Merck Antiviral Drug Moves Closer to Approval
Jeffrey A. SingerA Food and Drug Administration Advisory Panel justapproved, narrowly, the Merck antiviral drug Molnupiravir. This is just step one. We now have to wait for the FDA to decide on emergency use authorization.The U.K. approved Molnupiravir on November 4.Merck applied to the FDA for approval on October 11. Vaccines are the best long ‐term defense against COVID-19, but antivirals are the best first‐line defense, especially when new variants can develop that escape the immunity provided by vaccines.Rather than wait weeks for the vaccine to take effect, antivirals —like antibiotics—work immediately to kill the pathogen.The FDA ’s bureaucratic foot‐dragging must stop, especially with politicians considering reinstating lockdowns and bans on elective procedures.Pfizer submitted its antiviral, Paxlovid, to the FDA on November 20. Let ’s hope the FDA is quicker on Paxlovid—especially since the clinical trials were so impressive that, for ethical reasons, Pfizer interrupted the trial and immediately sought emergency use authorization.
NIH-sponsored study assessed dose in adults fully vaccinated with any EUA or approved COVID-19 vaccine
Individuals with moderate to severe depressive symptoms are more likely to say they believe misinformation about COVID-19 vaccines than those without depressive symptoms, according to areport in JAMA Open Network. Moreover, individuals who believed misinformation about COVID vaccines were less likely to be vaccinated or be willing to get the vaccine.“As such, individuals already burdened with depression may be at a higher risk of COVID-19,” wrote lead author Roy H. Perlis, M.D., M.Sc., of Massachusetts General Hospital and colleagues.The researchers analyzed data from U.S. adults who responded to at least one o...
(New York) — The COVID-19 booster drive in the U.S. is losing steam, worrying health experts who have pleaded with Americans to get an extra shot to shore up their protection against the highly contagious Omicron variant. Just 40% of fully vaccinated Americans have received a booster dose, according to the Centers for Disease Control and Prevention. And the average number of booster shots dispensed per day in the U.S. has plummeted from a peak of 1 million in early December to about 490,000 as of last week. Also, a new poll from The Associated Press-NORC Center for Public Affairs Research found that Americans are mor...
When Jeremy Luban first looked over the genetic sequence of the Omicron variant on his phone one day last November, it was five o’clock in the morning. But even at that hour, the University of Massachusetts virus expert knew right away Omicron was a problem. First, there was the sheer number of new mutations—by some counts, as many as 50, with 30 of them in the critical places that vaccines and drug treatments target. Second, this new version of the SARS-CoV-2 virus seemed to appear out of nowhere, unpredictably and with no immediately obvious connection to previous variants. [time-brightcove not-tgx=”tru...
Condition: COVID-19 Intervention: Behavioral: Telephone call about vaccination Sponsors: Norwegian Institute of Public Health; City of Oslo, Norway Recruiting
Condition: COVID-19 Intervention: Drug: siCoV/KK46 Sponsors: National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia; St. Petersburg Research Institute of Vaccines and Sera Completed
Russia has expanded a domestically developed coronavirus vaccine for children aged 12-17 to include more regions, amid the country’s biggest infection surge yet due to the spread of the highly contagious omicron variant
Germany’s parliament is holding its first debate on a possible wide-ranging coronavirus vaccine mandate