For the next several days, the folks who keep up with COVID statistics are taking off work for the holidays.
This comes at a bad time; the East Texas numbers are now going up. Even vaccinated people should wear masks, space out, avoid crowds — especially indoor crowds in buildings with poor ventilation. If you don’t feel well, don’t go out. When in doubt, test if you can find a test. Avoid immunocompromised folks. Avoid sick folks. We still have hospital beds in this area at this time. Most of the new cases are almost certainly Omicron which is probably less lethal than Delta. In the next six months, we will have several new drugs to treat Covid as well as enhanced and available testing capabilities. New vaccines will be developed for any and all of the Variants when and if they appear. The situation is improving. It remains prudent to be vaccinated and boosted.
(FROM THE NYT. WE ARE IN THE EXTREME RISK CATAGORY AGAIN)
Merck says it will have 10 million packs of its new COVID-19 treatment available by the end of the month…The U.S. Food and Drug Administration has authorized the second antiviral pill to treat COVID-19 at home….The medicine, called molnupiravir and made by Merck and Ridgeback Biotherapeutics, is taken twice a day for five days. Merck says it will have 10 million packs available by the end of the month…These new antiviral pills could totally change how people treat COVID-19 infections at home, since the only FDA-authorized treatment for nonhospitalized COVID-19 patients is monoclonal antibodies, which typically require an intravenous infusion.
The agency authorized Pfizer’s Paxlovid treatment for COVID-19 on Wednesday.
FROM HOPKINS CITATIONS:
1. US AUTHORIZES ORAL ANTIVIRALS The US FDA this week authorized the use of 2 oral, at-home antiviral therapies for COVID-19, a significant step in treatment of the disease that comes as the number of new cases begins to surge in the US, driven primarily by the Omicron variant of concern (VOC). The agency today authorized the use of the oral antiviral molnupiravir, developed by Merck and Ridgeback Biotherapeutics, for COVID-19 patients aged 18 years and older who have a positive SARS-CoV-2 viral test result, are within 5 days of symptom onset, are at high risk of severe disease or hospitalization, and who cannot access or do not qualify for alternative authorized COVID-19 treatments. Molnupiravir reduced the risk of hospitalization among high-risk patients by 30%, according to clinical trail data, but some experts are concerned over the potential for side effects and the development of drug resistance. The drug is not recommended for use during pregnancy, and men and women of childbearing age are recommended to use birth control, with men suggested to continue using it for 3 months post-administration. Molnupiravir—administered as capsules taken twice a day for 5 days—works by causing errors in the virus’s genetic code, disabling its reproduction capacity but also raising concerns that it could cause mutations in people who take it or lead to new variants.
On December 22, the FDA authorized the first oral antiviral to treat COVID-19 patients. The emergency use authorization (EUA) is for Pfizer’s Paxlovid—a new antiviral called nirmatrelvir co-packaged with the older antiviral ritonavir—that is taken as tablets twice a day for 5 days. Paxlovid is indicated to treat mild-to-moderate COVID-19 in individuals ages 12 and older weighing at least 40 kg (about 88 pounds) who have a positive SARS-CoV-2 test result and are at high risk of progression to severe disease. Administration of the pills, which are available by prescription only, should be started within 5 days of symptom onset and could be available to patients as early as this weekend, although initial supplies will be limited due to manufacturing constraints. Pfizer’s clinical trial results (not yet peer-reviewed) showed Paxlovid reduced the overall risk of hospitalization by 88% if started within 5 days of symptom onset, and the company’s laboratory studies show the pills should be effective against Omicron.
The authorizations come as healthcare providers face the realization that 2 of the 3 authorized monoclonal antibody treatments—previously shown to be highly effective at keeping high-risk patients out of the hospital—are not working against Omicron. The European Medicines Agency (EMA) has made recommendations for both Paxlovid and molnupiravir (known as Lagevrio outside of the US) for use in certain COVID-19 patients, paving the way for authorization in Europe.
2. CONVALESCENT PLASMA The results of a clinical trial evaluating antibody-rich plasma as an outpatient treatment for people with symptomatic COVID-19 was posted as a preprint to medRxiv on December 21, reopening debate over the use of convalescent plasma therapy. The study, conducted in the US and led by researchers from Johns Hopkins Medicine and the Johns Hopkins Bloomberg School of Public Health, showed outpatient treatment with convalescent plasma, when given within 8 days of symptom onset, reduced the risk of hospitalization by 54% compared with the placebo-control group. The trial primarily used plasma collected before vaccines were widely available and ended prior to the arrival of the Omicron SARS-CoV-2 variant in the US. However, the authors of the study believe that antibody-rich plasma could be an effective treatment against Omicron and other variants if taken from patients who are fully vaccinated and recovered from a breakthrough case of COVID-19. Individuals who fall into this category are believed to have higher levels of neutralizing antibodies than either individuals who are only vaccinated or only recovered from previous infection.
The study’s data come only a few weeks after the WHO recommended against the use of convalescent plasma to treat COVID-19.
”…Conclusions and Relevance The findings of this cohort study suggest that, in the era of available vaccinations and highly transmissible SARS-CoV-2 variants, colleges and universities should continue to test residential students and use mitigation strategies to control on-campus COVID-19 cases.”
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