- U.S. Lifts Pause, Will Restart J&J Vaccinations with Warning (nationalreview.com)FDA, CDC Decide Benefits of J&J Vaccine Outweigh the Risks (biospace.com)
The United States will resume Johnson & Johnson COVID-19 vaccinations after health officials lifted an 11-day pause on the shots at the recommendation of a Centers for Disease Control and Prevention advisory panel...The panel voted 10 to 4 to recommend restarting the vaccinations, saying the benefits of the shot outweigh the rare risk of blood clots. However, the group suggested that the vaccine include a warning about the increased risk of the very rare but severe blood clots...READ MORE
- COVID-19 Pandemic Causes Dramatic Shifts in Prescription Drug Spending (pharmacypracticenews.com)
The COVID-19 pandemic heavily influenced U.S. spending for prescription drugs in 2020, according to ASHP's National Trends in Prescription Drug Expenditures and Projections for 2021...Shifts in care related to the pandemic will be a significant driver of drug expenditures in 2021, along with uptake in the use of biosimilars, a large pipeline of new cancer drugs and increased approvals of specialty medications...Prescription drug spending in 2020 grew at a moderate rate of 4.9% to $535.3 billion. Increased use drove the growth, which accounted for 2.9% of the total increase, according to the report. Spending on new drugs accounted for 1.8% of the increase, and price changes accounted for 0.3%...READ MORE
- How specialty prescription apps are expanding into other services (healthcareitnews.com)
Some companies are betting on telehealth's "gold rush," but virtual care may run into limiting factors...It's become somewhat common in the last year to see news about prescription delivery apps expanding, either to offer more kinds of services or to offer telehealth more generally...Part of this activity is in response to customer demand: Companies say users are increasingly accustomed to a one-stop-shop experience, especially online, and they're starting to expect similar seamlessness from health-and-wellness tools...Another part, of course, stems from the spike in telehealth interest triggered by the pandemic...READ MORE
- CDC, FDA Recommend Pausing J&J COVID-19 Vaccine Rollout Over Blood Clots (biospace.com)J&J says delaying rollout of COVID-19 vaccine in Europe (reuters.com)U.S. FDA to scrutinize vaccine design behind COVID-19 shots linked to blood clots (reuters.com)
The U.S. Centers for Disease Control and Prevention and the U.S. Food and Drug Administration have identified six cases in the U.S. of a “rare and severe” type of blood clot, which seems to be linked to the COVID-19 vaccine by Johnson & Johnson...That is six cases out of more than 6.8 million doses that have been given in the U.S...The blood clots are cerebral venous sinus thrombosis, which were observed in combination with low levels of blood platelets. All cases were in women between 18 and 48 years of age. The symptoms occurred six to 13 days after vaccination...READ MORE
- Johnson & Johnson says it has negotiated Covid-19 vaccine warning label with FDA (msn.com)
Johnson & Johnson said Friday that it has negotiated a warning label for its Covid-19 vaccine to make health care providers aware of a potentially increased risk of rare but severe blood clots and low platelet counts...The vaccine maker revealed the warning text, which it said the Food and Drug Administration had agreed to, during a presentation Friday before a Centers for Disease Control and Prevention vaccine advisory panel...Neither the FDA nor CDC has said they will adopt a warning label...READ MORE
- With less demand for surgical relief during pandemic, Sun cuts poppy production in Tasmania (fiercepharma.com)
For many, the sedative power of poppies was introduced by Dorothy in the Wizard of Oz, galloping through flowers before falling fast asleep...Those blooms now provide raw materials for opioid painkillers used by the millions worldwide. But like the Wicked Witch of the West, who cast that poppy spell on Dorothy, the coronavirus pandemic has put a sleeper hold on the production of poppies for pharmaceutical use...The global demand for opium-based products plummeted last year as COVID forced the cancellation of most elective surgeries, and now, that diminished need for surgical pain relief products has forced Sun Pharma of India to reduce its number of contracted poppy growers in Tasmania and to eliminate two of its field officers...READ MORE
- As blood clot concerns mounted, J&J reached out to rival COVID-19 vaccine makers to form alliance: WSJ (fiercepharma.com)
Johnson & Johnson reached out to vaccine rivals—including AstraZeneca, Moderna and Pfizer—last week, hoping to join forces to study cases of rare and severe blood clots cropping up in some vaccinated people...The goal: to forge an alliance that would communicate the vaccines' benefits and risks to allay fears among the public...Regulators were already investigating a small number of cases possibly linked to AstraZeneca's vaccine...the FDA and its European counterparts said they were examining four cases in people dosed with the J&J shot...READ MORE
- FDA orders shutdown at Emergent’s troubled plant 2 weeks after handing J&J the keys (fiercepharma.com)
Johnson & Johnson’s takeover of COVID-19 vaccine manufacturing at an error-prone Emergent BioSolutions plant in Baltimore didn’t last long...Two weeks after the U.S. stepped in and handed control of vaccine manufacturing at the plant to J&J, Emergent agreed to temporarily halt producing new drug substance there...READ MORE
- More therapeutics but no surge in vaccine for Michigan, Biden administration says (reuters.com)Michigan Governor Says COVID-19 Infections Could Be Dropping (usnews.com)
Michigan Governor Gretchen Whitmer
The White House said on Monday it was prepared to send additional therapeutic treatments to the state of Michigan, which is experiencing a worrying number of COVID-19 cases, but declined to promise more vaccine as the state has sought...White House coronavirus adviser Andy Slavitt told reporters the U.S. government would work to ensure that states such as Michigan were ordering the full amount of vaccine that was available to them but said that shifting distribution was not in line with the administration’s public health strategy...READ MORE
- Pfizer CEO says third Covid vaccine dose likely needed within 12 months (cnbc.com)Moderna watches for 'waning immunity' as new data show durable vaccine protection (biopharmadive.com)
CEO Albert Bourla, Pfizer
Pfizer CEO Albert Bourla said people will "likely" need a booster dose of a Covid-19 vaccine within 12 months of getting fully vaccinated..Bourla said it's possible people will need to get vaccinated against the coronavirus annually..."A likely scenario is that there will be likely a need for a third dose, somewhere between six and 12 months and then from there, there will be an annual revaccination, but all of that needs to be confirmed. And again, the variants will play a key role,"...READ MORE