- Pfizer’s COVID-19 vaccine faced EMA manufacturing concerns ahead of emergency nod: report (fiercepharma.com)
About a month before Pfizer and BioNTech won an emergency nod for their COVID-19 vaccine in Europe, regulators raised flags about lower-than-expected levels of intact mRNA in commercial batches, the BMJ reports...The European Medicines Agency outlined “a significant difference" in the RNA in clinical batches and the proposed commercial batches, according to information leaked from an EMA cyberattack in December, which the BMJ subsequently reviewed...While the production issue has since been resolved—and Pfizer's vaccine has since won approval in Europe—the leaks show the “complexities of quality assurance” for mRNA vaccines, especially with regards to RNA instability, the BMJ said. It’s an issue that affects all mRNA developers, including Moderna and CureVac. That instability is the reason for the shots’ frigid cold chain requirements and the need to encapsulate mRNA in lipid nanoparticles, BMJ said...READ MORE
- AstraZeneca’s COVID-19 vaccine faces distrust in Europe, even as it gets rave reviews in neighboring UK, survey finds (fiercepharma.com)
AstraZeneca’s COVID-19 vaccine is facing a wave of mistrust in Europe—but that's a striking difference from its stellar reputation in the U.K...A recent survey from YouGov found that 81% of Britons believe the AZ vaccine is safe, on par with a similar 79% of U.K. citizens who trust the Pfizer vaccine. However, in Germany only 43% think the AZ vaccine is safe, and in France, just 33% consider it safe...READ MORE
- FDA’s inspection woes to grow if agency doesn’t address COVID-19 backlog: GAO (fiercepharma.com)
The Government Accountability Office has concerns about the FDA's widening inspection backlog. COVID-19 certainly amplified the problem, but the issues had been mounting long before last March...As the FDA looks to honor lockdown rules and protect its staffers, the agency has largely paused inspections since the pandemic started last spring, conducting only those deemed “mission-critical.” In fact, the FDA was unable to complete more than 1,000 planned inspections in 2020—and that backlog will likely grow with time, the U.S. Government Accountability Office (GAO) said in a release...READ MORE
- FDA panel endorses Johnson & Johnson vaccine in 22-0 vote (chaindrugreview.com)
The Food and Drug Administration advisory committee endorsed Johnson & Johnson’s coronavirus vaccine late Friday afternoon...The vaccine appears widely effective against the virus and is especially good at preventing severe cases...And because the vaccine is given as a single dose and is easy to ship, it presents an appealing profile for public health officials struggling to vaccinate hard-to-reach or skeptical populations...READ MORE
- Major European nations suspend use of AstraZeneca vaccine (apnews.com)EXPLAINER: Why countries are halting the AstraZeneca shot (apnews.com)
A cascading number of European countries — including Germany, France, Italy and Spain — suspended use of AstraZeneca’s COVID-19 vaccine Monday over reports of dangerous blood clots in some recipients, though the company and international regulators say there is no evidence the shot is to blame...The EU’s drug regulatory agency called a meeting for Thursday to review experts’ findings on the AstraZeneca shot and decide whether action needs to be taken...Germany’s health minister said the decision to suspend AstraZeneca shots was taken on the advice of the country’s vaccine regulator, the Paul Ehrlich Institute, which called for further investigation into seven cases of clots in the brains of people who had been vaccinated...READ MORE
- Nevada COVID-19 vaccinations rise to 1 in 6 people statewide (apnews.com)
Nevada health officials reported Monday that about 1 in 6 people statewide has received at least a first dose of a COVID-19 vaccine since shots became available in mid-December...“I do think progress is starting to finally click and continue to increase,” said James English, COVID-19 response operations chief in Washoe County, where state statistics show 16.8% of residents have received their first shot and 9.8% have been fully vaccinated...READ MORE
- Getting your COVID shot at CVS or Walgreens? Prepare for an onslaught of texts and coupons as the pharmacies plan to use customer data to ‘keep in touch’ and promote services (dailymail.co.uk)
CVS, Walgreens and Walmart are enrolling customers in patient systems in order for them to book vaccine appointments...Perk of data allows these chains to use information to promote their stores and services, which includes coupons and promotions, and tailor marketing...After customers create profiles for Walgreens, they get marketing emails and agree to let Walgreens 'automatically collect information about you'...READ MORE
- Effective March 15: Joint Commission Returning to Unannounced Onsite Surveys (pharmacypracticenews.com)
As the COVID-19 caseload continues to dip across the country, at least one regulatory body—the Joint Commission (TJC)—has taken notice by stepping up its enforcement activities. The group is returning to unannounced, on-site surveys beginning March 15...“Over the last nine months, traditional onsite survey activity has been delayed or interrupted due to the restrictions and strain on the health care system caused by COVID-19,”...READ MORE
- Patent protection barriers not holding back vaccine production: drug groups say (reuters.com)
Manufacturing capacity and ingredients shortages are the main bottlenecks to expanding COVID-19 vaccine production, several global drug groups said...not patents that some critics are demanding be removed...“IP (intellectual property) rights is not the issue,” said Thomas Cueni, who heads the International Federation of Pharmaceutical Manufacturers and Associations...“The bottlenecks are the capacity, the scarcity of raw materials, scarcity of ingredients, and it is about the know-how.”...READ MORE
- J&J Covid-19 Vaccine Authorized for Use in U.S. (msn.com)Johnson & Johnson's COVID-19 vaccine scores FDA authorization, adding key third shot to U.S. supply (fiercepharma.com)
The first single-dose Covid-19 vaccine, a shot from Johnson & Johnson, was authorized for use...the third issued by the U.S. Food and Drug Administration, will give health authorities a desperately needed new source of doses as they scramble to ramp up inoculations ahead of elusive emerging strains...J&J said it has begun shipping the vaccine to the U.S. government, which is managing allocation and distribution. That indicates first doses could be administered during the coming week...READ MORE