Tag Archives: Pharmaceuticals & Drug Trials

Merck’s COVID-19 antiviral pill is the second authorized by the FDA

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Pfizer's COVID-19 antiviral pill will already have some competition in the US. As the Associated Pressreports, the Food and Drug Administration has given emergency use authorization for Merck's Molnupiravir pill. The treatment limits replication of SARS-CoV-2 by inserting "errors" in the virus' genetic code while an infection is relatively young, ideally preventing mild or moderate cases from becoming severe in high-risk patients.

The medicine might not get as much use as Pfizer's Paxlovid, however. Merck's offering will only be available to those 18 years or older versus 12 years for Pfizer's, as there are concerns it might affect bone and cartilage development in younger patients. There are also warnings against using it during pregnancy or while attempting to conceive — the FDA said people should use birth control both during and after treatment, with women waiting days and men waiting three months.

Molnupiravir also doesn't appear to be as effective as Paxlovid. While Pfizer's solution reduced hospitalization and death by as much as 90 percent, Merck's only managed 30 percent. This pill may become the secondary option, particularly in situations where Paxlovid isn't available. Both companies' products are expected to remain effective against the virus' Omicron variant as they don't target mutating spike proteins.

Still, this might become another useful tool for minimizing COVID-19 hospitalizations and deaths. Pfizer's pill will be the most readily available when the US is ordering enough to treat 10 million patients, but there will be enough of Merck's drug to address 3.1 million. Even if the effectiveness is limited, that could spare hundreds of thousands of people from the worst the disease has to offer.

FDA authorizes Pfizer’s Covid antiviral pill for people 12 and older

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The FDA has issued an emergency authorization for Pfizer's antiviral pill Paxlovid, making it the first oral method for treating mild to moderate cases of COVID-19. The treatment is meant for high-risk people 12 and older who could progress to a more serious COVID infection. The best part? The FDA says it could be available to use within a few days, making it another tool as we face the Omicron variant wave.

Paxlovid is available by prescription only, and it's meant to be taken within five days of first noticing COVID symptoms. According to Pfizer's tests, it can prevent hospitalization or death by 88 percent in high-risk patients. The treatment, which can be prescribed to both vaccinated and unvaccinated people, consists of 30 pills taken over five days. It includes the protein inhibitor nirmatrelvir and rotinavir, which keeps that inhibitor from breaking down in your body. Side effects include an impaired sense of taste, high blood pressure, diarrhea and muscle aches. 

“This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19," Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

So far, the US has ordered enough pills to treat 10 million people, the New York Times reports. The company plans to deliver enough pills to cover 65,000 Americans within a week. And after that, production is expect to ramp up, with 150,000 courses delivered in January and 150,000 in February. It also won't be the only antiviral pill around: Merck's competing treatment is expected to be approved soon, and it'll likely be more readily available than Pfizer's. Merck's option is far less effective, though—tests show it can only prevent hospitalization or death by 30 percent. (Still, that's better than having no treatment.) 

FDA authorizes Pfizer’s Covid antiviral pill for people 12 and older

Posted on by

The FDA has issued an emergency authorization Pfizer's antiviral pill Paxlovid, making it the first oral method for treating mild to moderate cases of COVID-19. The treatment is meant for high-risk people 12 and older who could progress to a more serious COVID infection. The best part? The FDA says it could be available to use within a few days, making it another tool as we face the Omicron variant wave.

Paxlovid is available by prescription only, and it's meant to be taken within five days of first noticing COVID symptoms. According to Pfizer's tests, it can prevent hospitalization or death by 88 percent in high-risk patients. The treatment, which can be prescribed to both vaccinated and unvaccinated people, consists of 30 pills taken over five days. It includes the protein inhibitor nirmatrelvir and rotinavir, which keeps that inhibitor from breaking down in your body. Side effects include an impaired sense of taste, high blood pressure, diarrhea and muscle aches. 

“This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19," Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

So far, the US has ordered enough pills to treat 10 million people, the New York Times reports. The company plans to deliver enough pills to cover 65,000 Americans within a week. And after that, production is expect to ramp up, with 150,000 courses delivered in January and 150,000 in February. It also won't be the only antiviral pill around: Merck's competing treatment is expected to be approved soon, and it'll likely be more readily available than Pfizer's. Merck's option is far less effective, though—tests show it can only prevent hospitalization or death by 30 percent. (Still, that's better than having no treatment.) 

Moderna enters clinical trials for its mRNA-based flu vaccine

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Moderna has injected its mRNA-derived vaccine for the seasonal flu into a human volunteer for the first time as part of a Phase 1/2 clinical study, the company announced on Wednesday. 

This is a very early test for the new vaccine technology, geared primarily towards building a baseline understanding of the treatment's "safety, reactogenicity and immunogenicity," according to a Moderna release. mRNA-1010, as the vaccine has been dubbed, is designed to be effective against the four most common strains of the virus including, A H1N1, H3N2, influenza B Yamagata and influenza B Victoria. 

According to the World Health Organization, these strains cause between 3 and 5 million severe cases of flu every year, resulting in as many as 650,000 flu-related respiratory deaths annually. In the US alone, roughly 8 percent of the population comes down with the flu every winter. The company hopes this vaccine will prove more potent than the current 40 to 60 percent efficacy rate of conventional flu vaccines.  

“We are pleased to have begun this Phase 1/2 study of mRNA-1010, our first mRNA seasonal flu vaccine candidate to enter the clinic. We expect that our seasonal influenza vaccine candidates will be an important component of our future combination respiratory vaccines,” Moderna CEO Stéphane Bancel said. “Respiratory combination vaccines are an important pillar of our overall mRNA vaccine strategy. We believe that the advantages of mRNA vaccines include the ability to combine different antigens to protect against multiple viruses and the ability to rapidly respond to the evolution of respiratory viruses, such as influenza, SARS-CoV-2 and RSV. Our vision is to develop an mRNA combination vaccine so that people can get one shot each fall for high efficacy protection against the most problematic respiratory viruses."

This vaccine has been generated using the same genomic techniques the company utilized to develop its COVID-19 treatment in 2020. The technique works by exploiting the human body's own cells to reproduce snippets of viral DNA to instigate an immune response and prime the body against future infection. Since this method doesn't require the entire virus (either weakened or dead) but rather just a birt of its genetic code, mRNA vaccines could be applied to any number of deadly modern diseases including malaria, TB — even cancer.