people vaccinated with the Pfizer/BioNTech shots, compared to 1.6 cases per thousand recipients of the Moderna vaccines. The vaccines protected equally well against death, but the hospitalization rate was 12.7% for infected Moderna recipients and 13.3% for Pfizer/BioNTech recipients. When the researchers compared 62,584 Moderna recipients to a closely-matched equal-sized group of Pfizer/BioNTech recipients, the risk for breakthrough infection was 15% lower in the Moderna group.
“Although there is a difference in breakthrough infections, both vaccines are highly protective against SARS-COV2 infection and especially against the most severe consequences of infection,” said coauthor Pamela Davis of Case Western Reserve University School of Medicine in a statement.
Click for a Reuters graphic on vaccines in development.
(Reporting by Nancy Lapid; Editing by Bill Berkrot)
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