FDA Assessing Risk To Pregnancies From Merck’s Covid Pill
Molnupiravir was supported by a Food and Drug Administration expert panel two weeks ago, but regulators are still concerned of DNA mutation risks during pregnancy. And in concerning news from China, a study says 10% of covid patients may have had incubation periods longer than 14 days.
The New York Times:
Merck’s Covid Pill Might Pose Risks For Pregnant Women
A new Covid-19 pill from Merck has raised hopes that it could transform the landscape of treatment options for Americans at high risk of severe disease at a time when the Omicron variant of the coronavirus is driving a surge of cases in highly vaccinated European countries. But two weeks after a Food and Drug Administration expert committee narrowly voted to recommend authorizing the drug, known as molnupiravir, the F.D.A. is still weighing Merck’s application. Among the biggest questions facing regulators is whether the drug, in the course of wreaking havoc on the virus’s genes, also has the potential to cause mutations in human DNA. Scientists are especially worried about pregnant women, they said, because the drug could affect a fetus’s dividing cells, theoretically causing birth defects. (Mueller, 12/13)
Also —
CIDRAP:
10% Of Chinese COVID Patients May Have Had Incubations Of 14+ Days
A modeling study of COVID-19 patients in China in 2020 published late last week in BMC Public Health estimates that 10% had incubation periods longer than 14 days. The incubation period is the time between infection and symptom onset or diagnosis. A team led by researchers at Fudan University in Shanghai determined that, of 11,425 patients who tested positive from COVID-19 from January to August 2020, 268 (10.2%) had incubation periods longer than 14 days. (12/13)
NBC News:
Doctors Expected MIS-C Cases To Surge After The Delta Wave. They Didn't.
Rates of a rare inflammatory condition tied to Covid-19 in children appear to have dropped in some parts of the country — an unexpected development for many doctors who had been bracing for a rise in cases following the late summer delta wave. "We held our breath for that four to eight weeks after the surge, saying, 'OK, get ready, here comes MIS-C,'" said Dr. Buddy Creech, a pediatric infectious disease expert at the Vanderbilt University Medical Center in Nashville, Tennessee. "It just never materialized." (Edwards, 12/13)
And in updates about covid data —
Fox News:
FDA Faces Legal Challenge Over COVID-19 Approval Data, Report Says
A nonprofit group will get its day in court Tuesday when it argues that the Food and Drug Administration should release all documents tied to the approval of the Pfizer/BioNtech's COVID-19 vaccine, which the plaintiffs claim could take decades to produce, a report said. Public Health and Medical Professionals for Transparency sued the FDA under a Freedom of Information Act and seeks more than 400,000 additional pages about the approval process, Reuters reported. The FDA has offered to release 12,000 pages by the end of January, and "a minimum" of 500 pages a month going forward, which the group said could mean that it may be 2097 before all documents are made public, the report said. (DeMarche, 12/14)
The Gainesville Sun:
University Of Florida Investigating Attempts To Destroy COVID Research
The University of Florida is investigating possible violations of its research integrity policy following a 274-page faculty committee report that included claims of pressure to destroy and barriers to publish COVID-19 data. It is the latest development of the university's academic freedom saga, which began in late October when it became public that multiple professors were restricted from participating in lawsuits against the state. The issue has developed into a nationwide debate over academics, freedom of speech, politics, prestige and money that has reached as far as UF's accreditor and U.S. Congress. (Ivanov, 12/13)
The Baltimore Sun:
Maryland Health Department COVID Data Still Unavailable In Wake Of Cyberattack
Several COVID-19 data points remain missing from the Maryland Department of Health website after a cyberattack earlier this month forced the agency to temporarily take its website offline. The daily COVID-19 hospitalization tally has returned and shows a dramatic increase in volume since the website stopped reporting other disease surveillance numbers such as the daily case count, daily death toll, testing volume and testing positivity rate. Since Dec. 3, hospital bed occupancy has spiked nearly 45%, according to state data. (Miller, 12/13)
