- Nearly 4K people may have gotten slightly lower Pfizer COVID-19 dose at a Kaiser Permanente location (fiercehealthcare.com)
Nearly 4,000 people may have received a slightly less than recommended dose of the Pfizer COVID-19 vaccine at a Kaiser Permanente location in California last year. The health system is offering repeat vaccinations to anyone affected...The vaccinations were given at the Kaiser Permanente Walnut Creek Medical Center...Individuals may have received between 0.01 and 0.04 milliliters less than the correct 0.3-ml dose. The health system reportedly said the incident was a misunderstanding among staff, which it has retrained, and is contacting patients about the error...READ MORE
- GlaxoSmithKline rushes to accelerate COVID-19 antibody output amid omicron-driven demand (fiercepharma.com)
GlaxoSmithKline and Vir Biotechnology are rushing to speed up production of their COVID-19 therapy, now that they're the only companies with an antibody that appears to be truly effective against omicron...The FDA...cleared a Samsung Biologics site as a second manufacturing facility to make GSK and Vir’s Xevudy (sotrovimab)...Along with adding the new facility, GSK and Vir worked with external partners to secure additional batches of drug substance to support supply this year...READ MORE
- Pill for treating COVID at home comes to Nevada, but in short supply (reviewjournal.com)
The first pill authorized in the U.S. for treating COVID-19 at home will initially be offered in Nevada primarily to patients in long-term care and skilled nursing facilities because of scarce supplies...The remainder, less than 10 percent of the state’s initial allotment of Pfizer’s antiviral medication Paxlovid, has been given to University Medical Center in Las Vegas and to Renown Regional Medical Center in Reno, members of the Nevada State Board of Pharmacy said...The drug’s authorization is “hands down, next to the vaccine, the most significant milestone in the pandemic,” said Dr. Shadaba Asad, the medical director of infectious disease at UMC...Supplies of the Pfizer pill currently are extremely limited across the country. Nevada’s initial supplies are enough to treat 480 patients, with allocations expected to grow as production ramps up, pharmacy board executive secretary David Wuest said...READMORE
- Moderna vaccine weaker against omicron, but third shot boosts protection (biopharmadive.com)
A booster shot of Moderna's authorized coronavirus vaccine significantly increases antibody levels against the omicron variant, according to the results of laboratory tests the company disclosed... The update comes days after another analysis indicated the initial two-shot regimen is less effective at neutralizing omicron than other variants like delta...As a result of the booster's apparent cross-protection against multiple variants, Moderna said it will focus its efforts away from a more complex "multivalent" shot and toward further study of its existing booster dose formulation. The biotech said it will still develop an omicron-specific booster, however, and aims to begin clinical testing of that in early 2022...READMORE
- COVID vaccines help Pfizer, Moderna reign supreme reputation-wise, but they’re a double-edged sword for J&J and AZ (fiercepharma.com)
Pfizer and Moderna are now two of the leading pharma companies in the U.S. when it comes to public image, thanks to their COVID vaccines. On the flip side, vaccine rivals J&J and AstraZeneca have seen their reputations plummet...This is according to a new survey by market research firm Leger, which looked into how the pharma industry’s reputation has changed during COVID and the creation of new vaccines against the disease...READ MORE
- Judge: FDA Cannot Have Until 2076 to Disclose Pfizer/BioNTech Vaccine Data (biospace.com)
...federal judge in Texas has denied attempts by the U.S. Food and Drug Administration to conceal data on Pfizer’s COVID-19 vaccine. The judicial rule overturned the regulatory agency’s plan to withhold data for up to 55 years...The ruling follows a lawsuit filed by a nonprofit organization called Public Health and Medical Professionals for Transparency, which was formed to promote transparency of the COVID-19 vaccine data used to secure Emergency Use Authorization. In its lawsuit...the PHMPT claimed that under federal law, the data and information in the biological product file that was submitted to the FDA are expected to be available for public disclosure unless extraordinary circumstances have been shown. The judge presiding over the lawsuit agreed...The judge’s ruling demands that the FDA make the data publicly available within a span of eight months...READ MORE
- Pfizer antiviral pills may be risky with other medications (nbcnews.com)Paxlovid (drugs.com)
One of the two drugs in the antiviral cocktail could cause serious interactions with widely used prescriptions, including statins, blood thinners and some antidepressants...the first antiviral pills for Covid-19 promise desperately needed protection for people at risk of severe disease. However, many people prescribed Pfizer’s or Merck’s new medications will require careful monitoring by doctors and pharmacists, and the antivirals may not be safe for everyone, experts caution...could cause severe or life-threatening interactions with widely used medications, including statins, blood thinners and some antidepressants. And the FDA does not recommend Paxlovid for people with severe kidney or liver disease...READ MORE
- Nevada enlisting nursing students for hospital staff crisis (apnews.com)
With Nevada hospitals reporting a staffing “crisis” and health officials reporting COVID-19 patient tallies at pandemic highs, Nevada Gov. Steve Sisolak highlighted a program...to enlist nursing students to help meet the demand for medical providers...“The state continues to work with all of our partners to leverage existing resources and break down barriers so Nevadans in need can access care,” the governor...said on a day that health officials reported what Dr. John Hess, a University of Nevada School of Medicine associate faculty member, called a “challenging time” with case counts “incredibly high right now.”...READ MORE
- Nevada hospitals request state aid as virus strains staffing (apnews.com)
Hospitals throughout Nevada are facing twin challenges as beds fill with COVID-19 patients and staff falls ill from the highly contagious omicron variant...“Nevada is experiencing an abrupt increase in COVID-19 hospitalizations, predominantly in the southern region following the holidays. People are flocking to hospital emergency departments seeking COVID-19 testing, compounding the staffing problem,” they said, describing the second week of January...“Hospitals are not over-run by a COVID-19 surge as much as being understaffed as employees in all fields report being sick and unable to work. This is also further compounded by a significant increase in people coming to the emergency department solely for testing. Hospitals are not testing sites,” the Nevada Hospital Association said...READ MORE
- COVID-19 pills from Pfizer, Merck authorized by FDA in major pandemic milestone (biopharmadive.com)
Paxlovid and molnupiravir are the first oral treatments for COVID-19, potentially valuable new tools as the fast-spreading omicron variant fuels a sharp surge in cases across the U.S...The Food and Drug Administration...authorized the first pill for COVID-19, clearing for emergency use an antiviral treatment from Pfizer at a precarious moment in the two-year-old pandemic. One day later...the agency cleared a second pill developed by Merck & Co...READ MORE