- 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
- Oxford pauses COVID-19 vaccine study in kids, awaits more data on blood clot issues (reuters.com)Johnson & Johnson's COVID-19 vaccine under scrutiny at EMA after 4 'serious cases' of unusual blood clots (fiercepharma.com)
The University of Oxford said...it had paused a small UK trial testing the COVID-19 vaccine it developed with AstraZeneca Plc in children and teenagers, as it waits for more data on rare blood clotting issues in adults who received the shot...The trial disruption is the latest blow to the vaccine, once hailed as a milestone in the fight against the pandemic, after several countries restricted its use in light of reports of medical issues after inoculations...READ MORE
- Nevada gets $30 million from CDC to help ensure maximum vaccination of the population (thenevadaindependent.com)
Nevada was awarded $30.2 million from the Centers for Disease Control to beef up the state’s COVID-19 vaccine program, including a push to vaccinate communities of color...“Millions of Americans are getting vaccinated every day, but we need to ensure that we are reaching those in the communities hit hardest by this pandemic,” CDC Director Rochelle Walensky said... “This investment will support state and local health departments and community-based organizations as they work on the frontlines to increase vaccine access, acceptance, and uptake.”...READ MORE
- Tracking the success of Johns Hopkins’ high-profile COVID-19 website (healthcareitnews.com)Johns Hopkins Coronavirus Resource Center (coronavirus.jhu.edu)
Here's a look at how it was created, what it offers – and how it grew to reach more than 38 million visits in seven months...Amid the COVID-19 pandemic, Johns Hopkins Medicine needed to provide accurate content very quickly in an information environment that was changing by the hour...In a pre-pandemic world, the organization's content team would look to search engine optimization strategies to see what questions people are asking and determine what information would be most useful. However, that data was just not yet available for COVID-19 when the pandemic hit...READ MORE
- Pfizer and BioNTech request regulatory agencies expand emergency use of their COVID-19 vaccine to adolescents (worldpharmanews.com)
Pfizer Inc. and BioNTech SE...requested amendments to the U.S. Emergency Use Authorization of the Pfizer-BioNTech vaccine (BNT162b2) to expand the use in adolescents 12 to 15 years of age. The companies plan to request similar rulings by other regulatory authorities worldwide in coming days. These requests are based on data from the pivotal Phase 3 trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, which demonstrated 100 percent efficacy and robust antibody response after vaccination with the COVID-19 Vaccine...READ MORE
- Australia calls for release of 3.1 million vaccine doses, if EU not blocking exports (reuters.com)Australia to continue AstraZeneca vaccine rollout, review EU findings (reuters.com)
Australia said on Wednesday it will ask the European Union to release more than 3 million doses of AstraZeneca PLC's COVID-19 vaccine, testing Brussels claim it is not blocking shipments, as the country struggles to vaccinate its population...The European Union...denied blocking vaccine shipments to Australia, which has fallen dramatically behind in its scheduled vaccination programme...READ MORE
- Emergent BioSolutions’ plant behind the lost J&J vaccine batch hit with several FDA red flags last year: report (fiercepharma.com)
With Johnson & Johnson's COVID-19 vaccine rollout off to a slower than expected start, the recent news that millions of doses were ruined in a production error came as a rude awakening. But the Emergent BioSolutions plant at the heart of the issue has faced scrutiny for its shortcomings from federal regulators before...An FDA investigator last April discovered improper training, record keeping, testing procedures and more at Emergent BioSolution's Baltimore Bayview facility...The inspection came just two months before the CDMO snared an eye-popping $628 million deal from the U.S. government to scale up production capacity...READ MORE
- A third of COVID survivors suffer neurological or mental disorders: study (reuters.com)
One in three COVID-19 survivors in a study of more than 230,000 mostly American patients were diagnosed with a brain or psychiatric disorder within six months, suggesting the pandemic could lead to a wave of mental and neurological problems...Researchers who conducted the analysis said it was not clear how the virus was linked to psychiatric conditions such as anxiety and depression, but that these were the most common diagnoses...“Although the individual risks for most disorders are small, the effect across the whole population may be substantial,”...READ MORE
- Big Las Vegas vaccine clinics bustle, but many more doses available (reviewjournal.com)
In stark contrast to earlier this year, Clark County has plenty of COVID-19 vaccine this week, as well as staff to administer it and space in which to do so. Local public health officials now face a different challenge...“Now we need people to come and get vaccinated,” JoAnn Rupiper, chief administrative nurse for the Southern Nevada Health District, said...READ MORE
- Up to 15M Johnson & Johnson coronavirus vaccine doses ruined due to human error: NYT (fiercepharma.com)
Workers at an Emergent BioSolutions plant in Baltimore mixed up vaccine ingredients weeks ago and ruined a large batch of the vaccine containing up to 15 million doses...The FDA is investigating the mistake, but the episode has led to a temporary halt of future J&J shot deliveries from the site...In a statement, J&J said it's working with federal authorities to deliver 24 million doses of the vaccine in April...The mistake happened early in the production process, so none of the doses made it out to distribution...READ MORE